NIH, CDC, and FDA Program Descriptions and Research Topics

NIH, CDC, and FDA Program Descriptions and Research Topics 1

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PHS 2024

OMNIBUS SOLICITATION OF THE

NATIONAL INSTITUTES OF HEALTH,

CENTERS FOR DISEASE CONTROL AND PREVENTION, AND

FOOD AND DRUG ADMINISTRATION FOR

SMALL BUSINESS INNOVATION

RESEARCH (SBIR)

AND

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR)

GRANT APPLICATIONS

NIH, CDC, and FDA Program Descriptions and

Research Topics

SUBMISSION DATES

SEPTEMBER 5, 2024, JANUARY 5, 2025, AND

APRIL 5, 2025

National Institutes of Health (SBIR and STTR)

Centers for Disease Control and Prevention (SBIR)

Food and Drug Administration (SBIR)

NIH, CDC, and FDA Program Descriptions and Research Topics 2

Notices of Funding Opportunities, Application Instructions, and Appendices are contained in separate files. Follow the

links below to view these documents.

NOTICES OF FUNDING OPPORTUNITIES

REMINDER: ALL APPLICATIONS MUST BE SUBMITTED IN RESPONSE TO A NOTICE OF

FUNDING OPPORTUNITY THROUGH GRANTS.GOV

PHS 2023-02 OMNIBUS SOLICITATION OF THE NIH, CDC, AND FDA FOR SMALL

BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS (PARENT SBIR

[R43/R44] CLINICAL TRIAL NOT ALLOWED)

PHS 2023-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS

TECHNOLOGY TRANSFER GRANT APPLICATIONS (PARENT STTR [R41/R42]

CLINICAL TRIAL NOT ALLOWED)

PHS 2023-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS INNOVATION

RESEARCH GRANT APPLICATIONS (PARENT SBIR [R43/R44] CLINICAL TRIAL

REQUIRED)

PHS 2023-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS

TECHNOLOGY TRANSFER GRANT APPLICATIONS (PARENT STTR [R41/R42]

CLINICAL TRIAL REQUIRED)

ADDITIONAL SPECIAL ANNOUNCEMENTS FOR SMALL BUSINESS RESEARCH

OPPORTUNITIES

APPLICATION INSTRUCTIONS

SF424 (R&R) APPLICATION INSTRUCTIONS AND ELECTRONIC SUBMISSION

INFORMATION

 
 
 
 
NIH, CDC, and FDA Program Descriptions and Research Topics   3 
 
TABLE OF CONTENTS 
NIH, CDC, AND FDA PROGRAM DESCRIPTIONS AND RESEARCH TOPICS 
PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS ........................................... 5 
NATIONAL INSTITUTES OF HEALTH (NIH)  5 
NATIONAL INSTITUTE ON AGING (NIA)  7 
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)  12 
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)  18 
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES 
(NIAMS)  33 
NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING (NIBIB)  36 
NATIONAL CANCER INSTITUTE (NCI)  42 
EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN 
DEVELOPMENT (NICHD)  47 
NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)  60 
NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS 
(NIDCD)  73 
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR)  76 
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES 
(NIDDK)  84 
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS)  98 
NATIONAL EYE INSTITUTE (NEI)  109 
NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS)  113 
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI)  117 
NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI)  124 
NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)  128 
NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES (NIMHD)  132 
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)  135 
NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)  140 
NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS)  143 
NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH (NCCIH)  149 
NATIONAL LIBRARY OF MEDICINE (NLM)  154 
DIVISION OF PROGRAM COORDINATION, PLANNING, AND STRATEGIC INITIATIVES 
(DPCPSI), OFFICE OF RESEARCH INFRASTRUCTURE PROGRAMS (ORIP)  156 
OFFICE OF RESEARCH ON WOMEN’S HEALTH  161 

NIH, CDC, and FDA Program Descriptions and Research Topics 4

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 164

NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES

(NCBDDD) 167

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION

(NCCDPHP) 168

NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES

(NCEZID) 170

NATIONAL CENTER FOR ENVIRONMENTAL HEALTH (NCEH) 175

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD, AND TB PREVENTION (NCHHSTP)

177

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES (NCIRD) 179

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL (NCIPC) 181

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH) 189

FOOD AND DRUG ADMINISTRATION (FDA) 195

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) 195

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) 196

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) 197

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) 198

CENTER FOR VETERINARY MEDICINE (CVM) 199

OFFICE OF CRITICAL PATH PROGRAMS 200

OFFICE OF ORPHAN PRODUCTS DEVELOPMENT 201

NIH, CDC, and FDA Program Descriptions and Research Topics 5

PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS

The research topics shown in this solicitation represent program areas that may be of interest to small

businesses and fall within the missions of the NIH, CDC, and FDA. Small businesses are encouraged to

submit SBIR and STTR grant applications in these areas. Grant applications will be accepted and

considered in any area within the mission of the awarding components (i.e., Institutes and Centers (ICs))

identified in this solicitation. Information about the HHS SBIR and STTR programs for applicants and

awardees, including resources and programs available to HHS SBIR and STTR awardees, can be found

at https://seed.nih.gov/.

Applicants are strongly encouraged to subscribe to the NIH Guide for Grants and Contracts LISTSERV or

query program administrators periodically via email to learn of new or emerging scientific interests of the

NIH, CDC, and FDA awarding components.

You may also subscribe to the SBIR-STTR LISTSERV to get timely information about the NIH SBIR and

STTR Programs.

Additional information on each of the awarding components (ICs) and their research interests is available

electronically on the home pages shown throughout the “Research Topics” section of the solicitation.

NATIONAL INSTITUTES OF HEALTH (NIH)

NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of

fundamental knowledge about the nature and behavior of living systems and the application of that

knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

The goals of the agency are as follows:

1. to foster fundamental creative discoveries, innovative research strategies, and their applications

as a basis for ultimately protecting and improving health;

2. to develop, maintain, and renew scientific human and physical resources that will assure the

Nation's capability to prevent disease;

3. to expand the knowledge base in medical and associated sciences in order to enhance the

Nation's economic well-being and ensure a continued high return on the public investment in

research; and

4. to exemplify and promote the highest level of scientific integrity, public accountability, and social

responsibility in the conduct of science.

In realizing these goals, the NIH provides leadership and direction to programs designed to improve the

health of the Nation by conducting and supporting research:

in the causes, diagnosis, prevention, and cure of human diseases;

in the processes of human growth and development;

in the biological effects of environmental contaminants;

in the understanding of mental, addictive and physical disorders; and

in directing programs for the collection, dissemination, and exchange of information in medicine and

health, including the development and support of medical libraries and the training of medical

librarians and other health information specialists.

In addition, the NIH sponsors training of research personnel; career development of new and established

scientists; construction and renovation of research facilities and provision of other research resources.

Information about the NIH SBIR and STTR programs for applicants and awardees, including resources

NIH, CDC, and FDA Program Descriptions and Research Topics 6

and programs available to NIH SBIR and STTR awardees, can be found at https://seed.nih.gov/support-

for-small-businesses.

To carry out these responsibilities, the NIH is organized into awarding components (Institutes and

Centers). Those components that have an extramural element, that is, those that provide funds for

research and research training activities in organizations external to the NIH, are shown below. The NIH

makes every effort to finance worthy applications, including the co-funding of such applications by one or

more awarding components having relevance in the projects.

Total funding support (direct costs, indirect costs, fees) normally may not exceed $306,872 for Phase I

awards and $2,045,816 for the duration of the Phase II awards. However, this amount is subject to

change and the most current information can be found on the NIH SEED website. Awards exceeding

these amounts may be made at the discretion of an Institute or Center for applications within one of the

SBA-Approved Waiver Topics. Applicants considering a requested budget greater than these limits are

strongly encouraged to contact program staff before submitting an application.

Funding levels for projects are determined through the combined interaction among peer review, grants

management, program, budget, and other Institute and/or Center staff. These levels are based on

allowable costs that are consistent with the principles of sound cost management and in consideration of

Institute or Center priorities, constraints on the growth of average grant costs, and the availability of

funds.

Before considering and/or preparing an application to the SBIR and STTR programs, all applicants are

strongly encouraged to review the agencies’ and NIH Institutes’ and Centers’ websites and to contact

the SBIR and STTR program coordinators listed below. The Fogarty International Center, which provides

support only for conferences, postdoctoral fellowships for research in the United States and abroad, and

senior scientist exchanges between the United States and other countries, does not participate in the

SBIR and STTR program.

Contact Information

Questions of a general nature about the HHS SBIR and STTR program may be directed to:

SEED (Small business Education and Entrepreneurial Development)

Email: SEEDinfo@nih.gov

For Agency, Institute and Center Scientific/Research (Program) and Financial/Grants Management

contacts, please see the contact page

NIH, CDC, and FDA Program Descriptions and Research Topics

NIA 7

NATIONAL INSTITUTE ON AGING (NIA)

Mission

NIA’s mission is to:

•

Support and conduct genetic, biological, clinical, behavioral, social, and economic

research on aging.

•

Foster the development of research and clinician-scientists in aging.

•

Provide research resources.

•

Disseminate information about aging and advances in research to the public, health

care professionals, and the scientific community, among a variety of audiences.

Strategic Directions for Research

https://www.nia.nih.gov/about/aging-strategic-directions-research

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website, unless the application fits an

SBA-approved NIA waiver topic. For topics listed in the SBA-Approved Waiver Topics, the NIA

generally will not fund Phase I applications to the Omnibus greater than $400,000 total costs or

project periods greater than 2 years; or Phase II applications greater than $2,250,000 total costs or

project periods greater than 3 years.

However, if your application is AD/ADRD focused, you may come in at $500,000 for Phase I and

$2,500,000 for Phase II (total costs). For budgetary, administrative, or programmatic reasons, the

NIA may not fund an application or may decrease the length of an award and/or the budget

recommended by a review committee.

Specific SBIR and STTR Program Information

The NIA SBIR-STTR Programs support research and product development focusing on aging and

aging- related conditions and diseases, as well as other problems and needs unique to older

Americans. NIA supports SBIR and STTR research and product development under four divisions:

Behavioral and Social Research, Biology of Aging (Aging Biology), Geriatrics and Clinical

Gerontology, and Neuroscience.

The NIA will consider any application relevant to the NIA’s mission, even if it does not

directly address one of the topics below. For additional information about NIA’s SBIR and

STTR programs please visit: https://www.nia.nih.gov/research/osbr

Specific Funding Opportunities and Programs

In addition to this Omnibus program announcement, the NIA releases targeted Notices of Funding

Opportunities (NOFOs) throughout the year. These NOFOs are listed to inform potential applicants

about other funding opportunities to which they can apply; applications submitted in response to

this Omnibus program announcement are not limited to research and development areas described

in the following targeted NOFOs. NOFOs may specify specific budget caps that are above the caps

listed for Omnibus applications. Applicants are encouraged to visit the following webpage for an up

to date list of NIA SBIR/STTR funding opportunities: https://www.nia.nih.gov/research/nia-small-

business-funding- opportunities.

For projects that aim to address Alzheimer’s Disease and Related Dementias, applicants are

encouraged to consider the following funding opportunities which allows Phase I budgets up to

$500,000 and Phase II budgets up to $2.5M (for topics covered by the approved waiver from SBA):

NIH, CDC, and FDA Program Descriptions and Research Topics

NIA 8

•

Advanced Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related

Dementias (ADRD) (R43/R44 Clinical Trial Optional): Accepts Phase I, Phase II, Direct-

to-Phase II and fast- track applications. Details can be found

herehttps://grants.nih.gov/grants/guide/pa-files/pas-22- 196.html

•

Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related

Dementias (ADRD) (R41/R42 Clinical Trial Optional): Accepts Phase I, Phase II, and fast-

track applications. Details can be found here: https://grants.nih.gov/grants/guide/pa-

files/PAS-22-197.html

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIA welcomes submission of Phase IIB Competing Renewal grant applications from Phase II

SBIR/STTR awardees to continue the process of developing a wide range of aging-focused products,

including digital- mobile/cyber-health technology, pharmaceutical compounds, and medical devices.

The Phase IIB Competing Renewal award is intended to allow small businesses the opportunity to

realize further progress in commercialization, including stimulating interest in and investment by third

parties. NIA will generally not fund Phase IIBs greater than $3M total costs.

Prospective Phase IIB Competing Renewal applicants are strongly encouraged to contact NIA’s SBIR-

STTR program contact prior to consideration and preparation of a Phase IIB application and well in

advance of the SBIR-STTR submission due dates.

NIA also welcomes the submission of CRP applications to the 2 CRP NOFOs (and subsequent reissued

NOFOs):

• SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and

Late Stage Development - Clinical Trial Not Allowed (PAR-23-219)

• SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and

Late Stage Development - Clinical Trial Required (PAR-23-220)

Clinical Trials

Does NIA accept Clinical Trials through

the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NIA accept Clinical Trials through

specific Notices of Funding Opportunities?

Yes

•

Advancing Research on Alzheimer's Disease

(AD) and Alzheimer's-Disease-Related

Dementias (ADRD) (R41/R42 Clinical Trial

Optional) (PAS-22-197) )

•

Advancing Research on Alzheimer's Disease

(AD) and Alzheimer's-Disease-Related

Dementias (ADRD) (R43/R44 Clinical Trial

Optional) (PAS-22-196) )

NIH, CDC, and FDA Program Descriptions and Research Topics

NIA 9

Does NIA support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

NOFOs include but are not limited to:

•

Alzheimer's Drug-Development Program

(U01 Clinical Trial Optional) (PAR-22-047)

•

Blueprint Neurotherapeutics Network (BPN):

Biologic-based Drug Discovery and

Development for Disorders of the Nervous

System (UG3/UH3 Clinical Trial Optional)

(PAR-21-163)

•

Early and Late Stage Clinical Trials for the

Spectrum of Alzheimer’s

Disease/Alzheimer’s Related Dementias

and Age-Related Cognitive Decline (R01

Clinical Trial Optional) (PAR-23-081)

•

Pilot Studies for the Spectrum of

Alzheimer’s Disease/Alzheimer’s Disease-

Related Dementias and Age-Related

Cognitive Decline (R61 Clinical Trial

Optional) (PAR-23-083

• Seamless Early-Stage Clinical Drug

Development (Phase 1 to 2a) for Novel

therapeutic Agents for the Spectrum of

Alzheimer's Disease (AD) and AD-related

Dementias (ADRD) (UG3/UH3 Clinical Trial

Required) (PAR 23 274)

• Alzheimer's Clinical Trials Consortium

(ACTC) Clinical Trials (R01 Clinical Trial

Required) (PAR 20 309)

Research Topics

The NIA will consider any application relevant to the NIA’s mission, even if it does not directly

address one of the topics below. The below topics provide an overview of interest areas for both

non-clinical trial and clinical trial applications.

Alzheimer’s Disease (AD), AD-Related Dementias (ADRD), and Age-Related

Change in Brain Function. Research and development of novel interventions to

ameliorate AD/ADRD; improve AD/ADRD care; or further the understanding of the

etiology of AD/ADRD, neurodegeneration, brain connectivity, neuroplasticity, or

brain-– behavior relationships. This includes drug and non-drug interventions for

age-related cognitive decline, delirium, sleep disorders, or other central nervous

system dysfunctions, including dysfunctions of the motor, emotional, sensory, and

neuroimmune systems. This also includes novel biomarkers of neural stem cell

functions and new technologies or imaging devices that improve or study brain

connectivity; metabolism; sleep; or cognitive, motor, emotional, or sensory activity.

For projects addressing AD/ADRD, you may want to consider applying to PAS-

22-196 (SBIR) and PAS-22-197 (STTR), which have higher budget limits.

Aging in Place of Choice. Research and development of social, behavioral, and

environmental interventions that promote independence and aging in place by

addressing the unique needs of older adults, their healthcare providers, and

caregivers. This includes prosthetics, assistive devices and robotics, digital

technologies and software, and technology to mitigate age-related physical and

behavioral health challenges or toimprove healthcare delivery, care coordination,

NIH, CDC, and FDA Program Descriptions and Research Topics

NIA 10

and disease management.

Age-Related Diseases and Conditions. Research and development of new

diagnostic tools and methods, biomarkers, therapeutics, imaging devices, and

technologies to monitor, diagnose, predict, prevent, treat, and further the

understanding of the molecular mechanisms of aging or age-related diseases and

conditions.

Research Tools. Development and validation of innovative tools, resources, or

methodologies that promote the efficient, cost-effective, and high-quality

collection, analysis, or interpretation of aging-related quantitative or qualitative

data. This includes bioinformatics tools; screening platforms; surveying,

sampling, and behavioral/behavioral economics methods; and clinical

instruments to enhance the study of aging, cellular resiliencies, and aging-

related diseases.

Special Areas of Interest

Areas of particular interest related to aging biology, aging-related diseases and conditions,

behavioral health, and AD/ADRD include, but are not limited to the following:

Companion diagnostics and other forms of personalized medicine.

Bioinformatics, public health informatics, or data science

technologies/methods (e.g., machine learning, artificial intelligence) to

better understand aging biology and/or predict health outcomes.

Novel cell and gene therapies, as well as other novel therapeutic approaches to AD/ADRD.

Biomarkers and diagnostic tools for the early detection of disease.

Prevention and therapeutics that directly target mechanisms related to aging biology.

Assistive technology, devices, and mobile applications for older adults and caregivers.

Tools, technologies, and analytic methods to address health disparities among

older adults and/or biological determinants of health disparities.

Contact Information

For more information on research topics and questions about potential NIA SBIR/STTR grant

applications and NIA’s participation in the Phase IIB or CRP programs, please contact:

Program Contacts, NIA Small Business R & D Programs:

Michael-David (“M-D”) A.R.R.Kerns, M.M., M.S., Ph.D.

National Institute on Aging (NIA)

Email: niasmallbusiness@mail.nih.gov

Bio:

https://www.nia.nih.gov/about/staff/kerns-michael-david

Rajesh Kumar, Ph.D.

National Institute on Aging (NIA) Email:

niasmallbusiness@mail.nih.gov

If there are specific questions pertaining to the interests or activities of the NIA scientific divisions, contact:

NIH, CDC, and FDA Program Descriptions and Research Topics

NIA 11

Division of Aging Biology:

Leonid Tsap, Ph.D.

National Institute on Aging (NIA)

Email: Leonid.Tsap@nih.gov

Bio: https://www.nia.nih.gov/about/staff/tsap-leonid

Division of Behavioral and Social Research:

Dinesh John, Ph.D.

National Institute on Aging (NIA)

Email: dinesh.john@nih.gov

Bio:

https://www.nia.nih.gov/about/staff/john-dinesh

Division of Geriatrics and Clinical Gerontology:

Lyndon Joseph, Ph.D.

National Institute on Aging (NIA)

Telephone: 301-496-6761

Email: lyndon.joseph@nih.gov

Bio:

https://www.nia.nih.gov/about/staff/joseph-lyndon

Division of Neuroscience:

Zane Martin, Ph.D.

National Institute on Aging (NIA)

Email:zane.martin@nih.gov

Bio: https://www.nia.nih.gov/about/staff/martin-jones-zane

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 12

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)

Mission

NIAAA supports research on the causes, prevention, control, and treatment of the major health

problems associated with alcohol misuse. NIAAA supports research on the causes, prevention,

control, and treatment of the major health problems associated with alcohol misuse. Through its

extramural research programs, NIAAA funds a wide range of basic and applied research to

develop new and/or improved technologies and approaches for increasing the effectiveness of

diagnosis, treatment, and prevention of Alcohol Use Disorder (AUD) and alcohol-related health

complications. NIAAA also desires to strengthen research dissemination, scientific

communications, public education, and data collection activities in the areas of its research

priorities.

Studies that examine racial, ethnic, and gender minorities as well as other underserved populations that

experience more negative alcohol-related consequences of illness and premature death than the general

population are highly encouraged and sought.

Budget Guidance

NIAAA will make awards compliant with all statutory guidelines as outlined above. Total funding

support (direct costs, indirect costs, fees) normally may not exceed the amounts defined by the

Small Business Administration (SBA), which can be found on the NIH SEED website. With the

exception of the topics indicated therein, NIAAA will generally not fund Phase I applications to the

Omnibus greater than $385K or Phase II awards over $3M total costs even if topics are listed

under the SBA-Approved Waiver Topics. Applicants considering a requested budget greater than

the standard limits are strongly encouraged to contact the NIAAA SBIR/STTR Program Director

before submitting an application. For budgetary, administrative, or programmatic reasons, NIAAA

may decrease the length of an award and/or the budget recommended by a review committee, or

not fund an application.

Specific Funding Opportunities and Programs

In addition to the Omnibus program announcement, NIAAA has targeted Notices of Funding

Opportunities (NOFOs). Please visit our NIAAA SBIR/STTR program webpage to view the latest

targeted NOFOs.

NIAAA Phase I grantees may consider applying for the I-Corps at NIH pilot program (PA-22-073).

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIAAA will accept SBIR/STTR Phase IIB Competing Renewal grant applications from Phase

II SBIR/STTR awardees to continue the process of developing products that require approval

of a Federal regulatory agency (e.g., FDA, FCC). Such products include, but are not limited to,

medical implants, drugs, vaccines, biologicals, and new treatment or diagnostic tools that

require FDA approval. This renewal grant should allow small businesses to get to a stage

where interest and investment by third parties is more likely. To be eligible for Phase IIB

consideration, the project must retain high significance in the light of current market

conditions.

Prospective applicants are strongly encouraged to contact NIH staff well in advance of

submitting a Phase IIB Competing Renewal application by submitting to

niaaasbirsttr@mail.nih.gov a letter of intent that includes the following information:

•

Name, address, and telephone number of the Principal Investigator

•

Names of other key personnel

•

Participating institutions

•

Grant number and title

•

Progress of the Phase II award

•

Goals and justification for the Phase IIB request

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 13

It is expected that only a portion of NIAAA SBIR/STTR Phase II awards will be eligible for a Phase IIB

Competing Renewal grant.

NIAAA will accept submission of CRP applications to the following NOFOs (and reissues):

•

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance

and Late-Stage Development - Clinical Trial Not Allowed (PAR-23-219)

•

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance

and Late-Stage Development - Clinical Trial Required (PAR-23-220)

Clinical Trials

Does NIAAA accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NIAAA accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

https://www.niaaa.nih.gov/research/niaaa-

sbir/funding-opportunities

Does NIAAA support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

https://niaaa.nih.gov/grant-funding/funding-

opportunities

Research Topics

The topics listed below reflect examples of NIAAA’s program priorities at the time of the NIH Omnibus

solicitation and should not be considered all-inclusive. NIAAA will consider ALL applications relevant to

NIAAA’s mission. The topics below include areas of interest for both pre- clinical and clinical research.

BASIC SCIENCE

Through basic scientific research, great strides have been made in understanding the mechanisms by

which alcohol exerts its effects on human health and behavior. New tools, techniques, paradigms, and

technology are needed to enable researchers to further understand the underlying biological and

behavioral mechanisms through which conditions associated with AUD develop.

Research Tools/Technologies/Devices

Induced pluripotent stem cells (iPS), including disease specific cell lines and gene-edited

models (e.g., alcohol-related organ damage and disease with human iPS cell-derived

organoids) and from adult-derived human iPSCs cells representing genetic variations in

alcohol metabolism (e.g., alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH),

cytochrome P450 isozyme CYP2E1, and glutathione S-transferase (GST)) or models of

normal development and alterations by prenatal alcohol exposure, and embryonic stem cell

models of development and effects of alcohol exposure.

Novel technologies to measure and interpret non-coding RNA (ncRNA) gene

expression, following alcohol exposure, in the brain at the cellular level or in

non-animal research models.

Using single-cell transcriptomics and multiomics technologies and sequencing to reveal

the molecular fingerprint of cell states and their predicted signaling circuits in tissues

across development and AUD.

Tools to detect dynamic and concurrent changes of neurotransmitters and neuromodulators

in the brain of behaving animals.

Tools to detect the effects of alcohol on the central nervous system (CNS) structure and activity.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 14

Novel animal models, including transgenic animals.

Hepatocyte cell line capable of maintaining viability and metabolic functions in culture systems

for an indefinite period.

Experimental systems that mimic organ function.

New methods of ethanol administration to animals that produce precise dose control

or that closely mimic types of alcohol exposure occurring in humans.

10.

New ligands that will enhance the potential usefulness of PET and SPECT

neuroimaging technologies for the study of the etiology of AUD and related

brain pathology.

11.

Humanized animal models to study AUD in different organ systems.

12.

Methods to detect epigenetic changes as disease drivers due to metabolic reprogramming by

alcohol.

13.

Tools to determine the prevalence of alcohol associated organ diseases:

alcoholic cardiomyopathy, sarcopenia, pancreatitis, pulmonary, immune

and bone diseases.

14.

Optoelectronics probes and devices used to manipulate nerve cell activity in awake

animals to better study nerve cell function in the body’s periphery.

15.

Generate organoids from iPSCs that specifically model sleep-regulating brain regions

affected by alcohol, providing a platform for studying alcohol's neurobiological impacts on

sleep at the organ level.

PREVENTION/TREATMENT/RECOVERY

Prevention strategies/programs and educational services, behavioral treatment programs, medications,

and digital health technologies are crucial in ameliorating the negative health effects and consequences

associated with AUD and alcohol misuse and recovery.

Medications Development

Preclinical and/or clinical development of therapeutics for AUD and alcohol-related

complications (e.g., craving, sleep problems, withdrawal symptoms, and negative

affect).

Early therapeutic discovery activities (e.g., target ID, lead compound target validation).

Investigational New Drug (IND)-enabling studies.

Extended formulations or reformulations of existing medications that improve

efficacy or compliance.

Therapeutics for individuals with co-occurring health conditions, such as post-traumatic

stress disorder (PTSD), HIV, alcoholic hepatitis, liver fibrosis, cirrhosis, pancreatitis,

cardiomyopathy, or other alcohol-induced tissue damage.

Development of precision medicine tools (e.g., biomarker panel) to predict

treatment outcomes among AUD patients.

Programs or Therapies to Prevent or Treat AUD and/or the Consequences of Alcohol Misuse,

Hazardous Drinking, and AUD Across the Lifespan

Novel behavioral health or educational programs aimed at preventing or treating AUD

or associated consequences of AUD, alcohol misuse, or hazardous drinking across

the life span.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 15

Prevention or treatment programs tailored specifically to the needs of the following groups:

children of individuals with AUD, women, racial and ethnic underrepresented populations,

sexual and gender minority populations, individuals with Fetal Alcohol Spectrum Disorders

(FASD) across the lifespan, persons with disabilities, adolescents/young adults, the elderly,

individuals in rural settings, individuals with psychiatric comorbidities (e.g., PTSD, major

depressive disorder, etc.).

Computerized versions of empirically supported prevention or treatment programs,

including but not limited to in languages other than English.

Prevention curricula, videos, multi-media programs, and training materials for

use with adolescents and other population groups and in the NIAAA priority

areas.

Therapeutic, skill-building, and educational program products that enhance

behavioral, neurocognitive, social, adaptive, and motor function to improve

the overall well-being of individuals with FASD and their families.

Therapies to mitigate alcohol-associated adverse impact on the development of liver

and/or lung diseases.

Strategies and methods to increase awareness and salience among high-risk groups of

the tragic consequences of driving after drinking.

Therapies or programs specifically focused on sustaining mid- and long-term recovery from AUD.

Digital Health Tools (mHealth, health IT, wearable devices, telehealth, telemedicine, and

personalized medicine)

Wearable Alcohol Biosensor - minimally invasive, near real-time detection, remote

monitoring, infrared or other non-sweat based technology preferred.

Validation of promising technologies, biosensors, and research tools.

Development of precision medicine tools to predict an individual’s risk for developing AUD

and/or quantify progression to an AUD diagnosis.

Tools to improve the prevention or treatment of AUD and alcohol-related problems.

Applications that facilitate long-term recovery support and improve continued

engagement in recovery support services.

Tools to improve the identification and diagnosis of FASD and prenatal alcohol exposure.

Applications or tools to improve medication safety (e.g., multiple medications,

interactions with alcohol).

Mobile device applications or other health technologies to improve the effectiveness,

accessibility, and use of behavioral interventions for AUD and co-occurring disorders,

including HIV.

Solutions or applications to improve minority health and health disparities with

capabilities of reaching persons in rural, remote, and under-resourced/under-served

communities.

10.

Virtual reality (VR) technology to create immersive environments that simulate real-

world scenarios involving alcohol consumption and its effects on behavior and sleep,

for understanding environmental and social factors in AUD.

11.

Non-invasive, wearable devices capable of monitoring physiological and biochemical

markers of alcohol intake and its impact on sleep patterns in real-time, utilizing

technologies like bioimpedance.

12.

App-based digital platforms that offer personalized cognitive-behavioral therapy for

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 16

insomnia (CBT-I) and other sleep improvement techniques for individuals with AUD,

integrating wearable sleep data.

DIAGNOSTICS

Improving the current battery or developing new approaches to measurement, diagnosis, and

assessment of the severity of AUD, alcohol misuse and health consequences, FASD, and alcohol-

related organ damage.

Imaging Examination Technologies for Early and Precise Diagnosis of Alcohol-Related Organ

Damage

Biomarkers for AUD and alcohol-related health effects

Detection (e.g., biochemical, unbiased assay) of alcohol intake for extended period

(e.g., 2 weeks, 2 months) after drinking episode.

Signatures of alcohol-induced organ damage and familial risk.

Reduction of time to results for current assays (e.g., phosphatidylethanol (Peth),

ethyl glucuronide (EtG)).

Increase accuracy of alcohol intake detection by developing a novel combination

of biomarkers (e.g., PEth, EtG)).

Improve assay methodologies for established biomarkers of alcohol consumption considering

cost, timeliness, and accessibility in a range of clinical settings.

Point of care devices, for use in rural or remote primary care and hospital settings.

Validation of promising biomarkers that can be used to improve clinical

research and practice (for example, diagnosis, prognosis, and treatment

response) for alcohol related health conditions, including AUD, FASD, and

alcohol associated organ injury.

Tools or kits to measure aristolochic acid (AA)-adducts and advanced glycation end

products (AGEs) in serum, cerebral spinal fluid, and brain and other organs impacted by

AUD in animal models and pre-clinical settings including their relationship to the

biomarkers of neuro- inflammation.

Tools to detect alcohol-induced damage in those patients with HIV infection or co-infection.

10.

Measurement and integration of ‘omics data for AUD and alcohol-related organ damage.

DATA SCIENCE

Software and tools can be used for discovery of new biomarkers and targets, precision medicine, and

other applications to increase the efficiency and efficacy of treating AUD and alcohol-related health

effects.

Data Science Tools

Algorithms for integrative analysis incorporating multiple current NIAAA supported (current

and legacy), government, and public datasets, including machine learning, deep learning,

artificial intelligence, data mining and other model based and model-free approaches.

Software applications for data interfaces for aggregation, imputation, harmonization,

or visualization of data from multiple sources, including current and future NIH data

systems.

Algorithms and/or software tools for improving data collection, i.e., smart phone

apps, extraction of specific alcohol research parameters from existing large

databases and established public health studies, biological sensors or wearable

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAAA 17

devices.

Computational and/or systems biology models of alcohol exposure, tolerance, and resilience.

Computational, statistical or bioinformatics tools to organize and manage high

throughput data obtained by genomic, functional genomic, or other ‘omic strategies.

Computational tools to combine multiple data modalities (e.g., omics, imaging).

Application of machine learning and artificial intelligence, including large language

models, in alcohol research, including ethics and privacy concerns.

Translation of ‘omics’ data into clinically relevant predictions and outcomes for AUD

and alcohol- related organ damage.

Contact Information

Megan Ryan, M.B.A.

NIAAA SBIR/STTR Program Director

National Institute on Alcohol Abuse and Alcoholism

6700B Rockledge Dr.

Rockville, MD 20852-1705

Phone: 301-827-6166

Email: mryan1@nih.gov

For general inquiries: NIAAASBIRSTTR@mail.nih.gov

For administrative and business management questions,

contact:

Jeff Thurston

SBIR/STTR Grants Management Lead

National Institute on Alcohol Abuse and Alcoholism

Phone: 301-443-9801

Email: jeffrey.thurston@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 18

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

Mission

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately

prevent infectious, immunologic, and allergic diseases. Read more about the NIAID Mission at our

website.

Budget Guidance

Total funding support (direct costs, indirect costs, fee) normally may not exceed the dollar amounts

specified by the SBA, which can be found on the NIH SEED website. Budget requests at or near

these hard caps should be well justified. Phase II/IIB applicants should note that NIAID will not

generally allow awards (of any duration) that exceed $1,000,000 total costs per year.

NIH has received a waiver from SBA, as authorized by statute, to exceed total award amount hard

caps for specific topics. The current list of approved NIAID topics is included in the SBA-Approved

Waiver Topics. Topics that align with NIAID’s priority research areas are listed for each Division; any

listed NIAID topic is sufficient to consider budget requests that exceed the hard caps. Budget

requests exceeding the hard caps must be very well justified in the “Budget Justification” attachment

to the Research and Related Budget form and be clearly consistent with the scope of the proposal.

For proposals that address an approved topic, NIAID will allow Phase I applications with budgets of up to

$300,000 total costs per year for up to 2 years; and Phase II or Phase IIB applications with budgets of up to

$1,000,000 total costs per year for up to 3 years. Requests for these budget levels must be very

well- justified. In all cases, applicants should propose a budget that is reasonable and appropriate for

completion of the research project.

NIAID staff cannot provide prior approval to exceed hard caps. Compliance with a pre-approved topic will

be confirmed at time of award by the applicant’s Grants Management Specialist and Program Officer.

NIAID will consider well justified Technical and Business Assistance (TABA) costs up to the limits

specified on the NIH SEED Website. These costs can be requested in addition to the Phase I and II

limits indicated above.

NIAID will generally not make SBIR or STTR awards with budgets that exceed these guidelines.

For budgetary, administrative, or programmatic reasons, NIAID may decide not to fund an

application or may decrease the length of an award and/or the budget recommended by a review

committee.

Specific SBIR and STTR Program Information

NIAID's Division of AIDS (DAIDS), Division of Allergy, Immunology, and Transplantation (DAIT), and

Division of Microbiology and Infectious Diseases (DMID) encourage SBIR/STTR applications related

to their mission and activities as described below. Questions regarding specific research areas may

be addressed to the NIAID Program Officials listed below. General questions about the NIAID SBIR

and STTR programs or administrative and business management concerns may be directed to the

NIAID Small Business Program Team.

When possible, applicants are encouraged to use email for communication.

For information about NIAID's Small Business Programs, please visit our website.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 19

Specific Funding Opportunities and Programs

Targeted Funding Opportunities and Notices of Special of Interest can be reviewed on the NIAID

website. However, NIAID welcomes all Phase I and II proposals (except clinical trials) for research

that is consistent with our Mission through the SBIR and STTR Omnibus Solicitations [Clinical Trial

Not Allowed].

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIAID welcomes Phase IIB Competing Renewal Applications (SBIR only) for Phase II grants

and contracts via the Omnibus Solicitation for SBIR Grant Applications, and as indicated by

other NIAID Notices of Funding Opportunities (NOFOs). Standard NIAID Phase II funding policy

applies unless otherwise stated in the NOFO. STTR Phase II awardees may apply but must

switch programs to SBIR. Non-NIAID Phase II awardees must contact NIAID prior to submission

to confirm programmatic interest.

NIAID welcomes CRP applications from eligible NIAID Phase II/IB awardees through PAR-20-129 (and

subsequent reissued NOFOs) Please review this Notice of Funding Opportunity for details.

Clinical Trials

Does NIAID accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Does NIAID accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

NIAID SBIR Phase II Clinical Trial

Implementation Cooperative Agreement (U44):

https://grants.nih.gov/grants/guide/pa-files/PAR-

21-082.html (and subsequent reissued NOFOs)

Does NIAID support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

NIAID Clinical Trial Implementation Cooperative

Agreement (U01):

https://grants.nih.gov/grants/guide/pa-files/PAR-

21-083.html (and subsequent reissued NOFOs)

NIH Research Project Grant (Parent R01

Clinical Trial Required):

https://grants.nih.gov/grants/guide/pa-files/PA-

20-183.html (low risk clinical trial proposals,

only)

NIAID will generally consider clinical trial proposals consistent with the research topics listed

below. However, applicants are strongly encouraged to consult with NIAID Program Staff at least

10 weeks before the receipt date.

For further information, please consult NIAID’s Investigator-Initiated Clinical Trial Resources page:

https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources

Research Topics

Division of AIDS (DAIDS)

The Division of AIDS (DAIDS) supports a global research portfolio to advance biological knowledge

of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an

“AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical

research needed to: 1) Reduce HIV incidence through the development of effective biomedical

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 20

prevention strategies, including vaccines that are safe and desirable, 2) Develop novel approaches

for the treatment and cure of HIV infection, 3) Develop interventions to treat and/or prevent co-

infections and co-morbidities of greatest significance, and 4) Engage scientific and community

stakeholders to equitably implement effective interventions.

Basic Sciences Program

Supports basic and applied research on the causes, diagnosis, treatment, and prevention of HIV and AIDS.

Epidemiology Branch. Population-based research, modeling, and comparative

effectiveness studies (not including clinical trials) that assess the natural history, biologic,

and clinical course of HIV/AIDS, and related outcomes, and could advance treatment

and prevention of HIV. Specific interests include phylodynamics and other factors related

to HIV transmission and associated biological and behavioral factors, basic research on

immunology, virology, and antiretroviral therapy, issues surrounding care for HIV and

other co-morbidities, interactions and impact on clinical outcomes. Development of novel

electronic tools, including devices and computer programs to enhance behaviors, such

as treatment adherence or uptake of treatment guidelines, is also of interest.

Pathogenesis & Basic Research Branch. Innovative technologies for at-home self-

testing to directly detect HIV during the earliest stages of acute infection (before antibody

response) or to detect viral rebound following long-term suppression of viremia.

Identification and validation of new targets for discovery or design of strategies to prevent

HIV transmission, inhibit replication, control viremia in the absence of antiretroviral drugs,

or eradicate reservoirs of HIV that persist despite long-term antiretroviral therapy.

Innovative approaches for predicting post-treatment immunologic control of viral rebound

or for monitoring changes in the size of the rebound- competent HIV reservoir.

Determination of atomic structures relevant to HIV prevention, treatment, or cure.

Targeted Interventions Branch. Discovery and development of small molecule inhibitors

with novel or underexplored mechanisms of action using standard and high-throughput

technologies; cell-based and gene therapies; RNA-based therapeutics; next-generation

biologics; novel targeting and delivery vehicles for agents active against HIV; therapeutic

vaccines and monoclonal antibodies; protein chemistry-based anti-HIV approaches;

assays to quantitate latent virus; animal models to facilitate evaluation of agents to treat or

cure HIV infection.

Vaccine Research Program

Supports the discovery, development and clinical evaluation of an HIV/AIDS vaccine.

Vaccine Clinical Research Branch. Research areas: (1) phase I, II, and III domestic and

international clinical trials of candidate AIDS and TB vaccines and anti-HIV antibodies; (2)

evaluation and characterization of immune responses, virologic markers, and improved

diagnostic approaches in HIV-infected and uninfected immunized volunteers, and (3)

technologies and methods to improve clinical efficacy or reduce the burden of vaccine or

monoclonal antibody administration.

Preclinical Research and Development Branch. Preclinical research to assess and

overcome specific biomedical obstacles in HIV vaccine discovery, especially by application of

innovative technologies, and/or by the development and supply of novel reagents/resources

useful for advancing original vaccine platforms including monoclonal antibody discovery and

development for prevention of HIV infection.

Vaccine Translational Research Branch. VTRB enables research by advancing innovative

vaccine concepts and scalable unit operations into the development of cGMP manufactured

products. VTRB’s efforts to accelerate the development of preventive HIV-1 vaccines involves

identifying, supporting and advancing: (a) cell line development to increase Env expression,

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 21

production, quality, and yield; (b) evaluation of phase-appropriate upstream and downstream

manufacturing processes;(c) scalable and prototype process development and purification

platforms; (d) cGMP manufacturing of broad portfolio of vaccine products ranging from complex

HIV Env protein immunogens, nanoparticle-based vaccines, viral vectors, virus-like particles

(VLP), nucleic acid-based vaccines (DNA and mRNA), monoclonal antibodies for testing in

early phase human clinical trials; (e) manufacturing new and/or alternative adjuvant analogs

with similar agonist functions as those currently available for optimal immune response; (f)

novel and emerging nanoparticle antigen and adjuvant delivery modalities and dosage forms,

coformulation technologies and platforms for immunization; (g) antigen-adjuvant formulation

development, analytics development to support product characterization, in-process

operations, release, and stability testing; and (h) preclinical safety, immunogenicity, and

toxicology testing.

Therapeutics Research Program

Develops and oversees research and development of therapies for HIV disease, including

complications, co-infections and co-morbidities, in adults.

A. Drug Development and Preclinical Research Branch. Basic, preclinical, and translational

research for development of new therapies for HIV and HIV-associated co-infections, including

Mycobacterium tuberculosis and viral hepatitis; development of safer, more efficacious antiviral,

antimicrobial, and immune-based therapies, and combinations thereof, including long-acting/extended-

release approaches; target identification and validation for HIV-related co-infections and assay

development for screening potential therapeutics; preclinical research to elucidate the biology of HIV-

related co-infections, including pathogenesis, immune protection and control, and persistence and

latency; maintenance of a database of potential anti-infectives for HIV and HIV-related coinfections.

B. Laboratory and Clinical Sciences Branch. Research focused on biomarker discovery/validation

and assay development for diagnostics, including development and evaluation of practical and affordable

tests to measure viral load, drug toxicities, and drug resistance for clinical use; development and testing

of new or improved methodologies for diagnosing, monitoring, and following patients under treatment,

including tests to detect early infection in seropositive HIV-infected adult and pediatric individuals in poor

resource settings; clinical development of laboratory assays; clinical immunology, virology, and

pharmacology related to the design and conduct of clinical trials; management of quality assurance

contracts for oversight of the quality of clinical laboratory testing in support of clinical trials.

C. HIV Research Branch. Clinical research in adults to evaluate chemotherapeutic and immune-

based interventions to treat acute and chronic HIV infection and approaches to achieve sustained

remission or cure; strategies to augment HIV-specific immune responses and general host immunity to

control or clear HIV infection.

D. Complications & Co-Infections Research Branch. Clinical research in adults to evaluate new

or improved therapies and related strategies for the treatment and/or prevention of HIV-related co-

infections (exclusive of Mycobacterium tuberculosis) and non-infectious co-morbidities, including Immune

Reconstitution Inflammatory Syndrome (IRIS), in people living with HIV.

E. Tuberculosis Clinical Research Branch. Clinical research in adults to evaluate therapeutics,

therapeutic vaccines and strategies to prevent disease recurrence for tuberculosis in people living with

HIV, including those with additional medical conditions that may affect disease outcomes; clinical trials

with a primary objective to elucidate the pathophysiology and immunopathogenesis of HIV/TB co-infection

including the study of co-infection interactions and changes in the course, pathology, treatment

responses, and outcome of either infection.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 22

Prevention Science Program

Develops and oversees research and development of 1) non-vaccine biomedical HIV prevention

strategies in adolescents and adults, and 2) therapies for cure, management, treatment and prevention of

HIV and HIV-associated complications in pregnant women, infants, children, and adolescents, including

pediatric-friendly formulations. Supports domestic and international phase I, II, and III clinical trials to

evaluate these prevention or therapeutic strategies in relevant populations.

Preclinical Microbicides and Prevention Research Branch. Development of non-

vaccine biomedical HIV prevention products including topical microbicides, pre-

exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and multipurpose

prevention technologies (MPT). Emphasis on drug delivery systems (DDS) designed

to achieve systemic protection for ≥ 3 months. Development of shorter-duration

products (i.e., minimum of 7 days to <3 months), which address a compelling specific

public health need. Key populations are adolescents, cisgender women, men who

have sex with men (MSM), and transgender people.

Clinical Prevention Research Branch. Development of safe and effective non-

vaccine biomedical and integrated HIV prevention interventions to reduce the

number of new HIV infections in adults and adolescents. Support the development

of HIV incidence assays, biomarkers of adherence, mathematical modeling, and

other tools needed to accomplish these objectives. Clinical development of topical

microbicides to prevent HIV infection with the goal to advance safe, effective, and

acceptable microbicide products toward licensure.

Maternal, Adolescent and Pediatric Medicine Branch. Therapies for cure,

management, treatment and prevention of HIV and HIV-associated complications

including TB, in pregnant women, infants, children, and adolescents, including

development of pediatric-friendly formulations. Strategies to reduce transmission of

HIV and HIV co-infections from mother to child.

Division of Allergy, Immunology, and Transplantation (DAIT)

The Division of Allergy, Immunology, and Transplantation (DAIT) supports studies of the immune

system in health and the cause, pathogenesis, diagnosis, prevention, and treatment of disease

caused by immune dysfunction.

Allergy, Asthma and Airway Biology Branch. Conditions of interest: asthma, food

allergy, eosinophilic esophagitis and gastroenteritis in relation to food allergy, atopic

dermatitis, urticaria, rhinitis, rhinosinusitis, drug allergy, sepsis. The Branch supports basic

and clinical studies investigating mechanisms of disease and new approaches to diagnose,

treat or prevent these conditions. Special interest for SBIR/STTR includes a) the

development of biomarkers as diagnostic markers, markers of disease severity and

predictive markers for treatment effectiveness, particularly of immunologic interventions such

as allergen immunotherapy for food and respiratory allergy; b) the development of new

forms of allergen immunotherapy aiming at increased tolerogenic immune responses and

decreased allergenicity.

Basic Immunology Branch. The Branch supports basic and clinical research in the

following areas: adjuvant discovery and development; origin, maturation, and interactions of

immune cells; immune cell receptors, and ligands; cytokine biology; molecular basis of

immune activation, antigen recognition, and immune tolerance; immune response

regulation; hematopoiesis and stem cell biology; computational immunology; immunologic

mechanisms associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome;

assessment and analysis of vaccine effectiveness in neonates, pregnant women, and

adults, and basic immunology of vaccines and immunotherapeutics as medical

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 23

countermeasures for biodefense. Special interests for SBIR/STTRs include: adjuvant

discovery , development, production of biosimilars, and/or head-to-head comparisons;

bioinformatics tools for immune epitope predictions/visualization, and/or for the analysis of

multi-parameter or systems immunology data; development and validation of immunologic

reagents for analysis of immunity in non-mammalian (e.g., Xenopus laevis, zebrafish, C.

elegans) and under-represented mammalian (e.g., pig, ferret, cow, sheep, bat) models, and

development of novel/improved sample sparing methods to analyze human immune

responses from limited amounts of human sample (tissue, cells, serum, etc.).

Autoimmunity and Mucosal Immunology Branch. Preclinical and clinical research to

develop and improve the diagnosis and treatment of autoimmune diseases and primary

immune deficiencies/inborn errors of immunity (not HIV); basic research of autoimmune

disease mechanisms and biomarkers; immunotherapy of disease processes; disorders

mediated by lymphocyte products; and discovery and/or development of reagents and other

tools for analysis of mucosal immunity.

Transplantation Branch. Preclinical and clinical research in organ, vascularized composite

tissue and cellular transplantation: acute and chronic graft rejection, allogeneic and

xenogeneic transplantation, development of immunomodulatory agents to prevent and treat

graft rejection and to promote acute and long term graft acceptance and immunologic

tolerance, genomics of the alloimmune response, graft versus host disease for

hematopoietic stem cell transplantation, minor histocompatibility antigens, complications of

immunosuppression in transplantation, and major histocompatibility complex (MHC) region

genomics, technologies for MHC typing, and clinical applications of high-resolution HLA

typing.

Radiation and Nuclear Countermeasures Program (RNCP). The RNCP will consider

preclinical research to support product development activities leading to interactions with the

Food and Drug Administration (FDA). Approaches could include those used to diagnose,

mitigate, and/or treat acute or delayed effects of radiation exposure resulting from a

radiological or nuclear incident. It is anticipated that in most cases, approval will occur in

accordance with the FDA Animal Rule (21 CFR 314.600 Subpart I for drug products and 21

CFR 601.90 Subpart H for biologic products).

Proposed activities could include:

•

Animal model studies or ex vivo approaches (e.g., human tissue chips) to

confirm/optimize product efficacy;

•

Mechanism of action studies needed for FDA consideration;

•

Good Laboratory Practice (GLP)/non-GLP

pharmacology/toxicology/pharmacokinetics/pha

rmacodynamics;

•

GLP pilot animal efficacy studies;

•

Good Manufacturing Practice product scale-up and stability studies;

•

Biomarker and biodosimetry assay/device development to determine

radiation dose and/or the biological impact of radiation exposure (in vivo and

ex vivo models acceptable).

Priority areas of product development include:

•

Approaches targeting organ systems/microbiota, for which no treatments

are available (e.g., gastrointestinal, lung, kidney, cardiac, vascular, and

skin);

•

Approaches to mitigate and/or treat radiation injury given 24 hours or later post-

irradiation;

•

Minimally invasive, predictive radiation markers, diagnostics and devices for

biodosimetry;

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 24

•

Radionuclide decorporation agents.

Division of Microbiology and Infectious Diseases (DMID)

The Division of Microbiology and Infectious Diseases (DMID) supports research to better understand,

treat, and ultimately prevent infectious diseases caused by virtually all infectious agents, except HIV.

DMID supports a broad spectrum of research from basic molecular structure, microbial physiology, and

pathogenesis, to the development of new and improved vaccines, therapeutics, and vector control

measures. DMID also supports medical diagnostics research, which is defined as research to improve

the quality of patient assessment and care that would result in the implementation of approp riate

therapeutic or preventive measures. In addition, DMID supports studies to better understand

mechanisms of pathogen transmission that may include environmental factors. DMID does not support

research directed at decontamination or the development of environmentally oriented detectors, whose

primary purpose is the identification of specific agents in the environment. Note that some of the

organisms and toxins listed below are considered NIAID priority pathogens or toxins for biodefense and

emerging infectious disease research.

Bacteriology and Mycology Branch.

The branch oversees research and product development related to:

•

Bacterial infections with emphasis on hospital-associated pathogens, including

Acinetobacter, Klebsiella, Serratia, Legionella, Pseudomonas, Aeromonas,

Enterobacter, Proteus, non-enteric E.coli, staphylococci, enterococci, actinomycetes

among others;

•

Bacterial zoonoses, including plague, anthrax, tularemia, glanders, melioidosis, Lyme

disease, borrelial relapsing fevers, rickettsial diseases, anaplasmosis, ehrlichiosis,

bartonellosis, scrubtyphus, Q fever, and leptospirosis;

•

Fungal infections including those caused by Candida, Aspergillus, Cryptococcus,

Coccidiodes, Histoplasma, Blastomyces, Pneumocystis, Microsporidia, and other

pathogenic fungi.

Research is encouraged in the following general areas: (1) vaccines, adjuvants, therapeutics and

diagnostics (including target identification and characterization, device or apparatus development,

novel delivery, and preclinical evaluation); (2) strategies to combat antibacterial and antifungal drug

resistance; (3) applied proteomics and genomics; (4) host-pathogen interactions, including

pathogenesis and host response; (5) genetics, molecular, and cell biology; and (6) microbial

structure and function.

Research on all of the above is welcome, but the following areas are of particular interest to the

branch:

•

Vaccines, therapeutics, and medical diagnostics for hospital infections

•

Adjunctive therapies and non-traditional approaches to combat and treat antimicrobial

resistance

•

Diagnostics for invasive fungal diseases

•

Novel approaches for the diagnosis of Lyme disease

•

Vaccines against Coccidioidomycosis

Enteric and Sexually Transmitted Infections Branch.

Enteric Section:

Enteric Infections Section research portfolios focus on enteric bacterial pathogens, their toxins,

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 25

and their infectious diseases; related sequela; and the gastrointestinal microbiota and

microbiome.

Special emphasis areas include but are not limited to those below:

• Development of vaccines to prevent bacterial enteric diseases, to protect against neurotoxins

and enterotoxins, and to combat enteric diseases in vulnerable populations.

• Development of therapeutics that focus on novel targets, that target toxin activities, and that

treat recurrent diseases.

• Development of live biotherapeutic products to restore colonization resistance to enteric

pathogens, to combat recurrent or chronic enteric disease, and to restore host immunity against

enteric pathogens.

• Development of adjunctive therapies and non-traditional approaches to treat resistant bacteria

and to combat further development of antibacterial resistance.

• Development of rapid diagnostics to identify multiple pathogens and their antimicrobial

resistance profiles that are appropriate for use in low-resource, outbreaks, and clinical settings,

as well as diagnostic approaches that differentiate asymptomatic colonization from infection.

Sexually Transmitted Infections Section:

Areas of emphasis include the development of medical diagnostics including better and more

rapid multiplex point of care tests, ability to rapidly determine antibiotic sensitivity, and novel

technologies enabling testing in low resource settings while maintaining high

sensitivity/specificity; development of new classes of antimicrobials and non-antimicrobial

treatment approaches, particularly those focused on reducing the development of antibiotic

resistance; novel delivery systems for multipurpose prevention technologies, vaccines and

therapeutics for Sexually Transmitted Infections (STIs) and other reproductive tract syndromes

such as bacterial vaginosis and pelvic inflammatory disease; understanding vaginal ecology and

immunology and approaches to developing synthetic microbiota for use as biotherapeutics or as

adjunct therapy to antibiotic treatment; development of epidemiologic and behavioral strategies

to reduce transmission of STIs; developing and evaluating interventions and products to better

serve adolescents, medically underserved populations, and minority groups who are

disproportionately affected by STIs; development of multipurpose prevention technologies to

prevent STIs, HIV, and unintended pregnancies; better understanding of the role of STIs in

infertility, premature birth, and adverse outcomes of pregnancy and how to improve outcomes;

and better understanding of the role of STIs in HIV transmission and the role of HIV in altering

the natural history of STIs.

Respiratory Diseases Branch.

Research areas include: (1) viral respiratory diseases caused by influenza viruses, human

coronaviruses including SARS, MERS, and novel emerging coronaviruses, rhinoviruses,

respiratory syncytial virus and other related pneumoviruses and paramyxoviruses; (2)

mycobacterial diseases, including tuberculosis (TB) caused by bacteria of the Mycobacterium

tuberculosis complex, leprosy, Buruli ulcer and non- tuberculous mycobacterial (NTM)

diseases, particularly pulmonary infections in persons not afflicted with HIV/AIDS; (3) other

bacterial respiratory diseases including bacterial pneumonia primarily caused by Streptococcus

pneumoniae, Pseudomonas aeruginosa, and Haemophilus influenzae, pertussis, Group A and

B streptococcal diseases, meningitis, upper respiratory infections, acute exacerbations of

chronic obstructive pulmonary disease, and cystic fibrosis; and (4) mixed viral/bacterial

respiratory infections.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 26

Special emphasis areas include:

•

Development of new or improved antimicrobials (especially for antimicrobial-resistant

pathogens) and antivirals, including immunotherapeutics, immunomodulators, and host-

directed therapies to augment anti-infectives;

•

New or improved vaccines (with and without adjuvants);

•

Improved delivery systems and formulations for drugs/vaccines;

•

Microbial and host biomarkers and biosignatures suitable for diagnostic tests;

•

Development of novel or improved diagnostic tools for detection of infection and drug

resistance, including rapid point of care diagnostics and quantitation of pathogen in

response to therapy;

•

Diagnostics to distinguish viral from bacterial infections.

There is particular need for preventive and treatment countermeasures for influenza, including

universal vaccine platforms and broad-spectrum antivirals; for novel treatment of respiratory

syncytial virus (RSV) and related pneumovirus and paramyxovirus infections; for next

generation vaccines, therapeutics, and diagnostics for the prevention and treatment of

COVID-19, including pan-coronavirus approaches; for diagnostics including diagnostics for

pediatric populations, novel therapeutics, and vaccines (including adjuvants) against

Mycobacterium tuberculosis (TB); for relevant diagnostics, preventive and curative

interventions against non-HIV associated pulmonary Non-tuberculous mycobacteria (NTM);

and for the prevention, diagnosis, and treatment of Bordetella pertussis, Group A

streptococcus, and Streptococcus pneumoniae infections and other antibacterial resistant

infections.

Parasitology and International Programs Branch.

Research areas: (1) protozoan infections, including amebiasis, cryptosporidiosis, cyclosporiasis,

giardiasis, leishmaniasis, malaria, trypanosomiasis, toxoplasmosis; helminth infections, including

cysticercosis, echinococcosis, lymphatic filariasis, schistosomiasis, onchocerciasis, others (e.g.,

roundworms, tapeworms, and flukes); invertebrate vectors/ectoparasites responsible for human

disease (.e.g., mosquitoes, black flies, sandflies, tsetse flies, ticks, triatomine bugs, fleas, lice,

mites), and selected intermediate hosts of parasites (e.g., snails); (2) parasite biology (genetics,

genomics, physiology, molecular biology, and biochemistry); (3) protective immunity,

immunopathogenesis, and evasion of host defense; (4) clinical, epidemiological, and natural

history studies of parasitic diseases;

(5) research and development of vaccines, drugs, immunotherapeutics and immunoprophylaxis,

and medical diagnostics; and (6) vector biology and management/control and mechanisms of

pathogen transmissions.

Research on the above is welcome, but research on the following is of particular interest to the branch:

•

New drug discovery or re-purposing of existing drugs to prevent infection and/or transmission,

or to treat parasitic diseases

•

Highly sensitive and specific diagnostics tools for parasitic diseases

•

Vaccines and vaccine technologies, monoclonal antibodies, and other immune-

mediated interventions applicable to prevention or elimination of parasitic

diseases

•

Technologies or approaches that address arthropod vector monitoring, management, and

control, to prevent transmission of vector-borne pathogens to humans

Virology Branch.

The Virology Branch focuses on:

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 27

Acute viral infections caused by arthropod-borne (e.g., mosquito, tick-borne) and rodent-

borne viruses, including: dengue, zika, west nile, Japanese encephalitis, chikungunya,

yellow fever, hanta, crimean-congo hemorrhagic fever (CCHF), hazara, severe fever with

thrombocytopenia syndrome (SFTS), heartland, bourbon, tick-borne encephalitis (TBE),

powassan , lacrosse, cache valley, rift valley fever, punta toro, andes, sin nombre, hantaan;

viruses causing hemorrhagic fevers:

ebola, lassa, junin, venezuelan equine encephalitis (VEE), etc.; and other viruses, including

nipah, hendra, measles, polio, coxsackie, entero, pox, rabies, rubella, astro, calici, and rota;

pathogen X

Persistent viral infections caused by viruses including adeno, borna, corona, herpes,

human T-lymphotrophic, human papilloma, parvo, and human polyoma (JC, BK, and

emerging);

Acute infections with hepatitis viruses A, B, C, D and E (HAV, HBV, HCV, HDV,

and HEV); chronic infections with hepatitis viruses, B, C, D and E;

Transmissible Spongiform Encephalopathies (TSE)

Areas of emphasis for SBIR/STTR applications include:

•

Development of vaccines and vaccine platforms;

•

Development of techniques to improve vaccine stability;

•

Approaches to identify antiviral targets and agents;

•

Chemical design and synthesis of novel antiviral agents;

•

Development of therapeutic, prophylactic, and postexposure prophylactic interventions;

•

Development and validation of point of care assays for disease diagnosis and to

measure response to therapy;

•

Development of new preclinical animal model systems that predict clinical efficacy of

vaccines, therapeutics and diagnostics.

The Virology Branch does not support applications covering environmental

detection and decontamination.

Office of Genomics and Advanced Technologies

The Office of Genomics and Advanced Technologies focuses on broad-based research that

emphasizes the development and improvement of high-throughput and large-large scale genomics

and other advanced technologies for the understanding of infectious diseases and the development

of multiplex platforms for medical diagnostics. The technological scope encompasses genomics,

genomic epidemiology, phylogenomics, functional genomics, proteomics, metabolomics, glycomics,

structural biology, systems biology, computational biology, bioinformatics, and diagnostics, usually

across multiple pathogens or pathogen groups.

The goal of our program is (1) to support large-scale experiments using omics, structural and

computational biology approaches, (2) to deepen the comprehension of pathogen-host interactions

and (3) to accelerate the discovery of innovative diagnostics, vaccines, and therapeutics for infectious

diseases. Our program supports the advancement of technologies and platforms that are pathogen-

independent or address multiple pathogens and may include sample preparation, instrumentation,

and instrument validation.

Special emphasis areas include:

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 28

• Development and advancement of genomic, phylogenomic, proteomic, metabolomic,

glycomic, structural biology and related technologies for infectious diseases, including single-

cell omics technologies and platforms;

• Development of bioinformatic and computational biology, including artificial

intelligence/machine learning methods and tools to advance infectious disease research; and

• Development of modeling and bioinformatic tools to integrate omics data that supports the

development of vaccines, therapeutics and diagnostics.

Office of Biodefense Research and Surety (OBRS)

The Office of Biodefense Research and Surety (OBRS) supports and oversees a trans-NIH

research portfolio to advance discovery and early development of medical countermeasures

(MCMs) against chemical threats. To learn more about OBRS and its leadership role in chemical

countermeasures research at the NIH, see NIH CCRP: A Collaborative Opportunity to Develop

Effective and Accessible Chemical Medical Countermeasures for the American People, published

in the Wiley journal Drug Development Research.

Biodefense Research Countermeasures Branch (BRCB)

The Chemical Countermeasures Research Program (CCRP) supports preclinical basic and

applied research towards understanding acute and long-term chronic toxicity resulting from

exposure to Department of Homeland Security-designated Chemicals of Concern (CoC) and

early development of MCMs to prevent mortality and serious morbidities. The ideal MCM should

have rapid post-exposure efficacy, is easily administered in a mass casualty situation (likely by first

responders in personal protective equipment) and is widely accessible in the community.

The specific injuries caused by toxic chemical exposure often manifest similarly to conditions

observed in conventional clinical practice, such as acute lung injury, acute respiratory distress

syndrome, coagulopathy, tissue fibrosis, keratopathy, neovascularization, seizure, and

neurodegeneration. As such, "treat the symptom” projects aiming to repurpose already FDA-

approved products or those in late-stage development for a conventional clinical indication are

highly encouraged.

Areas of Emphasis include but not limited to:

•

Pulmonary Agents: Development of MCMs to prevent and treat acute and/or chronic lung

injury (including edema, capillary leak, and fibrosis) resulting from exposure to agents such

as sulfur mustard, chlorine, acrolein, and phosgene.

•

Ultra-Potent Synthetic (UPS) Opioids: Development of MCMs to treat life-threatening

respiratory depression caused by acute intoxication. Treatments should be fast-acting and

effective against a variety of synthetic UPS opioids such as fentanyl, carfentanil, and

related analogs, and have a mechanism of action different from existing opioid receptor

antagonists.

•

Vesicants: Development of MCMs that mitigates dermal, ocular, and/or systemic

(including myelosuppression) toxicities after exposure to chemicals such as sulfur mustard,

nitrogen mustard, Lewisite, phosgene oxime. Candidate MCM(s) with the potential to

prevent or ameliorate chronic effects such as keratopathy is encouraged.

•

Blood/Cellular Respiration Agents: Development of MCMs to treat metabolic dysfunction

and/or coagulopathy resulting from exposure to agents such cyanide, hydrogen sulfide, and

brodifacoum. Candidate cyanide and hydrogen sulfide MCM(s) should also be effective

against smoke inhalation-related exposure.

•

Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 29

acute muscarinic and nicotinic toxicities, including benzodiazepine refractory seizures,

after exposure to agents such as sarin, soman, and VX.

OBRS does not support research directed at diagnostic device development, decontamination, or the

development of environmentally oriented detectors, whose primary purpose is the identification of

specific chemicals in the environment.

Contact Information

For more information on NIAID’s SBIR/STTR research topics, program policy or to identify NIAID

Subject Matter Experts for a specific topic, please contact:

Dr. Natalia Kruchinin

SBIR/STTR Program

Coordinator Division of

Extramural Activities

National Institute of Allergy and Infectious

Diseases Phone: 240-669-2919

Email: kruchininn@niaid.nih.gov

Division of AIDS

Director: Dr. Carl Dieffenbach

Telephone: 301-496-0545

Email: CDieffenba@niaid.nih.gov

Division Small Business Representative:

Dr. Brigitte Sanders

Telephone: 240-627-3209

E-mail: sandersbe@niaid.nih.gov

Basic Sciences Program (BSP)

Director: Dr. Diana Finzi

Telephone: 301-451-2598

Email: Dfinzi@niaid.nih.gov

Epidemiology Branch (EB)

Contact: Lori Zimand

Telephone: 240-627 3212

Email: lzimand@niaid.nih.gov

Pathogenesis and Basic Research Branch (PBRB)

Contact: Dr. Karl Salzwedel

Telephone: 301-496-5332

Email: salzwedelkd@niaid.nih.gov

Targeted Interventions Branch (TIB)

Contact: Dr. Brigitte Sanders

Telephone: 240-627-3209

E-mail: sandersbe@niaid.nih.gov

Vaccine Research Program (VRP)

Director: Dr. James Lane (acting)

Telephone: 301-435-3727

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 30

Email: laneji@mail.nih.gov

Vaccine Clinical Research Branch (VCRB)

Contact: Dr. Patricia D’Souza

Telephone: 240-627-3037

Email: pdsouza@niaid.nih.gov

Preclinical Research and Development Branch (PRDB)

Contact: Dr. Anjali Singh

Telephone: 240-627-3030

Email: anjalisingh@niaid.nih.gov

Vaccine Translational Research Branch (VTRB)

Contact: Dr. Michael Pensiero

Telephone: 301-435-3749

Email: mpensiero@niaid.nih.gov

Therapeutics Research Program (TRP)

Director: Dr. Peter Kim

Telephone: 301-451-2761

Email: peter.kim2@nih.gov

Drug Development and Preclinical Research Branch (DDPRB)

Contact: Roger Ptak

Telephone: 301-761-7424

Email: roger.pt[email protected]ov

Laboratory and Clinical Sciences Branch (LCSB)

Contact: Dr. Fatima Jones

Telephone: 240-550-7863

Email: maria.jo[email protected]ov

HIV Research Branch (HIVRB)

Contact: Tia Morton, RN

Telephone: 240-627-3073

Email: frazierti@niaid.nih.gov

Complications and Co-infections Research Branch (CCRB)

Contact: Dr. Beverly Alston

Telephone: 301-435-3773

Email: balston@niaid.nih.gov

TB Clinical Research Branch (TCRB)

Contact: Dr. Andrew Vernon

Telephone: 301-761-5130

Email:

andy.vernon@nih.gov

Prevention Sciences Program (PSP)

Director: Dr. Sheryl Zwerski

Telephone: 301-402-4032

Email: szwerski@niaid.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 31

Preclinical Microbicide & Prevention Research Branch (PMPRB)

Contact: Dr. James Cummins

Telephone: 240-292-4800

Email: cumminsje@niaid.nih.gov

Clinical Prevention Research Branch (CPRB)

Contact: Dr. Lydia Soto-Torres

Telephone: 240-292-4807

Email: lsoto-torres@niaid.nih.gov

Maternal, Adolescent and Pediatric Research Branch (MAPRB)

Contact: Judi Miller

Telephone: 240-292-4801

Email: jmillera@niaid.nih.gov

Division of Allergy, Immunology and Transplantation (DAIT)

Director: Daniel Rotrosen, M.D.

Telephone: 301-496-1886

Email: drotrosen@niaid.nih.gov

Division Small Business Representative:

Dr. Michael Minnicozzi

Telephone: 240-627-3532

E-mail: minnicozzim@niaid.nih.gov

Allergy, Asthma, and Airway Biology

Branch Chief: Alkis Togias, M.D.

Telephone: 301-496-8973

Email: togiasa@niaid.nih.gov

Basic Immunology Branch

Chief: Dr. Alison Deckhut-Augustine

Telephone: 301-496-7551, Fax: 301-480-2381

Email: augustine@niaid.nih.gov

Autoimmunity and Mucosal Immunology Branch

Chief: Dr. Ellen Goldmuntz

Telephone: 240-627 3502

Fax: 301-480-1450

Email: egoldmuntz@niaid.nih.gov

Transplantation Branch Chief:

To be announced

Telephone: TBD

Email: TBD

Radiation and Nuclear Countermeasures

Program Director: Andrea L. DiCarlo, PhD

Telephone: 240-627-3492

Email: cohena@niaid.nih.gov

RNCP SBIR Contact:

Carmen I. Rios, PhD

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAID 32

Telephone: 240-627-3553

Email: carmen.rios@nih.gov

Division of Microbiology and Infectious Diseases (DMID)

Director: Emily Erbelding, M.D., M.P.H.

Telephone: 301-435-3384

Email: emily.erbelding@nih.gov

Division Small Business Representative:

Dr. Barbara Mulach

Telephone: 240-627-3322

Email: bmulach@niaid.nih.gov

Division Small Business Representative:

Dr. Alyssa Werner

Telephone: 301-761-7525

Email: alyssa.werner@nih.gov

Bacteriology and Mycology Branch (BMB)

Contact: Dr. Alec Ritchie

Telephone: 240-627-3356

Email: aritchie@niaid.nih.gov

Enteric and Sexually Transmitted Infections Branch (ESTIB)

Contact: Dr. Tom Hiltke

Telephone: 240-627-3275

Email: thiltke@niaid.nih.gov

Parasitology and International Programs Branch (PIPB)

Contact: Dr. Annie Mo

Telephone: 240-627-3320

Email: moa@niaid.nih.gov

Respiratory Diseases Branch (RDB)

Contact: Dr. Xin-Xing Gu

Telephone: 240-627-3265

Email: guxx@niaid.nih.gov

Virology Branch (VB)

Contact: Dr. Julie Dyall

Telephone: 301-631-7296

Email: Julie.dyall@niaid.nih.gov

Office of Genomics and Advanced Technologies (OGAT)

Contact: Dr. Inka Sastalla

Telephone: 301-761-6431

Email: sastallai@mail.nih.gov

Office of Biodefense Research and Surety (OBRS)

Biodefense Research Countermeasures Branch (BRCB)

Contact: Dr. Dave Yeung

Telephone: 301-761-7237 Email: dy[email protected]ov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAMS 33

NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN

DISEASES (NIAMS)

Mission

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to

support research into the causes, treatment, and prevention of arthritis and musculoskeletal and

skin diseases, the training of basic and clinical scientists to carry out this research, and the

dissemination of information on research progress in these diseases.

For additional information about areas of interest to NIAMS, please visit the NIAMS Strategic

Plan at https://www.niams.nih.gov/about-niams/strategic-plan-fiscal-years-2020-2024.

Budget Guidance

For budgetary, administrative, or programmatic reasons, NIAMS may decide not to fund an

application or may decrease the length of an award and/or the budget recommended by a review

committee. Total funding support (direct costs, indirect costs, fees) normally may not exceed the

amounts defined by the SBA, which can be found on the NIH SEED website.

For topics listed in the SBA-Approved Waiver Topics, the NIAMS does not apply these topics to the

Omnibus Program Announcements. The NIAMS only applies the waiver topics to special Notices of

Funding Opportunities that specifically allow higher budgets than those in the Omnibus Program

Announcements. When the waiver topics are applied, NIAMS generally will not fund Phase I

applications greater than $350,000 total costs or project periods greater than 2 years; or Phase II

applications greater than $2,300,000 total costs or project periods greater than 3 years. Applicants

considering a requested budget greater than these limits are strongly encouraged to contact

program staff before submitting an application.

NIAMS provides Technical and Business Assistance (TABA) Funding. Small Businesses may

request up to $6,500 per year for a Phase I and up to $50,000 per Phase II project (across all

years) to support subcontracts or consultants above the budget cap. Small businesses should

include this budget request as part of the application and provide a detailed budget justification.

Specific SBIR and STTR Program Information

NIAMS does not participate in the SBIR/STTR clinical trial funding opportunities. NIAMS NON-

SBIR/STTR clinical trial funding opportunities support all research within the NIAMS mission areas.

It is not the intent of NIAMS to support clinical trials through the SBIR/STTR mechanism.

Applicants who wish to submit clinical trials applications to the NIAMS are encouraged to utilize

one of the NIAMS NOFOs listed at https://www.niams.nih.gov/grants-funding/conducting-clinical-

research/investigator- clinical-trial- policies.

Specific Funding Opportunities and Programs

NIAMS has published the SBIR funding opportunity PAR-23-032 promote the

translation of academic/non-profit lab research results to marketplace.

In addition, the NIAMS participates in funding opportunities for the SBIR/STTR HEAL

initiative, the Administrative Supplements to Promote Diversity in Research and

Development, and the Small Business

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAMS 34

Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health. For

currently active Notices of Funding Opportunities, please contact the program staff.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIAMS does not accept Phase IIB renewal applications. NIAMS participates in the CRP program

and sets its own budget limits for the CRP applications in the program announcements. NIAMS

does not support clinical trials through the CRP program.

Clinical Trials

Does NIAMS accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Does NIAMS accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does NIAMS support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

https://www.niams.nih.gov/grants-

funding/conducting-clinical-

research/investigator-clinical-trial-policies

Research Topics

The NIAMS small business program supports research and development of products and

services for prevention, diagnosis and treatment of rheumatic, musculoskeletal and skin

diseases. The research topics include, but are not limited to, the following:

Rheumatic Diseases. The NIAMS supports research on rheumatic and related

diseases including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Lyme

arthritis, viral arthritis, gout, calcium pyrophosphate deposition disease (CPDD),

spondyloarthropathies, and systemic autoimmune diseases such as systemic lupus

erythematosus (SLE), systemic scleroderma (SSc), and autoimmune myositis.

Musculoskeletal Diseases. The musculoskeletal system is composed of the skeleton,

the muscles, and connective tissues such as cartilage, tendon, and ligament. The

NIAMS supports research aimed at improving the diagnosis, treatment, and prevention

of diseases and injuries of the musculoskeletal system and its component tissues. The

topics in this area include research on musculoskeletal diseases such as osteoporosis,

osteoarthritis, muscular dystrophy, and osteogenesis imperfecta, tissue engineered

products, orthopedic devices and implants, and sports medicine and fitness.

Skin Diseases. The NIAMS supports research on a wide range of skin diseases and

conditions including chronic inflammatory skin diseases such as psoriasis, rosacea,

acne vulgaris, and atopic dermatitis and autoimmune diseases such as pemphigus,

vitiligo, and alopecia areata. The NIAMS also supports research on skin repair and

regeneration in treatment of chronic wounds and reducing scar formation. Skin cancer is

an area of overlap with the National Cancer Institute (NCI), with the NIAMS focus on the

response of keratinocytes to UV light and early stages in the development of non-

melanoma skin cancer and products for prevention of melanocyte tumorigenesis.

This is not an inclusive list of all research topics covered by the NIAMS. To learn more, please

visit the NIAMS supported scientific areas at https://www.niams.nih.gov/grants-

funding/funding- opportunities/supported-scientific-areas

NIH, CDC, and FDA Program Descriptions and Research Topics

NIAMS 35

Research Topics of High Program Priority

NIAMS supports all Research and Development activities within its mission. Particular areas of

programmatic interest relative to small business initiatives include, but are not limited to:

Innovative research on women’s health in the areas of musculoskeletal,

rheumatic and skin diseases

Innovative research on health disparity in the areas of musculoskeletal,

rheumatic and skin diseases

Innovative diagnostic technology for improving outcomes for maternal health

in NIAMS mission areas

Innovative research on rare musculoskeletal, rheumatic and skin diseases

Multiplex assay development for arthritis and musculoskeletal and skin diseases

Lab to marketplace: translation of scientific discoveries in NIAMS mission

areas from labs into products on the market

Test and/or validation of novel, state-of-the-art candidate biomarker platforms

for predicting the onset and progression of inflammatory diseases of interest to

the NIAMS and for determining the pharmacodynamics, safety and/or efficacy

of therapeutic agents targeting those diseases.

Research Topics of Lower Program Priority

The general purpose of the SBIR/STTR program is to stimulate technological innovation and increase

private sector commercialization of Innovations. Due to budget constraints, NIAMS will consider the

following research topics a lower program priority:

•

Research on a product or a technology to show equivalence to existing products

•

A product or a technology has been well funded for more than 10 years, but has not

shown any progress towards clinical testing

•

A research topic on which multiple similar technologies have been funded and

have shown scientific success

Contact Information

For general SBIR/STTR program information, contact: Dr.

Xibin Wang, NIAMS SBIR/STTR Coordinator Telephone:

301-451-3884

Fax: 301-480-1284

Email: wangx1@mail.nih.gov

For administrative and business management questions, contact:

Ms. Victoria Matthews

Telephone: 301-594-3968

Fax: 301-480-5450

Email: victoria.matthews@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 36

NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

(NIBIB)

Mission

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform

through technology development, our understanding of disease and its prevention, detection,

diagnosis, and treatment. NIBIB supports new tools and technologies to improve human health within

its internal laboratories and through grants, collaborations, and training.

Budget Guidance

• Normally, total funding support (direct costs, indirect costs, fees) may not exceed the amounts

defined by the Small Business Administration (SBA), which can be found on the NIH SEED

website.

• Applicants considering a requested budget greater than the current SBA guidelines should ensure

that the project falls within a topic listed in the SBA-Approved Waiver Topics.

• Generally, NIBIB will not support Phase I (R41/R43) project periods greater than 1 year, or Phase

II (R42/R44) project periods greater than 2 years.

• For budgetary, administrative, or programmatic reasons, NIBIB may decide not to fund an

application or may decrease the length of an award and/or the budget recommended by a review

committee.

Specific SBIR and STTR Program Information

•

NIBIB does not typically support Phase II STTRs. Applicants interested in submitting a Phase II

application should consider the SBIR program and contact program staff at least one month before

the application deadline.

•

NIBIB does not accept Phase IIB renewal applications through the omnibus solicitations.

•

NIBIB will accept applications for support of early-stage clinical trials (see NOT-21-005) in any of

the scientific program areas within NIBIB’s mission.

Applicants are strongly encouraged to contact program staff at NIBIB-SBIR@mail.nih.gov at least

one month before submitting an application.

Specific Funding Opportunities and Programs

•

NIBIB Concept to Clinic: Commercializing Innovation (C3i) Program:

The C3i Program is designed to provide medical device innovators with specialized business

frameworks and essential tools for successful translation of biomedical technologies from the lab

(concept) to the market (clinic). Through this program, the NIH fosters the development and

commercialization of early-stage biomedical technologies by engaging investigators who are

interested in better understanding the value of their innovation in addressing an unmet market

need. The curriculum and customized mentoring provided by the C3i Program are intended to

guide investigators as they assess the commercial viability and potential business opportunity for

their innovation.

•

Targeted Funding Opportunities and Notices of Special of Interest can be reviewed on the NIBIB

website.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

•

NIBIB does not accept Phase IIB renewal application through the omnibus solicitations.

•

NIBIB participates in the Commercialization Readiness Pilot (CRP) program for

Phase II applications only.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 37

Clinical Trials

Does NIBIB accept Clinical Trials through

the Omnibus/Parent Notices of Funding

Opportunities?

Yes

See NOT-21-005 for NIBIB Clinical Trial Funding

Information

Does NIBIB accept Clinical Trials through

specific Notices of Funding Opportunities?

Yes

See NOT-21-005 for NIBIB Clinical Trial Funding

Information

Does NIBIB support Clinical Trials

through Non-SBIR/STTR Notices of

Funding Opportunities?

Yes

See NOT-21-005 for NIBIB Clinical Trial Funding

Information

Research Topics

Bio-Electromagnetic Technologies. Development of technologies that use static or dynamic

electromagnetic fields for sensing, imaging, or therapeutic effects. The emphasis is on increasing

the sensitivity, spatial/temporal resolution, efficacy, or safety of bioelectromagnetic devices

through the development of novel hardware, method of operation, or pre-/post-processing

techniques for single modalities or the combination of multiple modalities. This program may

support the development of magnetic particle imaging, electrical impedance tomography,

electroencephalography, magnetoencephalography, electromagnetic-field-induced

hyperthermia/ablation, and microwave/terahertz imaging, for example.

Bioanalytical Sensors. Development of sensor technologies for the detection and quantitation of

clinically relevant analytes in complex matrices for use in biomedical applications. Emphasis is on

engineering the components and functionality of bioanalytical sensors. Detection could be based on

optical, chemical, electrochemical, and/or physical (such as mechanical, gravimetric, thermal)

perturbation of a sample, for example. Examples of technologies of interest include, but are not

limited to, nano-textured substrates for analyte detection, DNA sensors for liquid biopsy, and small

molecule detectors for diagnosing infectious diseases.

Image-Guided Interventions. Development of novel image-directed technologies for guidance,

navigation, tissue differentiation, and disease identification for reaching specified targets during

therapeutic procedures, which may range along the continuum from non-invasive to minimally

invasive to open surgical interventions. These technologies may range from molecular to macroscopic

scale levels. Overall emphasis is on the engineering of novel image-guided interventions to

improve outcomes of interventional procedures. In addition, emphasis includes technologies that

expand needed procedural access for individuals otherwise excluded by disease characteristics,

co-morbidities, and other parameters. Areas of priority include development of real-time or near

real-time novel image-guided technologies, with robust procedural direction or a robust receiver

operating characteristic curve. In addition, cost-efficient technologies, appropriate for low resource

settings, and/ or applicable to multiple types of interventions are strongly encouraged.

Magnetic Resonance Imaging. Development of in vivo MR imaging and MR spectroscopy, for both

animal and human research and potential clinical applications. The emphasis is on the

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 38

development of MRI hardware and methodologies, including image acquisition and reconstruction

techniques, that would improve the speed, spatial resolution, information content, efficiency,

robustness, quality, patient experience, and safety. The emphasis should be on technological

development rather than detailed applications to specific diseases or organs.

Molecular Probes and Imaging Agents. Development and biomedical application of molecular

probes and imaging agents across all imaging modalities for the visualization, characterization and

quantification of normal biological and pathophysiological processes and anatomy in living organisms at

the molecular, cellular and organ levels. The emphasis is on engineering of targeting and responsive

molecular probes of high sensitivity and specificity for PET and SPECT (radiotracers), MR (T1, T2,

CEST, hyperpolarized agents), EPR, CT, optical (fluorescent and bioluminescent probes), ultrasound

(microbubbles) and photoacoustic imaging. The imaging agents may be based on nano- and micro-

particles, liposomes, dendrimers, proteins, small organic and inorganic molecules etc., and

detectable by one or more imaging modalities. Imaging agent development through methodologies

such as chemical synthesis, biological mutagenesis, microfabrication, etc., may be pursued with an

intent of leading to in vivo biomedical application.

Nuclear Medicine. Research and development of technologies and techniques that create images

out of the gamma- ray (SPECT) or positron (PET) emissions from radioactive agents that are

injected, inhaled, or ingested into the body. The emphasis is on simulation and development of

new detectors, collimators, and readout methods that enhance the signal quality of detecting

isotope emissions; designs of novel camera geometries; and correction methods that compensate

for the radiation physics properties to improve the clinical reliability of the image. Of interest are

improvements and corrections for interaction events in PET detectors and enhancement to time of

flight (TOF) image generation methods (reconstructions algorithms); as well as new collimator and

camera designs for SPECT.

Optical Imaging and Spectroscopy. Development and application of optical imaging, microscopy,

and spectroscopy techniques for improving disease prevention, diagnosis, and treatment in the

medical office, at the bedside, or in the operating room. Examples of research areas include

fluorescence imaging, bioluminescence imaging, OCT, SHG, IR imaging, diffuse optical

tomography, optical microscopy and spectroscopy, confocal microscopy, and multiphoton

microscopy. The emphasis is on development of cost effective, portable, safe, and non-invasive or

minimally invasive devices, systems, and technologies for early detection, diagnosis, and treatment

for a range of diseases and health conditions.

Ultrasound: Diagnostic and Interventional. Development and improvement of technologies for

diagnostic or therapeutic uses of ultrasound. The diagnostic ultrasound program includes, but is not

limited to the design, development and construction of transducers, transducer arrays, and transducer

materials, innovative image acquisition and display methods, innovative signal processing methods

and devices, and optoacoustic and thermoacoustic technology. It also includes the development of

image-enhancement devices and methods, such as contrast agents, image and data presentation and

mapping methods, such as functional imaging and image fusion. The therapeutic ultrasound program

includes, but is not limited to the design, development, and construction of transducers, transducer

arrays, interventional technologies, adjunct enhancement of non-ultrasound therapy applications,

high-intensity focused ultrasound (HIFU), or hyperthermia applications. It also includes non-

invasive or minimally invasive interventional surgical or therapy tools, ultrasound contrast agents

for therapy, targeted drug delivery, neuromodulation, and biopsy.

X-ray, Electron, and Ion Beam. Research and development of technologies and techniques that

create images of internal structures, contrast agents, or molecular probes using x-rays

transmitted through the body (CT, mammography) or x-ray stimulation of secondary emissions

(x-ray fluorescence tomography). Emphasis is on simulation, design and development of new

detector systems; new readout methods that enhance the signal quality for x-ray image

generation; designs of novel imaging geometries; algorithms that compensate for the physical

properties of the detection system to improve the clinical reliability of the image (reconstruction

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 39

algorithms); and approaches to radiation dose reduction, especially in CT. Of interest are

diagnostic image enhancements via photon counting, dual energy, and new applications of cone-

beam tomography.

Biomolecular Technologies. Development and demonstration of broadly applicable biomolecular

technologies to enable new paradigms of human health. The emphasis is on the development of

biomolecular technologies and associated computational models for biomedical intervention. NIBIB

interests include but are not limited to: molecular switches for synthetic genetic circuits; nucleases

and genome editors for DNA manipulation and regulation; engineered viruses and extracellular

vesicles for therapeutic agent delivery; transmembrane CARs for extracellular sensing; photoactive

molecular complexes for optogenetics.

Bionics. Development and demonstration of broadly applicable bionic systems to enable new

paradigms of human health. The emphasis is on the development of bionic systems hardware,

software, and methodologies to improve patient health. NIBIB interests include but are not limited

to: artificial organs to replace function; electrodes and 3D printed tactile sensors for prosthetics;

implantable bioelectronic sensors and actuators for real-time, closed-loop control of tissues and

organs.

Cellular and Multicellular Technologies. Development and demonstration of broadly applicable

cellular and multicellular technologies to enable new paradigms of human health. The emphasis is

on the development of cellular and multicellular technologies and associated computational models

for biomedical intervention. NIBIB interests include but are not limited to: synthetic genetic circuits

for cellular control and decision-making; engineered bacteria for microbiome regulation;

engineered T-cells for immune regulation and cancer therapy; organoids and scaffold-free tissue

assemblies for replacing organ function.

Living Materials. Development and demonstration of broadly applicable living materials to enable

new paradigms of human health. The emphasis is on the development of living materials and

associated computational models for biomedical intervention. NIBIB interests include but are not

limited to: bacteria-laden hydrogels to deliver therapeutics; co-designed stem cells and scaffolds to

grow implantable tissues.

Manufacturing and Biomanufacturing Tools. Development and demonstration of broadly applicable

manufacturing and biomanufacturing tools to enable the translation of new paradigms of human

health. The emphasis is on the development of manufacturing and biomanufacturing tools and

associated computational models to enable biomedical interventions. NIBIB interests include but

are not limited to: bioinks and bioprinters for 3D tissue construction; continuous production

methods for scalable manufacturing of drug delivery vehicles; inline sensors for non-destructive

evaluation of manufactured therapeutic cells; bioreactors for organoid manufacturing.

Medical Devices. Development and demonstration of broadly applicable biomedical devices to

enable new paradigms of human health. The emphasis is on the development of medical device

hardware, software, and models to improve patient health. NIBIB interests include but are not

limited to: implantable bioelectronic stimulators and sensors for monitoring and modulating human

physiology; wearable sensors for monitoring health vitals; micro devices and injection systems for

therapeutic delivery; anti-bacterial and anti-coagulating coatings for implantable devices; biohybrid

devices for replacing organ function.

Medical Simulators. Development and demonstration of broadly applicable medical simulators to

enable new paradigms of human health. The emphasis is on the development of medical simulator

hardware, software, and methodologies, primarily to improve patient outcomes, especially through

the reduction of medical errors. NIBIB interests include but are not limited to: virtual coaches

incorporating artificial intelligence for performance training in medical procedures and workflows;

simulation interfaces to facilitate dissemination and use of virtual environments; realistic

representations of anatomy, tissue, instrument, tactile feedback, and collision dynamics; simulator

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 40

designs that focus on complicated or rare procedures, including rare adverse events; simulators

that replicate realistic workflows, including planning, warm-up exercises, and rehearsal leading up

to the actual procedure; portable, easy-to-use simulators for skilled practitioners in rural and low-

resource settings.

Molecular Materials. Development and demonstration of broadly applicable molecular materials to

enable new paradigms of human health. The emphasis is on the development of molecular

materials and associated computational models for biomedical intervention. NIBIB interests include

but are not limited to: lipid nanoparticle coatings for evading the immune system; supramolecular

polymers for targeted protein degradation; drug conjugates for targeted drug delivery.

Nanomaterials. Development and demonstration of broadly applicable nanomaterials to enable

new paradigms of human health. The emphasis is on the development of nanomaterials and

associated computational models for biomedical intervention. NIBIB interests include but are not

limited to: magnetic and acoustic nanoparticles for ablating cells and tissues; plasmonic nanorods

for tissue suturing; functionalized nanocarriers for drug delivery and immunotherapy.

Physiomimetic Materials. Development and demonstration of broadly applicable physiomimetic

materials to enable new paradigms of human health. The emphasis is on the development of

physiomimetic materials and associated computational models for biomedical intervention. Projects

might focus on: elucidating important engineering design rules or key foundational principles

underlying future engineering, including the use of computational methods; prototyping or

redesigning platform technologies; characterizing (in vitro, ex vivo, or in vivo) broadly applicable

technologies and prototypes. NIBIB interests include but are not limited to: electrically conductive

and mechano-sensitive scaffolds for repairing tissue; photoactive adhesives for surgical sealants;

biomimetic matrices for T cell activation; artificial cells for therapeutic agent delivery.

Robotics. Development and demonstration of broadly applicable robotic systems to enable new

paradigms of human health. The emphasis is on the development of robotic systems hardware,

software, and methodologies to improve patient health. NIBIB interests include but are not limited

to: robots for minimally invasive surgeries; microgrippers and drills for surgical robots; robotic

nurses for isolated patient care; soft robotic exoskeletons to replace lost capabilities; soft

elastomeric actuators for assistive robotics.

Screening and High-Throughput Tools. The emphasis is on the development of screening and

high-throughput tools and associated computational models to enable biomedical

interventions. Projects might focus on: elucidating important engineering design rules or key

foundational principles underlying future engineering, including the use of computational methods;

prototyping or redesigning platform technologies and approaches; characterizing (in vitro, ex vivo,

or in vivo) broadly applicable technologies, prototypes, and lead candidate products. NIBIB

interests include but are not limited to: evolution methods for identifying therapeutic protein targets;

organs-on-chips for drug screening; microfluidic systems for high-throughput screening of

extracellular vesicles.

Artificial Intelligence, Machine Learning, and Deep Learning. Design and development of artificial

intelligence, machine learning, and deep learning to enhance analysis of complex medical images

and data. The emphasis is on development of transformative machine intelligence-based systems,

emerging tools, and modern technologies for diagnosing and recommending treatments for a range

of diseases and health conditions. Unsupervised and semi-supervised techniques and

methodologies are of particular interest.

Biomedical Informatics. Development of structures and algorithms to improve the collection,

annotation, aggregation, anonymization, classification, retrieval, integration, analysis, and

dissemination of quantitative and qualitative biomedical data. The emphasis is on using biomedical

information to achieve better health outcomes and smarter health care. Examples of technical

development areas in this program include but are not limited to informatics tools and resources

NIH, CDC, and FDA Program Descriptions and Research Topics

NIBIB 41

such as: databases, standards for enhanced interoperability, collaborative analysis environments,

data modeling and representation, and techniques for the integration of heterogeneous data, rational

data-driven design of experiments, visualization of data, and digital representation of rich qualitative

data. This program is intended to support NIBIB’s other program areas in biomedical imaging and

bioengineering research.

Digital Health-Mobile Health and Telehealth. Development of enabling technologies that emphasize the

integration of wireless technologies with human and biological interfaces. This program includes the

development of software and hardware for telehealth and mobile health studies. This program includes

the development of software and hardware for telehealth and mobile health studies and the input

and delivery of healthcare information digitally for the analysis or monitoring of health or disease

status. The emphasis is on developing mobile health technologies driven by clinical needs and

integrating these technologies in healthcare delivery, wellness, and daily living.

Point of Care Technologies-Diagnostics. Development of rapid in-vitro diagnostic technologies and

monitoring platforms that provide real time medical evaluation and analysis of the disease status or

condition at the time and place of patient care. The program includes the delivery of healthcare that

is safe, effective, timely, patient-centered, efficient, and available in centralized and decentralized

locations. The emphasis is on developing technologies driven by clinical needs. Examples of

technology development areas in this program include but are not limited to disposable lateral flow

assays, nucleic acid testing platforms, glucose monitoring devices, etc.

Image Processing, Visual Perception, and Display. Design and development of algorithms for post-

acquisition image processing and analysis, the development of theoretical models and analysis tools

to evaluate and improve the perception of medical images, and the development of visualization

tools for improved detection. The emphasis is on using image data to achieve better health

outcomes and smarter health care. Examples of technology development areas in this program

include but are not limited to models, algorithms, software, methodologies, and other tools that will:

facilitate medical imaging research; support clinical detection, diagnosis and therapy; and improve

patient healthcare.

Contact Information

For additional information on research topics, contact:

Dr. Kari Ashmont

National Institute of Biomedical Imaging and Bioengineering

Telephone: 301-451-4772, Fax: 301-480-1614

Email: NIBIB-SBIR@mail.nih.gov

For administrative and business management questions, contact:

Mr. James Huff

National Institute of Biomedical Imaging and Bioengineering

Telephone: 301-451-4786, Fax: 301-451-5735

Email: huffj@mail.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NCI 42

NATIONAL CANCER INSTITUTE (NCI)

Mission

The National Cancer Institute’s SBIR Development Center program is one of the nation’s largest

sources of financing for small businesses engaged in technology innovation. NCI’s funding,

mentoring, and networking assistance is offered to small businesses demonstrating promising

next-generation cancer cure technologies, with the ultimate goal being successful

commercialization and benefiting public health. NCI’s SBIR/STTR Programs offer funding for

therapeutic agents and devices; in vitro and in vivo diagnostics, including companion diagnostics

and imaging agents; agents and technologies for cancer prevention; tools for research in cancer

biology, cancer control, and epidemiology; digital health, including health information technology

and bioinformatics; and many more areas of interest to the NCI.

The goal of NCI’s SBIR/STTR program is to increase small business participation and private-

sector commercialization of novel technologies that can prevent, diagnose, and treat cancer.

The major NCI SBIR/STTR portfolio areas are listed below as a guide to general technology

areas funded through the program. However, NCI will accept any applications outside these

topic areas, and proposing innovative cancer-related technologies with strong commercial

potential is encouraged.

Budget Guidance

For budgetary, administrative, or programmatic reasons, NCI may decide not to fund an

application or may decrease the length of an award and/or the budget recommended by a review

committee. Total funding support (direct costs, indirect costs, fees) normally may not exceed the

amounts defined by the SBA, which can be found on the NIH SEED website. However, for certain

research topics, the U.S. Small Business Administration has approved a list of SBA-Approved

Waiver Topics for which the NCI generally will fund Phase I applications with higher budgets up to

$400,000 total costs combined over all years, and project periods up to 2 years; similarly, for

certain research topics, NCI will consider Phase II applications with higher budgets up to

$2,250,000 total costs combined over all years, and project periods up to 3 years.

Specific SBIR and STTR Program Information

NCI SBIR program is technology agnostic. We welcome all innovative solutions with

commercial potential that is relevant to the mission of the NCI and that reduces the burden on

cancer patients, their caregivers, and providers.

For up-to-date information on high-priority technology areas, and to learn about

programmatic initiatives and upcoming events, visit the NCI SBIR Development Center

homepage: http://sbir.cancer.gov.

In addition, please see the contact list at the end of the NCI section to identify the NCI SBIR/STTR

Program Director(s) that specializes in your technology area.

NCI will accept applications for support of clinical trials in the NCI priority area

mentioned above or any other areas that are relevant to the NCI’s mission.

Prior to Submission

Applicants are strongly encouraged to contact SBIR/STTR staff prior to submitting any

NIH, CDC, and FDA Program Descriptions and Research Topics

NCI 43

application. To schedule a meeting, please email ncisb[email protected]ov with a copy of your

specific aims page that includes answers to the following questions:

•

What is your product?

•

What would be the impact of your technology on cancer patients, providers, or

caregivers?

•

How is your product innovative and how is it different from the current standard?

•

What are your aims for the application? What will be your milestones or success

criteria?

•

Who is the end-user of your product? Who is the purchaser?

For NCI-related SBIR Information, visit http://sbir.cancer.gov.

Specific Funding Opportunities and Programs

Commercialization Readiness Pilot (CRP) and Phase IIB Competing Renewal

Awards CRP

The National Cancer Institute (NCI) welcomes CRP applications from companies that have active

or completed NCI SBIR (Phase II and Phase IIB) or STTR (Phase II) awards (PAR-20-128).

Please note that NCI will provide funding support up to a maximum of $250,000 in total costs

(direct costs, indirect costs, and fee). Potential applicants are strongly encouraged to contact NCI

SBIR Program staff to discuss prior to submission the CRP activities for which support will be

requested. The NCI may decline funding of any application for reasons of program balance or

budget. NCI does not participate in the SBIR/STTR Commercialization Readiness Pilot Program

Technical Assistance and Late-Stage Development (SB1) NOFOs (PAR-20-129 or PAR-20-130).

For SBIR/STTR Phase II awardees in need of additional assistance for late-stage development

and/or clinical trials, the NCI recommends its SBIR Phase IIB program.

Phase IIB

The NCI does not accept applications for Phase IIB SBIR competing renewal awards through this

Omnibus solicitation. However, the NCI offers Phase IIB opportunities in the form of the NCI SBIR

Phase IIB Bridge Award, which is announced via a separate funding solicitation:

https://sbir.cancer.gov/bridge. Please note that NCI will provide funding support up to a maximum

of $4,500,000 in total costs (direct costs, indirect costs, and fee). The NCI Phase IIB Bridge Award

is designed to support the next stage of development for cancer-related technologies previously

funded under SBIR or STTR Phase II awards from any Federal agency. The purpose of this award

is to address the funding gap known as the "Valley of Death" between the end of the SBIR Phase

II award and the subsequent round of financing needed to advance a product or service toward

commercialization. To achieve this goal, the Bridge Award funding opportunity is specifically

designed to incentivize partnerships between federally funded SBIR Phase II awardees and third-

party investors and/or strategic partners. Competitive preference and funding priority will be given

to applicants that demonstrate the ability to secure substantial independent third-party investor

funds (i.e., third-party funds that equal or exceed the requested NCI funds).

To ensure that you will be notified upon the release of the NCI SBIR Phase IIB Bridge Award

solicitation, please sign up for the NCI SBIR mailing list: https://bit.ly/NciSbirEmailSignUp. If you

have any questions regarding the NCI SBIR Phase IIB Bridge Award, please contact your Phase

II program director.

NIH, CDC, and FDA Program Descriptions and Research Topics

NCI 44

Technical and Business Assistance (TABA) Funding

NCI will consider well-justified Technical and Business Assistance (TABA) costs up to the

limits specified on the NIH SEED Website. These costs can be requested in addition to the Phase

I and II budget caps set by NCI. TABA costs must be requested under the original application. NCI

will not fund TABA costs as a supplement and does not participate in the administrative

supplement program for TABA (NOT-OD-21-062).

Clinical Trials

Applicants are strongly encouraged to contact SBIR/STTR staff prior to submitting any application

containing clinical trials.

Does NCI accept Clinical Trials through

the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NCI accept Clinical Trials through

specific Notices of Funding

Opportunities?

Yes

https://seed.nih.gov/small-business-

funding/find-funding/sbir-sttr-funding-

opportunities

Does NCI support Clinical Trials through

NON-SBIR/STTR Notices of Funding

Opportunities?

Yes

R21, R01, P01, K08

https://www.cancer.gov/grants-training/grants-

funding/funding-opportunities

Research Topics

NCI will accept applications in any of the NCI priority areas mentioned below or any other areas

that are relevant to NCI’s mission. NCI is technology agnostic and will fund any technology as

long as it benefits cancer patients, providers, or caregivers. Applications proposing innovative

cancer-related technologies, with strong commercial potential, that fall outside these topic areas

are also welcomed through the Omnibus Solicitation. NCI accepts and encourages SBIR & STTR

applications to support clinical trials.

Major NCI SBIR/STTR Portfolio Areas:

•

Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, and Cell-based Therapies)

•

In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics and Prognostic Technologies)

•

Imaging Technologies (e.g., Agents, Devices, and Image-Guided Interventions)

•

Devices for Cancer Therapy (e.g., Interventional Devices, Surgical, and

Radiation and Ablative Therapies, Hospital Devices)

•

Agents and Technologies for Cancer Prevention

•

Technologies for Cancer Control (e.g., Behavioral Health Interventions,

Tools for Genetic, Epidemiologic, Behavioral, Social, and/or Surveillance

Cancer Research)

•

Tools for Cancer Biology Research

•

Digital Health Tools and Software Platforms for Cancer-Related Technologies

Diversity Statement from NCI SBIR

The statutory purpose of the SBIR program is to strengthen the role of innovative SBCs in Federally

NIH, CDC, and FDA Program Descriptions and Research Topics

NCI 45

funded research or research and development (R/R&D) (See the Policy Directive). Specific

program purposes are to: (1) stimulate technological innovation; (2) use small business to meet

Federal R/R&D needs; (3) foster and encourage participation by socially and economically

disadvantaged SBCs (SDBs), and by women-owned SBCs (WOSBs), in technological innovation;

and (4) increase private sector commercialization of innovations derived from Federal R/R&D,

thereby increasing competition, productivity, and economic growth. To understand more about

how the NCI SBIR/STTR program fosters and encourages participation by WOSBs and SDBs,

please check the following link: https://sbir.cancer.gov/diversity

Contact Information

For additional information about the NCI SBIR/STTR programs, please contact the NCI SBIR

Development Center:

National Cancer Institute

Small Business Innovation Research (SBIR) Development Center

9609 Medical Center Drive

Rockville, MD 20850

Website: http://sbir.cancer.gov

Email: NCIsbir@mail.nih.gov

Phone: 240-276-5300

For additional information on research topics, please contact a Program Officer with the relevant

area of expertise:

Michael Weingarten, MA

Director, NCI SBIR Development Center

Email: weingartenm@mail.nih.gov

Gregory Evans, PhD

Program Director and Team Leader

Email: evansgl@mail.nih.gov

Areas of Expertise: Therapeutics (Immunotherapy, Gene Therapy), Cancer Imaging, Cancer Control,

Tools for Cancer Biology Research, and Digital Health

Jonathan Franca-Koh PhD, MBA

Program Director and Team Leader

Email: jonathan.franca-koh@nih.gov

Areas of Expertise: Cancer Biology, Biologics, Small Molecules, and Cell-Based Therapies

Monique Pond, PhD

Program Director and Team Leader

Email: monique.pond@nih.gov

Areas of Expertise: Biologics, Small Molecules, Therapeutic Devices, Digital Health, Regulatory

Resources

Patricia Weber, DrPH

Program Director

Email: weberp[email protected]ov

Areas of Expertise: Digital Health and Therapeutics (Small Molecules, Biologics, Immunotherapy)

Xing-Jian Lou, PhD

Program Director

Email: loux@mail.nih.gov

Areas of Expertise: In Vitro Diagnostics and Therapeutics (Gene Therapy, Biologics, Small Molecules)

NIH, CDC, and FDA Program Descriptions and Research Topics

NCI 46

Ming Zhao, PhD

Program Director

Email: zhaoming3@mail.nih.gov

Areas of Expertise: In Vitro Diagnostics, Cancer Stem Cells, Molecular Imaging, Bioinformatics,

Therapeutics (Small Molecules, Biologics, Immunotherapy), and Cancer Control (Community -Based

Participatory Research)

William Bozza, PhD

Program Director

Email: william.bozza@nih.gov

Areas of Expertise: Biologics, Protein Therapeutics, Regulatory (CMC)

Sarra Djemil, PhD

Program Director

Email: sarra.d[email protected]ov

Areas of Expertise: Therapeutics, Digital Health, Mentoring

Saroj Regmi, PhD

Program Director

Email: saroj.reg[email protected]ov

Areas of Expertise: Therapeutics, Diagnostics, Imaging, Digital Health, Investor Initiatives, Small Business

Transition Grant, I-Corps

Swamy Tripurani, PhD

Program Director

Email: swamy.tripurani@nih.gov

Areas of Expertise: Therapeutics, Biologics, Small Molecules, Diagnostics, Devices, and Regulatory

(CMC and Nonclinical)

Melissa Li, PhD

Program Director

Email: melissa.[email protected]ov

Areas of Expertise: Biologics, Small Molecules, Digital Health

Linda Zane, PhD

Program Director

Email: linda.zane@nih.gov

Areas of Expertise: Therapeutics, Diagnostics, Research Tools

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 47

EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND

HUMAN DEVELOPMENT (NICHD)

Mission

The mission of the NICHD is to lead research and training to understand human development, improve

reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.

The NICHD has a broad and diverse research portfolio, including biological, behavioral, and clinical

research related to conception and pregnancy, normal and abnormal development in childhood,

reproductive health, rehabilitation, and population dynamics across the lifespan.

For up-to-date information on priority research areas of scientific interest to the NICHD, please visit

our home page at http://www.nichd.nih.gov.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. It is strongly encouraged to

contact program staff prior to applying.

The NICHD received a budgetary guideline waiver from the Small Business Administration for

applications relating to a limited list of scientific topics in SBA-Approved Waiver Topics. For these the

NICHD will accept applications up to $400K total costs for Phase I and $2.25M for Phase II.

Applicants should propose a budget that is reasonable and appropriate for completion of the

research project and requests for these budge levels must be very well justified. Applicants are

encouraged to contact the listed NICHD Branch Contact Program Officer for scientific-related

questions about a project’s eligibility for a budgetary waiver.

For general budgetary questions, applicants should contact NICHD’s SBIR/STTR Grants

Management Coordinator. The NICHD may decrease the budget or length of an award or

decide not to fund an application for budgetary, administrative, or programmatic reasons.

Specific SBIR and STTR Program Information

The NICHD will generally consider clinical trial proposals consistent with the topics listed below

with the following exception:

Developmental Biology and Congenital Anomalies Branch

The DBCAB does not support clinical trials through the SBIR/STTR program.

Pre-submission Resources & Commercialization Assistance

There are several resources and programs available throughout the SBIR/STTR process. For more

information, please visit our Commercialization Resources webpage.

Specific Funding Opportunities and Programs

In addition to the Omnibus program announcement, for up-to-date NICHD releases on targeted

funding announcements and programmatic initiatives visit: https://seed.nih.gov/small-

business-funding/find- funding/sbir-sttr-funding-opportunities or

https://www.nichd.nih.gov/grants- funding/SBIR_STTR/Pages/default.aspx.

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 48

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

The NICHD accepts Phase IIB SBIR Competing Renewal applications to support additional R&D

necessary for approval of a federal regulatory agency (e.g., FDA, FCC). Such products may include

medical implants, pediatric devices, drugs, vaccines, and new treatment or diagnostic tools

Applicants who received NICHD SBIR Phase II support and who are currently Phase II awardees are

eligible. If the project meets the criteria for a budgetary waiver (see SBA-Approved Waiver Topics),

the Phase IIB should not exceed $3M total costs for three years. The amount of award may vary year

to year depending on the research proposed. Funding priority will be given to those small

business concerns that show the ability to develop innovative products and demonstrate

growth towards independence from the SBIR/STTR programs.

Prospective applicants are strongly encouraged to contact NICHD program staff well in advance of

submitting a Phase IIB Competing Renewal application.

Clinical Trials

Does NICHD accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NICHD accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

RFAs

https://seed.nih.gov/small-business-

funding/find-funding/sbir-sttr-funding-

opportunities

Does NICHD support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

Check the NICHD website for active

NOFOs: https://www.nichd.nih.gov/grants-

funding/opportunities-mechanisms/active-

foa/Pages/default.aspx

Research Topics

The major NICHD research priority areas for each Branch are listed below. Investigator initiated

applications that have commercial potential that fall outside these topic areas but fall within the

research mission of the NICHD are also considered through this Omnibus solicitation.

Child Development and Behavior Branch

The CDBB encourages innovative developmentally-sensitive, theoretically-grounded, and evidence-

based small business initiatives that develop technology and products addressing the psychological,

social and emotional, psychobiological, language, numerical, literacy, cognitive and intellectual

development and health of persons from infancy through the transition to adulthood, recognizing the

important role others have in contributing to the healthy development of an individual. Products that

target at-risk populations and/or exploit new technologies that can expand the effective reach or

inclusion of underserved populations in order to encourage healthy development and/or our

understanding of the influences of context and/or behavior on development are especially

encouraged. CDBB is also interested in research on innovative approaches to both imaging and

other non-invasive measurement approaches to capture real time brain activation activity in typical

and atypical infants and young children (birth to age three).

Foci of specific interest include, but are not limited to (please also see the CDBB description for

research priorities):

•

Enhancing Bilingual and Biliteracy Development: Adaptive learning technology to enhance

bilingual and/or biliteracy development in English-language learning children and youth.

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 49

•

Bi- or Multi-Lingual Measures of Neurodevelopment: Develop easy to administer

objective neurodevelopmental measures from evidence-based neurocognitive research

specific to typically developing infants through pre-K children from diverse language

homes that are shown to correlate with development of brain connectivity and activation.

Remote administration measures are a high priority.

•

Pediatric Primary Care Behavioral and Health Promotion Interventions: Facilitate

research on the impact of behavioral and health promotion interventions in pediatric

primary care and related clinical settings with a focus on child and adolescent health

outcomes.

•

Psychosocial Adjustment for Individuals in High-Risk Environments: Develop

measures to identify and tools to stimulate developmental factors and mechanisms which

promote short- and long-term psychosocial adjustment for children and adolescents

exposed to high-risk family and neighborhood environments.

•

School Readiness Skills in Economically and Socially Disadvantaged Children:

Develop mobile device apps and/or hand-held devices that assess and/or promote the

development of executive functioning (EF) and school readiness skills and abilities in

infancy and early childhood and in diverse populations of children as well as measures of

home, childcare and preschool environments and practices that are related to child

learning and development.

•

Reading, Writing, and Mathematics Struggling Learners: Develop assistive

technology to enhance learner outcomes for individuals that struggle to acquire literacy

and/or numeracy skills, grounded in current scientific understanding of these challenges.

•

Assessment and Enhancement of Reasoning Development: Develop validated and

specific assessment tools that are sensitive to contributing factors (e.g., biobehavioral,

environmental, cultural, academic, and cognitive factors) to facilitate research on and the

promotion of neurocognitive development of reasoning (e.g., quantitative, deductive,

inductive, causal) in typically developing populations.

•

Fostering inclusion of typically-developing or at-risk infants, toddlers and children in

neuroimaging activities: Develop products or new strategies to facilitate neuroimaging

of typically-developing or at-risk infants, toddlers and children.

Contraception Research Branch

The CRB supports research on developing new and improved methods of fertility regulation as well

as research on the benefits and risks of contraceptive drugs, devices and surgical procedures.

Areas of interest include, but are not limited to:

•

Development of new and improved methods of fertility regulation, for men and women,

that are safe, effective, inexpensive, reversible and acceptable with priority given to non-

hormonal and on-demand methods

•

Synthesis and testing of novel chemical compounds that are potential contraceptives

•

Multipurpose prevention technologies designed to prevent sexually transmitted infections,

such as HIV, as well as pregnancy

Developmental Biology and Congenital Anomalies Branch

The DBCAB supports biomedical research on the cellular, molecular, and genetic aspects of typical and

atypical embryonic development including early embryogenesis, organogenesis, as well as topics in

stem cell and regenerative biology. The overall goal is to promote research on developmental biology to

understand the causes of structural birth defects.

Areas of interest include but are not limited to:

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NICHD 50

•

Development of new model systems (animal or other) to study developmental

mechanisms and causes of structural birth defects

•

Innovative technologies for in vivo imaging of developmental processes (cell and tissue

dynamics) and gene expression

•

Development of antibodies, novel ligands, and other probes to facilitate our

understanding of typical and atypical embryonic development in model organisms

•

Technologies for quantitative measurement of physical properties of cells/tissues in vivo during

development

•

Innovative technologies for studying metabolomics in developing vertebrate embryos

•

Technologies to facilitate and advance systems biology approaches to the study of

embryonic development and structural birth defects

•

Technologies to facilitate and advance high throughput chemical screening (including

small molecules) for advancing structural birth defects research

•

Software development to facilitate the collection and analyses of data generated using

medium-high throughput screening platforms in model systems (model organisms, cell-

based models)

•

Software development to facilitate the collection, mining and analyses of genomic and

phenotypic data from children affected with structural birth defects, and cross-analysis

with model organism data

•

Development of user-friendly software for biomedical researchers with limited knowledge

of computational biology to analyze large-scale human and other datasets associated

with structural birth defects

•

Technologies/methodologies to generate, and software to mine, data related to wound

healing and regenerative responses across animal species

•

Novel reagents for activation and mobilization of endogenous/adult stem cells to

promote in vivo tissue regeneration

•

Methodologies to drive limb regeneration in higher vertebrates (including in mammals)

that might otherwise lack the capacity for regeneration.

•

Technologies for iPSC-based regenerative medicine in the context of structural birth defect

•

Screening technologies for small molecules in human Embryonic Stem (ES) Cells or

Induced Pluripotent Stem Cells (iPSCs) and disease specific iPSCs for targeted

modification of regulatory networks affected in structural birth defects

Fertility and Infertility Branch

The FIB supports research on the reproductive processes of men and women and of animals with

similar reproductive systems related to developing safer and more effective means of regulating,

preserving or achieving fertility.

Areas of interest include but are not limited to:

•

Development of reagents and tools, such as high-resolution technologies to

facilitate study of reproductive and developmental processes, including gamete

and early embryo development, and reproductive track development

•

Development of techniques and identification of novel biomarkers to produce, identify,

and use healthy gametes as well as advancement on preservation of human gametes

•

Development of organoid cultures and physiomimetic systems ideal for study of

gametogenesis and normal or diseased reproductive tissues/organs

•

Development of improved methods of growing and differentiating stem cell lines in vitro,

including feeder cell-free approaches to facilitate reproductive research

•

Development of improved technologies for the reprogramming of cells, including

embryonic stem cells or adult cells, into eggs and sperm

•

Development of improved technologies for preimplantation genetic diagnosis

•

Development of omics technologies to diagnose impairments in sperm function, fertilization,

ovulation, implantation, decidualization and other aspects of reproductive processes

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•

Use of genomics and proteomics to develop novel diagnostics and treatments for

reproductive diseases and disorders

•

Use of semen, vaginal or cervical fluid, or menstrual effluent to diagnose fertility

status or other health conditions

•

Development of novel assays, kits, and devices to monitor and treat infertility

•

Development of Artificial Intelligence techniques/methods for selection of best sperm cells,

oocytes, and embryos to generate better predictive models for in vitro fertilization

•

Development of innovative technologies for point-of-care testing for fertility/infertility and

reproductive diseases and disorders

•

Development of patient-specific treatment regimen for infertility diseases using Artificial

Intelligence methods/technologies

•

Development of tools, technologies or apps for diagnosis and treatment of infertility in

resource limited settings to increase community and individual resources to address

infertility

•

Development of tissue engineering technologies for uterine tissue regeneration and

reproductive track reconstruction for treatment of infertility

•

Identification and/or validation of putative male or female infertility targets

•

Development of novel drugs or devices to treat male or female infertility.

•

Development of high-throughput screening methodologies for small molecule drugs

addressing infertility

Gynecologic Health and Disease Branch

The GHDB supports biomedical research related to gynecologic health throughout the reproductive

lifespan, beginning at puberty and extending through perimenopause.

Areas of interest include, but are not limited to:

•

Development of new diagnostic approaches and treatments for female pelvic floor

disorders, including drugs, and devices used for treatment of pelvic organ prolapse,

urinary incontinence, fecal incontinence, and other female pelvic floor disorders

•

Development of new diagnostic methods and novel surgical and non-surgical treatments

for uterine fibroids, endometriosis, adenomyosis, and benign ovarian cysts. Non-invasive

diagnostics and/or diagnostics that make use of menstrual effluent are of particular interest.

•

Production of marketable novel or improved methods, devices, and technologies for the

diagnosis, monitoring and therapy of gynecologic pain disorders including chronic pelvic

pain, vulvodynia/vestibulodynia, and dysmenorrhea

•

Generation of new approaches for the diagnosis, monitoring and treatment of abnormal

menstrual cyclicity

•

Surgical and non-surgical treatments for girls and women with reproductive tract

abnormalities, including congenital structural abnormalities and complications from

female genital cutting

•

Devices and/or technologies designed to address surgical challenges in gynecologic

surgeries, including hysterectomy

•

Technologies designed to apply -omics platforms (genomics, proteomics, metabolomics

etc.) to questions of gynecologic health and disease

Intellectual and Developmental Disabilities Branch

The IDDB sponsors research aimed at preventing, diagnosing, and ameliorating intellectual and

developmental disabilities (IDD). Emphasis is on studies related to IDD, including common and rare

neurodevelopmental and neuromuscular disorders, such as autism spectrum disorders, Down,

Fragile X, and Rett syndromes, mitochondrial conditions, inborn errors of metabolism, and others.

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Areas of interest include, but are not limited to:

•

Innovative tools, including molecular, imaging, statistical or behavioral tools, to

characterize the etiology and pathophysiology of abnormal nervous system development.

•

Methods and devices to delineate genetic, genomic, and epigenetic causes of IDD and

develop gene-based treatments.

•

Methods or devices designed to screen for, diagnose, treat, and manage IDD and other

conditions, particularly those identified or identifiable by newborn screening.

•

Assessment tools for use in the clinic or community settings to enable the accurate

measurement of change in response to interventions.

•

Development of early interventions leading toward the prevention, diagnosis,

treatment, and management of IDD.

•

Methods or devices to develop or adapt smart technologies (such as wearable devices,

mobile health applications (apps), and electronic medical records (EMR)-based tools) to

assist in remote health monitoring, to service as point-of-care diagnostic tools, and/or to

enhance screening, diagnosis, prevention, treatment, or management for individuals with

IDD to improve their quality of life.

•

Development of assessment measures or treatments for co-morbid symptoms in those

with IDD including disordered sleep, self-injurious behaviors, obesity, gastrointestinal

dysfunction, seizures/epilepsy, attention deficit/hyperactivity disorder, anxiety,

depression, psychosis, immune dysregulation, self-injurious behaviors, and ADHD and

other mental health disorders.

•

Innovative and new digital technologies and mHealth solutions for improving transition of

adolescents to adult healthcare providers by improving health literacy, enabling self -

management, and encouraging adherence to existing treatments among adolescents.

•

Methods and devices to facilitate inclusion of people with all levels of IDD in research and

clinical care – both research/care targeted toward IDD populations and research/care for

more general populations where people with IDD are typically categorically excluded.

Maternal and Pediatric Infection Disease Branch

MPIDB supports domestic and international research on human immunodeficiency virus

(HIV)/acquired immune deficiency syndrome (AIDS) and other infectious diseases (such as CMV,

Syphilis, tuberculosis, hepatitis and malaria) in people of child bearing age, pregnant people,

mothers, fetuses, infants, children and adolescents. Specific areas of interest include but are not

limited to epidemiology, clinical manifestations, immune-pathology, pathogenesis, transmission,

treatment and prevention (including immune-therapeutics like monoclonal antibodies, vaccines and

other biomedical modalities) of HIV infection, severe acute respiratory syndrome coronavirus 2

(SARS-CoV-2) infection, and other pertinent infectious diseases in children, adolescents and

pregnant people, with a focus on prevention of vertical transmission of HIV and other congenital

infections, and HIV-related and other infectious-disease related complications in these populations.

Additional areas of interest include:

•

New technologies relevant to resource-limited countries for:

Screening, diagnosis, and management of infectious diseases in pregnant women,

infants, and children, including but not limited to HIV such as SARS-CoV-2, congenital

CMV, congenital Syphilis, tuberculosis, and Zika virus)

Rapid assays to monitor disease activity and response to therapy as well as immune

response to vaccinations against relevant infections in infants and children (e.g., malaria,

tuberculosis), which can be used at the individual level and/or as part of public health

campaigns (e.g., eradication of outbreaks and prevention of spread)

Diagnosis and treatment of HIV-related co-morbidities (e.g., diagnosis of tuberculosis,

STIs)

Diagnosis and treatment of SARS-CoV-2 infection-related outcomes in mothers and

infants

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Simple and less technologically demanding point of care assays to monitor CD4 cell

percentage/count, HIV viral load, or other surrogate markers of HIV disease progression

in children

Simple and easy to use/at home use diagnostics and point of care assays to monitor

clinical symptomatology and prognosis of SARS-CoV-2 infection and recovery in children

 Interventions designed to promote or optimize medication adherence

 Child-friendly formulations (preferably not liquid preparations) of drugs used to treat or prevent

HIV infection, complications of HIV infection, and/or other high-priority infections such as

tuberculosis, hepatitis, Syphilis, CMV, and malaria relevant to children, particularly in resource-

limited countries; Fixed-dose drug formulations and innovative methodologies for development

of solid heat stable formulations capable of being administered to young children (e.g.,

sustained release beads, etc.) and/or improve pill or volume burden

•

Innovative long-lasting drug formulations for antiretroviral and other anti-infective drugs

that would allow less frequent drug administration (e.g., once daily, weekly, or monthly)

•

Simple, standardized, validated tools to evaluate neurodevelopmental outcomes in children

•

Innovative data collection and database development approaches to leverage and link

electronic medical records and/or other health information systems to better

understand treatment and prevention of infectious diseases among infants, children,

adolescents, and people of child-bearing age.

•

Biomedical modalities including vaccines and methods to assess efficacy of vaccines, to

prevent acquisition of HIV and other infectious diseases in children, adolescents, and

women.

•

Topical microbicide agents, wearable, implantable, or insertable devices releasing

medications alone or as part of multipurpose prevention technologies (MPTs), to

prevent sexual acquisition of HIV and other sexually transmitted infections in

adolescents, adult women, and pregnant or postpartum people.

•

New, non-invasive technologies to evaluate complications of antiretroviral drugs (e.g.,

mitochondrial toxicity, bone toxicity) in HIV-infected infants, children, adolescents,

pregnant people, and their fetuses.

•

New or improvements to existing technologies for measuring the HIV latent reservoir, or

other long-term effects of infectious diseases, including high-throughput, visualization

algorithms, and improvement in assay reliability and sensitivity in children.

Obstetric and Pediatric Pharmacology and Therapeutics Branch

The OPPTB supports research and research training on the development and use of safe and

effective therapeutic drugs and therapeutic-related medical devices for children and pregnant and

lactating people, including during the postpartum period. The branch promotes basic, translational,

and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceutical

drugs and medical devices. It is responsible for developing and supporting a comprehensive national

effort to increase the knowledge base for understanding how to appropriately treat disease during

pregnancy, lactation, infancy, childhood, and adolescence using evidence-based therapeutic

approaches. This includes support for the development and validation devices to inform treatment

decisions and enhance precision drug delivery. The goal of these efforts is to assure that

medications are appropriately tested for dosing, safety, and effectiveness for individuals within their

target populations. Of note: NICHD considers applications for pediatric conditions that have

significant efforts at other NIH institutes (e.g., sickle cell disease, pediatric oncology, juvenile

diabetes) to be of lower programmatic priority.

Applications to advance the study of obstetric and pediatric therapeutics include but are not limited to:

•

Understanding Differences and Heterogeneity in Pediatric Disease Treatment. Research to

quantitatively understand differences in drug action and related pathophysiology between

childhood and adult disease and conditions unique to pediatrics. This includes developing tools

(e.g., biomarkers, outcome measures, and physiologically based

pharmacokinetic/pharmacodynamic models) to support pediatric drug discovery and

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NICHD 54

development and to facilitate the application of precision medicine approaches in children.

•

Pharmacology and Pathophysiology of Pregnancy. Developmental pharmacology research and

approaches that explore the intersections of physiological changes in pregnant people and

during fetal development with drug action (e.g., pharmacokinetic, pharmacodynamics, and

pharmacogenomics) and with molecular pathways that may serve as novel therapeutic targets

for disease-modifying therapies specific to these populations. Critical areas include pain

management in pregnant and lactating people and treatment of gestational diabetes,

preeclampsia, and prevention of preterm delivery.

•

Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials. Development of

innovative approaches and algorithms to determine drug dosing, safety, and

effectiveness in children and in women during pregnancy and lactation. This includes

artificial intelligence-driven modeling and simulation methods, novel approaches to

utilizing existing data and archived biosamples/biospecimens, and pragmatic trials.

•

Population- and Individual-Specific Diagnostic and Therapeutic Devices that can advance

precision medicine through individualized diagnosis, drug delivery, and non-drug therapy

appropriate for use in neonates, children, and obstetric and lactating people. This may

include 3D bioprinting, AI-enhanced pharmacometrics modeling, AI-driven diagnostic and

decision-making tools, novel drug delivery devices, and formulations.

•

New Uses for Drugs, Biologics, and Other Therapeutics. This includes the development

and use of preclinical experimental models (e.g., animal models and human biomimetics),

use of organotypic microphysiologic cell culture systems and strategies for assessing

pharmacologic and toxicologic effects of therapeutics, use of genetically diverse model

organisms to assess precision prescribing approaches for interindividual manifestation of

disease or response to therapeutic agents, and computation models or the accumulation

of real-world evidence in support of new therapeutic uses.

Pediatric Growth and Nutrition Branch

The PGNB supports research designed to support short and long-term health so that children can

achieve their full potential through an expanded understanding of those factors that influence

metabolism, growth (body composition and linear growth) and neurodevelopment. An additional

focus is on those biological (e.g., genetic, nutritional, endocrinological) factors that contribute the

early life origins of non-communicable disease (e.g., obesity, diabetes, cardiovascular disease,

osteoporosis). The PGNB encourages research that focuses on detecting the biological antecedents

of these conditions during pregnancy, infancy, and childhood.

Areas of interest include, but are not limited to:

New research tools, improved measurement methods, and technologies that enhance our understanding

of:

•

Growth:

Physical growth, body composition, bone health, nutrition, and obesity

Determinants of normal bone mineral accretion and peak bone mass. Interactions of

muscle and bone during infancy and childhood

Neuroendocrinology of puberty, linear growth, body composition

Mechanisms of hormone action during linear growth, pubertal maturation, and other

aspects of physical development

•

Biological antecedents of childhood obesity and its short and long-term consequences:

Genetic and molecular mechanisms of obesity, psychosocial risks of obesity, and

therapeutic interventions for obesity in children and adolescents

Impact of early life exposures including infant feeding practices on short and long- term

health and development

•

Biology of nutrition as it pertains to health and development (physical and neurological function)

during pregnancy, infancy and childhood including discovery, development and deployment of

biomarkers for early detection of:

Mal-(over-/under) nutrition; including biomarkers of exposure, status, function and effect (i.e.,

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NICHD 55

impact on early life development including neurodevelopment)

Enhanced understanding of the role of human milk in child health and

development.

Maternal nutrition (pre-pregnancy, pregnancy, and lactation)

Novel approaches to enhanced infant feeding practices in term and pre-term

infants

•

Developmental origins of health and disease including:

Ascertain biomarkers early in life that predict the onset of chronic diseases such as

diabetes, osteoporosis, and the metabolic syndrome later in life. The PGNB emphasizes

the life course model to develop primary preventive approaches to chronic diseases.

Develop platforms for implementation of biomarkers of disease status, nutritional

status, and biological function from infancy through adolescence

Pediatric Trauma and Critical Illness Branch

The PTCIB supports research and research training in pediatric trauma, injury prevention, and

critical illness across the continuum of care. These efforts include research focused on the

prevention, treatment, and management of physical and psychological trauma and the surgical,

medical, psychosocial, and systems interventions needed to improve outcomes for critically ill and

injured children and adolescents.

Additionally, the PTCIB supports basic, clinical, and translational research that explores short- and

long- term consequences of traumatic experiences such as exposure to disasters, all forms of

violence against children, exposure to critical illness environment, and experiences of

bereavement, grief, and loss.

Applications of interest include, but are not limited to the research and development of:

•

Technologies, devices, and equipment used by pediatric critical care, emergency care,

and trauma care personnel.

•

Novel technologies in caring for injured children prior to and during transport to treatment

settings.

•

Tools and technologies for screening and diagnosis of injuries related to forms of

child maltreatment.

•

Devices and innovative therapeutic technologies for management of medical conditions

and related problems stemming from critical illness and serious or life-threatening

injuries.

•

Preventive intervention tools, materials, and technologies designed to improve clinical

practice, parenting, and social system support for injured or traumatized children.

•

Tools, materials, and technologies designed to reduce pediatric trauma exposure and the

number and severity of pediatric injuries and deaths.

•

Tools and technologies to improve the environment of pediatric intensive care including

resources to promote patient safety and to enhance clinical education and training of

critical care personnel

•

Tools and technologies that support the diagnoses and treatment of critical illness in

children, including nosocomial infections and iatrogenic injury.

Population Dynamics Branch

PDB supports research and research training in demography, reproductive health, and population

health. In demography, the Branch supports research on the scientific study of human populations,

including fertility, mortality and morbidity, migration, population distribution, nuptiality, family

demography, population growth and decline, and the causes and consequences of demographic

change. In reproductive health, the Branch supports behavioral and social science research on

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 56

sexually transmitted diseases, HIV/AIDS, family planning, and infertility. In population health, the

Branch supports data collection and research on human health, productivity, behavior, and

development at the population level, using such methods as inferential statistics, natural

experiments, policy experiments, statistical modeling, and gene/environment interaction studies.

Applications are encouraged, but are not limited to these areas:

•

Technological innovations or inventions to improve collection of biomarker and

anthropometric data in large population-representative surveys

•

Hardware or software to improve the collection of accurate cause of death information or

health diagnosis such as information related to infant and maternal morbidity and

mortality, in large population-representative surveys or in administrative data sets

•

Methods for integrating data science, including artificial intelligence and machine

learning, into demographic research

•

Methods for improving the collection, documentation, archiving, linking, and

dissemination of population representative data sets, especially data sets that are

complex, multilevel or multimodal

•

Methods for protecting and assuring confidentiality for human subjects when collecting,

archiving, linking, or disseminating population-representative data sets, especially data

sets that are longitudinal or that include both spatial and individual-level data

•

Methods for reducing the costs of collecting, linking, and disseminating large-population-

representative data sets

•

Development and dissemination of effective tools for prevention research and

intervention programs related to STIs/HIV; pregnancy; contraceptive use; adolescent,

young adult, and maternal mortality; child health; at-risk youth; and other health-related

topics relevant to PDB science

•

Innovative approaches and techniques for research design, measurement, and data

collection and analysis in the social and behavioral sciences, with particular attention to

methodology and measurement issues related to protecting research subjects, archiving

and disseminating complex datasets, and studying diverse populations and/or sensitive or

confidential behaviors

Pregnancy and Perinatology Branch

The PPB supports research in the following areas: the physiology of pregnancy and labor; high- risk

pregnancies, including those with hypertensive disorders, diabetes or seizure disorders; fetal

pathophysiology; premature labor and birth; diagnostic, monitoring, and therapeutic devices and

instruments for newborn infants in the nursery and in Neonatal ICU setting; improving the existing

products or developing new products that would improve the routine and extended care of the

newborn infants; products and agents related to breastfeeding; hospital supplies specifically related

to use in the care of newborn infants; nanotechnology and its application for the care of newborn

infants; instruments and devices for assessing and monitoring the nursery environment (noise,

lighting, and odor); disorders of the newborn; sudden infant death syndrome; and biological and

behavioral antecedents of low birth weight.

The following topic areas are of high priority:

•

Non-invasive (or minimally invasive) methods to assess preeclampsia; gestational

diabetes; fetal well-being; spontaneous preterm birth; and stillbirth

•

Methods to characterize the bioactive components of human milk

•

Non-invasive methods to longitudinally identify predictors and indicators of placental

dysfunction including malperfusion, abnormal placental development, and impaired

placental function (nutrient transfer, metabolic function, exchange of respiratory gases, and

hormone production).

•

Devices, instruments, and tools to minimize bacterial colonization, reduce proclivity for

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NICHD 57

thrombus formation, and reduce healthcare associated infection risks

•

Lab-on-a-chip; specifically, non- or minimally-invasive approaches for assessing

metabolic profiles (e.g., glucose and lactate/pyruvate), ketone bodies, bilirubin

(unconjugated, free, indirect, and total), and other major analytes (Na+ Ca+ Cl+ K+ etc.)

•

Rapid methods for diagnosis of bacterial infections and the assessment of antibiotic

sensitivity

•

Improved syringes, needles, and injection set ups to help administer small doses of

medications over prolonged periods (e.g., insulin for treating hyperglycemia)

•

Methods to assess pain in the newborn, analgesia, and the evaluation of neonatal opioid

withdrawal syndrome

•

Non-invasive measures to assess brain energy utilization in the newborn, especially

glucose, oxygen, lactate, ketones, and other energy substrates

•

Improved devices and instruments for assisted ventilators for use in the neonatal ICU

National Center for Medical Rehabilitation Research

This Center supports innovative research on the restoration, replacement, enhancement or adaptation of

function for people with chronic physical disabilities. This includes rehabilitative approaches across

etiologies and the lifespan, as well as the environmental and policy factors that promote full participation.

We encourage studies that integrate biomedical, engineering and/or psychosocial approaches to develop

practical and creative solutions to the daily functioning of people with disabilities and their families. The

mission of the NCMRR is to increase the effectiveness of medical rehabilitation practices through

research. Information about specific program areas within NCMRR can be found here.

Examples may include but are not limited to:

•

Adaptation and Plasticity: Develop non-invasive and surrogate measures of plasticity

that would be appropriate for use in a clinical setting to target rehabilitation therapies and

monitor treatment effectiveness (e.g., biomarkers, imaging)

•

Novel Technology: Orthotics, prosthetics, and robotics devices and interfaces; Assistive

technologies; Invasive and non-invasive biological sensors, prosthetic systems or implants

to improve function; New control methods and improved sensory feedback; Strategies for

controlling and adapting to the environment; Advanced wheelchair designs and

enhancements and other mobility devices; Biomaterials and tissue interfaces,

nanotechnology, bionics

•

Rehabilitation Interventions: Development and use of robotics; Gaming applications;

Virtual and Augmented Reality; Simulations; M-health and other approaches to promote

participation, understand and support healthy behaviors, reduce health disparities, and

enhance clinical compliance, especially in children with physical disabilities.

•

Chronic Symptom Management: Methods to increase screening for chronic conditions or

preventable secondary conditions in individuals with physical disability; Prevention and

treatment strategies for mitigating symptoms associated with multiple chronic conditions in

individuals with physical impairments, including persistent pain, symptoms of obesity,

diabetes, cardiovascular deconditioning, fatigue, symptoms of overuse injuries, pressure

ulcers, sleep disturbances, and depressive symptoms; Improving muscle c apacity in

chronic physical disability to include therapeutic or adaptive exercise and muscle

stimulation; muscle-disuse syndromes and contractures; Rehabilitation interventions for

improvement of physical disability and comorbid cognitive, sensory, or somatic

consequences of impairment, disease or injury; Autonomic function in the context of injury

or specific conditions.

•

Rehabilitation in the Community: Strategies to build or modify community and/or

environmental resources that provide effective rehabilitation and health promotion services

within the individual’s own community. Development of engineering, crowdsourcing, and social

science approaches to promote, monitor, and sustain outcomes in real world settings.

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 58

Investigators proposing budgets exceeding the guidelines are encouraged to contact program staff

six weeks prior to submitting the application.

Contact Information

Child Development and Behavior Branch

NICHD CDBB Small Business (SB) Program Director

Phone: 301-435-6855 OR 301-435-3602

Email: NICHDCDBB-SB-Program@mail.nih.gov

Contraception Research Branch

Steven C. Kaufman, MD, MS

Phone: 301-435-6989

Email: kaufmans@exchange.nih.gov

Developmental Biology and Congenital Anomalies Branch

Mahua Mukhopadhyay, PhD

Phone: 301-435-6886

Email: mukhopam@mail.nih.gov

Fertility and Infertility Branch

Clara Cheng, PhD

Phone: 301-435-6992

Email: clara.cheng@nih.gov

Gynecologic Health and Disease Branch

Candace M. Tingen, PhD

Phone: 301-435-6971

Email: candace.tingen@nih.gov

Intellectual and Developmental Disease Branch

Sujata Bardhan, PhD

Phone: 301-435-0471

Email: sujata.bardhan@nih.gov

Maternal and Pediatric Infection Disease Branch

Sai Majji, PhD

Phone: 301-402-8048

Email: sai.majji@nih.gov

Obstetric and Pediatric Pharmacology and Therapeutics Branch

Antonello Pileggi, MD, PhD,

MSCTI Phone:301-402-5019

Email: pileggia@nih.gov

Pediatric Growth and Nutrition Branch

Andrew A. Bremer, MD,

PhD Phone: 301-402-7886

Email: andrew.bremer@nih.gov

Pediatric Trauma and Critical Illness Branch

Tessie October, MD, MPH

Phone: 301-827-6757

Email: tessie.october@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NICHD 59

Population Dynamics Branch

Ronna Popkin, PhD

Phone: 301-827-5121

Email: ronna.popkin@nih.gov

Pregnancy and Perinatology Branch

Diane Gumina, PhD

Phone: 301-827-7304

Email: diane.gumina@nih.gov

National Center for Medical Rehabilitation Research

Toyin Ajisafe, PhD

Phone: 301-827-9242

Email: toyin.ajisafe@nih.gov

For additional SBIR/STTR program administrative information and research topics

contact: Toyin Ajisafe, PhD

Phone: 301-827-9242

Email: toyin.ajisafe@nih.gov

For additional financial/business management questions contact:

Mindy Bixby, Grants Management Specialist

Phone: 301-402-3204

Email: mindy.bixby@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDA 60

NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

Mission

NIDA is the lead federal agency supporting scientific research on drug use and its consequences. Our

mission is to advance science on the causes and consequences of drug use and addiction and to apply

that knowledge to improve individual and public health through 1) strategically supporting and conducting

basic and clinical research on drug use, its consequences, and the underlying neurobiological, behavioral,

and social mechanisms involved; and 2) ensuring the effective translation, implementation, and

dissemination of scientific research findings to improve the prevention and treatment of substance use

and addiction and enhance public awareness of addiction as a brain disorder.

Budget Guidance

Award budgets and project periods are listed in the Section II Award Information of the Omnibus/Parent

Notices of Funding Opportunities for SBIR and STTR. Total award budgets include direct costs, indirect

costs, and fees and are capped not to exceed the total award amounts listed.

NIDA also sets its budget limits for specific research topics that received a waiver from the U.S. Small

Business Administration to exceed the hard budget caps. The current list of approved NIDA topics can be

found in the SBA-Approved Waiver Topics. NIDA budget limit for Phase I on SBA-approved waiver topics

is $400,000 in total costs and a project period of up to 1 year. NIDA budget limit for Phase II on SBA -

approved waiver topics is $3,000,000 in total costs and a project period of up to 3 years.

In all cases, applicants should propose a budget and a project duration period that are reasonable and

appropriate for the completion of the research project. Applicants are strongly encouraged to contact NIDA

program officials early in the application process to receive assistance regarding the program.

SBIR and STTR Program Information

SBIR and STTR programs at NIH are primarily intended to encourage private-sector technology

commercialization and increase small business participation in federally funded research and

development (R&D). The goal of the NIDA SBIR/STTR program is to increase small business participation

and private-sector commercialization of novel products or services that can help manage, prevent,

monitor, diagnose, and treat acute substance use, chronic substance use, and substance use disorders.

The NIH/NIDA dual peer review system is mandated by statute. A Scientific Review Group (SRG)

composed primarily of non-federal scientists with expertise in relevant scientific disciplines and current

research areas carries out the first level of review. The National Advisory Council on Drug Abuse (NACDA)

performs the second level of review. Only applications that are recommended for approval by both the

SRG and the NACDA may be recommended for funding. Final funding decisions are made by the NIDA

Director.

NIDA funding decisions for small business programs are based on a combination of factors:

• Programmatic priorities and current portfolio balance (for funded projects, please search the NIH

RePORTER database at https://reporter.nih.gov/)

• Potential for commercialization and public health impact;

• For Phase II applications: results of Phase I (or equivalent) clearly indicating that both technical

feasibility and commercial feasibility were established, and the scientific merit and commercial

potential of the project proposed in Phase II;

• For applicants who received preceding SBIR and STTR grants: quality of prior performance and

evidence of Phase III activities;

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• Peer review critiques and overall impact score;

• Security risk, as assessed by the HHS Due Dilligence Program;

• Availability of funds.

Disclosure Requirements Regarding Ties to Foreign Countries

(https://seed.nih.gov/small-business-funding/small-business-program-basics/foreign-disclosure-and-risk-

management)

Applicants to the SBIR and STTR programs are required to disclose all funded and unfunded relationships

with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign

Countries Form (hereafter referred to as the SBIR STTR Foreign Disclosure Form), for all owners and

covered individuals. Applicants who do not submit the completed SBIR STTR Foreign Disclosure Form

during the NIDA JIT process will not be considered for funding. Details of the SBIR and STTR Foreign

Disclosure and Risk Management Pre-award and Post-Award Requirements can be found in NOT-OD-24-

029.

NIDA-specific SBIR and STTR Program Information

NIDA is the largest source of initial funding for research efforts to address the needs of acute substance

use, chronic substance use, and substance use disorder (SUD) markets, undertaken with the goal of

commercialization. Commercialization is a process of delivering new products or services into the market.

Historically, the engagement of large private biomedical enterprises in the SUD space was limited.

Therefore, NIDA is devoted to achieving meaningful impact through enabling small businesses and

startups to commercialize substance use and drug addiction products, services, or technologies. NIDA

acknowledges the importance of project management in successful new product development and

encourages the use of project management tools and terms by the grant applicants.

The SBIR and STTR programs are phased programs:

Phase I: Supporting Feasibility and Proof of Concept. The objective of this phase is to establish the

technical and commercial feasibility of the proposed research or R&D efforts and to determine the quality

of performance of the applicant (small business concern or SBC) before providing further federal support

in Phase II.

Phase II: Supporting Research and Development. The objective of this phase is to continue the research

or R&D efforts initiated in Phase I. Funding will be based on the results of Phase I and the scientific and

technical merit and commercial potential of the Phase II application.

Phase III. The objective of Phase III is for the small business concerns (SBC) to pursue commercialization

objectives resulting from the Phase I/II R&D activities. A Phase III is defined as an award that derives

from, extends, or completes prior SBIR effort and is funded with non-SBIR funds. NIDA encourages

grantees to seek commitment(s) of funds and/or resources from an investor or partner organization for the

commercialization of the product(s) or service(s) resulting from the SBIR/STTR Phase I/II grant. Phase III

funding may come from different sources: private investors, venture capital firms, strategic alliances,

research contracts, sales of prototypes, public offerings, state finance programs, non-SBIR-funded R&D,

or production commitments from industrial firms or a federal agency for use by the U.S. government. NIDA

monitors SBC efforts to pursue, with non-SBIR/STTR funds, the commercialization of Phase I and II

outputs.

While both the SBIR and STTR programs are organized to provide government funding only in Phase I

and Phase II, NIDA is committed to assuring that its grantees are also prepared to successfully execute

Phase III.

Feasibility and Milestones

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This section provides additional requirements and instructions which relate to definitions of the terms

“feasibility” and “milestones” for NIDA-specific applications, as well as addressing funding for assistance

in developing and executing in these areas.

Feasibility

To improve the odds of reaching Phase III, NIDA suggests using a simple desirability-feasibility-viability

(DFV) framework. While envisioning the goal for the Phase I project, NIDA applicants are encouraged to

address both technical feasibility (e.g., “can this offering [product or service] be built?”) and commercial

feasibility (e.g., “should this offering be built?”), which may include the initial explorations into desirability

(e.g., “does anyone want or need this offering?”) and viability (e.g., “how can financial stability be

assured?”).

It is important to understand the resources that NIH allows to establish commercial feasibility. The NIH

Grant Policy (see section 18.5.5.1 Market Research), states that “NIH will not support market research,

including studies of the literature that lead to a new or expanded statement of work ”, under the SBIR or

STTR grant, with the exception of Technical and Business Assistance (TABA) funds (see “Technical and

Business Assistance (TABA)” section below). The policy defines market research as follows: “For

purposes of the SBIR/STTR programs “market research” is the systematic gathering, editing, recording,

computing, and analyzing of data about problems relating to the sale and distribution of the subject of the

proposed research. It includes various types of research, such as the size of potential markets and

potential sales volume, the identification of consumers most apt to purchase the products, and the

advertising media most likely to stimulate their purchases. However, “market research” does not include

activities under a research plan or protocol that include a survey of the public as part of the objectives of

the project to determine the impact of the subject of the research on the behavior of individuals”.

Milestones

In NIDA small business grant applications, a clear understanding of the term “milestone” needs to be

demonstrated. In project management, the milestone is used to define an important decision point at

which significant uncertainty for a given project is resolved. The quest to conduct research activities to

establish technical and commercial feasibility should culminate in reaching a significant milestone. The

NIH SF424 (R&R) Application Guide instructs the applicants to include milestones for every Phase I,

Phase II, Fast Track and SBIR direct to Phase II applications, as these will be used in the evaluation

process. Milestones are evaluated as part of Approach and Investigator(s) review criteria. Missing or

inadequate technical and commercial milestones can therefore negatively affect the application’s impact

score.

In NIDA small business applications, NIDA expects meaningful milestones and milestone deliverables,

associated with each milestone. Specific Aims and milestones are related but distinct elements in the

application. As stated by the SF424 (R&R) Application Guide, Specific Aims are goals, specific objectives,

and expected outcomes of the proposed research. These Specific Aims are the activities that enable a

company to reach a milestone (go / no-go decision point). Each Specific Aim in the application should

therefore have at least one milestone associated with it.

Moreover, milestones, e.g. decision points, are tied to deliverables which are always tangible. Accordingly,

NIDA expects its awardees to identify meaningful milestones and to develop tangible deliverables

associated with each milestone that are specific, measurable, achievable, relevant, and time-bound.

These can be written in the following format:

• Milestone A…

o Specific Aim A…

▪ Milestone Deliverable A (specific, measurable, achievable, relevant, time-bound)…

For example,

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To establish Technical feasibility for a drug discovery and development project:

Milestone 1: In-vitro assay validation for SAR studies

Specific Aim 1: Validate and optimize in vitro assays (Potency and Selectivity)

Milestone deliverable 1 (specific, measurable, achievable, relevant, and time-bound): Within 2

months, achieve Z’ factor of ≥0.5, based on values from at least ½ plate of positive and negative

controls.

Milestone deliverable 2 (specific, measurable, achievable, relevant, and time-bound): Within 4

months, demonstrate that concentration response testing over at least 8 concentrations

generates reproducible IC50 values withing a 3-fold range for 3 standard compounds.

To establish Commercial feasibility for a medical device development project:

Milestone 1: Payor Feedback

Specific Aim 1: Obtain payor feedback regarding requirements for coverage and reimbursement.

Milestone deliverable (specific, measurable, achievable, relevant, and time-bound): Within 3

months of receiving the NIDA Notice of Grant Award, initiate the contact with The FDA CDRH

Early Payor Feedback Program (EPFP) and submit EPFP Overview Request; meet with at least

3 payors to obtain feedback about clinical study design and proposed endpoints necessary to

obtain payor coverage.

Fast-Track Application

The NIH Fast-Track process allows Phase I and Phase II grant applications to be submitted and reviewed

together. It expedites award decisions and funding of SBIR and STTR Phase II applications for

scientifically meritorious projects that have a high potential for commercialization. Fast-Track applications

receive a single rating. Before submitting applications for Fast-Track review, applicants are strongly

encouraged to consult with NIDA program staff to assure that Fast-Track is appropriate. NIDA encourages

Fast-Track mechanisms for those applications for which a high potential for commercialization is

established. For its Fast-Tracks, NIDA also encourages preliminary data that clearly supports technical

and commercial feasibility. If repurposing already-existing drugs or devices for SUD diagnosis or

treatment, preliminary data about existing drug/device and scientific rationale for the feasibility in the SUD

space is required. In addition, NIDA requires a commercialization plan that demonstrates a high probability

of commercialization and letters of Phase III support/interest, additional funding commitments, and/or

resources from the private sector or non-SBIR/STTR funding sources. Letters of interest from potential

commercial partners or investors and letters of commitment of funds or other resources that will enhance

the likelihood of commercialization should be placed following the letters of support for consultants and

collaborators.

Importantly, before Fast-Track Phase II could start, NIDA conducts an administrative review and evaluates

the achievement of the stated milestones. In addition to Approach and Investigator(s), Fast-Track

milestones are assessed in the peer review under Additional Review Criteria: Does the phase I

applications specify milestones that should be achieved prior to initiating Phase II? Applicant’s failure to

provide milestones and specific, measurable, achievable, relevant, and time-bound milestone deliverables

may be sufficient reason for the peer review to exclude the application form the Fast-Track review.

Fast-Track applicants must propose two separate sets of milestones and associate them with specific,

measurable, achievable, relevant, and time-bound milestone deliverables, one set for Phase I and another

set for Phase II. The timelines for milestone deliverables are to be completed sequentially. It is important

to clearly state the go / no-go milestones that will determine a transition to Phase II. Failure to adequately

address these criteria may negatively affect the application's impact score. The following format is

encouraged:

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Phase I

o Specific Aim A…

▪ Milestone Deliverable A (specific, measurable, achievable, relevant, time-bound)…

Phase I Milestone A (go/no-go, pivot)

Phase II

o Specific Aim A…

▪ Milestone Deliverable A (specific, measurable, achievable, relevant, time-bound)…

Phase II Milestone A…

Based on peer review recommendations, NIDA Program Officers may negotiate the Phase I milestones

with applicants and potential Fast-Track awardees before they are included in the terms of the award.

Fast-Track applications will receive a secondary review by the NIDA advisory council. Phase II

applications will be selected for funding based on NIDA's assessment of the Phase I progress, and

determination that the Phase I milestones were achieved; an update and verification of the

Commercialization Plan and any commitment(s) for funds and/or resources from an investor or partner

organization, the project’s potential for meeting the mission of NIDA and for commercial success; and the

availability of funds. NIDA may find it appropriate for an outside reviewer(s) to be involved in the process

of administrative review. If NIDA staff determines that the progress has not been adequate during Phase I,

additional information may be requested. Because of the intricacy of the Fast-Track mechanism, NIDA

staff invites open communication with applicants regarding this complex mechanism. NIDA staff will

monitor program progress against proposed milestones and make non-competing award decisions based

on achieving milestones. If NIDA program staff determines that progress in Phase I has not been

adequate, milestones were not met, and the Fast-Track Phase II is not recommended for funding, that

decision is not appealable.

Technical and Business Assistance (TABA)

NIDA informs its applicants about additional capabilities that may assist in establishing technical and

commercial feasibility through the dedicated TABA funding. Through TABA, small business applicants may

request up to $6,500 per year for a Phase I project and up to $50,000 across all years for a Phase II

project to help address the development and commercialization of their new products and processes

resulting from such projects, including intellectual property protections. TABA funding could be requested

to assist with product sales, intellectual property protections, market research and/or validation,

development of regulatory or manufacturing plans, and access to technical and business literature

available through online databases. Importantly, TABA activities are conducted externally, and, if NIDA

applicants wish to utilize the outside TABA provider/vendor that is not associated with the small business

applicant, they are required to include the vendor as a consultant in the budget and to provide a det ailed

budget justification. All instructions in the SF424 (R&R) Application Guide must be observed. Fast-Track

applications are a combination of both Phase I and Phase II and small businesses can request TABA

funding in both phases within their Fast-Track application up to these amounts for each phase. NIDA does

not allow requesting TABA funding through an Administrative Supplement.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIDA does not participate in the CRP program. NIDA will not accept Phase IIB applications through the

Omnibus or specific program announcements.

Specific Funding Opportunities and Programs Translational Research

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NIDA offers additional funding opportunities and programs to accelerate the preclinical discovery and

development of new medical products for SUD patients, including pharmacotherapeutics and medical

diagnostic and therapeutic devices.

Blueprint MedTech:

(https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint- medtech/blueprint-medtech)

The program aims to support innovators by accelerating the development of cutting-edge medical devices

to diagnose and/or treat disorders of the nervous system. The program provides: (a) non-dilutive funds to

support medical device development activities led by investigators, and (b) additional resources and

support services.

Contact: Leonardo Angelone, PhD, Blueprint MedTech Program Lead (leonardo.angelone@nih.gov)

Blueprint Neurotherapeutics Network (BPN) for small molecules:

(https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-small-molecules)

The program provides both non-dilutive funding and additional resources for small molecule drug

discovery and development, from hit-to-lead chemistry through phase I clinical testing. The program offers

funding, access to NIH-funded contract research organizations (CROs), and access to consultants with

expertise in various aspects of drug discovery and development.

Contact: Elena Koustova, PhD, MBA, Director, NIDA Office of Translational Initiatives and Program

Innovations (koustovae@nida.nih.gov)

Both programs utilize the cooperative agreement (U44) mechanism, which is milestone-driven and

involves NIH program staff participation in developing the project plan, monitoring research progress, and

appropriate go/no-go decision-making. SBIR applicants considering projects involving translational

research are strongly encouraged to contact program staff well in advance of submission.

Clinical Trials

Does NIDA accept Clinical Trials through

the Omnibus/Parent Notices of Funding

Opportunities?

Yes

Does NIDA accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

NIDA accepts and supports SBIR and STTR

clinical trial applications through specific

opportunities, which can be found on the

NIDA Funding Opportunities webpage:

https://nida.nih.gov/funding

Does NIDA support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

NIDA accepts and supports non-SBIR/STTR

clinical trial applications through specific

opportunities, which can be found on the

NIDA Funding Opportunities webpage:

https://nida.nih.gov/funding

Research Topics

The major NIDA SBIR/STTR portfolio areas of interest are listed below as a general guide. Applications

proposing innovative technologies in substance use and addiction with strong commercial potential that

fall outside these portfolio areas are also encouraged through this Omnibus solicitation.

1. Biomarker Development for SUDs

2. Personalized Medicine for SUDs

3. SUD Drug Discovery and Development

4. FDA-regulated Medical Therapeutic and Diagnostic Devices for Substance Use and Addiction

5. Harm Reduction Technologies

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6. Technological Approaches to Decrease Stigma Associated with Substance Use and Addiction

7. Prevention Technology to Address Substance Use and Addiction in Various Underserved

Populations

Biomarker Development for SUDs

Currently, there are no biomarkers to assess or predict treatment efficacy or categorize SUDs into clinical

subtypes. Thus, it is impossible to design treatments for effective and long-term recovery by classifying

SUD patients into categories that have reproducible and predictive validity.

Long-term use of opioids and other substances alters the integrity of homeostasis, changing the

endogenous opioid, endogenous cannabinoid, and almost all receptor systems studied so far in the brain

and peripheral immune cells. Biomarkers and signatures in patients diagnosed with an SUD can be very

different from those observed in patients without SUDs. These biomarkers or potential predictive markers

could serve as objective prognostic indicators to develop SUD. In addition, they could act as response

predictors to SUD therapeutics in adults, or as diagnostic biomarkers for infants with neonatal abstinence

syndrome (NAS). Furthermore, artificial intelligence (AI)-related technologies are being investigated in

healthcare to analyze patients’ big data, such as electronic health records of historical and current patient

treatments, to create more effective and better patient outcomes and to identify new diagnostic tools and

novel analyses. Accordingly, AI-related tools are of interest to accelerate traditional and innovative areas

of SUD biomarker development.

The proposed biomarker research should emphasize the importance of biomarker signatures that can

intersect SUD and related conditions that are considered important to the mission of NIDA. Proposed

projects may include biomarkers that assess the probability of SUD or allow an assessment of the

treatment trajectory in patients under treatment for SUD. Specific projects may encompass, but not

restricted to:

• Biomarkers with high specificity and sensitivity for opioids, stimulants, cannabis and other

emerging substances;

• Biomarkers that can detect substance use in early stage;

• Development of biomarkers that provide objective measures of substance use.

• Biomarkers that can predict an individual’s response to different treatment modalities.

• Biomarkers suitable for longitudinal monitoring of substance use.

• Biomarkers capable of detecting concurrent use of multiple substances

Projects solely focused on biomarkers for pain and alcoholism are of limited interest.

Personalized Medicine for SUDs

Advancements in technology and our deepening understanding of underlying neurobiology have provided

us with the chance to target specific neurobiological processes and tailor interventions approaches to

individual patients based on their unique genetic, neurobiological, and environmental characteristics. This

personalized approach recognizes the significant variability among individuals in how they respond to

medications, therapies, and other interventions. Genetic variations can influence a person’s susceptibility

to developing SUD, and treatment response. Genetic testing would identify specific gene variants

associated with SUD risk, metabolism of drugs and treatment response. Further, neurobiological

differences in brain structure and function can impact how an individual’s experiences and respond to

different substances. Identifying aberrant brain connectivity patterns and assessing neurotransmitter

levels can guide the treatments to modulate the pathways. Finally, social, cultural, and environmental

factors play a significant role in the development and course of SUDs. Areas of interest include but are not

limited to: a) Identifying and leveraging existing social support networks and recognizing environmental

triggers that contribute to substance use and modifications to mitigate the impact and b) utilizing big-data

analytics and predictive modeling to identify patterns and predictors of treatment response and refine

personalized treatment approaches. Overall, personalized medicine holds promise for improving the

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effectiveness and outcomes of SUD treatment by addressing the biological and social factors that

contribute to substance use disorders.

SUD Drug Discovery and Development

Pharmacotherapy offers an important means of treating SUDs. Currently, there are five

pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of Opioid Use

Disorder (OUD) and mitigation of opioid withdrawal symptoms: methadone, buprenorphine, extended-

release naltrexone, naloxone, and lofexidine. In addition, varenicline is an approved drug for the treatment

of nicotine cessation. However, given the diverse nature of SUDs, many patients have limited responses

to available medications and, consequently, there is an urgent need for novel treatments. It remains of

program interest to identify and develop improved pharmacotherapeutics with clear advantages over our

current approved pharmacotherapeutics for OUD treatment and for nicotine cessation treatment.

Additionally, there are no FDA-approved medications for cocaine, methamphetamine, or cannabis use

disorders.

Broadly, novel pharmacotherapeutics are encouraged for the range of unmet medical needs in SUD, for

polysubstance use, and for emerging novel treatment modalities and mechanisms of action for SUD

treatments. Developing and evaluating new, more efficacious medications remains a high priority.

Candidate medications may include either novel or re-purposed compounds.

Specific areas of interest include medications that target one or more domains of the addiction cycle,

including reward, stress and negative affect, incentive salience, executive function, habituation, and

impulsivity/compulsivity. Proposed projects may include emerging technologies and platforms for SUD

medication development with a focus on products with the potential to minimize drug seeking, compulsive

behavior, overdose prevention, and reversal. Specific projects may include, but are not limited to:

• Early therapeutic discovery activities ranging from target identification and validation through lead

development;

• SUD phenotypic assay development (e.g., organoids, organ-on-a-chip technologies, and higher

content invertebrate models, ex vivo bioassays) with validation studies in animal models (e.g.,

rodent models).

• Preclinical and/or clinical drug development;

• Medications that would address specific symptoms of withdrawal, such as cravings, depression,

cognitive impairments, pain, and sleep problems;

• Medications (neurochemicals) involved in social bonding that also modulates key processes

associated with addiction, including reward and stress responses, and may enhance the efficacy

of psychosocial addiction treatments;

• Big-data analytics and machine-learning algorithms analysis yielding insight into behavioral and

biological markers of relapse risk;

• Artificial Intelligence (AI)-related tools in SUD drug discovery and development to increase

innovation and support a cost- and time-effective SUD drug development of pharmacotherapies.

• Combination of pharmacotherapeutics to improve SUD treatment adherence and decrease risk of

relapse. Molecules may include new and investigational compounds and repurposed approved

medications

Projects proposing to study compounds already extensively investigated or currently being studied in

patients with SUD, and projects solely focused on pain or on alcoholism not associated with SUD are of

limited interest.

FDA-regulated Medical Therapeutic and Diagnostic Devices for Substance Use and Addiction

Medical Devices, including Software as Medical Device (SaMD), offer promising means to monitor,

diagnose, and treat patients who use substances for medical purposes, in addition to patients with SUDs.

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Currently, there are only a few devices that are cleared by the FDA for the treatment of SUD. As such, the

investigation and development of new safe and effective medical devices intended to prevent, monitor,

diagnose, and treat substance use and addiction is a high priority. Applications in this area are expected to

address the needs of those who actively use substances, chronically use substances, or have a

diagnosed SUD, and their caregivers, to ensure access to high-quality, safe, and effective medical

devices. It is expected that proposed approaches will include activities that will lead to regulatory

submissions for pre-market clearance / approval, including interactions with the FDA via the following

pathways: pre-submission (Q-submission), Investigational Device Exemption, 510(k), DeNovo, or

Premarket Approval (PMA) application. Additional pre-clinical activities may include, but are not limited to,

a) bench testing or computational modeling studies; b) good laboratory practice animal studies; c) good

manufacturing practice studies; d) toxicology and biocompatibility studies; e) software verification and

validation; f) usability/user experience testing.

Specific areas of interest include, but are not limited to:

• Imaging devices intended to investigate brain function and enhance monitoring, diagnosis, and/or

treatment of SUD;

• Devices that directly diagnose and/or reduce craving and withdrawal symptoms;

• Devices that identify and/or treat NAS;

• SaMD focused on behavioral health interventions to alleviate the burden of SUD;

• Therapeutic devices (e.g., neuromodulation) intended to improve SUD treatment outcomes and

relapse prevention;

• Physiological monitoring devices, including remote detection (e.g., wearables, sensors, health

monitoring/emergency notification systems), specifically intended for use in patients affected by

substance use and addiction.

Harm Reduction Technologies

Harm reduction is an evidence-based public health approach that that directly engages people who use

drugs (PWUD) to prevent overdose, disease transmission, and other harms associated with drug use.

NIDA included harm reduction in its FY 2022-2026 Strategic Plan in Priority Scientific Area #2: Develop

and Test Novel Prevention, Treatment, Harm Reduction, and Recovery Support Strategies. Harm

reduction was also identified as a federal drug policy priority in the 2022 National Drug Control Strategy

from the White House Office of National Drug Control Policy (ONDCP) and is also one of the strategic

priorities of the U.S. Department of Health and Human Services (HHS) Overdose Prevention Strategy.

Decades of evidence has shown that strategies for harm reduction substantially reduce HIV and hepatitis

C infection among people who inject drugs, reduce overdose risk, enhance health and safety, and

increase the likelihood of PWUD to initiate substance use disorder (SUD) treatment (SAMHSA Harm

Reduction Framework 2023).

The ideology behind harm reduction is based on helping PWUD increase their quality of life even if they

are not yet ready to enter treatment. The ONDCP’s Guiding Principles on Harm Reduction are: 1)

supporting individuals and overcoming obstacles in accessing all types of care, from overdose prevention

strategies to medications and mental health services, 2) providing ongoing support to individuals once

harm reduction or treatment services are initiated, 3) creating connections for PWUD with caring staff or

volunteers as part of receiving health and social services, and 4) treating PWUD with respect and dignity

to help them achieve better outcomes. Harm reduction strategies can address safer practices, safer

settings, access to healthcare, transitions to care, sustainable infrastructure, and a sustainable workforce.

Applications addressing harm reduction principles include, but are not limited to, technologies for:

• Education about the value of harm reduction and reduction of stigma surrounding drug use;

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• Prevention, treatment, recovery, and general health promotion for PWUD;

• Addressing overdose education, detection, and naloxone use;

• Promoting safer use (e.g., drug-checking, reducing infection risk);

• Prevention, testing, and treatment for sexually transmitted infections;

• Ensuring access to and assistance with nutrition, clothing, shelter, housing;

• Enabling peer support and the inclusion of people with lived experience in all aspects of care;

• Increasing access to low-barrier treatment services, including access to healthcare and oral

health services;

• Ensuring access to medication and treatment on-demand, including mobile buprenorphine and

methadone;

• Expanding telehealth and addressing low technology literacy;

• Ensuring coordination of care for individuals leaving carceral settings.

Technological Approaches to Decrease Stigma Associated with Substance Use and Addiction

Stigma is understood as a socially constructed phenomenon that occurs when members of a group

experience status loss or discrimination based on some shared characteristic that is deemed undesirable

by others. Its effects can occur through attitudes and beliefs internalized by impacted individuals (self-

stigma), through overt discrimination by others (experienced or enacted stigma), and through the fear of

such discrimination (felt stigma). The stigma around substance use and addiction represents a signific ant

public health problem, despite the growing understanding that substance use and addiction are complex

brain disorders with behavioral and physiological components. As for other disorders, medical care is

often necessary to facilitate recovery and prevent adverse outcomes, including overdose. Patients can

recover from substance use and addiction and lead healthy lives; however, stigma limits successful

access to care. Stigma often may be related to multiple conditions, such as SUD, mental illness, or

infectious disease; behaviors such as specific drug use practices (e.g., opioid injection); or identity

statuses related to gender, sexual orientation, sexual identity, race/ethnicity, or socioeconomic factors,

such as personal income. It is expected that leveraging state-of-the-art technologies and the latest

science will allow to develop and commercialize the products and services aimed at reducing the stigma

around substance use and addiction.

Applications in this topic may propose projects demonstrating how latest technology and evidence-based

science could meaningfully reduce the stigma associated with substance use and addiction. Applications

may address individual (internalized, anticipated, or enacted), interpersonal, organizational, and/or

structural levels of stigma.

Applications and focus can be on any entry point along the continuum of care. Areas of specific research

interest and substance use and addiction service contexts include, but are not limited to:

• Providing anti-stigma training for medical professionals;

• Targeting stigma reduction of non-medical providers (social workers, criminal justice, family

members, and educators);

• Enhancing both employee well-being and effectiveness of a drug-free and stigma-free workplace

program;

• Anti-stigma training specific to adolescent substance use and prevention;

• Digital certification program for nonprofessional care givers who provide support services for

patients with SUD;

• Virtual employee assistance programs with focus on SUD and mental health.

Additionally, examples of technological approaches include, but are not limited to:

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• Natural language processing, computer vision, and other machine learning tools to detect and

analyze provider behaviors and medical records reflecting stigma around substance use and

addiction alone and intersectional stigma;

• Digital compassion (anti-stigma) coaching for medical professionals delivering treatment to SUD

patients exploring immersive technologies such as extended reality;

• Ecological momentary sampling and other digital phenotyping patient-centered tools to detect

points of vulnerability and counteract internal stigma supporting the whole-person model of

recovery;

• Neural activity-based tools and services to help develop and disseminate the most effective anti-

stigma campaign.

Prevention Technology to Address Substance Use and Addiction in Various Underserved

Populations

Differences in race, socioeconomic status, sex, and geography have created inequities in care for

substance use and addiction. Alternatives in healthcare that emerged during the pandemic, such as virtual

doctor visits, along with new tools to facilitate telehealth, may help address some of the barriers to SUD

care for currently underserved populations.

There are three categories for which prevention technology can address substance use and addiction in

various underserved populations despite the aforementioned differences. Primary prevention provides

tools to intervene before health effects occur. Secondary prevention provides screening tools to identify

diseases in the earliest stages before the onset of signs and symptoms. Tertiary prevention provides tools

to manage disease post-diagnosis to slow or stop disease progression.

Applications may address micro- (individual, internalized, anticipated, or enacted), or macro-

(interpersonal, organizational, and/or structural) levels of health inequities related to various underserved

populations. The focus of applications can be on any entry point along the continuum of substance use

and addiction care. Examples include:

• Primary prevention through measures such as altering risky behaviors (cannabis and/or tobacco

use), and banning substances known to be associated with a disease or health condition.

• Secondary prevention through measures such as SBIRT (Screening, Brief Intervention, Referral

to Treatment).

• Tertiary prevention through measures such as rehabilitation, and medication assisted therapy.

Areas of specific research interest with respect to substance use and addiction service contexts include,

but are not limited to:

• Providing prevention education and behavior change training for medical professionals; targeting

knowledge awareness and behavior change for non-medical providers (social workers, criminal

justice, family members, and educators);

• Digital or non-digital behavior change interventions enhancing both employee well-being and

effectiveness of a drug-free workplace program;

• Digital or non-digital prevention education training specific to adolescent substance use and

prevention;

Additionally, examples of technological approaches include, but are not limited to:

• Machine learning tools (e.g., natural language processing) for provider/medical record substance

use and addiction bias;

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDA 71

• Digital mindfulness coaching for medical professionals delivering substance use and addiction

services with virtual reality;

• Ecological momentary sampling and other digital phenotyping patient-centered tools to detect

points of vulnerability and address them with a whole-person model of recovery.

Contact Information

Prior to Submission: Applicants are strongly encouraged to request a technical assistance meeting with

NIDA SBIR/STTR staff prior to submitting any application. To schedule a meeting, please email:

Ernestine Lenteu

Program Specialist

NIDA Office of Translational Initiatives and Program Innovations

NIDASBIR@mail.nih.gov.

For additional information on research topics, please contact a Program Officer with the relevant

area of expertise:

Leonardo Angelone, PhD

Program Officer

Email: leonardo.angelone@nih.gov

Areas of expertise: FDA-regulated therapeutic and diagnostic devices for substance use and addiction.

Morris Flood, DHSc

Program Officer

Email: morris.flood@nih.gov

Areas of expertise: Consumer products and approaches that address the health-related social needs that

impact substance use and addiction; and digital health technology translation to commercial substance

use and addiction products that address the overall social determinants of health.

Stacie Gutowski, PhD

Program Officer Email: stacie.gutowski@nih.gov

Areas of expertise: FDA-regulated therapeutic and diagnostic devices for substance use and drug

addiction, including neuromodulation.

Saravanan Karuppagounder, PhD

Program Officer

Email: saravanan.karuppagounder@nih.gov

Areas of expertise: Therapeutics for Stimulant Use Disorders and Marijuana or Cannabis Use Disorder,

Biomarker Development and Validation.

Yordan Kostov, PhD

Program Officer

Email: yordan.kostov@nih.gov

Areas of expertise: FDA-regulated monitoring and diagnostic devices for substance use and addiction,

including target-agnostic detection.

Tam Nguyen, PhD

Program Officer

Email: tam.nguyen@nih.gov

Areas of expertise: Pharmacotherapeutics for opioid use disorder, overdose reversal, and smoking

cessation.

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NIDA 72

Boris Sabirzhanov, PhD

Program Officer

Email: boris.sabirzhanov@nih.gov

Areas of expertise: Helping to End Addition Long-term (HEAL) initiative.

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NIDCD 73

NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION

DISORDERS (NIDCD)

Mission

The NIDCD supports research on the normal mechanisms of, as well as on diseases and

disorders of hearing, balance, smell, taste, voice, speech and language. The Institute also

supports research related to disease prevention and health promotion. The NIDCD addresses

special biomedical and behavioral problems associated with people who have communication

impairments or disorders. The NIDCD also supports efforts to create and refine devices, as well

as develop cellular-based applications that may replace or substitute for lost and impaired

sensory and communication functions. For more information about areas of interest, please visit

our home page at http://www.nidcd.nih.gov/ and the NIDCD Strategic Plan website

(https://www.nidcd.nih.gov/about/strategic-plans). Potential applicants are encouraged to

contact the program staff noted below early in the process of preparing the application.

Budget Guidance

Total funding (direct costs, indirect costs, fees) normally may not exceed the amounts defined by

the SBA, which can be found on the NIH SEED website. Applicants considering a requested

budget greater than these limits are strongly encouraged to contact program staff before

submitting the application. The Small Business Administration has allowed NIDCD to make

awards that exceed these amounts for the areas noted in the SBA-Approved Waiver Topics. For

topics listed in the SBA-Approved Waiver Topics, the NIDCD generally will not fund Phase I

applications greater than $385,000 total costs or Phase II applications greater than $3,000,000

total costs. All applications must contain sufficient detail to justify the requested budget, and

NIDCD may decrease the length of an award and/or the budget as recommended by a review

committee or administrative review.

Specific SBIR and STTR Program Information

NIDCD will accept applications for support of clinical trials in any of the areas noted above.

NIDCD does not accept applications for Phase IIB competing renewal awards.

NIDCD participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program.

Clinical Trials

Does NIDCD accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NIDCD accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does NIDCD support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

NIDCD accepts and supports non-SBIR/STTR

clinical trial applications through specific

opportunities, which can be found on the

NIDCD Funding Opportunities webpage:

https://www.nidcd.nih.gov/research/clinical-

studies/researchers-professionals/know-what- is-

available

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCD 74

Research Topics

The NIDCD accepts a broad range of small business applications that are significant,

innovative, and relevant to its mission. Some examples of research topics within the NIDCD

mission areas include topics shown below; further example can be found on the NIDCD

Strategic Plan website (https://www.nidcd.nih.gov/about/strategic-plans).

Priority is given to meritorious applications that are likely to develop innovative technologies, provide

clear evidence of effectiveness, and bring novel products to the commercial marketplace.

Hearing and Balance Program

Development of treatment modalities to prevent or lessen the effects of hearing disorders;

development of new hearing aids, over the counter hearing aids, cochlear implants, and other

assistive devices; development of improved screening technologies to assess hearing loss, in

adults as well as in neonates and infants. Development of technologies that provide self-fitting,

self-adjusting, or other features that increase performance, accessibility, or affordability of

hearing aids; development of new outcome measures for assessing the efficacy of treatments for

hearing disorders. Development of technologies for the diagnosis and treatment of tinnitus.

Development of technologies for the diagnosis and treatment of otitis media including non-

invasive diagnostics to identify middle ear pathogens, novel antibacterial strategies, and

prophylactic anti-microbial strategies. Development of technologies for the study, diagnosis and

treatment of noise-induced and age-related hearing loss.

Development of technologies for the study, diagnosis and treatment of balance disorders,

particularly for the elderly; development of clinical tests and instruments to assess

balance/vestibular function; development of instruments and tests measuring head stability and

vestibular function during natural stimulation of the vestibular system; development of perceptual

reporting techniques and psychological indices for clinical assessment of the balance-disordered

patient; development of tests and new outcome measures for assessing the efficacy of physical

rehabilitative regimens for balance disorders; and development of assistive devices for balance

disorders, including neural prostheses for the vestibular system.

Development of new research tools to aid in the study of the auditory and/or balance systems

that can provide an improved understanding of fluctuating patterns of neural circuit structure and

function over time and across large assemblies of neurons; new animal models of impaired

function; improved diagnostic tools for inner ear function, including DNA-based assays and

biochemical markers of disease; innovative tests and instruments to screen for and diagnose

inner ear function. Development of technologies to enable gene transfer to the inner ear,

including viral vectors and cell type specific markers and probes to examine cell lineage in inner

ear regeneration. Development of innovative in vivo imaging capabilities to significantly advance

visualization, diagnosis, and treatment of disorders in the clinic.

Voice, Speech, and Language Programs

NIDCD is interested in the development of technologies for the study of communication

disorders: nature, causes, diagnosis, treatment, and prevention. These communication

disorders include but are not limited to: aphasia, apraxia, developmental language disorders,

dysarthria, dysphonia, and stuttering. In addition, research is needed for communication

challenges that may accompany individuals with autism, deafness, hearing loss, or the inability

to rely on spoken language as a primary means of communication. NIDCD is particularly

interested in projects that employ a user-centered design or similar approach that engages the

target end user throughout the development and research process. In addition, these

technologies should be accessible to culturally and linguistically diverse populations.

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NIDCD 75

The emphasis of responsive projects may include the development of technologies such as:

augmentative and alternative communication (AAC) devices; assistive device enhancements

that better simulate natural speech (e.g. age, gender, emotion); brain computer interface (BCI)

communication prosthesis; mobile health applications; gender affirming voice care; flexible and

adaptable treatment delivery systems or intervention protocols that can be easily tailored to the

needs of an individual; improved artificial larynges and tracheoesophageal shunts; artificial

intelligence computer models that simulate normal and disordered communication;

virtual/augmented reality approaches to treatment; and technologies that assist in the access to

or delivery of healthcare during a public health crisis.

Taste and Smell Program

Development of easily administered diagnostic tools for testing human chemosensory function

throughout the lifespan; development of intervention strategies and targeted drugs for the

treatment of taste and smell disorders; preventive measures to limit the harmful effects of

infections, airborne toxins, radiation, chemotherapy and other drugs on chemosensory function;

novel therapies to stimulate regeneration of mature sensory neurons in damaged and/or aged

tissue; development of biomarkers for neurodegenerative disease; development of tools to

facilitate chemosensory research including improved neuroimaging techniques and visualization

at structural and cellular levels.

Contact Information

For administrative and business management questions,

contact:

Ms. Samantha Tempchin

Grants Management Officer

National Institute on Deafness and Other Communication

Disorders 301-435-0713, Fax: 301-451-5370

Email: tempchins@nidcd.nih.gov

For additional information on the following research topics, contact:

Hearing and Balance, BCI Communication Prostheses, Taste and Smell Programs

Roger L. Miller, Ph.D.

National Institute on Deafness and Other Communication

Disorders 301-402-3458

Email: roger.miller@nih.gov

Language Program

Holly L. Storkel, Ph.D.

National Institute on Deafness and Other Communication

Disorders 301-451-6842, Fax: 301-402-0390

Email: holly.storkel@nih.gov

Voice & Speech Program

Lisa M. Kopf, Ph.D.

National Institute on Deafness and Other Communication

Disorders 240-678-2544, Fax: 301-402-0390

Email: lisa.kopf@nih.gov

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NIDCR 76

NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

(NIDCR)

Mission

The NIDCR advances fundamental knowledge about dental, oral, and craniofacial (DOC) health

and disease, and translates these findings into prevention, early detection, and treatment

strategies that improve overall health for all individuals and communities across the lifespan. For

more specific information about areas of interest to the NIDCR, please visit our home page at

http://www.nidcr.nih.gov.

NIDCR’s small business programs are highly focused on maximizing translational science

opportunities – moving rapidly and translating basic dental and orofacial discoveries into useful

products.

Budget Guidance

Total funding (direct costs, indirect costs, fees) normally may not exceed the amounts defined by

the SBA, which can be found on the NIH SEED website. Applicants considering a requested budget

greater than these limits are strongly encouraged to contact program staff before submitting the

application. The Small Business Administration has allowed NIDCD to make awards that exceed

these amounts for the areas noted in the SBA-Approved Waiver Topics. All applications must

contain sufficient detail to justify the requested budget, and NIDCR may decrease the length of an

award and/or the budget as recommended by a review committee or administrative review.

Specific SBIR and STTR Program Information

Special Statement regarding clinical trials:

NIDCR does not support clinical trials through SBIR/STTR programs. Small business concerns

proposing a clinical trial must use the UG3/UH3 program. Projects seeking to propose technology

validation studies within SBIR/STTR applications that involve human subjects research must

provide a detailed justification describing that the funds available through these awards can

adequately support the proposed human subject study especially if the study is testing a drug,

device or biologic in support of an investigational new drug (IND) or investigational device (IDE)

application.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIDCR does not accept Phase IIB renewal applications. NIDCR participates in the CRP program but

does not support clinical trials through the CRP program.

Clinical Trials

Does NIDCR accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Does NIDCR accept Clinical Trials

through specific Notices of Funding

Opportunities?

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 77

Does NIDCR support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

NIDCR Clinical Trial Planning and

Implementation Cooperative Agreement

(UG3/UH3 Clinical Trial Required) and

subsequent reissues

NIDCR Behavioral and Social Intervention

Clinical Trial Planning and Implementation

Cooperative Agreement (UG3/UH3 Clinical

Trial Required) and subsequent reissues

Research Topics

Translational Developmental Biology and Mammalian Genetics and Genomics

Priorities are to 1) understand the development of craniofacial complex and 2) elucidate the

mechanisms underlying dental, oral, and craniofacial (DOC) conditions and disorders. The ultimate

goal is to enable early prevention, diagnoses, and treatments of DOC conditions and disorders on

individual basis. Interests in this area include but are not limited to:

Develop advanced assays and reagents that allow robust and scalable throughput to

genetically engineer and functionally characterize organisms in craniofacial development

and genetics studies.

Develop novel or improved methods and devices that are minimally or non-invasive, cost

effective, and sensitive, for early detection of DOC conditions and disorders using

imaging, multi-omic, and other state-of-the art technologies and approaches. Methods

and devices suitable for Point of Care, at home, and telemedicine uses are encouraged.

Develop methods that are applicable to early treatments (as early as in utero or

perinatal, or at a later developmental stage) for human DOC conditions and disorders.

Translational Dental, Oral, and Craniofacial Data Science

Priorities are to 1) maximize the utility of Big Data to accelerate DOC research and 2) better

enable evidence-based and data science-driven clinical practices. Interests in this area include but

are not limited to:

Develop advanced analytics to retrieve diverse, multi-dimensional data from data

repositories, knowledgebases, literature, electronic health/dental/medical/records, and

other sources, and infer relations between data elements to inform basic and clinical

DOC research. Machine Learning/Deep Learning/Artificial Intelligence (ML/DL/AI) and

natural language processing tools are considered highly relevant.

Develop phenotyping, data curation, and data analysis web interfaces for clinicians to

support clinical decision making.

Develop devices, including those for Point of Care, at home, and telemedicine uses, for the

diagnoses of DOC conditions and disorders. Examples include, but are not limited to,

imaging and AI based facile devices.

Infectious Diseases and Immunity

Research relating to the etiology, pathogenesis, prevention, diagnosis and treatment of infectious

diseases of the oral cavity is supported by the NIDCR. This includes research on practical ways to

effectively use the host immune system to prevent or treat oral infectious diseases and microbial-

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 78

induced inflammation. Infectious diseases of the oral cavity include caries, periodontitis, candidiasis,

peri- implantitis, pulpitis, and various viral, bacterial, and fungal infections of the oral mucosa and

research on the diagnosis and prevention of oral manifestations and malignancies of HIV infection

and AIDS. Specific examples of technology development needs include but are not limited to:

Develop ways to overcome or eliminate the risk of oral infections in persons who smoke

or chew tobacco, drink alcohol, or are immunosuppressed, have diabetes, are

malnourished, or are psychologically stressed.

Explore novel methods or agents to eradicate oral biofilms (dental plaque) on teeth, oral soft

tissues, and dental implants without adversely affecting the normal oral flora.

Isolate, synthesize or prepare new antibiotics and antimicrobial agents that can overcome

bacterial and fungal resistance to current compounds. Formulate combinatorial drug

regimens to attack microbes growing in oral biofilms (dental plaque).

Develop controlled release systems for local delivery of synthetic peptides, recombinant

proteins, or other chemical or immunotherapeutic agents to prevent, control, and/or treat

oral infectious diseases, or the oral manifestations of HIV infection.

Develop biological response modifiers or other immunological approaches to reduce or

eliminate microbial-induced chronic inflammation or the tissue destruction associated

with chronic inflammation in the oral cavity.

Develop ways to interfere with microbial colonization and growth through the use of

antimicrobial agents and chemotherapy.

Identify and exploit the structural features of oral biofilms for increased therapeutics delivery.

Develop computer programs and apply systems biology approaches to model

biologically active peptide regions of oral components that have anti-fungal, anti-

bacterial and anti-viral activities.

Develop substitutes of naturally occurring chemicals (phytochemicals) known to have

a role in controlling opportunistic infections induced by HIV.

Develop synthetic peptides and recombinant proteins of oral components with anti-

fungal, anti- bacterial and anti-viral activities including those against HIV and oral

opportunistic pathogens.

Develop oral topical formulations with combined microbicide, analgesic, and anti-

inflammatory activities to enhance oral mucosal defenses and prevent and/or control oral

infections and lesions in HIV-infected and/or immunosuppressed subjects.

Discover, test, standardize, and validate novel biomarkers present in oral

biospecimens for screening and clinical diagnosis of HIV, and oral opportunistic

pathogens infections and AIDS malignancies. Apply similar strategies as listed below

for oral, oropharyngeal and salivary gland cancers to AIDS malignancies.

Develop the next generation of rapid tests and point of care devices to detect, quantify,

screen, and diagnose HIV and oral opportunistic pathogens. Develop novel assays to

quantify oral mucosal reservoirs for oral viruses, oral immune responses to viral

prophylactic and therapeutic vaccines, and viral changes due to anti-viral treatments.

Develop safe and effective targeted diagnostic and therapeutic technologies in

response to endemic and pandemic infections.

Oral, Oropharyngeal and Salivary Gland Cancers

Emphasis is on molecular mechanisms of oral epithelial cell deregulation that lead to oral

cancers. Research related to early detection, diagnosis, and prevention, and treatment of oral

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 79

cancers is of particular interest. Examples include but are not limited to the following areas:

Develop imaging techniques for the early detection, diagnosis and prognosis of pre-

malignant lesions.

Develop effective pharmacological, immunological and radiological modalities for

treatment of pre- malignant and malignant lesions in preclinical models.

Develop novel technologies for the genetic and molecular-targeted therapy (e.g. siRNAs,

peptide- based therapies) in preclinical models.

Develop genetic animal models of oral cancer premalignancy and oral cancer progression

that mimic human oral cancers, including HPV-associated oropharyngeal cancers.

Develop animal models to facilitate the testing of therapeutic and chemopreventive

agents for oral cancers.

Temporomandibular Disorders and Orofacial Pain

Emphasis is on research for chronic disabling painful diseases of the oral-craniofacial-dental areas

including chronic pain, neuropathies, and diseases of the temporomandibular joint. NIDCR

encourages applications that include but are not limited to:

Develop improved methods and technologies for measuring nociceptive,

chemosensory, tactile, kinesthetic, or proprioceptive function involving craniofacial

structures. Such measures may be useful in screening for deficits, improving

diagnosis, or for evaluating responses to orofacial treatments or interventions.

Develop improved biomarkers for neuropathic pain conditions affecting oral-craniofacial

tissues or structures.

Develop assays facilitating reliable evaluations of relationships between biological and

other risk factors as they relate to onset, and exacerbation of pain and for examining

transition from acute pain to chronic pain conditions.

Identify and develop novel pharmacologic or biological agents, and non-pharmacologic

methods/approaches, including but not limited to small molecules, peptides,

recombinant proteins, nucleic acids, electrical stimulation, and others which could

be grouped broadly to electromagnetic induction to modulate mood/nerves, to

prevent, control, and/or treat orofacial pain.

Develop animal models to facilitate testing of therapeutic agents for orofacial pain.

Saliva, Salivary Diagnostics, and Salivary Gland Diseases

Emphasis is on salivary gland physiology and pathophysiology and in the repair and restoration of the

damaged gland. Examples include but are not limited to:

Develop viral, non-viral and gene therapy-based approaches to address compromised

salivary gland function. Develop cell and tissue-based strategies and technologies for

restoration of damaged or destroyed salivary gland function.

Develop novel compounds or materials that protect and preserve salivary glands from

head and neck cancer irradiation therapy.

Develop non-invasive methods for the determination of efficacy and safety of

artificial saliva, sialogogues, and their delivery vehicles used in addressing the

diminution or lack of saliva (xerostomia) due to Sjögren’s Syndrome or head and

neck cancer irradiation therapy.

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NIDCR 80

Develop biomarker-based technologies for the identification of Sjögren’s Syndrome using

blood or saliva as body fluids.

Identify biomarkers derived from oral fluids that are predictive of the onset,

progression and recurrence of oral diseases and conditions, such as periodontal

diseases, caries, and oral, oropharyngeal and salivary gland cancers.

Develop immunological strategies and immunotherapy-based approaches for addressing

xerostomia from Sjögren’s Syndrome.

Improve existing or develop new tools for early detection of salivary gland cancers.

Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental

and Craniofacial Tissues

Emphasis is placed on the development of a broad range of technologies targeted at regeneration

and restoration of diseased and injured hard and soft tissues of the oral and craniofacial complex

and on translating these applications to the clinic. Tissues of interest include craniofacial and

alveolar bone, the periodontal ligament, TMJ bone and cartilage, oral mucosa, facial skeletal

muscle, vasculature and nerves. Also of interest are multi-tissue composites and organs, such as

vascularized and innervated bone and muscle, salivary gland, tooth, periodontium, bone-

periodontal ligament-cementum interface and osteochondral complexes. Specific topics could

include but are not limited to:

Develop technologies for design, fabrication, and manufacturing of biomimetic and

biocompatible biomaterials and a range of structurally complex scaffolds, including

nanomaterials and self-assembling nano-scaffolds, for tissue engineering and

regenerative medicine applications. Projects need to include assessments

demonstrating the ability of biomaterials and scaffolds to support generation and

regeneration of mineralized tissues that replicate the mechanical, physical and biological

properties of dentin, enamel, cementum, or bone.

Develop cell-based technologies, including stem cell-based technologies. These include,

designing strategies for isolation, purification, differentiation, scaled up production,

manufacturing, standardization and quality control of stem and progenitor cells and their

differentiated progenies, derivation of efficient and predictable methodologies for cellular

reprogramming, and advancing technologies for reconstruction of stem cell niches for

augmenting tissue regeneration.

Develop bioreactor systems to facilitate design, fabrication, and manufacturing of soft and

hard tissues of dental, oral and craniofacial complex. These bioreactors may be able to

mimic biophysical forces, such as mechanical and electrical forces that normally guide

tissue morphogenesis in vivo. Among other desirable features of the bioreactors are

maintenance of tissue construct oxygenation and real-time tissue assessment to

encompass metabolites, gene expression, or proteomics evaluation, in addition to

morphology and spatial imaging by labeling capabilities.

Develop improved dental composite materials and bonding agents, including biomimetic

and self-healing materials and adhesive sealants. These include but are not limited to

materials to replace Bis-GMA resin-based systems that are suitable for restoring crowns of

posterior teeth and exposed roots of the teeth. Any novel dental composite restorative

components or systems must include assessments in a physiologically relevant test

system that mimics microbial and physicochemical conditions found in the oral cavity.

Develop methods, materials, and devices for orthodontic, prosthetic, periodontic,

endodontic and craniofacial applications including those that can be used for craniofacial

bone distraction, reconstruction, hard and soft craniofacial tissue healing and regeneration,

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 81

and scarless craniofacial tissue repair.

Develop miniaturized artificial tissue and organ mimics/tissue chips and organoids that can

be adapted to high-throughput formats for a broad range of applications, such as analysis of

biomaterial and tissue function, drug efficacy and toxicology assays, biocompatibility

assays, genetic screening and elucidating mechanisms of dental, oral and craniofacial

development and disease.

Develop mathematical, computational, and bioinformatics approaches for modeling oral

and craniofacial tissues and organ function and physiology to address needs of systems

biology, synthetic biology, and single cell analysis. Develop new approaches for utilizing

novel biomolecules, including growth factors, cytokines, small molecules, siRNAs, and

others for counteracting diseases and injuries of oral and craniofacial tissues and

promoting their healing and regeneration.

Develop new approaches to study molecular or cellular interactions between hard and soft

tissues such as between the nervous system and mineralized tissues. Approaches can

include development of new technologies or application of existing technologies that are

newly applied to the dental and craniofacial field.

Develop advanced viral and non-viral based biomolecule delivery approaches, including

nanotechnology-based technologies that can precisely deliver and release therapeutic

proteins, nucleic acids, small molecules, or combinations thereof with predictable temporal

kinetics to target specific tissue sites.

Develop imagining diagnostics to accelerate clinical implementation of reliable,

reproducible, highly specific and sensitive diagnostic instruments for various applications,

including but not limited to dental caries, cracked teeth, pulp vitality, bone quality, and

periodontal disease.

Develop imaging diagnostics to accelerate clinical implementation of reliable, reproducible,

highly specific and sensitive diagnostic instruments for various applications, including but

not limited to dental caries, cracked teeth, pulp vitality, bone quality, and periodontal

disease.

Develop safe and effective biosensors for noninvasive, dynamic real-time monitoring of

physiological processes in the human body using the oral cavity as the sensing site. These

biosensors will be able to assess health and disease states and receive feedback from body

fluids and clinical compounds that are found in or pass through the oral cavity and in certain

cases, will be able to communicate these outputs wirelessly and remotely.

Develop safe and effective biosensors, monitoring devices and systems, data driven and

computer science tools for automated detection, diagnosis and treatment of dental, oral and

craniofacial disease.

Develop effective multimodal breakthrough technologies for real-time detection of proven

disease biomarkers, viruses and/or pathogens with high sensitivity and specificity that

integrate detection technologies, such as optical spectroscopy, electrical impedance, radio

frequency, acoustic, and immunosensing, with multiplexing capability.

Preclinical Research

Preclinical research and development activities for dental and craniofacial technologies

including the translation of innovations devices, drugs, biologic and combination products

(reconstructive materials, regenerative products, pharmaceuticals, therapeutics, vaccines,

digital health technologies) that require review and approval by the FDA as a regulated

product before commercial distribution.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 82

Biomedical Clinical Research

Emphasis is on development of methods, drugs and materials to diagnose or treat oral and craniofacial

diseases and conditions. Areas of interest include but are not limited to projects that:

Develop improved methods to detect and predict progression of dental caries, periodontal

disease, reversible and irreversible pulpitis.

Develop improved methods or materials to prevent dental, oral, and craniofacial diseases or

conditions.

Develop new or improved methods or materials to enhance oral and craniofacial surgery.

This would include both intraoral and extra-oral surgery.

Develop improved methods or materials to mechanically and/or biologically repair or treat

tooth structure damaged by dental caries or periodontal disease.

Develop, customize, and validate data-driven technologies coupled with automated high

throughput tools that accelerate development and regulatory evaluation of novel

biomaterials.

Develop improved appliances to aid suckling and improve speech production by newborn infants

with cleft palate and cleft lip.

Develop safe and efficacious methods to diagnose caries, pulp vitality and / or periodontal

diseases utilizing non-ionizing radiation.

Develop technologies for local delivery of drugs to treat oral and craniofacial diseases or

disorders.

Develop novel non-opioid pharmacological medications for management of acute dental pain.

Develop safe and efficacious methods or medications to manage complications of head and

neck cancer treatment.

Develop tools for implementation of precision medicine in the oral cavity.

Develop methods and tools to detect soft tissue pathologies in the oral cavity.

Develop oral devices and materials for monitoring local and systemic conditions.

Behavioral Clinical Research

Provides support for the development of evidence-based products related to behavioral and

social aspects of oral health, oral health prevention or treatment interventions, and other patient-

oriented aspects of oral health. This includes support for clinical trials and patient-oriented

research to establish safety and initial efficacy of products. NIDCR is especially interested in

applications that significantly improve oral health by 1) being broadly applicable to many

populations, 2) contributing to meaningful oral health improvements for a specific population, 3)

expediting translation of research findings into oral health improvements, and/or 4) equipping oral

health care providers, educators or researchers with tools to improve public oral health.

Examples of studies of interest include, but are not limited to, the following:

Develop and test the effectiveness of innovative teaching or educational tools or curricula to

inform oral health professionals and dental students regarding the role of genetics and

genomics, including the oral microbiome, in oral diseases, conditions and oral health care;

and/or oral cancer prevention and early detection.

Develop and test digital health, connected technologies, and approaches to improve time-

sampled monitoring of behavioral adherence with preventive, condition management, or

therapeutic regimens specifically relevant to oral diseases/conditions. Such devices or

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDCR 83

methods could be utilized in a variety of settings, including naturalistic settings, within

clinical trials, within oral health care delivery systems, etc.

Develop and test novel compliance and survey measures or tools to identify the underlying

causes of insufficient preventive dentistry for specific underserved populations.

Develop and test for safety, efficacy, and/or effectiveness of measures or materials for

diagnosing, preventing, or treating oral, dental, and craniofacial conditions and disorders.

Develop or adapt for use in new populations or settings: Novel measures or methods for

identifying individual, family, group, or other processes that explain oral health behavior;

oral health interventions utilizing technology to improve efficiency of delivery (e.g.,

management of chronic pain related to temporomandibular joint disorders, etc.);

interventions addressing health behaviors highly associated with oral health (e.g., tobacco,

alcohol, and other drug use; management of diabetes, HIV infection, or other chronic

illnesses; etc.).

Develop and test innovative methods for facilitating collaborations, referrals, and/or ongoing

follow- ups between oral health professionals and other health care professionals across

primary and specialty practices.

Develop technologies or modules beyond existing web-based platforms to improve

preventive oral health hygiene for children and adolescents (e.g., social marketing via app-

and web- based interaction, virtual reality “worlds”, “massively multiplayer online games”,

etc.).

Develop and test web-based training or other innovative approaches for oral health care

professionals to accelerate accurate translation of new knowledge regarding oral diseases

and their effective prevention or treatment into clinical or public health practice.

Contact Information

For additional information on research topics,

contact: Orlando Lopez, Ph.D.

Dental and Craniofacial Small Business Coordinator

Division of Extramural Research

National Institute of Dental and Craniofacial Research

NIH

6701 Democracy Blvd., Rm. 612

Bethesda, MD 20892-4878

(301) 402-4243

Email: orlando.lopez@nih.gov

For administrative and business management questions,

contact: Gabriel Hidalgo, MBA

Acting Chief Grants Management Officer

National Institute of Dental and Craniofacial Research

6701 Democracy Blvd., Rm. 656

Bethesda, MD 20892-4878

(301) 827-4630

Email: gabriel.hidalgo@nih.gov

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NIDDK 84

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY

DISEASES (NIDDK)

Mission

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to

conduct and support medical research and research training and to disseminate science-based

information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional

disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health

and quality of life. For additional information about areas of interest to the NIDDK, please visit our

home page at http://www.niddk.nih.gov. See our SBIR/STTR page at

https://www.niddk.nih.gov/research-funding/research-programs/small-business.

Please also find the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Strategic Plan for Research, published in December 2021, at https://www.niddk.nih.gov/about-

niddk/strategic-plans-reports/niddk-strategic-plan-for-research.

Budget Guidance

For budgetary, administrative, or programmatic reasons, the NIDDK may not fund an application or

may decrease the length of an award and/or the budget recommended by a review committee.

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts defined

by the SBA, which can be found in the “Award Budget” section of the current Omnibus Solicitations.

With appropriate justification from the applicant, the NIDDK may consider budgets that exceed these

amounts to support research that aligns with an approved waiver topic (see SBA-Approved Waiver

Topics).

The NIDDK generally considers:

•

Phase I budgets up to $350,000 total costs or project periods up to 2 years.

•

Phase II applications up to $2,200,000 total costs or project periods up to 3 years

(Phase II budgets generally should not exceed $1,100,000 total costs in any

year).

•

Phase IIB (see below) applications up to $3,000,000 total costs or project periods up to

3 years (Phase IIB budgets generally should not exceed $1,100,000 total costs in any

year).

Applicants considering a requested budget greater than these limits are strongly encouraged to contact

program staff with a draft of their Specific Aims page before submitting an application.

The NIDDK also participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program.

Applicants should review the Award Budget section of relevant Notices of Funding Opportunities. For

Phase II awardees, especially those developing products that require clinical evaluation or approval

by a Federal regulatory agency, the NIDDK strongly encourages potential applicants to apply to

NIDDK’s Phase IIB program.

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Specific SBIR and STTR Program Information

NIDDK will accept clinical trials in most of the areas within the mission of the NIDDK. NIDDK does

not support clinical trials in hematologic diseases.

Final Progress Reports

As detailed in NOT-OD-17-085, the NIH has implemented the Final Research Performance Progress

Reports (Final RPPR) for SBIR/STTR Final Progress Reports.

The NIDDK is interested in tracking the progress of the small business concerns it funds and the

products they develop. Funding priority will be given to those small business concerns that show not

only their ability to develop products but also their growth as a small business concern towards

independence from the SBIR/STTR program.

Additional Programs and Services for NIDDK SBIR/STTR Awardees

The NIDDK encourages awardees to apply to participate in programs NIH offers to support the

development of their products (https://seed.nih.gov/support-for-small-businesses). The NIDDK may

offer additional programs throughout the year, and awardees are encouraged to keep their contact

information current so that they receive announcements regarding these programs.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIDDK will accept Phase IIB SBIR/STTR Competing Renewal grant applications (only) from NIDDK-

supported Phase II awardees that propose to continue the process of developing products that

ultimately require 1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3)

continuing refinements to durable medical equipment (DME) designs such as cost reduction, testing

for safety, durability, and reliability, and meeting or establishing standards. This renewal grant should

allow small businesses to get to a stage where interest and investment by third parties is more likely.

Such products include, but are not limited to biological products, devices, drugs, medical implants,

etc. related to the mission of the NIDDK. These awards are intended to support completion of

research needed for an Investigational New Drug (IND) application or Investigational Device

Exemption (IDE). Applicants must provide evidence that they have consulted formally with the U.S.

the Food and Drug Administration (FDA) concerning the research needed for the development of a

drug, biologic or medical device and that the proposed research will address these regulatory

requirements. Such evidence should include FDA correspondence from a pre-IND meeting for an

IND application or a pre-IDE meeting for an IDE application, and the status of the project in a

timeline related to Federal regulatory approval processes. Applicants should describe these

consultations and the outcomes in the Progress Report section of the Research Strategy and

provide FDA correspondence or meeting minutes as part of Just-in-Time procedures.

Examples of research that would be considered responsive to this announcement are listed below for

illustrative purposes and are not exclusive of other appropriate activities.

•

Completion of studies as required by the FDA for an IND or Radioactive Drug Research

Committee (RDRC) application.

•

Assessment of devices with regard to performance standards related to the FDA approval process.

•

Clinical studies in support of an application for clearance or approval by the FDA. See the

table below and review NIDDK’s Policies for Clinical Researchers

(https://www.niddk.nih.gov/research- funding/human-subjects-research/policies-clinical-

researchers) when considering an application involving human subjects.

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The NIDDK also participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program.

Please review CRP NOFOs for NIDDK’s participation. For Phase II awardees, especially those

developing products that require clinical evaluation or approval by a Federal regulatory agency, the

NIDDK strongly encourages potential applicants to apply to NIDDK’s Phase IIB program.

Clinical Trials

Does NIDDK accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

The NIDDK accepts SBIR, but not STTR

applications with NIH-defined clinical trials.

Does NIDDK accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does NIDDK support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

Small businesses are eligible to apply for several

non-SBIR/STTR funding opportunities.

Comprehensive information on Human Subjects

Research at NIDDK can be found here:

https://www.niddk.nih.gov/research-

funding/human-subjects-research

The NIDDK has a R01 funding opportunity for

pilot & feasibility clinical trials and accepts low-

risk clinical trials within the mission of the

NIDDK through the parent NIH NOFOs for clinical

trials.

For high-risk clinical studies (see NOT-DK-20-

051: https://grants.nih.gov/grants/guide/notice-

files/NOT-DK-20-051.html) that involve more

than one research centers, NIDDK uses a two-

part process that usually requires use of a U34

planning grant followed by a separate application

for the clinical trial or study (U01). Potential

applicants are strongly encouraged to

contact NIDDK staff to discuss their proposed

study and determine the most appropriate

mechanism for submitting their application.

Clinical Trials Allowed and Optional funding

opportunities to which NIDDK is subscribed can

be found on NIDDK’s Current Funding

Opportunities page:

https://www.niddk.nih.gov/research-

funding/current-opportunities.

Research Topics

Diabetes, Endocrinology and Metabolic Diseases

The Division of Diabetes, Endocrinology and Metabolic Diseases supports SBIR/STTR projects in

the areas of type 1 and type 2 diabetes, endocrine disorders, and neuroendocrinology. High priority

topic areas are listed below:

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II.

Sensors, Hormone Replacement, Delivery Devices, and Other Technologies for Diabetes

Treatment:

Novel accurate, reliable, and user-friendly continuous monitoring sensor technologies

relevant to diabetes treatment and monitoring. Preferably, these sensors should have

long functional life, and for glucose sensing be accurate at all glycemic ranges,

particularly at concentrations below 54 mg/dl.

Use of Artificial Intelligence, Machine Learning (AI/ML) tools to enable fully automated

closed loop pancreatic hormone delivery systems in response to multi-analyte

physiological input.

Novel insulin and glucagon formulations showing improved kinetics and stability.

Telemedicine/remote monitoring approaches that can be incorporated as

components/and or adjuvants of closed loop systems for better diabetes self -

management.

Technologies that may promote and facilitate adherence/compliance by users of

diabetes monitoring and control devices.

More reliable and efficient biocompatible infusion sets for automated hormone delivery

and improved kinetics.

New implantable and easy to replace technologies that may mimic the beneficial effect

of gastric bypass/bariatric surgery for the treatment of diabetes without the need of a

major invasive surgical procedure.

III.

Diabetic Wound Healing and Diabetic Neuropathy:

Drugs, biologic therapies, and novel delivery systems that accelerate healing of

diabetic foot ulcers and prevent recurrences.

Off-loading devices that improve patient acceptability and adherence.

Diagnostic and predictive biomarkers, including improved outcome measures, for

diabetic foot ulcers that can be used to diagnose biofilms, predict healing, select

treatment strategies, or determine risk of primary or secondary occurrence of foot

ulcers. The biomarkers may use biosamples, images or sensors.

Educational approaches and new technologies that increase adherence to

preventative measures for diabetic foot ulcers in high-risk patients or increase

adherence to off-loading and other recommended treatment regimens for diabetic

foot ulcers.

Disease-modifying therapies for the prevention and treatment of diabetic neuropathy.

Sensors, algorithms, and patient interfaces that can provide feedback to diabetic

individuals with insensate feet to prevent diabetic foot ulcers.

Biomarkers to monitor disease progression and response to therapy for diabetic

neuropathy, including peripheral sensory, autonomic, and painful diabetic

neuropathy.

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IV.

Immune Modulation and Cell Replacement Therapies:

Development of immunomodulation/tolerance strategies, including cell-based, to

prevent, revert or slow progression of type 1 diabetes.

Development and optimization of engineered islet cell replacement sources with

improved transplant graft attributes, including but not exclusive to: graft function

durability under transplantation and metabolic stress; graft survival with lowered or no

systemic immunosuppression and non-invasive quantitative monitoring of graft mass.

Novel biomimetic and immuno-engineering strategies for the development of immune

evasive cells/islets and biomaterials/devices for successful long-term engraftment

with no need of systemic immunosuppression.

Development of reproducible methods that improve yield/viability/function of

islets/insulin producing cells and allow their ex-vivo expansion for transplantation.

Prediction, Screening, Diagnostics, and Monitoring:

Development of methodologies, products, or biomarkers useful for predicting,

preventing or delaying progression of pre-diabetes or diabetes, including tests for

identifying patients at risk, and methods of monitoring disease progression.

Validated tests for autoantibody detection, auto-reactive T-cells and other

immune/metabolic parameters for type 1 diabetes early diagnosis and monitoring.

Improvements could include higher throughput - point of care technologies (reliable,

accurate, cost-effective, highly sensitive, and standardized with rapid turnaround

time).

Multiplexed assays for peptides and proteins that are used as biomarkers in diabetes

and metabolic diseases (e.g., insulin, pro-insulin, glucagon, c-peptide, HbA1c..etc).

Development of non-invasive technologies such as imaging for the in vivo

measurement/evaluation of pancreatic islet’s cell mass, function and inflammation.

Artificial Intelligence, Machine Learning, and Deep Learning driven methods and

technologies that may optimize prediction, diagnosis, monitoring and treatment of

diabetes, endocrine and metabolic disorders.

VI.

Pre-Clinical Research and Disease Modeling:

Development and optimization of microphysiological/organ on chip platforms in the

application of pre-clinical testing and/or modeling of physiological and

pathophysiological aspects of diabetes, endocrine and metabolic disorders.

Development of methods utilizing replenishable cell sources, that generate functional

islet like cells/tissues that can be successfully tested in microphysiological systems

and/or in vivo models of the disease.

Development and testing of in silico/simulation models with predictive capability to

complement and/or replace in vitro and in vivo pre-clinical testing.

VII.

Tools for Measuring Peripheral Neurotransmitters and Neuromodulation:

Devices that modulate or control the hepatic or pancreatic branches of the vagus

nerve with the aim of relieving diabetes or other metabolic disorders. Projects

concerned with the liver should be focused on the regulation of glucose or lipid

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metabolism. Technologies would include closed- or open-loop neural stimulators of

sensory or motor nerves originating from or terminating in the endocrine pancreas or

liver.

Tools that provide high spatio-temporal resolution of neurotransmitter release in the

endocrine pancreas or liver.

Tools that measure autonomic activity in the liver, endocrine pancreas, or adipose

tissue in animal models or humans.

Digestive Diseases and Nutrition

The Division of Digestive Diseases and Nutrition supports research in diseases and disorders of

the digestive tract; esophagus, stomach, intestine, colon, anorectum, pancreas, liver, gallbladder,

and biliary tract; as well as research in nutrition and obesity. Innovative investigator-initiated

projects that are not mentioned below are also encouraged. Examples of areas that may be of

interest to small businesses include, but are not limited to:

Gastrointestinal

Development of new diagnostic techniques and tests, including non-invasive tests and

imaging for detecting Barrett’s esophagus, GERD, and other intestinal disorders.

Development of agents and techniques to measure, diagnose, stimulate regeneration

of enteric neurons, and treat motility disorders.

Development of novel therapies to modulate/enhance GI lymphatic function for the

treatment of GI pathologies.

Development of gut-derived biomarkers of neurodegenerative brain disease.

Development of approaches to simultaneously interrogate or modulate the central

nervous system (CNS) and the gastrointestinal system.

Development and validation of neurotechnologies that improve the association of

symptoms, pathophysiology, and function for gastrointestinal disorders.

Development of novel proteomic or metabolomic technologies designed to study

digestive diseases and their complications.

Development of assays and screening methods for detection of biomarkers for

diagnosis, grading and staging digestive diseases.

Development of Live Biotherapeutic Products (LBPs), such as probiotic organisms for

the prevention or treatment of gastrointestinal conditions, or to enhance the

nutritional properties of dietary components. These LBPs would not include vaccines,

oncolytic bacteria, or gene therapy agents.

II.

Liver

Development of novel antifibrotic therapies for chronic progressive liver diseases.

Development of quantitative tests of hepatic “reserve” for assessment of therapeutic

intervention, transplantation, or surgical risk in patients with liver disease.

Development of point-of-care, serologic, and rapid tests for rapid diagnosis, treatment

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDDK 90

requirements and genotyping of hepatitis.

Development of rapid, reliable, and inexpensive tests for genetic screening and risk

markers important in liver disease.

Development of sensitive and reliable non-invasive techniques to detect and monitor

liver fibrosis and other chronic liver diseases and the associated complications.

Creation of bio-artificial organs for temporary hepatic support in patients with acute liver

failure.

III.

Pancreas

Development of and validation of therapeutic interventions for treatment of pancreatitis

and its complications.

Development of more accurate, non-invasive approaches to the diagnosis of chronic

pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.

IV.

Nutrition/Obesity

Development of novel methods and tools to accurately evaluate nutritional status,

physical activity, and energy expenditure.

Development of non- or minimally invasive technologies that allow access and/or

delivery to discrete regions of the digestive tract.

Development of novel breath, urine, or blood tests to accurately measure dietary

intake.

Development of non-invasive neurotechnologies to stimulate and/or modulate

hormone/peptide release from the gastrointestinal system for the treatment of

metabolic disorders such as obesity.

Kidney, Urologic and Hematologic Diseases

The Division of Kidney, Urologic, and Hematologic Diseases provides research funding and

support for basic, translational, and clinical research studies of the kidney, urinary tract, and

disorders of the blood and blood-forming organs. Projects may include development of tools to

improve understanding of the physiology, pathophysiology, and diseases of the kidney, urinary

tract, and blood and blood forming systems, or to develop rational diagnostics, treatments, and

prevention strategies for these diseases. Projects may be to develop tools/technologies to

support clinical care, population health and/or pragmatic research to improve health outcomes in

populations with kidney diseases and/or urologic conditions. Projects to develop tools or

technologies to address health disparities or promote health equity are encouraged. NIDDK

encourages research that takes a holistic perspective of human health by considering biological,

behavioral, and social contributors to the scientific exploration, prevention, and management of

these diseases/conditions. Development of -omics, bioinformatics, and multi-scale technologies

for the study of these systems, especially where these systems interact, is also encouraged.

Research opportunities that may be of interest to small businesses include, but are not limited to:

KIDNEY DISEASES

Areas of research include chronic kidney disease, end-stage renal disease, diabetic kidney

disease, polycystic kidney disease, hypertensive kidney injury, acute kidney injury, kidney

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDDK 91

donation (delayed graft function and chronic rejection), congenital kidney disorders,

glomerular and tubulointerstitial diseases, IgA nephropathy, hemolytic uremic syndrome, fluid

and electrolyte disorders, kidney repair and regeneration, and normal and abnormal kidney

development and physiology.

Dialysis, Devices and Medical Technologies

Development of innovative forms of renal dialysis which improve efficiency, have

lower associated morbidity (e.g., tissue engineered artificial kidneys, implantable or

wearable dialyzers), reduce side effects and constraints of dialysis treatment, and/or

improve access, experience, and quality of life.

Development of functional nephrons for transplantation.

Development of pharmacological agents, devices, techniques, or diagnostics that

enhance maturation and longevity of a vascular access.

Development of dialysis membrane technologies with enhanced biocompatibility and

anti- fouling properties.

Development of a means to provide continuous anticoagulation to permit renal

replacement therapy.

Development of reliable, non-invasive, wearable or online monitoring systems for real-

time assessment and adjustment of treatment parameters such as blood volume,

access flow, and urea clearance.

Development of hemodialysis or peritoneal dialysis catheters using improved

biomaterials, which reduce catheter-related infections, the foreign body response,

biofouling, and biofilm formation.

Development of novel methods to generate dialysate for hemodialysis or peritoneal

dialysis.

Development of devices or techniques to enhance the long-term success of kidney

transplantation (e.g., techniques for repairing kidneys or for kidney storage and

preservation).

Development of technologies to improve kidney biopsies (i.e., to improve safety or

tissue acquisition).

Health Information Technologies

Development of health information technologies or mobile technologies that enhance

delivery of care, population health management, health equity, and/or research for

patients with kidney diseases.

Development of applications or application programming interfaces that use health

data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical

terminologies) to improve accessibility, accuracy, and/or completeness of real-world

health, behavioral, and societal/contextual data for research and care of individuals

with kidney diseases.

Development of technologies to engage patients with kidney diseases in their care or

to support interaction with caregivers.

Development of innovative technologies or platforms to facilitate kidney research

training and education, which could include software or simulation tools.

Diagnostics and Imaging

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Development of clinical assays that enable biopsychosocial precision medicine

approaches to treating kidney diseases.

Development of technologies that use artificial intelligence/machine learning (AI/ML)

or other advanced statistical approaches to integrate disparate data types to inform

diagnosis of kidney diseases. AI/ML approaches should leverage data from diverse

populations and apply equity considerations to ensure resulting models do not further

embed structural racism or discrimination.

Development of platforms for pre-analytical preparation, imaging, and automated

analysis of kidney tissue.

Development of non- or minimally invasive methods for evaluating kidney functions,

including in individuals with congenital genitourinary conditions.

Reliable, non-invasive, non-radioactive methods of measuring glomerular filtration

rate (GFR) or tubular functions.

Translation of biomarkers of acute kidney injury or chronic kidney disease with

clinical utility into commercial assays.

Translation of biomarkers for early detection of kidney diseases or prediction of

kidney disease progression, recovery, or drug response.

Development of improved renal imaging techniques, differential renal function

assessment, diagnostic assessment of non-malignant kidney diseases, or

measurement of perinatal nephron endowment.

Development of technology to improve collection of real-time data (e.g., biomarkers,

diet, physical activity, patient reported outcomes, vital signs, patient experience of

kidney or urologic disease or its treatment, social or environmental factors which

affect the development or progression of kidney disease), patient outcomes, and

adherence for clinical studies.

Development of imaging or molecular analysis technologies to enhance information

extraction from renal biopsies and development of antibodies or other probes for

unique cell types of the kidney.

Therapeutics Discovery and Development

Lead optimization and preclinical development of pharmacological agents that might

be used to intervene in acute or chronic renal disorders and in disorders of renal

hemodynamics, blood pressure, electrolyte metabolism, and extracellular volume

regulation.

Development of drugs or biologics designed to specifically target kidney cell types.

Development of drugs or biologics to stimulate productive kidney repair or

regeneration.

Development of technologies to enhance the validation of kidney disease targets or to

screen compounds for efficacy or toxicity (e.g., kidney organoids or tissue chips, more

relevant animal models of acute kidney injury).

Development of data and cell banks (e.g., of diabetic kidney disease families and

polycystic kidney disease families) for use by the research community.

AA.

Development of preventative measures for acute kidney injury (e.g., during coronary

artery bypass grafting, sepsis, or treatment with nephrotoxic agents).

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II.

UROLOGIC DISEASES

Areas of research include benign prostatic hyperplasia, lower urinary tract symptoms (LUTS)

including urinary incontinence, urinary tract infections, urinary stone disease, erectile

dysfunction, urologic chronic pelvic pain syndromes (including interstitial cystitis and chronic

prostatitis), congenital urologic disorders, repair and regeneration of lower urinary tract

organs, normal and abnormal lower urinary tract development, and physiology of the urinary

system and male genital organs (excluding applications targeting male fertility).

Diagnostics and Imaging

Translation of blood or urine biomarkers in the lower urinary tract or other urologic

disorders into commercial assays with clinical utility.

Development of non-invasive or minimally invasive methods to diagnose bladder

inflammation or changes in the urothelium that are not of a cancerous origin.

Development of new technologies for rapid clinical diagnosis and characterization of

urinary tract infection (UTI).

Development of new technologies or methods with reduced radiation dose for

evaluating vesico-ureteral reflux in children and infants.

Development of diagnostic modes to clinically and non-invasively or minimal-

invasively measure bladder outlet obstruction before and after surgical or

pharmaceutical intervention.

Development of objective diagnostic devices or methods for the assessment of

urinary storage and voiding disorders, including stress, urge, and mixed incontinence,

in both adults and children.

Development of wireless and non-invasive or minimally invasive measurement

technologies for real-time assessment of lower urinary tract function, which can

include neuro- pharmacological/neuro-physiological urodynamics.

Development of radiation-free and accurate imaging technologies for urinary stone

disease.

Development of technologies that use artificial intelligence/machine learning (AI/ML)

to integrate disparate data types to inform diagnosis of urologic diseases. AI/ML

approaches should leverage data from diverse populations and apply equity

considerations to ensure resulting models do not further embed structural racism or

discrimination.

Development of platforms for pre-analytical preparation, imaging, and automated

analysis of genitourinary tissues.

Drug and Device (Therapeutic) Interventions

Lead optimization and preclinical development of pharmacological agents for

treatment or prevention of urinary stone disease, urological chronic pelvic pain

syndromes, urinary tract infections, or other urologic diseases or conditions within

NIDDK’s mission.

Development of novel neuromodulation devices, which restore function or mitigate

pain conditions of the lower urinary tract.

Development of urinary catheters which reduce the incidence of infection in the

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urinary tract and decrease urethral and bladder inflammation.

Development of technologies for treatment of bladder outlet obstruction.

Development of bioengineered materials or structures, including cell-laden structures,

for the repair or regeneration of genitourinary organs.

Health Information Technologies

Development of health information technologies or mobile technologies that enhance

delivery of care, population health management, health equity, and/or research for

patients with urologic diseases or conditions.

Development of applications or application programming interfaces that use health

data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical

terminologies) to improve accessibility, accuracy, and/or completeness of real-world

health, behavioral, or social data for research and care of individuals with urologic

diseases or conditions.

Development of technologies to engage patients with urologic diseases or conditions

in their care or to support interaction with caregivers.

Development of innovative technologies or platforms to facilitate urology research

training and education, which could include software or simulation tools.

Research Tools

Development of tools for elucidating the role of urinary or gut microbiome in urinary

stone disease or other urologic diseases or conditions within NIDDK’s mission.

Development of novel models of benign prostatic hyperplasia.

Development of technology to improve collection of real-time data (e.g., biomarkers,

diet, physical activity, vital signs, psychological parameters, and social or

environmental factors), patient- reported outcomes, and adherence for clinical studies

(e.g., studies of gene-environment interactions in the manifestation of urologic

diseases).

III.

HEMATOLOGIC DISEASES

The NIDDK hematology research program focuses on understanding basic cellular and

molecular mechanisms that underlie the production and function of blood cells in health and

disease. The program emphasizes translational applications of new insights and knowledge

gained from basic research in these areas toward the development of novel or improved

approaches for the diagnosis, stratification, and treatment of hematologic diseases. This

includes the development of disease biomarkers, gene targeted therapies, or hematopoietic

stem cell transplantation for acquired and heritable blood diseases (e.g., hemoglobinopathies,

such as sickle cell disease or thalassemia; hemochromatosis, iron overload, porphyrias,

amyloidosis, iron deficiency anemia, and cytopenias resulting from bone marrow failure

disorders, congenital dyserythropoietic anemias, Schwachman-Diamond syndrome,

myelodysplastic syndrome, neutropenias, myelofibrosis, essential thrombocythemia, or

polycythemia vera), and the measurement and chelation of tissue iron in iron overload

disorders. The NIDDK hematology research program provides resources for basic and

preclinical development efforts leading up to IND or IDE submissions but does not fund

clinical trials. The program has a particular focus on myeloid lineage and hematopoietic stem

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cells, including the effects of aging on hematopoiesis.

Drug Discovery and Development

Establishment of robust in vitro or animal models of benign hematologic

diseases for drug discovery or development.

Development of therapeutics that target elements of hematopoietic stem cell

niches (e.g., stromal cells, osteoblasts, endothelium, macrophages, pericytes,

nerve cells).

Development of novel bone marrow conditioning regimens that promote

hematopoietic stem cell homing, engraftment, and hematopoiesis.

Development of therapeutics that modulate blood cell production from

hematopoietic stem cells and progenitors based upon understanding of physical

and chemical regulatory pathways.

Development of therapeutics that modulate metabolism, storage, and transport

of iron or heme.

Cell Therapies

Development of equipment, chemically defined reagents, and methods for high

volume ex vivo expansion, isolation, and/or differentiation of highly purified

human hematopoietic stem and progenitor cells.

Development of equipment, chemically defined reagents, and methods for

selective removal or destruction of diseased human hematopoietic stem and

progenitor cells (e.g., in myelodysplastic syndrome, MDS). Treatment of malignant

clones and blood cancers are not within the scope of the NIDDK Hematology

mission.

Development of therapeutics that induce fetal hemoglobin synthesis by

chemical means, genome editing, or other means.

Development of therapeutics that target blood cell membrane structure.

Diagnostics and Imaging, Medical Technologies, and Research Tools

Development and validation of sensitive, specific, reproducible, quantitative,

and clinically applicable assays for measuring levels or expression of iron

regulatory molecules or for measuring misfolded or aggregate amyloid

proteins such as amyloid A transthyretin or immunoglobulin light chain in

blood.

Development of technologies to track, purify, monitor or assay single-cells in vivo or in vitro.

Development of non-invasive systems for monitoring circulating blood cells,

blood chemistry or blood cell production.

Development of imaging technology for the non-invasive measurement of

bone marrow cellularity, fibrosis, and function.

Development of imaging technology for the non-invasive measurement of

tissue iron loading and distribution.

Development of technologies to understand the roles of mitochondria in non-

malignant hematologic diseases.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDDK 96

Development of technologies that use artificial intelligence/machine learning

(AI/ML) to integrate disparate data types (e.g., histomorphology, karyotyping,

next generation sequencing, immunophenotyping, and flow cytometry) to

inform diagnosis of non- malignant hematologic diseases. AI/ML approaches

should leverage data from diverse populations and apply equity

considerations to ensure resulting models do not further embed structural

racism or discrimination.

Development of platforms for pre-analytical preparation, imaging, and

automated analysis of the bone marrow.

Development of innovative technologies or platforms to facilitate hematology

research training and education, which could include software or simulation

tools.

Contact Information

For additional information on research topics, contact:

DIABETIC TECHNOLOGY, TYPE 1 DIABETES AND ENDOCRINE DISEASES

Dr. Guillermo Arreaza-Rubín

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-594-4724

Email: arreaza-rubing@niddk.nih.gov

DIABETIC WOUND HEALING AND TYPE 2 DIABETES

Dr. Yan Li

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-435-3721

Email: yan.li5@nih.gov

NEUROMODULATION, DIABETIC NEUROPATHY, AND TYPE 2 DIABETES DRUG DISCOVERY

Dr. Bradley M. Cooke

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-480-9896

Email: brad.cooke@nih.gov

GASTROINTESTINAL, OBESITY, AND NUTRITION DISORDERS AND DISEASES

Dr. Robert Lunsford

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-402-1397

Email: robert.lunsford@nih.gov

LIVER, PANCREATIC, AND NEUROBIOLOGICAL DISORDERS AND DISEASES

Ms. Christine Densmore

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-402-8714

Email: christine.densmorec@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIDDK 97

KIDNEY, UROLOGIC AND HEMATOLOGIC DISEASES

Dr. Daniel R. Gossett

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-594-7723

Email: daniel.gossett@nih.gov

For administrative and business management questions,

Ms. Christina Coriz

National Institute of Diabetes and Digestive and Kidney

Diseases Phone: 301-594-8848

Email: christina.coriz@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 98

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS)

Mission

The mission of the National Institute of Environmental Health Sciences www.niehs.nih.gov is to discover

how the environment affects people in order to promote healthier lives, with a vision of providing global

leadership for innovative research that improves public health by preventing disease and disability.

NIEHS achieves its mission and vision through a multidisciplinary biomedical research program,

prevention and intervention efforts, and a communication strategy that encompasses training,

education, technology transfer, and community outreach.

Budget Guidance

For all NIEHS research interest topic areas other than Hazardous Substances Remediation and Site

Characterization SBIR Program included in this PHS 2024 Omnibus SBIR/STTR Solicitation, NIEHS will

accept SBIR/STTR application total funding support (direct costs, indirect costs, and fee) requests up to

$306,872 for Phase I and $2,045,816 for Phase II. NIEHS will not fund applications at budget levels

exceeding these hard cap budget guidelines, except through specific RFAs. For budgetary,

administrative, or programmatic reasons, NIEHS may decide not to fund an application or may

decrease the length of an award and/or the budget. In all cases, applicants should propose a budget

that is reasonable and appropriate for completion of the research project, and the budget request must

be well justified. The Hazardous Substances Remediation and Site Characterization SBIR Program has

different limits on budget requests for both Phase I and Phase II, check under that topic below for

details.

NIEHS will consider well justified Technical and Business Assistance (TABA) costs up to the limits

specified on the NIH SEED website. These costs can be requested in addition to the Phase I and II

limits indicated above.

Specific SBIR and STTR Program Information

For additional information about NIEHS's Small Business Programs, please visit Small Business

Innovation Research & Small Business Technology Transfer Grants (SBIR/STTR, R41, R42, R43, R44)

(nih.gov). NIEHS DOES NOT Fund technologies for the detection and remediation of pathogens in

the environment.

Final Progress Reports

As detailed in NOT-OD-17-085, the NIH has implemented the Final Research Performance Progress

Reports (Final RPPR) for SBIR/STTR Final Progress Reports.

The NIEHS is interested in tracking the progress of the small business concerns it funds and the

products they develop. It is expected that small businesses who have received previous SBIR/STTR

grants have had success in commercializing their previously supported technologies. Small businesses

that are primarily interested in research and development (and not commercialization) should consider

other grant mechanisms at NIH, rather than the SBIR/STTR program. Funding priority will be given to

those small business concerns that demonstrate their ability to develop and commercialize products.

Specific Funding Opportunities and Programs

In addition to this omnibus program announcement, the NIEHS releases targeted SBIR/STTR

Notices of Funding Opportunities (NOFOs); signup for the listserv ( Subscribe or Unsubscribe to

the SBIR-NIEHS List (nih.gov) ) to be notified of NOFOs.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 99

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIEHS does not intend to support any new Phase II B grants in this funding period. NIEHS

currently participates in PAR-23-219: SBIR/STTR Commercialization Readiness Pilot (CRP)

Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed).

Clinical Trials

Does NIEHS accept Clinical Trials

through the

Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NIEHS accept Clinical

Trials through specific Notices of

Funding Opportunities?

Does NIEHS support Clinical

Trials through NON-SBIR/STTR

Notices of Funding Opportunities?

Yes

For non-SBIR/STTR clinical trials funding mechanisms

for which small businesses are eligible, please visit the

https://www.niehs.nih.gov/funding/grants/announceme

nts/request/index.cfm.

Research Topics

NIEHS Non-Clinical Trials Topics:

Exposure Assessment Tools

The NIEHS Exposure Biology and the Exposome Program supports technologies to better understand

how a person’s environment contributes to their health. Sensor technologies, computational

approaches, improved biomarkers, and biomonitoring capabilities, are needed to measure, analyze, and

predict a wide range of internal and external exposures and health outcomes across diverse geographic

populations. These tools should be designed fit-for-purpose in collaboration with the stakeholders (e.g.,

community engagement programs, citizen scientists, disaster response personnel, epidemiologists, or

clinical researchers).

Examples include:

Sensors and Other Exposure Assessment Tools

•

Technologies and methodologies to assess personal exposure to specific or

combined air pollutants in population studies, including wearable monitors and sensor

networks.

•

Devices for collecting exposure measurements across multiple stressors and scales,

with an emphasis on high sensitivity and specificity and low-cost devices, when

feasible. High-priority analytes include contaminants of emerging concern (e.g.,

perfluorinated compounds, and toxins produced in harmful algal blooms) as well as

ultrafine particulates, microplastics, pesticide exposures, and industrial chemicals.

•

Novel sampling technologies to enable subsequent targeted and untargeted laboratory

analysis

•

Sensor technologies that can be integrated into existing smart devices for sensing

personal environment as well as provide chemical speciation data.

•

Tools and approaches for identifying and characterizing contaminants in drinking water

that may pose a risk to human health, with a particular emphasis on new contaminants

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 100

or compounds that are of emerging concern.

Note that identification of environmental pathogens in drinking water is not within

the NIEHS mission.

Computational and Informatics-based Tools and Methods for Exposure Assessment

•

Informatics tools and platforms to organize, store, retrieve, extract, and integrate data

on exposures and health effects.

•

Application of machine learning methods and natural language processing for

extracting and integrating diverse data types and for generating causal networks from

experimental data and public knowledgebases

•

Computational and statistical approaches to integrate exposure data from different

sources, including publicly available databases and information from monitoring

approaches (e.g., sensors, remote sensing, and biomonitoring), to provide quantitative

exposure estimates, identification, and characterization of adverse effects on human

health.

•

Adapting or developing new methods and tools for automating environmental health-related

literature and systematic reviews, including article selection and prioritization, data

extraction, study quality evaluation, and summarization of for environmental health impacts

Additional information can be found on the NIEHS Exposure Biology and the Exposome Program

website Exposure Biology and the Exposome (nih.gov)

Nano Environmental Health and Safety

The NIEHS Nano Environmental Health and Safety (Nano EHS) program is interested in the detection of

engineered nanomaterials (ENMs) in the environment, in consumer products, and in biological samples,

and is interested in technologies or methods that can predict toxicity potential of ENMs.

High priority engineered nanomaterials of interest are those with a potential for human exposure.

Examples include:

•

Sensors, tools or technologies that can detect metal and carbon-based engineered

nanomaterials or micro/nanoplastics in air, water, and consumer products, and provide a

contextual assessment of the toxicological potential.

•

Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to

screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity,

and metabolic or other human relevant toxicity.

•

Methods and tools to assess leaching of engineered nanomaterials from nanotechnology-

based water filtration systems.

•

Technologies to assess the life cycle of nanomaterials from nano-enabled products in the

market

•

Development of tools and technology platforms for the isolation, quantification,

physical and chemical characterization of various forms of micro/nanoplastics from

diverse media including biological samples, aqueous sources, air and food samples

and assessment of their toxicity potential and human health effects

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 101

Information on the Nano EHS program can be found at Nano Environmental Health and Safety (nano

EHS)

Toxicity Screening, Testing, and Modeling

NIEHS supports research to identify the hazards, as well as the mechanistic understanding, of the

effects of environmental stressors on biological systems that can lead to adverse human health

outcomes. To increase the ability to characterize or predict the toxicity and hazard of environmental

stressors, the National Toxicology Program (NTP) Home - National Toxicology Program (nih.gov) at

NIEHS is interested in technologies to support the goals and initiatives of the Tox21 Program Tox21

(nih.gov).

Technologies that support Tox21 and other NTP goals may include the development and/or application

of in vitro physiologically relevant cell-based systems that effectively model responses in humans or

animals and may be used to reduce or replace in vivo animal use. High priority areas are the

development of metabolically competent in vitro screening models and assay systems for various tissue

types (e.g., cardiac, neurological, liver, GI tract, kidney, mammary gland, lung, and immune function) for

assessing the effects of the environmental stressors.

Toxicity Screening Approaches

•

Improved or new approach methodologies (NAMs) including human organotypic culture

models (OCM), and microphysiological systems (MPS) that more accurately predict in vivo

function for characterizing toxicity and/or related disease processes. Priority areas are

improved capability for generating more mature cells from embryonic stem (ES) or induced

pluripotent (iPS) cells for organotypic models, integrating multiple MPS together under

physiologically relevant conditions, and the ability to conduct in vitro pathology studies

using OCM, MPS or 3D culture models.

•

Organotypic models using cells from rat or mouse models or other experimental animal

models, with a focus on comparisons between in vivo and in vitro toxicity endpoints.

•

Approaches to characterize and integrate key molecular and cellular changes related to

effects of toxicant exposures in carcinogenicity, developmental neurotoxicity,

cardiotoxicity or immune functions.

•

In vitro model systems that incorporate barrier functionality and transport functions

into tissue models (e.g., kidney, placenta, or blood-brain barrier)

•

Enhanced lower organism models (e.g., zebrafish or C. elegans) for toxicity screening.

•

Stem cell models and assays for evaluating the effects of toxicants on cell

differentiation with multiple functional endpoints.

•

Screening systems that incorporate genetic diversity into toxicology testing (e.g., panels

of tissue- specific human iPS cells or rodent stem cells)

•

In vitro systems that focus on responses to mixtures of xenobiotics, chronic exposure

studies, or provide insights into the molecular characteristics of multiple chemical-

biological interactions and toxicodynamics.

•

Short-term tests, assays, or systems designed specifically to reduce or replace existing

regulatory animal studies for acute toxicity (oral or inhalation), reproductive or

developmental toxicity, carcinogenicity, or ocular toxicity.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 102

•

Cage-based technologies to monitor physiological and behavioral changes in experimental

animals in chemical toxicology studies.

Computational Approaches for Predictive Toxicology

•

New computational systems and tools for integrating toxicity data, including in vivo

and in vitro data, to analyze and visualize data across different screening systems

and predict chemical hazard/risk.

•

Computational tools to integrate and visualize transcriptomic and metabolomic data in

affected signaling and biochemical pathways.

•

Improved computational tools for in vitro to in vivo extrapolation of xenobiotic

exposures and modeling metabolic transformation of xenobiotics.

•

Advanced computational approaches (e.g., artificial intelligence/machine learning) to

integrate and develop multi-omics classifiers for exposures and pathology image analysis

tools for environmentally induced diseases.

Other Technologies Focused on Enhancing Toxicology Testing

•

Alternative or improved methods for fixing and preserving tissues that maintain cellular

structure for histopathology while minimizing degradation of nucleic acids (RNA, miRNA,

DNA, methylated DNA), proteins or metabolites, so that archival tissue blocks can be

better used for molecular analysis.

•

Liquid biopsy methods for isolation and novel assays of circulating nucleic acids that

reflect environmental chemical exposures or toxicity. These could include exosome-

packaged or cell-free nucleic acids altered by environmental exposures.

•

Alternative or improved methods for extracting high quality RNA, miRNA, DNA,

methylated DNA, proteins, or metabolites from existing archived tissues.

•

Tools and technologies for isolation and characterization of exosome and/or

extracellular microvesicles from biological fluids

Biomarkers of Exposure and Response

To better understand the risks to human health from environmental agents, NIEHS supports the

development and validation of biomarkers of exposure, including improved measures of internal dose,

DNA adduct identification, and untargeted analysis for metabolite identification, and biomarkers of

response, including assays that can distinguish reversible from irreversible changes in target organs or

surrogate tissues. Examples include:

Biomonitoring Technology

•

Personal or point-of-care monitoring technologies for rapid detection of multiple

exposures in biospecimens using non- or minimally invasive approaches.

•

Improved methods to detect DNA or protein adducts resulting from exogenous exposures.

•

Exposure assessment methods in novel matrices or small volumes

NIH, CDC, and FDA Program Descriptions and Research Topics

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Biological Response Markers

•

Markers of oxidative stress, inflammation, DNA damage response, immune function,

mitochondrial dysfunction, or altered epigenetic regulation.

High priority human biomarkers include, but are not limited to inflammation biomarkers, plasma-

serum-based markers that reflect altered RNA, protein expression, or metabolite profiles, markers

developed in exhaled breath, buccal cells, or other easily accessible, non-invasive biological samples,

miRNA or other exosome biomarkers, and epigenetic markers in surrogate tissue reflecting

modifications in target tissues.

Intervention Technologies

NIEHS supports efforts to prevent or reduce exposures to environmental chemical stressors that affect

human health. Technologies to reduce exposure may include:

•

Technologies for detecting and/or removing contaminants from drinking water, primarily

for home use.

•

Approaches for use in the home, workplace, and school settings for reducing volatile

compounds and other inhaled toxicants. Examples may include improved air filtration

systems as well as technologies to monitor the efficacy of filtration systems.

•

Technologies and applications that can provide real-time alerts about relevant

environmental exposure levels for sensitive populations (such as asthmatic

populations)

Education and Participatory Science

As part of its Partnerships for Environmental Public Health (PEPH) Program, NIEHS is interested in

developing tools that build capacity, improve environmental health literacy, and support participatory

science endeavors. These approaches or resources should be fit for purpose to meet the needs of the

following audiences: community members, health care and public health professionals, educators, and

students of all ages. Approaches may include:

•

Mobile applications that provide environmental health information about exposures of

concern in food, air, drinking water, or consumer products. These may include

•

Interactive apps that provide the context and risks of exposures such as single or

multiple, interacting exposures, level of exposure, frequency and proximity to

source and health risks

•

Apps that can be adapted for various age groups, races, ethnicities and/or

languages.

•

Devices for collecting and reporting information on exposures in environmental

samples for educational purposes in schools or communities.

•

Systems that can utilize public and voluntary population data from sensors, activity

trackers, GIS enabled devices, social communications, and surveillance cameras; for

example, to assist disaster response and communication.

•

Educational resources and tools related to environmental health in school settings or

community education programs.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 104

•

Training materials for wider dissemination of risk information (e.g., resources for

high school students or community leaders to build capacity of other community

residents)

Information on the PEPH program can be found at Partnerships for Environmental Public Health

(PEPH) (nih.gov).

Other Areas of Interest

Exposure and Response to Vaping and Electronic Nicotine Delivery Systems (ENDS)

NIEHS is interested in technologies to assess exposure to aerosols from e-cigarettes and other vaping

devices, including analyses of the chemical constituents in these aerosols. In addition, approaches to

test the toxicity and biological responses to ENDS aerosol constituents are of interest.

Disaster Response

NIEHS is interested in sensors and informatics tools that can be rapidly deployed after disasters,

including extreme weather events or climate change-related events. These tools can be used by

researchers to follow emergency response workers and individuals in the community to help understand

dermal, water and/or airborne exposure levels, locations, and times.

•

Environmental sensors that can be rapidly deployed during or after a disaster to track

exposures.

•

Informatic tools to rapidly build environmental health disaster research protocols similar

to the NIEHS RAPIDD Protocol Disaster Research Response (DR2) Program (nih.gov)

from existing information, tools, and platforms (e.g., PhenX, PROMIS, and Disaster

Research Response DR2 Repository) to support rapid research response efforts

•

Data management tools for disaster response that enable rapid collation and integration

of data from stationary sources and personal exposure monitors and survey information

collected from individuals.

•

Mobile devices and applications for collecting information on environmental exposures

from study participants involved in disaster research responses.

Hazardous Substances Remediation and Site Characterization SBIR Program

The NIEHS Superfund Research Program (SRP) "Hazardous Substances Remediation and Detection

Program" supports Small Business Innovation Research Grants (SBIR R43, R44) to foster the

commercialization of novel, cost-competitive technologies, products, and devices for remediation and

detection of hazardous substances in the environment. The SRP is specifically interested in proposals

applying new engineering, materials science, and biotechnology approaches. In addition, applicants are

encouraged to develop sustainable strategies such as offering low carbon footprint, reduced energy

consumption, utilization of renewable energy sources, resilient to weather extremes, and with reuse /

regeneration capabilities.

Remediation

•

Novel technologies for in situ remediation of contaminated sediments, soils, and

groundwater with testing/modeling to optimize product for long-term stability

•

Innovative bioremediation technologies including development and culturing/propagation

of novel plants, bacterial strains, or fungal species for implementing bioremediation

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 105

•

Technologies to remediate chemical mixtures in environmental media

•

New strategies for delivery of reagents/amendments for groundwater

remediation and/or recovery/extraction of contaminants in groundwater

•

New amendments to stabilize contaminants and/or to use in caps for soil and sediment

remediation

•

New technologies and strategies to cleanup large complex sites with multiple sources

•

Resilient novel remediation approaches capable of withstanding climate change-related

impacts such as: fire, flooding groundwater level fluctuation, land use changes, and

other catastrophic events

•

Sustainable, energy efficient approaches with a net lifecycle benefit such as net zero

emission technologies; technologies that reduce waste generation; processes that

recycle/reuse/regenerate active components; long-term remediation approaches

equipped with solar or wind energy

Detection Technologies

•

Machine learning, computational, geographical information system-based, or modeling

products for predicting fate and transport of contaminants, rates of remediation,

bioavailability, or for identifying contamination sources

•

Real-time, field deployable, on-site analysis: soil, surface water, groundwater,

subsurface, sediments, air (such as volatile releases from sites), including

•

rapid, portable monitoring and screening of contaminants

•

multi-analyte sampling

•

remote monitoring/data capture/data processing capabilities such as time-

integrated and/or repeated measures

•

Accurate and reliable new passive sampler devices

•

Products that allow for rapid sample clean-up/preparation for analysis of environmental

samples and/or technologies for rapid extraction or processing of soil for incremental

sampling methodologies (ISM)

•

Non-targeted or multi-analyte field sampling devices or kits, including sample collection

products that can sequester a suite of analytes for later analysis

•

Novel techniques, sensors, and field analytical methods and real-time mapping/data

visualization for development of subsurface conceptual site models

•

Innovative tracer technologies for tracking contaminant migration/pathways

Examples of remediation and detection technology needs:

•

Vapor Intrusion: Improved technologies for predicting/anticipating time-periods for

occurrence of reasonable maximum indoor exposure(s) in impacted buildings, during

which sampling is recommended.

•

PFAS: Soil, sediment, and groundwater remediation technologies for mixtures and

degradation byproducts of per- and polyfluoroalkyl substances (PFAS); including

technologies for complete PFAS destruction; sustainable solutions with low energy input

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 106

and/or minimal secondary waste generation; and/or PFAS removal technologies for

heterogenous water chemistries; rapid sensors to aid in site monitoring and/or prioritizing

site sampling protocols.

•

Novel, sustainable, nontoxic chemistries or processes to aid regeneration,

reuse, and/or reactivation of spent treatment residues (e.g., from granular

activated carbon).

•

Development of adsorption and concentration materials to reduce the volume of

material to be treated and/or to further concentrate the waste stream generated

from standard treatment technologies (e.g., granular activated carbon, reverse

osmosis) as part of a “treatment train”.

•

Development of polishing treatments tailored for specific PFAS (e.g.,

shorter chain, emerging PFAS replacements).

•

Development of novel catalysts or other additives to lower needed

temperature for complete thermal destruction.

•

Development of novel air pollution control technologies as a polishing step to

reduce emissions from PFAS management or treatment facilities (e.g., thermal

destruction, air sparging, Supercritical water oxidation (SCWO), hazardous

waste landfill facilities, etc.).

•

Development of novel materials or processes for solid waste and/or biosolids

treatment and/or stabilization.

• Mining: Active or passive remediation technologies for mining influenced water;

technologies to mitigate effects from acid drainage; portable neutralization treatment

systems; strategies to target remediation of sources such as mining waste piles; and

separation technologies that remove elements or compounds of concern from water and/or

reclaim potentially valuable critical elements dissolved in contaminated fluids

•

Complex Site/Geology:

•

Site characterization techniques and strategies for complex geology (fractured

bedrock, karst, and heterogeneous layered deposits) including understanding the fate

of contaminants within rock matrices and properties that affect back diffusion

•

Improved technologies for treating low permeability and heterogeneous lithology,

including amendment delivery methods

•

Devices to detect and measure non-aqueous phase liquids (NAPLs) in the subsurface

•

In-well real-time and/or continuous monitoring tools to assess the efficacy of

remediation; presence/absence of key factors required for remediation (e.g.,

biological, geological, chemical); and/or to identify rebound events

•

Robotic sampling for highly contaminated / remote sites

•

Disaster Response: Technologies for measuring/treating environmental contamination as

part of a disaster response effort

Applicants must demonstrate that the proposed technologies are relevant to Superfund and/or other

sites impacted by hazardous substances. Per program mandates described in the Superfund

Amendment Reauthorization Act (SARA), SRP does not accept applications targeting oil or gas site

characterization/remediation. Applicants are strongly encouraged to stay within total funding support

(direct costs, indirect costs, and fees) does not exceed $183,460 for Phase I awards and $1,223,064 for

Phase II awards. Applicants are encouraged to contact NIH program officials prior to submitting any

award budget for the "Hazardous Substances Remediation and Site Characterization Small Business

Innovation Research Program” in excess of these amounts. For budgetary, administrative, or

programmatic reasons, NIEHS may decide not to fund an application or may decrease the length of an

award and/or the budget. NIEHS will consider well justified Technical and Business Assistance (TABA)

costs up to the limits specified on the NIH SEED website. These costs can be requested in addition to

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 107

the Phase I and II limits indicated above. These costs can be requested in addition to the Phase I and II

limits indicated above. Please note: the NIEHS Superfund Research Program (SRP) "Hazardous

Substances Remediation and Site Characterization Small Business Innovation Research

Program" no longer accepts Small Business Technology Transfer Grant (STTR: R41, R42)

applications. Funding decisions will be made based on programmatic need with an emphasis on novel

technologies distinct from current or recently-funded SBIR grants that are applicable to Superfund

and/or other sites impacted by hazardous substances.

Please visit the “Small Business Innovative Research Grants (R43/R44) Hazardous Substances

Remediation and Site Characterization SBIR Program” section on the following webpage:

https://www.niehs.nih.gov/research/supported/centers/srp/funding.

Worker Training Program

The major objective of the NIEHS Worker Training Program (WTP) is to prevent work related harm by

training workers in how best to protect themselves and their communities from exposure to hazardous

materials. The NIEHS WTP is interested in the development of e-Learning Technology- Enhanced

Training Products from a variety of delivery methods to assist both students and instructors in the

training and education process. These Technology-Enhanced Training Products are for the health and

safety training of hazardous materials (HAZMAT) workers; waste treatment personnel; skilled support

personnel associated with an emergency/disaster; emergency responders in biological hazard

response, infectious disease response and medical waste cleanup; emergency responders in

disasters; and worker resiliency training. Technology-Enhanced Training Products as defined by the

WTP includes, but are not limited to, online training, mobile device training, augmented reality (AR),

virtual reality (VR), and serious gaming. These advanced technologies complement all aspects of

training that can enhance, supplement, improve, and provide health and safety training for hazardous

materials workers. WTP accepts solicitations via requests for applications (RFA). Please contact

Kathy Ahlmark (ahlmark@niehs.nih.gov) for information on the next solicitation date, which differs from

the standard receipt dates of this NIH omnibus.

Information on the WTP program can be found at About the Worker Training Program (WTP) - Training for

Workers in Hazardous Environments (nih.gov)

NIEHS Clinical Trials Topics:

NIEHS will accept SBIR/STTR applications that propose clinical trials related to:

•

Development and testing of sensor technology, biomarkers, or biomonitoring technologies,

including field testing of new technologies for exposure assessment and biological

responses to environmental exposures.

•

Evaluation of tools or approaches for education and dissemination of information on

environmental hazards, including evaluation of changes in behavior.

Contact Information

For additional information on research topics, contact:

Dr. Daniel Shaughnessy

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

POB 12233 (K3-12)

Research Triangle Park, NC 27709

(984) 287-3321

Email: shaughn1@niehs.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIEHS 108

Dr. Lingamanaidu V. Ravichandran

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

POB 12233 (K3-05)

Research Triangle Park, NC 27709

(984)-287-3309

Email: lingamanaidu.ravichandran@nih.gov

For information on the NIEHS Superfund Research Program -

Hazardous Substances Remediation and Site Characterization

SBIR Program, contact:

Dr. Heather Henry

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

POB 12233 (K3-12)

Research Triangle Park, NC 27709

(984) 287-3268

Email: henryh@niehs.nih.gov

For administrative and business management questions contact:

Mr. Clark A. Phillips

National Institute of Environmental Health Sciences

Division of Extramural Research and Training

Grants Management Branch

(984) 287-4037

Email: clark.phillips@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NEI 109

NATIONAL EYE INSTITUTE (NEI)

Mission

The mission of the NEI is to conduct and support research, training, health information

dissemination, and other programs with respect to blinding eye diseases, visual disorders,

mechanisms of visual function, preservation of sight, the special health problems and

requirements of the blind, and providing eye health care to underserved populations.

For up-to-date information on priority research areas of scientific interest to the NEI, please visit

our home page at http://www.nei.nih.gov.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. For budgetary,

administrative, or programmatic reasons, NEI may decrease the length of an award and/or the

budget recommended by a review committee, or not fund an application. For topics listed in

SBA-Approved Waiver Topics, NEI does not generally fund Phase I applications greater than

$300,000 total costs or project periods greater than 2 years; or Phase II applications greater than

$2,000,000 total costs or project periods greater than 3 years. Applicants are strongly

encouraged to contact program officials prior to submitting any application in excess of the hard

caps listed above and early in the application planning process.

Specific SBIR and STTR Program Information

The NEI's programs are described in more extensive detail in documents which are available

from the Institute. For additional information about the research programs of the NEI, please

visit our home page at http://www.nei.nih.gov.

Phase IIB Competing Renewal Awards and Commercial Readiness Pilot (CRP)

The NEI will only accept SBIR Phase IIB Competing Renewal grant applications from Phase II

SBIR awardees to continue the process of developing technologies that ultimately require

federal regulatory approval or require extraordinary time and effort in the Research and

Development phase. Such technologies include, but are not limited to, pharmacologic agents,

biological products, and devices. These technologies should be clearly related to the mission of

the NEI. This renewal grant should allow small businesses to reach a stage in the project where

interest and investment by third parties is more likely. The NEI expects that the Phase IIB grant

will accelerate the transition of SBIR Phase II projects to the commercialization stage. The NEI

encourages applicants to establish business relationships with third-party investors and/or

strategic partners who can provide substantial financing to help accelerate the commercialization

of promising new products and technologies that were initiated with SBIR funding.

The Competing Renewal application must be a logical extension of a previously completed Phase

II (R44) SBIR grant. NEI grantees seeking SBIR Phase IIB Competing Renewal funding must

submit an application within a period no later than the first six receipt dates following expiration

of the previous Phase II budget period. Cumulative budgets should not exceed $1,800,000 total

costs, or time periods beyond three (3) years.

Although matching funds are not required, the NEI strongly encourages that applicants obtain

significant private investment. Competitive preference and funding priority will be given to

NIH, CDC, and FDA Program Descriptions and Research Topics

NEI 110

applicants that demonstrate the ability to secure substantial independent third -party investor

funds.

Applicants are strongly encouraged to contact the NEI Program Officer, Dr. Paek Lee (contact

information provided below) prior to submitting any application in excess of the hard caps listed

above and early in the application planning process.

Clinical Trials

Does NEI accept Clinical Trials through

the Omnibus/Parent Notices of Funding

Opportunities?

Yes

Minimal risk clinical trials only.

See details below.

Does NEI accept Clinical Trials through

specific Notices of Funding

Opportunities?

Yes

U44 PAR-24-066

Does NEI support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

R01 PA-20-183

UG1 PAR-21-042, PAR-21-043, PAR-21-041

U01 PAR-22-149

NEI accepts clinical trial applications submitted under SBIR and STTR Omnibus/Parent Clinical Trial

Required Notices of Funding Opportunities that include human subjects prospectively assigned to

one or more interventions that are minimal risk as defined by 45 CFR 46. Minimal risk means that the

probability and magnitude of harm or discomfort anticipated in the research are not greater in and of

themselves than those ordinarily encountered in daily life or during the performance of routine

physical or psychological examinations or tests. As part of the review process, the application must

include a clear, detailed plan for monitoring safety that is commensurate with the risks to study

participants. In addition to the minimal risk designation from the Institutional Review Board, other

reporting to the NEI may be required and will be outlined in the Notice of Award Terms and

Conditions.

Applicants who wish to submit greater-than-minimal risk, complex, large-scale, high-resource or

safety-risk clinical trials that propose to test efficacy, effectiveness or safety should not submit to

these NOFOs. Instead, early-stage clinical trial applications with greater than minimal risk to subjects

must be submitted to PAR-24-006 NEI Small Business Innovation Research (SBIR) Cooperative

Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial

Required). Complex, large-scale, high-resource clinical trials must be submitted to one of the Clinical

Research cooperative agreement NOFOs listed here: https://www.nei.nih.gov/grants-and-

training/funding-opportunities/current-funding-opportunities.

Research Topics

General Research and Development Topics: NEI is interested in providing support for the

development of new technologies, strategies, research tools, reagents and methods that can be

applied to basic and translational research which will benefit vision health. This encompasses

research and development of innovative enabling technologies in areas of genomics, proteomics

and nanotechnology. More specific topics include drug and high throughput assays; drug delivery

systems; gene therapy, cell-based therapy and regenerative medicine; development of in vitro

and in vivo disease models; surgical devices and materials; telemedicine, mobile health, and

health education; and design/fabrication of new or improved ophthalmic instruments for diagnosis

and treatment of eye disorders.

Retinal Diseases: New therapeutic approaches for inflammatory and degenerative diseases and

for inhibition of abnormal angiogenesis in the retina and choroid; Better methods of diagnosing

and treating diabetic retinopathy and other vascular diseases; Non-invasive techniques for early

NIH, CDC, and FDA Program Descriptions and Research Topics

NEI 111

diagnosis of macular degeneration and other retinal degenerative diseases; Instruments and

procedures for improved surgical management of retinal detachments; Retinal prostheses to help

restore visual function; Gene therapy/optogenetic methods for light sensitivity restoration in the

retina; Better methods for cell or tissue transplantation; New animal models/systems that better

mimic human retinal disease.

Corneal Diseases: New diagnostic tools, therapeutic agents and drug delivery methods for the

treatment of corneal injury, infection, dry eye, ocular pain, and other ocular surface disorders;

New biomaterials for corneal prostheses and corneal transplants; Instruments and procedures for

correcting the refractive power of the cornea and/or measuring the cornea's optical properties or

other physiological properties.

Lens and Cataract: New approaches in the post-operative management of cataract surgery; New

surgical instruments for cataract extraction and new biomaterials for replacement of the natural

lens; Design/fabrication of aspheric, toric, multifocal and accommodating intraocular lenses.

Glaucoma and Optic Neuropathies: New therapeutic agents, instruments, and procedures for

the diagnosis and treatment of glaucoma; Non-invasive methods to measure changes in the optic

nerve head and retinal fiber layer.

Strabismus, Amblyopia, and Refractive Error: New approaches to detect and treat strabismus,

amblyopia, and myopia; New tools and techniques for vision screening; New or improved methods

and materials for correcting the refractive power of the eye and/or measuring the eye's optical

properties or other physiological properties; New materials and manufacturing processes for

eyeglasses and contact lenses; prosthetic devices (both cortical and subcortical) for vision

restoration.

Visual Impairment and Blindness: Instruments and methods to better specify, measure, and

categorize residual visual function; New or improved devices, systems, or programs that meet the

rehabilitative, adaptive, and everyday living needs of visually impaired/blind people.

Contact Information

For more information on research

topics, contact:

Paek Lee, Ph.D.

Program Director, Small Business

SBIR/STTR Division of Extramural Science Programs

National Eye Institute

6700B Rockledge Drive

Bethesda, MD 20817

301-435-8164

Email: paek.lee@nih.gov

Tony D. Gover, Ph.D.

Program Director, Small Business SBIR/STTR (Anterior Segment)

Division of Extramural Science

Programs National Eye

Institute 6700B

Rockledge Drive

Bethesda, MD 20817

301-529-7370

Email: tony.gover@nih.gov

For administrative and business management questions, contact:

NIH, CDC, and FDA Program Descriptions and Research Topics

NEI 112

Ms. Karen Robinson Smith

Chief Grants Management Officer

Grants Management Branch

Division of Extramural Activities

National Eye Institute, NIH, DHHS

6700B Rockledge Drive, Suite 3400

Bethesda, MD 20892

301-451-2020, Fax: 301-496-9997

Email: kyr@nei.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIGMS 113

NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS)

Mission

NIGMS supports basic research that increases our understanding of biological processes and

lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS-

funded scientists investigate how living systems work at a range of levels—from molecules and

cells to tissues and organs—in research organisms, humans, and populations. Additionally, to

ensure the vitality and continued productivity of the research enterprise, NIGMS provides

leadership in training the next generation of scientists, enhancing the diversity of the scientific

workforce, and developing research capacity throughout the country.

All NIH institutes and centers support basic research that’s relevant to the diseases, organ

systems, stages of life, or populations within their mission areas. In contrast, NIGMS supports

fundamental research that doesn’t focus on those specific areas. Its research mission is aimed

at understanding the principles, mechanisms, and processes that underlie living organisms,

often using research models.

NIGMS also supports the development of fundamental methods and new technologies to

achieve its mission. Supported research may utilize specific cells or organ systems if they serve

as models for understanding general principles.

NIGMS also supports research in specific clinical areas that affect multiple organ systems:

anesthesiology and peri-operative pain; sepsis; clinical pharmacology that is common to multiple

drugs and treatments; and trauma, burn injury, and wound healing.

The Institute is organized into divisions that support research, research training, and capacity building

in a range of scientific fields. To find out more information on the participating divisions and the

research supported, please visit the following links:

Division of Biophysics, Biomedical Technology, and Computational Biosciences

(BBCB) Division of Pharmacology, Physiology, and Biological Chemistry (PPCB)

Division for Research Capacity Building (DRCB)

Division of Training Workforce Development, and Diversity (TWD)

Budget Guidance

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally

may not exceed the amounts defined by the SBA, which can be found on the NIH SEED website.

NIGMS will not accept applications with budget requests exceeding this hard cap with the

exception of projects that fit within the SBA-Approved Waiver Topics list for awards over the

statuary budget limitations. NIGMS sets its own budget limits for the specific research topics that

are granted a waiver to exceed the U.S. Small Business Administration hard budget caps. The

NIGMS budget limit for a Phase I project on an approved topic is $350,000 in total costs with a

project period up to 1 year. The budget limit for a Phase II project on an approved topic is

$2,500,000 in total costs for a project period up to 3 years. If considering a project with a budget

exceeding the hard cap, applicants are strongly encouraged to contact NIGMS program officials

prior to submission, and preferably in the early stages of application preparation. In all cases,

applicants should propose a budget that is reasonable and appropriate for completion of the

research project.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIGMS 114

Specific SBIR and STTR Program Information

https://www.nigms.nih.gov/grants-and-funding/research-funding/small-business-research

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIGMS will accept Phase IIB SBIR-only Competing Renewal grant applications to continue the

process of developing products that ultimately require 1) clinical evaluation, 2) approval by a

Federal regulatory agency, or 3) continuing refinements that include but are not limited to cost

reduction, testing for performance, safety, reliability and/or durability, and meeting or establishing

standards, particularly for basic or clinical research instrumentation or durable medical

equipment (DME) designs. This renewal grant should enhance the likelihood that small business

will attract interest and investment by third parties. Such products include, but are not limited to

research equipment, biological products, devices, drugs, medical implants, etc. within the

mission of the NIGMS. Budgets for this Phase IIB Competing Renewal opportunity must follow

the guidelines for Phase II applications (described above). For awards that are intended to

support completion of research needed to obtain an Investigational New Drug application (IND)

or Investigational Device Exemption (IDE), applicants must provide evidence that they have

consulted formally with the FDA concerning the research needed for the development of a drug,

biologic or medical device and that the proposed research will address these regulatory

requirements.

Such evidence should include FDA correspondence from a pre-IND meeting for an IND

application or a pre-IDE meeting for an IDE application, and the status of the project in a

timeline related to Federal regulatory approval processes. Applicants should describe these

consultations and the outcomes in the Progress Report section of the Research Strategy and

provide FDA correspondence or meeting minutes as part of Just-in-Time procedures.

Prospective applicants considering a Phase IIB Competing Renewal application are strongly

encouraged to contact either the Program person of record for the Phase II award or NIGMS

contacts listed at the end of this NIGMS topics announcement.

To assist NIGMS in planning for Phase IIB applications, it is helpful for prospective applicants to

submit to the NIGMS Small Business Strategy Coordinator (listed below) a letter of intent that

includes the following information:

•

Descriptive title of the proposed research

•

Phase II grant number

•

Name, address, and telephone number of the Principal Investigator

•

Names of other key personnel

•

Participating institutions

•

Notice of Funding Opportunity Number

The letter is non-binding and does not enter the review process. It is anticipated that only a small

number of NIGMS SBIR Phase II awards will be eligible for a Phase IIB Competing Renewal

award.

NIH, CDC, and FDA Program Descriptions and Research Topics

NIGMS 115

Clinical Trials

Does NIGMS accept Clinical Trials

through the Omnibus /Parent Notices of

Funding Opportunities?

Does NIGMS accept Clinical Trials

through specific Notices of Funding

Opportunities

Does NIGMS support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

PA-20-206 https://grants.nih.gov/grants/guide/pa-

files/PA20-206.html

PA-20-183 https://grants.nih.gov/grants/guide/pa-

files/PA20-183.html

Contact Information

For general information on the NIGMS Small Business program, contact:

Eddie Billingslea, Ph.D., NIGMS Small Business Strategy Coordinator

Email: NIGMS_SmallBusiness@nigms.nih.gov

For scientific questions about NIGMS-funded SBIR/STTR research, contact:

DIVISION OF PHARMACOLOGY, PHYSIOLOGY, AND BIOLOGICAL

CHEMISTRY

Pharmacological and Physiological

Sciences Sailaja Koduri, Ph.D.

Email: Sailaja.Kodur[email protected]ov

Biochemistry and Bio-related

Chemistry Kadir Aslan, Ph.D.

Email: kadir.aslan@nih.gov

DIVISION OF BIOPHYSICS, BIOMEDICAL TECHNOLOGY, AND COMPUTATIONAL BIOSCIENCES

Ashley Barnes, Ph.D.

Email: ashley.barnes@nih.gov

DIVISION OF TRAINING, WORKFORCE DEVELOPMENT, AND DIVERSITY

Sailaja Koduri, Ph.D.

Email: Sailaja.Koduri@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIGMS 116

DIVISION FOR RESEARCH CAPACITY BUILDING

Krishan Arora, Ph.D.

301-435-0763

Email: arorak@nigms.nih.gov

Research and Development in Science Education

Tony Beck, Ph.D.

301-480-4623

Email: beckL@mail.nih.gov

For administrative and business management questions, contact:

ADMINISTRATIVE AND BUSINESS MANAGEMENT

Mr. Brian Iglesias

301-451-5903

Email: iglesiab@mail.nih.gov

Ms. Ilene Glassman

301-594-4648

Email:

ilene.glassman@nih.go

Ms. Alania Foster

301-451-8255

Email: Alania.foster@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NHLBI 117

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI)

Mission

The NHLBI plans, conducts, and supports research, clinical trials, demonstration, and educational

projects related to the causes, prevention, diagnosis, and treatment of heart, lung, blood, and sleep

disorders. It also supports research on the clinical use of blood products and all aspects of the

management and safety of blood resources. The NHLBI SBIR/STTR programs foster basic, applied,

and clinical research on all product and service development related to the mission of the NHLBI. The

NHLBI has four extramural program divisions, described below. For more information on the NHLBI

Strategic Vision, visit: https://www.nhlbi.nih.gov/sites/default/files/2017-11/NHLBI-Strategic-Vision-

2016_FF.pdf.

For the most up-to-date information on the NHLBI Small Business Programs, please visit the

NHLBI SBIR/STTR website: ( https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-

and-contacts/small-business-program) and subscribe to our listserv (http://bit.ly/NHLBI-SBIR-

Updates). You can also follow us on X at @NHLBI_SBIR. NHLBI encourages potential applicants

to contact us at: http://bit.ly/ContactNHLBIsbir.

Budget Guidance

Total funding support (direct costs, indirect costs, and fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. For budgetary, administrative, or

programmatic reasons, the NHLBI reserves the right to disapprove funding or decrease the length of

an award and/or the budget recommended by a review committee. NIH has received a waiver from

SBA, as authorized by statute, to exceed the statutory budget limitations set by the SBA for specific

topics relevant to the NHLBI that can be found in the SBA-Approved Waiver Topics. It is strongly

recommended for applicants who have a project that falls under one of the SBA-Approved Waiver

Topics to reference the corresponding topic in their Budget Justification document. For most projects

falling under one of the SBA-approved waiver topics, the NHLBI does not fund Phase I applications

greater than the current SBA-mandated budget guidelines (up to $306,872 total costs for Phase I

and up to $2,045,816 total costs for Phase II applications). However, the NHLBI may occasionally

fund projects above these guidelines for proposals falling under one of the approved waiver topics if

one or more of the following criteria have been fulfilled:

The application involves the clinical testing of therapeutics, devices, imaging agents,

biologics, diagnostics, clinical and rehabilitation tools, and/or technologies.

The application involves the use of a large animal model. For the purpose of this guidance,

large animal model species include: swine (porcine), sheep (ovine), cattle (bovine), cat

(feline), dog (canine), ferret, and nonhuman primates.

Applicants with budget requests exceeding these caps should be prepared to negotiate their

budget down if their proposal does not fall into one of the above categories.

Furthermore, all applicants with budget questions, or considering requesting a budget greater than

the set budget limitation amounts, are strongly encouraged to contact the NHLBI SBIR office at

http://bit.ly/ContactNHLBIsbir before submitting an application. For more information on the NHLBI

Budget Policy for SBIR/STTR grants, please refer to NOT-HL-24-008.

NIH, CDC, and FDA Program Descriptions and Research Topics

NHLBI 118

Specific SBIR and STTR Program Information

The NHLBI encourages applications proposing innovative technologies related to any area within the

NHLBI mission.

The NHLBI maintains a list of Notices of Special Interest (NOSIs) and funding opportunities that are

specific to the Institute. Instructions for submitting applications in response to these topics are posted on

the web page. The list is revised throughout the year, so please check regularly for updates.

For more information, contact the NHLBI Small Business team at http://bit.ly/ContactNHLBIsbir or

the Division contact associated with your technology area listed at the end of the NHLBI section.

Technical and Business Assistance

Applicants can request funding for technical and business assistance (TABA) in their application.

Small businesses should include this budget request as part of the application and provide a detailed

description of the vendor and services in the Budget Justification. TABA costs may be requested in

addition to the Phase I and II budget caps set by the NHLBI. The NHLBI may also fund TABA costs

through the administrative supplement program (PA-20-272). For more information about requesting

TABA funding through administrative supplements, please contact Dr. Jain Krotz at

jain.krotz@nih.gov.

Interim and Final Progress Reports

As detailed in NOT-OD-17-085, the NIH has implemented the Final Research Performance

Progress Reports (Final RPPR) for SBIR/STTR Final Progress Reports.

The NHLBI is interested in tracking the progress of the small business concerns it funds and the

products they develop. Funding priority will be given to those small business concerns that show

both their ability to develop products and their growth as a small business concern towards

independence from the SBIR/STTR program.

Additionally, the NIH requires all SBIR/STTR grantees to submit their Life Cycle Certification

document with their Interim Research Performance Progress Reports (Interim RPPR). For more

information on this requirement, please reference NOT-OD-19-025.

Specific Funding Opportunities and Programs

The NHLBI encourages applications focused on innovative technologies that align with its

Mission (https://www.nhlbi.nih.gov/about/mission-statement) through the Omnibus Notices of

Funding Opportunity (NOFOs). In addition to this Omnibus program announcements, the NHLBI

releases targeted NOFOs and Notices of Special Interest (NOSIs) throughout the year. Sign up

for the listserv (http://bit.ly/NHLBI- SBIR-Updates) to be notified of new NOFOs and NOSIs.

Please note that NOFOs and NOSIs can be released or expire at any time throughout the year;

please refer to the NHLBI SBIR/STTR website for active announcements supported by NHLBI.

Programs and Services for NHLBI Small Business Awardees

The NHLBI offers free assistance to applicants and awardees regarding intellectual property,

commercialization, and business plan development. Please visit https://nhlbi.my.salesforce-

sites.com/ to request services.

The NHLBI hosts “Small Biz Hangouts” - a free educational series covering the basics of biomedical

technology development. Previous Hangouts are archived on the NHLBI YouTube channel Small

Business Resources playlist. Sign up for the NHLBI listserv (http://bit.ly/NHLBI-SBIR-Updates) to learn

about upcoming live events, program announcements. Learn more about available resources at

NIH, CDC, and FDA Program Descriptions and Research Topics

NHLBI 119

http://www.nhlbi.nih.gov/about/org/dera/otac/resources.

Regulatory and Commercialization Guidance for Phase II and Fast-Track Applicants

The NHLBI strongly encourages applicants to include a robust regulatory strategy with

corresponding milestones in Phase II and Fast-Track applications. Applicants are also

encouraged to include letters of support or other evidence documenting their regulatory

strategy. Furthermore, the NHLBI also strongly encourages applicants to describe the

following elements in their commercialization plan: management team, market size/opportunity,

competitive advantage, intellectual property, potential impact on healthcare costs and

outcomes, pricing and reimbursement strategy, the clinical trial plan (if applicable), and the

proposed go-to-market strategy for the technology. The NHLBI will consider the strength of

these elements when making funding decisions for Phase II and Fast-Track applications.

For more information on additional factors that are involved with making funding decisions for

Phase II SBIR/STTR applications and other applications funded through the Zone of

Consideration, please visit https://www.nhlbi.nih.gov/current-operating-guidelines.

For assistance regarding the Phase II commercialization plan, watch the “Small Biz Hangout” for

advice on Writing Your Phase II Commercialization Plan (http://bit.ly/Ph2CommPlanHangout) and

contact Stephanie Davis (nhlbi_sbir@mail.nih.gov) with specific questions.

Phase IIB Competing Renewal Awards

NHLBI only accepts Phase IIB SBIR/STTR Competing Renewal applications through specific

opportunities. These opportunities can be found on the NHLBI Funding Opportunities webpage:

https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-

program. Applicants are strongly encouraged to contact Dr. Jain Krotz at jain.krotz@nih.gov for

additional information on Phase IIB funding opportunities.

Commercialization Readiness Pilot (CRP)

The NHLBI welcomes the submission of Commercialization Readiness Pilot (CRP) program

applications from current or past Phase II/IIB awardees. The CRP aims to facilitate the transition of

previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the

commercialization stage by providing additional support for technical assistance and later-stage

research and development (R&D) not typically supported through Phase II or Phase IIB grants or

contracts. NHLBI will accept budgets up to $500,000 total costs (direct costs, indirect costs, fee)

across up to two years. NHLBI participates in the following CRP NOFOs below:

•

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance

and Late Stage Development - Clinical Trial Not Allowed (PAR-23-219)

•

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance

and Late Stage Development - Clinical Trial Required (PAR-23-220)

Clinical Trials

Does NHLBI accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Please reach out to program staff at least 30 days

before the application deadline to discuss your

project if submitting a Clinical Trial application.

Does NHLBI accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

Please reach out to program staff at least 30 days

before the application deadline to discuss your

project if submitting a Clinical Trial application.

NIH, CDC, and FDA Program Descriptions and Research Topics

NHLBI 120

Does NHLBI support Clinical Trials

through NON-SBIR/STTR Notices

of Funding Opportunities?

Yes

For information on non-SBIR/STTR clinical trials

funding mechanisms for which small businesses

are eligible, please visit the NHLBI clinical trials

website

Research Topics

Cardiovascular Sciences

The Division of Cardiovascular Sciences (DCVS) supports basic, clinical, population, and health

services research on the causes, prevention, and treatment of cardiovascular diseases. The

research programs of the Division encompass investigator-initiated research, Institute-initiated

research in targeted areas of research need and scientific opportunity, specialized centers of

research focused on selected research topics, and clinical trials. Research supported by the Division

is concerned with the etiology, pathogenesis, prevention, diagnosis, and treatment of coronary artery

disease and atherothrombosis; pediatric and structural heart disease; heart failure and arrhythmias;

and hypertension and vascular diseases. DCVS also supports investigations into the development

and use of medical devices, imaging devices, software programs, AI/ML technologies, molecular

technologies and other tools to improve cardiovascular health. A broad array of epidemiological

studies is supported by the DCVS to describe disease and risk factor patterns in populations and to

identify risk factors for disease. Also supported are clinical trials of interventions to prevent and treat

disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk

and outcomes; and studies of the application of prevention and treatment strategies to determine

how to improve clinical care and public health. If you would like to learn more about the scientific

areas covered by the DCVS and connect with a program officer, please visit the division website:

Division of Cardiovascular Sciences | NHLBI, NIH.

Lung Diseases

The Division of Lung Diseases (DLD) supports research on the causes, diagnosis, management,

prevention, and treatment of lung diseases and sleep disorders. Research is funded through

investigator- initiated and Institute-initiated grant and contract programs in areas including

asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis,

respiratory neurobiology, critical care and acute lung injury, developmental biology, pediatric and

neonatal pulmonary diseases and care, immunologic and fibrotic pulmonary disease, rare lung

disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis.

Also supported are mechanistic and non-mechanistic clinical trials to predict, prevent and treat

pulmonary disease; digital health including mobile / tele-health, wearable devices, respiratory

surgical devices, aerosol drug or gas delivery, supplemental oxygen, bioinformatics, mechanical

ventilation, imaging devices, personalized medicine and AI/ML to help inform clinical decision

making in pulmonary medicine. If you would like to learn more about the scientific areas covered

by the DLD and connect with a program officer, please visit the division website: Division of Lung

Diseases | NHLBI, NIH.

Sleep and Circadian Biology

The National Center for Sleep Disorders Research (NCSDR) supports research on the causes,

prevention, and treatment of sleep disorders and the promotion of sleep health. Research is

funded through investigator- initiated and Institute-initiated, grant, and contract programs in

NIH, CDC, and FDA Program Descriptions and Research Topics

NHLBI 121

sleep and circadian biology research projects. The NCSDR is interested in funding projects

related to the regulation of sleep and sleep disorders including circadian disorders, insomnia and

obstructive sleep apnea. The NCSDR is also interested in research focused on the development

of tools, devices and data science approaches for the early prediction, detection, and treatment

of sleep deficiency and sleep and circadian disorders. If you would like to learn more about the

scientific areas covered by the NCSDR and connect with a program officer, please visit the

website: National Center on Sleep Disorders Research | NHLBI, NIH.

Blood Diseases and Resources

The Division of Blood Diseases and Resources (DBDR) supports research on the causes,

prevention, and treatment of nonmalignant blood diseases, including anemias, sickle cell disease,

hemophilia and thalassemia; premalignant processes such as myelodysplasia and myeloproliferative

disorders; and other abnormalities of hemostasis and thrombosis; and immune dysfunction.

Research supported by the Division encompasses a broad spectrum of topics ranging from basic

biology and mechanism of action, to medical management of blood diseases. The Division has a

major responsibility for research to improve the adequacy and safety of the nation's blood supply. It

also plays a leading role in transfusion medicine and blood banking, including research to evaluate

blood donation screening, manufacturing, processing technologies and storage. The Division also

has a major responsibility supporting research in hematopoiesis and stem cell biology and disease. It

also supports hematopoietic stem cell transplantation research and the application of stem cell

biology findings to the development of new cell-based therapies to repair and regenerate human

tissues and organs. If you would like to learn more about the scientific areas covered by the DBDR

and connect with a program officer, please visit the division website: Division of Blood Diseases and

Resources | NHLBI, NIH.

Center for Translation Research and Implementation Science

The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and

supports an integrated and coordinated program of research to understand the multi-level

processes and factors that are associated with successful integration of evidence-based

interventions within specific clinical and public health settings such as worksites, communities,

and schools; identifies and makes readily available to implementation and dissemination

practitioners emergent knowledge about the late phases of translation research, especially the

"T4" phase, for rapid and sustained adoption of effective interventions in real world settings;

leads the NHLBI effort in the rigorous, systematic evidentiary reviews and subsequent NHLBI

participation in the collaborative model for clinical practice guidelines development; supports

training and career development of personnel in "T4" translation research and health inequities

relating to heart, lung, and blood diseases; provides a focal point for advice and guidance on

matters pertaining to minority health, health inequities and minority participation in research;

represents the NHLBI to other governments, other Federal Departments and agencies,

international organizations, and the private sector on global health issues; and provides data

analytics and portfolio analysis to evaluate and inform future directions of implementation

research programs. If you would like to learn more about the scientific areas covered by the

CTRIS and connect with a program officer, please visit the division website: Center for

Translation Research and Implementation Science | NHLBI, NIH.

Contact Information

SBIR OFFICE

For general questions about the NHLBI SBIR/STTR grant program,

please contact:

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NHLBI 122

Stephanie Davis, Ph.D.

Division of Extramural Research Activities

Phone: 1-301-496-8412

Email:mailto: nhlbi_sbir@mail.nih.gov

For administrative and business management questions, please contact:

Andre Walker

Division of Extramural Research

Activities Phone: 1-301-827-8061

Email: walkera@nhlbi.nih.gov

CARDIOVASCULAR SCIENCES

Rahul Thakar, Ph.D.

Division of Cardiovascular Sciences

Advanced Technologies and Surgery Branch

Phone: 301-827-8151

Email: rahul.thakar@nih.gov

LUNG DISEASES AND SLEEP AND CIRCADIAN BIOLOGY

Lei Xiao, M.D., Ph.D.

Division of Lung Diseases

Restrictive and Vascular Lung Diseases Branch

Phone: 301-827-7852

Email: lei.xiao@nih.gov

Sidd Shenoy, Ph.D.

Division of Lung Diseases

Acute and Infectious Lung Diseases Branch

Phone: 301-827-4751

Email: sidd.shenoy@nih.gov

For sleep-related proposals, please contact:

Shilpy Dixit, Ph.D. Division of Lung Diseases

National Center for Sleep Disorders Research

Phone: 301-402-9064

Email: shilpy.dixit@nih.gov

BLOOD DISEASES AND RESOURCES

Ron Warren, Ph.D.

Division of Blood Diseases and Resources

Translational Blood Science and Resources Branch

Phone: 301-827-8288

Email: ronald.warren@nih.gov

Ilana Goldberg, Ph.D.

Division of Blood Diseases and Resources

Molecular, Cellular & Systems Blood Science

Branch Phone: 301-496-8587

Email: ilana.goldberg@nih.gov

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NHLBI 123

CENTER FOR TRANSLATION RESEARCH AND IMPLEMENTATION SCIENCE

Karen Plevock Haase, Ph.D.

Center for Translation Research and Implementation Science

Implementation Science Branch

Phone: 301-435-6820

Email: karen.plevock@nih.gov

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NHGRI 124

NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI)

Mission

The National Human Genome Research Institute (NHGRI) has been guided, since the inception

of the Human Genome Project in 1990, by a sequential series of plans, each of which has been

developed with considerable input from the scientific community. These plans have always laid

out ambitious goals and measurable objectives to gauge progress. The Institute recently

examined the current state of genomics and gathered input on its future directions, which

resulted in a 2020 strategic plan to guide NHGRI and research at the forefront of genomics

(Green et al. Strategic vision for improving human health at The Forefront of Genomics. Nature

586, 683–692 (2020).

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website, unless the application fits an

SBA-approved NHGRI waiver topic. For topics listed in the SBA-Approved Waiver Topics, the

NHGRI generally will not fund Phase I applications to the Omnibus greater than $400,000 total

costs or Phase II applications greater than $2,150,000 total costs (not including the costs of

technical and business assistance). For budgetary, administrative, or programmatic reasons, the

NHGRI may not fund an application or may decrease the length of an award and/or the budget

recommended by a review committee. Applicants with budget questions or considering

requesting a budget greater than these amounts are strongly encouraged to contact

program staff before submitting an application.

Specific SBIR and STTR Program Information

Information about the NHGRI Small Business Program and specific funding announcements is

available online. Applicants are strongly encouraged to discuss their research plans with NHGRI

Program Staff prior to submitting their applications.

Clinical Research Support

The National Human Genome Research Institute (NHGRI) will accept applications designated

as clinical trials for all program areas supported by the Institute as outlined below for non-clinical

trials small business grants. The broadened definition of clinical trials as defined in NOT-OD-15-

015 and on the NIH website is not intended to expand the scope of applications accepted by

NHGRI beyond studies that have a major genomic or Ethical, Legal and Social Implications

(ELSI) component and relate clearly to NHGRI’s mission. Information on areas of research

interest is available on the NHGRI Research Funding Divisions homepage and the ELSI

Research Domains website.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NHGRI does not accept applications for Phase IIB competing renewal awards through this

Omnibus solicitation. NHGRI participates in the CRP program.

NIH, CDC, and FDA Program Descriptions and Research Topics

NHGRI 125

Clinical Trials

Does NHGRI accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NHGRI accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does NHGRI support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

Research Topics

Technology and Methods Development

Technology development in DNA sequencing, genotyping, and single-cell analysis are

examples of activities that have changed the nature of what scientific research questions are

practical to address, have enabled new approaches, and have facilitated the development of

new community resource data sets. Many areas of critical importance to the realization of

the genomics-based vision for biomedical research require continued technological and

methodological developments before pilots and then large-scale approaches can be

attempted. Accordingly, the NHGRI will continue to support the development of new,

fundamental technologies in all areas of genomics. Important areas in which technology

development applications would be responsive include (but are not limited to) experimental

technologies and computational methods to analyze gene expression and other molecular

phenotypes; discovery and characterization of genetic variation; identification of the genetic

contributions to health, disease, and drug response; statistical analytic methods for

understanding human genomic variation and its relationship to health and disease; and

chemical genomics. There is also continued need to support technology development for the

comprehensive discovery of functional elements in the human and model organism

genomes and new nucleic acid sequencing technology. Many of these assays would benefit

from the ability to work with very small amounts of starting material down to the level of

single cells and subcellular compartments, along with minimally invasive human specimens

that are easy to collect, handle, and store. As these technologies mature, emphasis should

be on high throughput, cost-effective methods that consistently produce very high- quality

data.

The Institute also places high priority on contributing selectively to the development of new

and needed technology in related areas, such as proteomics and systems biology research,

when NHGRI funding can be used to further a truly unique development that will have a

significant impact on the field.

Further information on opportunities related to technology and methods development is

available on the NHGRI Genome Technology Program website.

Bioinformatics, Computational Genomics, and Data Science

The ongoing development of new sequencing technologies has dramatically increased the

amount of data produced for genomics in basic science and translation to medicine. NHGRI

encourages new computational approaches for the analysis, visualization, and integration of

genomic information in basic and clinical research and in applications to improve its utility in

healthcare. These approaches may include the development of methods for processing,

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NHGRI 126

annotating, interpreting, analyzing, and sharing of sequencing data with associated

phenotypes and other large-scale genomic data sets such as haplotype maps, genetic

variants, transcriptome measurements, functional elements, and, in some cases, protein

interactions. New tools for population-based analysis using the pangenome reference are of

interest. NHGRI also encourages the development of better computational solutions for

storage, access, compression, secure sharing, privacy, and transfer of large genomic

datasets by biomedical researchers.

NHGRI will support projects to improve informatics tools to make them more easily adopted

by any biomedical research laboratory that wishes to use genomic technologies to address

biomedical questions. This may include making them more efficient, reliable, robust, well-

documented, and well- supported, or deploying them in containers or at scale in a cloud-

based platform.

Where possible, existing or emerging community data standards, models, and methods for

data representation and exchange should be used in the development of these new

methods and tools as well as other approaches to enhance reproducibility. Standards-based

approaches such as GA4GH are also encouraged to integrate and share genomics and

phenotype data for data mining with other sources including for clinical application. Projects

that will make genomic digital objects Findable, Accessible, Interoperable, Reusable (FAIR)

in the broader community are highly recommended.

Further information on programs related to NHGRI supported research in these areas is

available on the Computational Genomics and Data Science Program website.

Population Genomics and Genomic Medicine

Advances in the understanding of genomic variation across human populations and the functional

consequences of variants independently, in combination, and in different environmental contexts

have significantly impacted how genomic information can be used in both public health and

clinical practice settings, alternatively known as genomic medicine. An existing challenge is how

to capture, interpret, and return genomic information at high volumes and in a cost-effective

manner. Innovative technologies and methods are needed to allow information on genomic

variation to be used broadly in clinical settings while meeting regulatory requirements, to inform

public health efforts, and to accurately convey genomic risk profiles to a lay audience.

Biotechnology and informatics have enhanced our ability to survey the entire genome within and

among populations. This progress has allowed for improved inferences about evolution of the

genome and better characterization of populations, key elements of populations genomics. An

existing challenge is how to assemble and analyze multiple genomes using computational

methods to identify patterns of genomic divergence. Technology is needed to enable nuanced

incorporation of population-based discovery with detailed investigation of disease-based cohorts

and prospective variant evaluation. Population genomic information can be used to understand

disease process, improve risk prediction, and apply the results in patient care.

The research scope of Population Genomics and Genomic Medicine at NHGRI includes:

characterizing the spectrum and distribution of genetic variation in humans and other biomedically

relevant organisms; developing statistical and computational methods for comparing genomes

and genome function within and across species as well as for relating genetic variation to health-

and disease-related traits; developing resources and statistical methods for observational studies

and clinical trials incorporating advanced genomic technologies; conducting proof -of-principle

studies that apply genomic technologies to epidemiologic and clinical research; developing

research methods and infrastructure needed for future epidemiologic and clinical studies of

genetic and environmental contribution to disease; investigations of whether and how clinical

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NHGRI 127

genome variation impacts disease prevention diagnosis, and treatment; studies of approaches to

improve the identification and interpretation of genomic variation for dissemination in clinical

settings; assessing phenotypic manifestations of genetic variation through electronic medical

records (EMRs); integrating genomic results and clinical decision support into EMRs; studies that

address current barriers to the implementation of clinical genome sequencing; and assessing the

impact of genetic information on clinical utility, health outcomes, and delivery of care.

For additional information about Genomic Medicine at NHGRI, please visit the Division of Genomic

Medicine website.

Ethical, Legal and Social Implications

NHGRI, through the ELSI Research Program, supports research studies that examine

and address the ethical, legal, and social implications of genomics. These studies may

focus on issues associated with genomic research, genomic healthcare, the interplay

between the field of genomics and organizations, institutions, or other organized

stakeholders, and broader values and societal effects that shape and are shaped by

genomics.

More detailed information on specific ELSI research priorities within each of these broad

areas is available on the ELSI Research priorities website.

Genomic training and education

NHGRI supports educational activities and curriculum development that increase genomics

knowledge of students, trainees, and genomics professionals. The goal of these activities is to

provide an avenue for entry and pursuit of genomics careers. The widespread impact of

genomics creates a need to train diverse groups of people to develop innovative and impactful

genomic research approaches and resources. Training opportunities may be proposed at the

undergraduate, postbaccalaureate, graduate, postdoctoral, or professional level.

For more information on genomic training and education at NHGRI, please visit the Training

Program website.

Contact Information

For more information on research topics,

contact:

Ian Nova, Ph.D.

Small Business Program Co-Lead (SBIR)

Phone: 240-987-2885

Email: ian.nova@nih.gov

Renee Rider, M.S., J.D., LCGC

Small Business Program Co-Lead (STTR)

Phone: 301-443-4336

Email: renee.rider@nih.gov

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NIMH 128

NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)

Mission

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and

treatment of mental illnesses through basic and clinical research, paving the way for prevention,

recovery, and cure. Mental disorders constitute an immense burden on the U.S. population, with

suicide as one of the leading causes of death in the US, major depression the leading cause of

disability in the U.S., and schizophrenia, bipolar disorder, and obsessive-compulsive disorder ranked

among the ten leading causes of disability. NIMH also takes a leading role in understanding the

impact of behavior on HIV transmission and pathogenesis, and in developing effective behavioral

preventive interventions. The NIMH conducts a wide range of research, research training, research

capacity development, as well as public information outreach and dissemination to fulfill its mission.

The NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) and

the National Advisory Mental Health Council’s workgroup report “From Discovery to Cure”

http://www.nimh.nih.gov/about/advisory- boards-and-

groups/namhc/reports/fromdiscoverytocure_103739.pdf present key scientific priorities across these

domains, and describe the need for technologies to realize these priorities. Research priorities for

the NIMH further include aspects of HIV/AIDS prevention, treatment, and care, in accordance with the

Trans-NIH Plan for HIV-Related Research (https://www.oar.nih.gov/hiv-policy-and-

research/strategic-plan).

For the Institute to continue fulfilling this vital public health mission, it must foster innovative thinking

and ensure that a full array of novel scientific perspectives is used to further discovery in the evolving

science of brain, behavior, and experience. In this way, breakthroughs in science can become

breakthroughs for all people with mental illnesses.

The NIMH SBIR/STTR programs support small businesses to develop technologies that can advance

the mission of the Institute, including in basic neuroscience research relevant to mental disorders,

translational and clinical research of mental disorders, clinical diagnosis or treatment of mental

disorders, and dissemination of evidence-based mental health care.

For additional information about areas of interest to the NIMH, please visit our home page at

http://www.nimh.nih.gov and the NIMH SBIR/STTR program priorities page at

https://www.nimh.nih.gov/funding/sbir/nimh-sbir-sttr-program-priorities.shtml. NIMH has released a notice

of considerations regarding the use of animal neurobehavioral approaches, please see NOT-MH-19-053:

https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-053.html. NIMH has specific requirements for

clinical trials, please visit: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-

foas/index.shtml. A 2020 NAMHC Workgroup on Drug Development provides further guidance on

pharmacologic trial designs.

NIMH has additional guidance on areas of interest in stress biology research, please see NOT-MH-

18-058: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-18-058.html. NIMH has released a

notice of considerations for preclinical research involving psychedelics and related compounds:

https://grants.nih.gov/grants/guide/notice-files/NOT-MH-23-125.html. The NIMH SBIR/STTR

programs will only consider preclinical psychedelics and/or related compound projects.

The NIMH SBIR/STTR website provides guidance and resources for applicants:

https://www.nimh.nih.gov/funding/sbir/.

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NIMH 129

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. NIH has received a waiver from

the SBA, as authorized by statute, to exceed the statutory budget limitations set by the SBA for

specific topics relevant to the NIMH that can be found in the SBA-Approved Waiver Topics. Please

note, for budgetary, administrative, or programmatic reasons, the NIMH may not fund an application

or may decrease the length of an award and/or the budget recommended by a review committee.

Applicants with budget questions or considering requesting a budget greater than the SBA

defined amounts are strongly encouraged to contact program staff before submitting an

application.

Specific SBIR and STTR Program Information

Potential SBIR/STTR applicants should contact NIMH prior to submitting an application to

ensure the application is of priority/interest to NIMH. Please see the Contacts section.

An additional criterion that the federal government considers in supporting a small

business with SBIR/STTR funds, is past commercialization performance. It is expected that

small businesses who have received previous SBIR/STTR grants, have had success in

commercializing their previously supported technologies. Small businesses that are mostly

interested in research and development (and not commercialization) should consider other

grant mechanisms at NIH, rather than the SBIR/STTR program. Program staff at NIMH

can help identify the most appropriate grant mechanism to use.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

The NIMH will accept Phase IIB SBIR/STTR Competing Renewal grant applications in two

categories: 1) to continue research and development of technologies that ultimately require federal

regulatory approval, and 2) to continue research and development of complex instrumentation,

clinical research tools, or behavioral/digital health interventions and treatments.

Technologies in the former category (those that ultimately require federal regulatory approval) include

but are not limited to pharmacologic agents and drugs, biological products, medical devices,

vaccines, etc. related to the mission of the NIMH. Phase IIB SBIR/STTR Competing Renewal grants

for such technologies should allow small businesses to move research and development to a stage

where interest and investment by third parties is more likely.

Companies that are developing technologies that do not focus on drug development, but that require

federal regulatory approval prior to commercialization, may be eligible to submit a Phase IIB

Competing Renewal application.

For both technology areas, Phase IIB applications may be submitted through the Omnibus

SBIR/STTR Notice of Funding Opportunity. Generally, for this opportunity, budget limits of $3 million

total costs and time periods up to 3 years may be requested. These budget allowances have been

approved by the SBA through a waiver. For budgets higher than $3 million, contact NIMH program staff

prior to submitting the application.

The following examples would make appropriate topics for proposed NIMH SBIR/STTR Phase IIB

Competing Renewal projects. These are meant for illustrative purposes only and are not exclusive of

other appropriate activities:

•

Preclinical studies, including pharmacology and toxicology, beyond those conducted under the

Phase I (R43/R41) and initial Phase II (R44/R42) grants. Some in vivo or in vitro studies would

be expected to have been carried out in Phase I or the initial Phase II grant.

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NIMH 130

•

Completion of studies as required by the Food and Drug Administration (FDA) for

Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC)

application.

•

Studies in normal healthy volunteers to determine a drug’s safety profile, metabolism, etc.

•

Assessment of devices with regard to performance standards related to the FDA approval process.

•

Safety and effectiveness studies of novel medical devices.

•

Evaluation of novel imaging approaches for diagnostic purposes.

•

Clinical studies in support of Pre-Market Approval for biomarkers/medical devices by the FDA.

Although technologies in the latter category listed above (complex instrumentation, clinical research tools,

or behavioral interventions/treatments) may not require federal regulatory approval, extraordinary time

and effort is needed for their research and development. Therefore, NIMH supports Phase IIB Competing

Renewal awards of existing Phase II grants for such technologies. The Phase IIB Competing Renewal

award for these would provide up to an additional three years of support at total cost funding levels of up

to $3 million (generally) for the project. These budget allowances have been approved by the SBA

through a waiver.

Please contact the Program Director in the appropriate Division or Dr. Margaret Grabb (listed

below) before beginning the process of putting an application together. In addition, prospective

applicants are encouraged to submit to the program contact a letter of intent that includes the

following information:

•

Descriptive title of the proposed research

•

Name, address, and telephone number of the Principal Investigator

•

Names of other key personnel

•

Participating institutions

•

Notice of Funding Opportunity (e.g., PA-19-273).

Although a letter of intent is not required, is not binding, and does not enter into the review of a

subsequent application, the information that it contains allows NIH staff to estimate the potential

review workload and plan the review. It is expected that only a portion of NIMH SBIR Phase II

awards will be eligible for a Phase IIB Competing Renewal grant.

Clinical Trials

Does NIMH accept Clinical Trials

through the Omnibus/Parent Notices

of Funding Opportunities?

Yes

NIMH will prioritize funding for SBIR/STTR

applications with a clinical trial focus that are

consistent with the stated research goals and priorities

relevant to clinical trials as outlined in the clinical trials

NOFOs. For more information

see: https://www.nimh.nih.gov/funding/sbir/sbir-

amp-sttr-funding-opportunity-announcements

Does NIMH accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

NIMH will prioritize funding for SBIR/STTR

applications with a clinical trial focus that are

consistent with the stated research goals and priorities

relevant to clinical trials as outlined in the clinical trials

NOFOs. For more information

see: https://www.nimh.nih.gov/funding/sbir/sbir-

amp-sttr-funding-opportunity-announcements

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NIMH 131

Does NIMH support Clinical Trials

through NON-SBIR/STTR Notices

of Funding Opportunities?

Yes

NIMH will prioritize funding for SBIR/STTR

applications with a clinical trial focus that are

consistent with the stated research goals and priorities

relevant to clinical trials as outlined in the clinical trials

NOFOs.

For more information

see: https://www.nimh.nih.gov/funding/sbir/sbir-

amp-sttr-funding-opportunity-announcements

And:

•

First in Human and Early Stage Clinical Trials of

Novel Investigational Drugs or Devices for

Psychiatric Disorders (U01 Clinical Trial

Required) PAR-21-133

•

Early Stage Testing of Pharmacologic or

Device-based Interventions for the Treatment of

Mental Disorders (R61/R33- Clinical Trial

Required) PAR-21-137

•

Early Stage Testing of Pharmacologic or

Device-based Interventions for the Treatment of

Mental Disorders (R33- Clinical Trial Required)

PAR-21-136

•

Development of Psychosocial Therapeutic and

Preventive Interventions for Mental Disorders

(R61/R33- Clinical Trial Required) PAR-21-135

•

Development of Psychosocial Therapeutic and

Preventive Interventions for Mental Disorders

(R33 Clinical Trial Required) PAR-21-134

•

Confirmatory Efficacy Clinical Trials of Non-

Pharmacological Interventions for Mental

Disorders (R01 Clinical Trial Required) PAR-21-

132

•

Pilot Effectiveness Trials for Treatment,

Preventive and Services Interventions (R34-

Clinical Trial Required) PAR-21-131

•

Clinical Trials to Test the Effectiveness of

Treatment, Preventive, and Services

Interventions (R01 Clinical Trial Required) PAR-

21-130

•

Clinical Trials to Test the Effectiveness of

Treatment, Preventive, and Services

Interventions (Collaborative R01 - Clinical Trial

Required) PAR-21-129

Research Topics

Division of Neuroscience and Basic Behavioral Science (DNBBS)

The Division of Neuroscience and Basic Behavioral Science provides support for research programs

in the areas of basic neuroscience, genetics, basic behavioral science, research training, resource

development, technology development, drug discovery, and research dissemination. The Division has

the responsibility, in cooperation with other components of the Institute and the research community,

for ensuring that relevant basic science knowledge is generated and then harvested to create

improved diagnosis, treatment, and prevention of mental and behavioral disorders.

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NIMH 129

In this Division, the SBIR and STTR programs support research and the development of tools

related to basic brain and behavioral science, genetics, and drug discovery and development

relevant to the mission of the NIMH. Such tools include software (such as informatics tools and

resources and tools for analyzing data); hardware (such as the development of instrumentation or

devices); wetware (such as the use of iRNAs or other bioactive agents as research tools or

molecular imaging agents or genetic approaches to label neural circuits or modify circuit functions);

and drug discovery related technologies such as high throughput screening (HTS) or computational

pharmacology approaches. Assay development projects should follow the best practices laid out in

the Assay Guidance Manual: https://www.ncbi.nlm.nih.gov/books/NBK53196/.

AREAS OF EMPHASIS

•

Novel imaging probes to study brain structure and function at all levels, from the

molecular level to the whole organ, using any imaging modality (PET, fMRI, optical, etc.)

in animal or human studies.

•

Drug discovery/drug development of novel compounds which act on molecular pathways

(receptors, enzymes, second messengers, etc.) that are not typically targeted with currently

available psychiatric drugs, and that have a strong biological justification as a novel

mechanism for treatment of psychiatric disorders.

•

First in human drug trials.

•

Novel screening assays for high throughput acquisition and analysis of data about behavior

and the brain, from the level of genes to behavior.

•

Novel technologies that would enable researchers to study how populations of neural

cells work together within and between brain regions, in order to understand how changes

in neural activity contributes to mental disorders, using animals or when applied to

humans.

•

Develop informatics tools to facilitate the analysis and sharing of data between laboratories

about behavior and the brain. This could include common data element efforts but is not

limited to that area.

•

Technologies consistent with the goals of the BRAIN Initiative:

http://www.braininitiative.nih.gov/, including human/ clinical-based technologies.

Prospective applicants are strongly encouraged to contact Dr. Margaret Grabb and Ms. Paige

Anderson (listed below) with questions about the relevance of their interests to the mission of this

division.

Division of Translational Research (DTR)

The DTR directs, plans, and supports programs of research and research training that translate

knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental

disorders and develops effective interventions for children and adults. DTR supports integrative,

multidisciplinary research on the following areas: the phenotypic characterization and risk factors for

psychiatric disorders; neurobehavioral mechanisms of psychopathology; trajectories of risk and

resilience based on the interactive influences of genetics, brain development, environment, and

experience; and design and testing of innovative psychosocial, psychopharmacologic, and somatic

treatment interventions.

In this Division, the SBIR and STTR Programs support research aimed at facilitating the validation

and commercialization of new methods of assessing psychopathology and measuring treatment

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NIMH 130

response to therapeutic agents. In addition, the SBIR and STTR Programs support the clinical

development of interventions, including novel pharmacologic agents or brain stimulation devices

as well as technology development used to deliver novel psychosocial approaches to the treatment

of mental illness in adults, pediatrics and geriatrics. For more information on NIMH supported

clinical trials and requirements, see: https://www.nimh.nih.gov/funding/opportunities-

announcements/clinical-trials-foas/index.shtml

AREAS OF EMPHASIS

•

Develop valid measures of the various constructs in the Research Domain Criteria (RDoC)

matrix (see https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/index.shtml),

e.g., behavioral tasks, psychometrically sophisticated self-report measures, and measures of

physiological and neural activity, into a commercial product.

•

Conduct early stage, proof of concept clinical trials to advance the development of novel

therapeutics. The clinical trials are expected to include biological/behavioral data to assess

target engagement and to help determine potential success or failure of the compound

before moving on to larger clinical trials (see NOT-MH-11-015

http://grants.nih.gov/grants/guide/notice-files/NOT-MH-11-015.html).

•

Develop, test and perform initial validation of reliable and stable biomarkers that can identify

at-risk individuals prior to disease onset, improve diagnosis and classification, predict

treatment response, or to measure disease progression. Biomarkers are also needed in

clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll

in a treatment trial, or to measure efficacy or toxicity/side effects. Biomarkers in psychiatry

will initially be appropriate as clinical research tools, and only after significant technical and

clinical validation, could move toward diagnostic utility or other context of uses.

•

Development of novel diagnostic tools and innovative measures of treatment response and

disease progression, preclinical or clinical efficacy testing, or toxicity measures for drug

development.

•

Development of hardware and software tools to enable refined physiological and

behavioral assessment of normal and atypical neurodevelopment focused on pediatrics,

adult and geriatric age ranges.

•

Web-based tools and biosensors to enhance prevention, early identification and treatment of

pediatric mental disorders by various educational and health professionals.

•

Development of hardware and software tools to support operations of multi-site clinical trials.

•

Development of novel methods to enhance efficiency of early phase clinical trials.

•

Novel technologies and data analytic tools to enable quantification of behavioral data that is

relevant to research or clinical trials in mental disorders and/or autism.

•

Development of imaging technologies that can reveal specific pathologies in major mental

disorders.

Prospective applicants are strongly encouraged to contact Dr. Margaret Grabb (listed below) with

questions about the relevance of their interests to the mission of this division.

Division of AIDS Research (DAR)

The NIMH DAR supports scientific research to understand and alleviate the consequences of HIV

NIH, CDC, and FDA Program Descriptions and Research Topics

NIMH 131

disease on the central nervous system, and research to strengthen the provision and outcomes of

HIV/AIDS prevention and treatment. Examples of high-priority research areas for SBIR/STTR

applications are described below.

•

Develop and test novel, non-invasive diagnostic approaches (instrumentation, imaging,

biomarkers, central nervous system [CNS] cell-based in vitro models) to comprehend HIV-

1 associated CNS dysfunction and innovative technologies to study the mechanisms

involved in HIV-1 associated neuropathogenesis and persistence of HIV-1 in the CNS.

•

Design and test novel therapeutic interventions aimed at amelioration of HIV-1

associated CNS dysfunction, and/or eradication of HIV-1 from CNS reservoirs, and/or

strategies to prevent viral resurgence in the CNS upon cessation of anti-retroviral

therapy.

•

Tools to assess neurotoxicity profiles of antiretroviral medications and pharmacological

strategies to reduce adverse effects of anti-retroviral drugs (neuropsychiatric side effects

and drug-drug interactions).

•

Develop new tools/ techniques to aid in deciphering the complex neuro-immune

interactions at a molecular and cellular level in the context of HIV.

•

Develop or adapt neurological/neuropsychological/neurobehavioral assessments to

evaluate HIV-1 associated abnormalities in adults or children in resource limited

environments that are adaptable to different cultures and languages.

•

Build and optimize informatics tools to aid in analyzing and characterizing the phenotype

of CNS disease modalities associated with HIV by using machine learning, big data and

systems biology- based approaches.

•

Develop technologies and tools to increase regular HIV testing and support uptake,

adherence, and persistence to biomedical HIV prevention regimens among persons

behaviorally vulnerable to HIV or to biomedical HIV treatment regiments among people

newly diagnosed with HIV.

•

Develop innovative tools and approaches that use existing patient-level data, such as

electronic medical records and prescription refill or claim data, to improve engagement in

HIV care or HIV treatment adherence to strengthen sustained viral suppression, including

development and testing of predictive algorithms to identify those at risk for future non-

adherence.

•

Develop approaches that seamlessly integrate tools for mental health screening and

treatment into HIV healthcare or increase the capacity of HIV clinics to address mental

health concerns.

•

Develop decision support tools that help individuals, couples, and clinicians make informed

choices about the increasing number of proven and available HIV prevention and

treatment regimens, including long-acting regimens and multipurpose prevention

technologies (MPTs).

•

Develop innovative wireless technologies, remote sensing devices, biomarkers, assays, or

other novel methods to improve scientific measurement of HIV exposure due to sexual

behavior, or scientific measurement of social determinants that influence HIV treatment and

prevention. Assessment approaches could occur retrospectively (not a clinical trial – using

existing data, such as electronic medical records).

•

Develop and improve digital communication technologies to raise HIV awareness and

NIH, CDC, and FDA Program Descriptions and Research Topics

NIMH 132

promote accurate and timely health information to users, groups, and geographic regions

most impacted by HIV.

•

Develop and test tools, curricula, and strategies that seek to reduce documented HIV-

related disparities and health inequities (e.g., age, sex, gender identity, sexual

orientation, race, ethnicity, socioeconomic circumstance, etc.) in HIV incidence and HIV

prevention, treatment, and cure outcomes.

•

Develop innovative long-acting systemic and non-systemic multipurpose prevention

technologies that prevent HIV infection and pregnancy (hormonal and non-hormonal

methods) in adolescents and young women.

Prospective applicants are strongly encouraged to contact Dr. Vasudev R Rao (listed below) with

questions about the relevance of their interests to the mission of this division.

Division of Services and Intervention Research (DSIR)

The Division of Services and Intervention Research (DSIR) SBIR/STTR supports two critical areas of

research for people with or at risk for mental illness:

•

Intervention research to evaluate the efficacy and effectiveness of pharmacologic,

psychosocial, somatic, rehabilitative, sequential and combination interventions on mental

and behavior disorders- including acute and longer-term therapeutic effects on functioning

across domains for children, adolescents, and adults.

•

Mental health services research to improve the access, continuity, equity, value, quality and

outcomes of mental health care, as well as to improve the dissemination of information about

and the implementation of effective interventions, to strengthen the public health impact of

NIMH research.

The intervention research program aligns with NIMH Strategic Objectives 3.2 and 3.3 and addresses

the efficacy/effectiveness of treatment and preventive interventions in usual practice and community

settings with the purpose of informing clinicians, patients, families, and health policy makers on

evidence-based practices. In funding decisions, special emphasis is placed on the potential clinical

and/or public health impact of the research activities and on the implications of the research findings

for improving community practice and health outcomes. Types of interventions include the full range

of behavioral, psychotherapeutic, pharmacologic, and non-pharmacologic somatic or

complementary/alternative interventions, as well as rehabilitation or other adjunctive services, e.g.,

integrated approaches to chronic mental illness. Examples of areas of interest are:

•

Analyses of naturalistic databases to evaluate the effectiveness of preventive and

treatment interventions.

•

Randomized clinical trials evaluating the effectiveness of preventive and treatment

interventions that have been augmented or refined with the intent to enhance their clinical

potency or efficiency.

•

Identifying moderators and mediators of intervention effects as a step to design and test

personalized interventions.

•

Moderator/mediator identification could occur retrospectively (not a clinical trial – using EHR).

•

Moderator/mediator identification could occur prospectively (within the context of a clinical trial).

•

Evaluating the effectiveness of predictive algorithms to improve identification and

intervention of individuals at elevated risk of mental illness and suicide.

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NIMH 133

•

Evaluating the combined or sequential use of interventions.

•

Evaluation of combined/sequential interventions could occur retrospectively (not a

clinical trial – using EHR).

•

Evaluation of combined/sequential interventions could occur prospectively (within the

context of a clinical trial).

•

Determining the optimal duration, frequency and intensity of an intervention to optimize

improvements in symptoms and functioning, establishing the utility of preventive intervention

or continuation or maintenance treatment (that is, for prevention of relapse or recurrence).

•

Evaluation of the optimal length of an intervention could occur retrospectively (not a

clinical trial – using EHR).

•

Evaluation of the optimal length of an intervention could occur prospectively (within the

context of a clinical trial).

•

Evaluating the long-term impact of preventive and therapeutic interventions on

symptoms, functioning, and quality of life.

•

Evaluation of the optimal length of an intervention could occur retrospectively (not a

clinical trial) – using EHR or survey data).

•

Evaluation of the optimal length of an intervention could occur prospectively (within the

context of a clinical trial).

Services research covers all mental health services across the lifespan for all mental health

disorders, includes clinical trial and non-clinical trial designs, and aligns with NIMH Strategic

Objective 4 , which includes but is not limited to:

•

Service settings at the patient, provider, health system, and cross system levels to include

primary care, specialty mental health, emergency departments, integrated care, general

medical, and other delivery settings (such as employment, educational, veteran, military,

criminal justice, child welfare, juvenile justice and other community settings).

•

Enhanced capacity for conducting services research by developing and utilizing

innovative and established methodologies, including health economics, to inform decisions

about the organization, delivery and financing of care.

•

The clinical epidemiology of mental disorders to include development and use of data

sets from health surveillance activities, decision support tools, administrative claims,

mobile apps and similar technologies, electronic health record (EHR), disease registries,

and other databases where epidemiological data (to include big data) reside.

•

Interventions and other research to improve access, continuity, engagement, quality,

uptake, equity, efficiency, and cost of care.

•

Research that reduces disparities and advances equity in mental health interventions,

services, and outcomes for racial and ethnic minority groups, individuals limited by

language or cultural barriers, sexual and gender minorities, individuals living in rural areas,

socioeconomically disadvantaged persons and other underserved groups.

•

The dissemination of information about and implementation of evidence-based

interventions, programs, support tools, or other practices or technologies into

service settings.

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NIMH 134

For both interventions and services research, DSIR supports the development and testing of digital

health tools. These tools include technology-assisted approaches to assessment (e.g., technology-

assisted screening and diagnosis) and intervention (e.g., m-health and other technology platforms to

support the delivery of preventive, therapeutic, and services interventions). DSIR encourages efforts

to employ technology-assisted approaches to expand the reach, efficiency, continuity, quality, and/or

boost the therapeutic benefit of research-informed strategies, rather than mere translation of

research-supported strategies onto new or emerging technology platforms. Collaboration with NIMH-

supported researchers for the development of software for new analytic techniques and/or decision-

making algorithms is encouraged. Also supported is research and the development or adaptation of

tools and technologies to be used to enhance the training and development of new generations of

researchers and practitioners and to keep established researchers and practitioners up-to-date on

the findings, implementation, and methods of interventions and services research.

Prospective applicants are strongly encouraged to contact Dr. Adam Haim (listed below) with

questions about the relevance of their interests to the mission of this division.

Contact Information

Margaret Grabb, Ph.D. (general questions about the NIMH SBIR program, Phase IIB program,

DNBBS, DTR divisional interests)

National Institute of Mental Health

6001 Executive Boulevard, Room 7133

Rockville, MD 20852 Telephone: 301-443-3563

Email: mgrabb@mail.nih.gov

Adam Haim, Ph.D. (DSIR divisional interests)

Division of Services and Intervention Research

6001 Executive Boulevard

Room 7273

Rockville, MD 20852 Telephone: 301-445-3593

Email: haima@mail.nih.gov

Maggie Sweeney, Ph.D. (DSIR divisional interests; send initial inquiries to Dr. Adam Haim above)

Division of Services and Intervention Research

6001 Executive Boulevard

Telephone: 301-480-1582

Email: maggie.swee[email protected]v

Dr. Vasudev R Rao M.B.B.S, M.S. (DAR divisional interests)

Division of AIDS Research

5601 Fishers Ln

Rockville MD 20852

Telephone: 240-669-5609

Email: vasudev.rao@nih.gov

Paige Anderson, M.S. (preclinical assay development)

6001 Executive Boulevard, Room 7120.3

Bethesda, MD 20892-9645

Rockville, MD 20852 (for express/courier

service) Telephone: 301-827-6550

Email: paige.anderson@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NIMHD 132

NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

(NIMHD)

Mission

The mission of the National Institute on Minority Health and Health Disparities (NIMHD) is to

promote minority health and to lead, coordinate, support, and assess the National Institutes of

Health (NIH) efforts to improve minority health and reduce and ultimately eliminate health disparities.

In this effort, the NIMHD conducts and supports basic, clinical, social and behavioral research;

facilitates the development of research infrastructure and training; fosters emerging programs; and

reaches out to racial/ethnic minority populations and other U.S. populations with health disparities,

defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as “health

disparity populations” based on higher overall rates of disease incidence, prevalence, morbidity,

mortality, or survival rates as compared to the health status of the general population. NIH-

designated U.S. health disparity populations currently include Blacks/African Americans,

Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other

Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and

sexual and gender minorities.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. For budgetary, administrative,

or programmatic reasons, the NIMHD may not fund an application or may decrease the length of

an award and/or the budget recommended by a review committee. NIH has received a waiver from

SBA, as authorized by statute, to exceed the statutory budget limitations set by the SBA for specific

topics relevant to the NIMHD that can be found in the SBA-Approved Waiver Topics. Applicants

with budget questions or considering requesting a budget greater than these amounts are

strongly encouraged to contact program staff before submitting an application.

Specific SBIR and STTR Program Information

The Small Business Innovation Research (SBIR) Program and the Small Business Technology

Transfer (STTR) Program enable the Nation’s small businesses to apply their unique research and

development capabilities toward accomplishing NIMHD’s mission. NIMHD has developed a

research framework and small businesses are encouraged to consider the factors operating within

and across the frameworks’ multiple ecosocial levels and domains before initiating the design of

products for potential research and development by NIMHD (see the NIMHD Research Framework

for more information). The framework, initially developed for researchers, can also inform small

businesses’ research and development of new technologies, products, and services for improving,

sustaining or enhancing minority health and extending longevity and for reducing or eliminating

health disparities. The factors identified in the framework are known to contribute to the creation

and perpetuation of poor minority health and health disparities over time and place. Entrepreneurs

are encouraged to consider these and other factors when conceptualizing, designing, and

prototyping novel products seeking NIMHD SBIR and STTR funding. Minority health and health

disparity academic researchers are encouraged to consider partnering with small businesses to

assist in translating NIMHD- or NIH-funded research findings into potentially commercializable

products for improving minority health or eliminating health disparities within one or more levels or

domains of influence.

Through small business Phase I, Phase II, and Fast-track awards, NIMHD supports multi- and

trans- disciplinary research and development leading to novel and or improved products capable of

contributing to NIMHD’s mission. Research and development informed by the NIMHD Research

NIH, CDC, and FDA Program Descriptions and Research Topics

NIMHD 133

Framework or other framework may proceed or be initiated at the molecular, cellular, individual,

community or population level. Funding support for focus groups, phase I/II clinical trials, and other

studies involving human participants needed to develop and test the proposed product may be

requested. Additionally, NIMHD seeks innovative strategies for improving minority health,

eliminating health disparities, and enhancing health and well-being where small businesses

engage, collaborate or partner with health disparity communities from conception, application

submission, and through completion of NIMHD funding periods and beyond. The NIMHD Research

Framework acknowledges the value of small businesses partnering with community-based or -

located organizations or small businesses and with health care providers and health care-

organizations. Applications partnering with community health centers or other patient providers are

encouraged and of interest. Applications developing innovative technologies or services for

enhancing minority health and well-being through partnerships with community-based small

businesses, such as beauty salons, barbershops, pharmacies, etc., that engage with racial and

ethnic minority or health disparity populations on a regular basis, are also of interest.

Technology that leverages indigenous community advisors and supporters in health promotion or

prevention efforts may contribute to overall community health improvement and well-being through

the processes of community empowerment and increased community cohesion.

An overarching objective of NIMHD’s investments in SBIR/STTR programs is to ensure that racial

and ethnic minorities and health disparity populations benefit equally from innovations in health

promotion, educational and medical curricula, prevention interventions, biotechnology, imaging

technologies, technologies for computational biology and informatics, including, for example,

systems and structural biology; and technologies designed to advance personalized medicine and

health, electronic health records, and systems, etc. New or improved instruments, devices, and

related methodologies to facilitate biomedical or behavioral research and efforts that seek to

simplify via redesign or the design of new instruments, devices, and methods likely to increase

access, reduce costs, and improve quality of care and outcomes are of special interest.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NIMHD welcomes Phase IIB Competing Renewal Applications for Phase II grants and contracts

via the Omnibus Solicitation for SBIR or STTR Grant Applications, and as indicated by other

NIMHD Notices of Funding Opportunities (NOFOs). Standard NIMHD Phase II funding policy

applies unless otherwise stated in the NOFO. Non-NIMHD Phase II awardees must contact

NIMHD prior to submission to confirm programmatic interest.

Clinical Trials

Does NIMHD accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NIMHD accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

https://seed.nih.gov/small-business-

funding/find-funding/sbir-sttr-funding-

opportunities

Does NIMHD support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

Research Topics

Applicants are encouraged to engage in research and development that results in a product,

NIH, CDC, and FDA Program Descriptions and Research Topics

NIMHD 134

process or service that will improve minority health and eliminate health disparities and that by

design targets or involves any of the topics listed in the NIMHD waiver list or otherwise will

contribute to the NIMHD mission. For additional information about research areas of interest to

the NIMHD, please visit our website at https://www.nimhd.nih.gov/programs/extramural/research-

areas/.

Contact Information

For additional information on research topics, contact:

Division of Community Health and Population Science

LCDR Michael Banyas, USPHS,

M.P.A, M.A, Program Manager

National Institute on Minority Health and Health

Disparities, NIH Email: michael.banyas@nih.gov

Phone: 301-827-7478

NIH, CDC, and FDA Program Descriptions and Research Topics

NINDS 135

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

(NINDS)

Mission

The mission of NINDS is to reduce the burden of neurological disease—a burden borne by every

age group, by every segment of society, by people all over the world

(https://www.ninds.nih.gov/About- NINDS/Who-We-Are/Mission). To this end, the Institute

supports and conducts research on the healthy and diseased brain, spinal cord, and peripheral

nerves. The NINDS SBIR/STTR (https://www.ninds.nih.gov/Funding/Small-Business-Grants)

program funds small business concerns to conduct innovative neuroscience research and/or

development (R/R&D) that has both the potential for commercialization and public benefit.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website, unless the application fits an

SBA-approved waiver topic. For topics listed in the SBA-Approved Waiver Topics, NINDS generally

will not fund Phase I applications to the Omnibus greater than $700,000 total costs, with no more

than $500,000 total cost in an year or project periods greater than 2 years; or Phase II applications

greater than $3,000,000 total costs, with no more than $1,500,000 or project periods greater than 3

years. For budgetary, administrative, or programmatic reasons, the NINDS may not fund an

application or may decrease the length of an award and/or the budget recommended by a review

committee. Information about the NINDS budget guidelines can be found on the NINDS SBIR

webpage https://www.ninds.nih.gov/funding/ninds-small-business-program/submitting-small-

business-application.

For all other funding opportunities, applications should follow the guidelines in the Award Budget

section of those announcements carefully.

All applicants are strongly encouraged to contact program staff before submitting an application.

Specific SBIR and STTR Program Information

NINDS Priorities

NINDS priorities are given to meritorious research proposals with the greatest potential to advance

the NINDS mission (see https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission). NINDS is

especially interested in:

Novel and innovative technologies that are new to the SBIR or STTR programs.

Technologies coming to the SBIR or STTR programs for their first indication

or market opportunity.

Companies and applicants that are new to the SBIR and STTR programs.

NINDS Cooperative Agreement (U44) Translational Programs. NINDS has specific

translational programs that utilize the SBIR cooperative agreement mechanism (U44)

as noted below. If eligible, companies are encouraged to apply through these

programs.

NINDS SBIR and STTR funding decisions are based on a combination of factors:

NIH, CDC, and FDA Program Descriptions and Research Topics

NINDS 136

potential for high impact on advancing the NINDS mission and the other programmatic

priorities described in NOT-NS-18-002 (https://grants.nih.gov/grants/guide/notice-

files/NOT-NS-18- 002.html);

potential for commercialization;

portfolio balance (to determine whether similar projects have already been funded,

search NIH Reporter http://projectreporter.nih.gov/reporter.cfm);

the quality of the previous performance of the applicant and/or company in the SBIR

and/or STTR program, including evidence of Phase III activities;

for Phase II applicants, the results of the Phase I;

the peer review scores and critiques; and

availability of funds.

Research Topics General Areas of Interest

The NINDS accepts a broad range of small business applications that are significant, innovative,

and relevant to its mission. Examples of research topics within the mission of NINDS are shown

below. This list is not all inclusive and some research areas fall into multiple categories.

Therapeutics and Diagnostics Development for Neurological Disorders, including

biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for

treatment of neurological disorders, and technologies/methodologies to deliver

therapeutics to the nervous system.

Clinical and Rehabilitation Tools, including intraoperative technologies for

neurosurgeons, rehabilitation devices and programs for neurological disorders, and

brain monitoring systems

Technology and Tools, including technologies to image the nervous system, neural

interfaces technologies, and tools for neuroscience research and drug development.

More information on NINDS areas of interest for the SBIR and STTR programs can be found

here: https://www.ninds.nih.gov/funding/ninds-small-business-program/ninds-small-business-

program-areas-interest.

Clinical Trials

Does NINDS accept Clinical Trials

through the Omnibus/Parent Notices

of Funding Opportunities?

Does NINDS accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

NINDS may accept and support SBIR and

STTR clinical trial applications through specific

opportunities, which can be found on the

NINDS Funding Opportunities webpage:

https://www.ninds.nih.gov/Funding/Find-

Funding-

Opportunities.

Does NINDS support Clinical

Trials through NON-SBIR/STTR

Notices of Funding Opportunities?

Yes

NINDS accepts and supports SBIR and STTR

clinical trial applications through specific

opportunities, which can be found on the

NINDS Funding Opportunities webpage:

https://www.ninds.nih.gov/Funding/Find-

Funding- Opportunities.

NINDS Clinical Trials Topics:

NIH, CDC, and FDA Program Descriptions and Research Topics

NINDS 137

NINDS is committed to identifying effective treatments for neurological disorders by supporting

well- executed clinical trials. NINDS may accept and support SBIR and STTR clinical trial

applications within the NINDS mission through specific opportunities. Other human subjects

research can be submitted through the SBIR and STTR Parent (Clinical Trials Not Allowed)

solicitation. However, NINDS may decline funding of any application that includes human subjects

for programmatic or administrative reasons. SBIR applicants considering projects involving human

subjects research are strongly encouraged to contact program staff in advance of submission.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NINDS only accepts Phase IIB SBIR/STTR Competing Renewal applications through specific

opportunities that focus on the commercialization of SBIR and STTR developed technologies.

These opportunities can be found on the NINDS Funding Opportunities webpage:

https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities. Contact

ninds_sbir@ninds.nih.gov for additional information.

Specific Funding Opportunities and Programs

NINDS Translational Research Programs

The NINDS offers a variety of specific funding opportunities and programs to accelerate the

preclinical discovery and development of new therapeutic interventions for neurological disorders.

These programs have specific funding opportunities and allow for budgets over the hard cap.

Several programs utilize the cooperative agreement (U44) mechanism, which is milestone-driven

and involves NIH program staff participation in developing the project plan, monitoring research

progress, and appropriate go/no-go decision-making. SBIR applicants considering projects

involving translational research are strongly encouraged to contact program staff well in advance of

submission.

•

Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) is dedicated to

biotechnology product- and biologics-based therapies, which broadly include modalities

such as peptides, proteins, oligonucleotides, gene therapies, and cell therapies. The

program supports lead optimization, IND-enabling studies for the candidate, and early-

phase clinical trials. Contact: Chris Boshoff (chris.boshoff@nih.gov)

•

Blueprint MedTech Program provides support for innovators developing

groundbreaking medical device technologies. The mission of the program is to

catalyze the translation of novel technologies from early-stage development to

readiness for first-in-human clinical studies. Contact: NINDS-Devic[email protected]v;

Blueprint-MedTech@nih.gov

•

Blueprint Neurotherapeutics Network (BPN) provides both funding and non-dilutive

support for small molecule drug discovery and development, from hit-to-lead chemistry

through phase I clinical testing. The program offers funding, access to NIH-funded

contract research organizations (CROs), and access to consultants with expertise in

various aspects of drug discovery and development. Contact: Charles Cywin

(charles.cywin@nih.gov)

•

NIH Countermeasures Against Chemical Threats (CounterACT) supports

research to understand the fundamental mechanisms of toxicity caused by chemical

threat agents and the development of new and improved therapeutics for reducing

mortality and morbidity caused by these agents. Chemical threats are toxic

compounds that could be used in a terrorist attack against civilians, or released at

NIH, CDC, and FDA Program Descriptions and Research Topics

NINDS 138

toxic levels by accident, such as from industrial production, storage, or shipping, or

natural disaster. NINDS supports partnerships between small business and not-for-

profit laboratories engaged in research related to the NIH CounterACT program that

falls within the NINDS mission, including devices that could be used during a

chemical emergency involving mass casualties, as well as some research on

therapeutics. The CounterACT program only supports research on chemical threats

that have been identified by the United States Government (USG) as Chemicals of

Concern (CoC). There are over 200 CoCs, grouped by primary mechanism of action

into toxidromes. The toxidromes that fall under the NINDS mission (with chemical

threat examples) are: Anticoagulants (e.g., brodifacoum, bromadiolone, diphacinone),

Blood/Metabolic (Knockdown) agents (e.g., hydrogen cyanide, hydrogen sulfide,

arsenic trioxide), Cholinergic (Organophosphate Nerve Agents and Insecticides)

(e.g., sarin, soman, parathion, phorate, aldicarb), and Convulsants (e.g., picrotoxin,

TETS, strychnine). All potential applicants should contact program staff to ensure

their chemical threat is of interest to the program. Contact: Shardell Spriggs

(shardell.spr[email protected]v)

•

Office of the Neural Exposome and Toxicology (ONETOX) supports research on

exposures that have an impact on neurological disease and disorders, and overall

nervous system health. The exposures described in the exposome not only include

environmental chemical and biological toxins, but also psychosocial factors and

internal factors such as diet and the microbiome, and these exposures may occur

anytime from in utero to late in life. NINDS only support studies within the NIND

mission space. Contact: David Jett (david.jett@nih.gov)

•

Translational Neuroscience Biomarker Program focuses on improving the quality

and efficiency of neurotherapeutic clinical research by supporting rigorous biomarker

development and validation. In order to achieve this goal, the program: 1) promotes

rigorous biomarker identification and validation through milestone-driven funding

opportunities, and 2) facilitates the validation of biomarkers and biomarker signatures as

fit for purpose tools for use in clinical trials to accelerate therapeutic development and

aid in decision making for patient care. Contact: Carol Taylor-Burds (carol.taylor-

burds@nih.gov).

•

Stroke Preclinical Assessment Network (SPAN) seeks to conduct late-stage

preclinical studies of putative neuroprotectants combined with reperfusion. SPAN

utilizes a novel, adaptive, secured system for parallel testing of promising interventions

designed to extend the treatment time window and/or improve outcome compared to

reperfusion when combined with thrombolysis, thrombectomy or both. Contact:

Francesca Bosetti (frances@mail.nih.gov)

Information about these and other programs can be found at

https://www.ninds.nih.gov/Current- Research/Research-Funded-NINDS/Translational-

Research.

Trans-NIH Initiatives

Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is a

Presidential project aimed at revolutionizing our understanding of the human brain. NIH is

one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH

component of the BRAIN Initiative is guided by the long-term scientific plan, “BRAIN 2025: A

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NINDS 139

Scientific Vision,” which details seven high-priority research areas. This report can be found

at https://braininitiative.nih.gov/.

NIH has a number of specific Notices of Funding Opportunities through the BRAIN Initiative that

are targeted to small business concerns. These funding opportunities can be found at

https://www.braininitiative.nih.gov/funding/. Applicants are encouraged to consider if these

funding opportunities may be appropriate to their research. Contact ninds_sbir@ninds.nih.gov

for additional information.

Helping to End Addiction Long-term (HEAL) Initiative

The Helping to End Addiction Long-term (HEAL) Initiative is an aggressive, trans-agency

effort to speed scientific solutions to stem the national opioid public health crisis. Further

information on the HEAL Initiative can be found at https://heal.nih.gov/. NIH has several

specific Notices of Funding Opportunities through the HEAL Initiative that are targeted to

small business concerns. These funding opportunities can be found at

https://heal.nih.gov/funding. Applicants are encouraged to consider if these funding

opportunities may be appropriate to their research. Contact ninds_sbir@ninds.nih.gov for

additional information.

Alzheimer's Disease and Related Dementias (AD/ADRD)

NINDS collaborates with NIH’s National Institute on Aging (NIA), the lead NIH Institute for

Alzheimer’s disease (AD) research and for NIH's response to the National Plan to Address

Alzheimer’s Disease, to establish research priorities and fund biomedical research to

decrease the burden of dementia on individuals, families, and communities. Learn more

about AD/ADRD funding opportunities here: https://www.ninds.nih.gov/current-

research/focus-disorders/focus-alzheimers-disease-and-related-dementias. Applicants are

encouraged to consider if these funding opportunities may be appropriate to their research.

Contact ninds_sbir@ninds.nih.gov for additional information.

For additional information about NINDS funding opportunities, please visit the NINDS Funding

Opportunities webpage at: https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities.

Contact Information

Scientific/Research Contact

Emily Caporello, Ph.D.

Director, NINDS Small Business Program

Phone: 301-496-1779

Email: emily.caporello@nih.gov

Program-wide Email: ninds_sbir@ninds.nih.gov

Financial/Grants Management Contact:

Chief Grants Management Officer

National Institute of Neurological Disorders and Stroke (NINDS)

Email: ChiefGrantsManagementOfficer@ninds.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NINR 140

NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)

Mission

The National Institute of Nursing Research (NINR) leads nursing research to solve pressing

health challenges and inform practice and policy – optimizing health and advancing health equity

into the future.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SBIR website. For budgetary, administrative,

or programmatic reasons, the NINR may not fund an application or may decrease the length of an

award and/or the budget recommended by a review committee. NIH has received a waiver from

the SBA, as authorized by statute, to exceed the statutory budget limitations set by the SBA for

specific topics relevant to the NINR that can be found in the SBA-Approved Waiver Topics. The

NINR will generally not fund:

•

Phase I applications to the Omnibus greater than $385,000 total costs or project

periods greater than 2 years, or

•

Phase II applications greater than $2,500,000 total costs or project periods greater than 3

years.

Applicants that are considering requesting a budget greater than these amounts are strongly

encouraged to contact program staff before submitting an application.

Specific SBIR and STTR Program Information

The NINR SBIR program is technology agnostic and welcomes all innovative solutions with

commercial potential that are relevant to the NINR mission and research topics listed below.

Technical and Business Assistance (TABA). NINR will consider well justified TABA costs up to

the limits specified on the NIH SEED Website. Applicants can request TABA funding within your

award or apply for an NIH TABA program. Applicants cannot receive both.

For additional information about NINR’s Small Business Programs, please visit NINR’s Small

Business Funding.

Specific Funding Opportunities and Programs

NINR will also consider SBIR/STTR application related to other NINR funding initiatives that is

relevant to the Institute’s mission. These funding opportunities are revised throughout the year, so

please subscribe to receive regular updates

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NINR does not accept Phase IIB applications.

NINR does not participate in the Commercialization Readiness Pilot (CRP) Program.

NIH, CDC, and FDA Program Descriptions and Research Topics

NINR 141

Clinical Trials

Does NINR accept

Clinical Trials through

the Omnibus/Parent

Notices of Funding

Opportunities?

Yes

Does NINR accept

Clinical Trials through

specific Notices of

Funding

Opportunities?

Yes

https://www.ninr.nih.gov/researchandfunding/fundingopportunities

Does NINR support

Clinical Trials through

NON-SBIR/STTR

Notices of Funding

Opportunities?

Yes

https://www.ninr.nih.gov/researchandfunding/fundingopportunities

Research Topics

NINR has developed a research framework that takes advantage of what makes the Institute

unique by focusing on a holistic, contextualized approach to optimizing health for all people,

rather than on specific diseases, life stages, or research topics. The framework builds on the

strengths of nursing research, spans the intersection of health care and public health, and

encompasses the clinical and community settings where nurses engage in prevention, treatment,

and care—including hospitals and clinics, schools and workplaces, homes and long-term care

facilities, justice settings, and throughout the community. The framework encourages research

that informs practice and policy and improves health and quality of life for all people, their families

and communities, and the society in which they live. NINR’s research framework includes guiding

principles and research lenses that promote innovative and rigorous multilevel study designs that

look upstream, midstream, and downstream to discover solutions to the nation’s most pressing

and persistent health challenges. NINR’s guiding principles describe the qualities that

investigators should emphasize in all NINR-supported research. In considering awards for

funding, the extent to which studies reflect these principles will factor into our decisions.

NINR will prioritize research that:

•

Tackles today’s pressing health challenges and stimulates discoveries to prepare for,

prevent, or address tomorrow’s challenges.

•

Discovers solutions across clinical, community, and policy settings to optimize

health for individuals, families, communities, and populations.

•

Advances equity by removing structural barriers from research, cultivating diversity in

perspectives and ideas, and fostering inclusion and accessibility in designing,

conducting, and participating in research; and

•

Is innovative, develops or applies the most rigorous methods, and has the

potential for the greatest impact on health.

NINR identified five complementary and synergistic research lenses that best leverage the

strengths of nursing research and promote multilevel approaches, cross-disciplinary and -

sectoral collaboration, and community engagement in research. It is important to note that the

lenses are not research topics, but rather perspectives through which to consider the full

spectrum of nursing research topics that encompass health and illness within the context of

people’s lived experiences. These lenses allow nursing research to examine new topics while

also allowing scientists to take a different look at long- standing areas of interest. The research

lenses are:

NIH, CDC, and FDA Program Descriptions and Research Topics

NINR 142

•

Health Equity: Reduce and ultimately eliminate the systemic and structural inequities

that place some at an unfair, unjust, and avoidable disadvantage in attaining their full

health potential.

•

Social Determinants of Heath: Identify effective approaches to improve health and

quality of life by addressing the conditions in which people are born, live, learn, work,

play, and age

•

Population and Community Health: Address critical health challenges at a macro

level that persistently affect groups of people with shared characteristics

•

Prevention and Health Promotion: Prevent disease and promote health through the

continuum of prevention – from primordial to tertiary

•

Systems and Models of Care: Address clinical, organizational, and policy challenges

through new systems and models of care

NINR encourages researchers to view the health equity and social determinants of health

lenses as primary foci through which to consider the population and community health,

prevention and health promotion, and systems and models of care lenses.

See NINR’s Strategic Plan for more information on each of the research lenses.

NINR does not generally support the development of technologies in the following topic areas:

•

Technologies designed for staffing purposes.

•

Technologies designed to provide nurse educational and professional training

(e.g., VR simulations).

•

Technologies that assess or limit exposure to occupational health stressors.

•

Technologies for sanitization or decontamination in a clinical setting.

NINR is particularly interested in applications from socially/economically disadvantaged small

businesses (SDB), women-owned small business (WOSB), and small businesses located in

under- represented states. Responsive entrepreneurs should aim to develop technologies that align

with the research topics above.

Applicants do not need to have a nursing background to apply.

NINR Clinical Trials Topics:

NINR accepts clinical trials in any of the topic areas above.

Contact Information

For additional information please contact:

Dr. Karen Kehl

Director, Small Business Innovation Research Program

National Institute of Nursing Research (NINR)

Division of Extramural Science Program (DESP)

6701 Democracy Blvd, Room 727

Bethesda, MD 20892-4870

Office: (301) 594-8010

Email: karen.kehl@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 143

NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

(NCATS)

Mission

NCATS is transforming translational science to improve human health; it relies on the power of data,

new technologies and teamwork to develop, demonstrate and disseminate innovations that reduce,

remove or bypass costly and time-consuming bottlenecks in translational research. For additional

information please visit the NCATS Strategic Plan webpage -

https://ncats.nih.gov/strategicplan/introduction

NCATS small business funding is designed specifically to transform the translational science process

so that new treatments and cures for diseases can be delivered to patients more quickly. The Center

supports the development of technologies, assays, drugs, devices, instruments, and methodologies

that may have broad application to any stage of the translational process from preclinical

development to clinical research and to implementation science in patient care and public health. For

additional information, please visit http://www.ncats.nih.gov.

NCATS is committed to supporting small business Phase I, Phase II, Fast-track and Phase IIB Competing

Renewal awards through the Small Business Innovation Research (SBIR) and Small Business

Technology Transfer Programs (STTR). For additional information, please visit

http://ncats.nih.gov/smallbusiness.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts defined

by the SBA, which can be found on the NIH SEED website. For budgetary, administrative, or

programmatic reasons, NCATS may decide not to fund an application or may decrease the length of

an award and/or the budget recommended by a review committee.

For certain topical areas, there is an SBA-Approved Waiver Topics list for which the NCATS generally

will not fund:

•

Phase I applications greater than $350,000 total costs or project periods greater than 2 years

•

Phase II applications greater than $2,150,000 total costs or project periods greater than 3 years

Applicants considering a requested budget greater than these limits are strongly encouraged to contact

program staff before submitting an application.

Specific SBIR and STTR Program Information

NCATS Clinical Trials Topics

NCATS will not accept SBIR and STTR applications that propose clinical trials under the Omnibus

solicitation.

Specific Funding Opportunities and Programs

There are more than 6,500 identified rare and neglected diseases, yet only about 250 treatments

are available for these conditions. The limited numbers of patients can make gathering information

and designing drug studies difficult. As a result, scientists often know little about the symptoms and

biology of these conditions. Also, some private companies may find it difficult to justify the cost of

developing drugs for such small rare disease markets.

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 144

The Therapeutics for Rare and Neglected Diseases (TRND) program is designed to combat these

challenges. Its mission is to encourage and speed the development of new treatments for diseases

with high unmet medical needs. TRND stimulates therapeutic development research collaborations

among NIH and academic scientists, nonprofit organizations, and pharmaceutical and biotechnology

companies working on rare and neglected illnesses. The program provides expertise and resources,

working with research partners to move therapeutics through preclinical testing, including plans for

clinical trials and submission of an IND application to the Food and Drug Administration. These

efforts effectively “de-risk” therapeutic candidates and make them more attractive for adoption by

outside business partners. To learn more about the TRND program goals, please visit

https://ncats.nih.gov/trnd/about/goals

Bridging Interventional Development Gaps (BrIDGs)

The Bridging Interventional Development Gaps (BrIDGs) program enables research collaborations to

advance candidate therapeutics for both common and rare diseases into clinical testing. Investigators

do not receive grant funds through this program. Instead, selected researchers partner with NCATS

experts to generate preclinical data and clinical-grade material through government contracts for use

in Investigational New Drug (IND) applications to a regulatory authority such as the Food and Drug

Administration (FDA). In general, BrIDGs provides synthesis, formulation, pharmacokinetic and

toxicology expertise and resources to its collaborators.

NIH contractors conduct preclinical studies under the direction of NCATS staff. NCATS, along with any

co-funding NIH Institutes and Centers, supports contract costs. The decision to collaborate on a

proposed project is based on an internal assessment of scientific merit, programmatic fit and the

availability of NIH funds. To find out how to submit a proposal to BrIDGs, please visit

https://ncats.nih.gov/bridgs/work

As of fall 2015, BrIDGs has generated data to support 18 investigator-initiated INDs that have been

cleared by the FDA and one clinical trial application cleared by Health Canada. A total of 14 projects

have been evaluated in clinical trials. Five BrIDGs-supported agents have been evaluated in Phase II

human clinical trials, in which researchers give an experimental therapy to a group of patients to

evaluate the effectiveness and safety of a treatment. Third-party organizations have licensed or

invested in 10 agents during or after their development by BrIDGs. To learn more about active and

completed BrIDGs projects, please visit https://ncats.nih.gov/bridgs/projects

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

Occasionally, NCATS may accept Phase IIB SBIR Competing Renewal grant applications of

NCATS supported Phase II awards to continue research and development of products that have a

potential to address bottlenecks in the translational process, and where additional time and effort is

needed to reach a stage where interest and investment by third parties would be likely. Such

products are expected to have broad applicability and be consistent with the mission of NCATS.

Applicants are strongly encouraged to speak to NCATS Program staff prior to submitting their

Phase IIB application. Budgets for Phase IIB grant applications must be approved by NCATS

Program staff prior to submission.

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 145

Clinical Trials

Does NCATS accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Does NCATS accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does NCATS support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

U01 – however the SBC can only participate if

repurposing an existing drug or biologic

(therapeutics) that have already completed at

least a Phase l trial for a different indication by

the time an award is made. These pharma drugs

and biologics are listed in PAR-18-332.

https://grants.nih.gov/grants/guide/pa-files/PAR-

18-332.html

Research Topics

Preclinical Drug Discovery and Development

•

Innovative platforms for identification and prioritization of targets for therapeutic

intervention with clear clinical impact; such as those that are: implicated for disease,

have genetic variations that have been identified in functional regions of receptor targets,

and/or have high potential for biased signaling that would promote the beneficial effects

of receptor signaling and reduce the unwanted effects

•

Tools and technologies to enable high throughput screening of compound activity on

currently “non- druggable” targets

•

Assays for high-throughput screening of rare-diseases-related targets

•

Co-crystallization high-throughput screening techniques

•

Fluorescence probes to replace antibodies for determination of cellular protein translocation

•

Phenotypic assay development, including stem cell technology platforms for human

“disease-in-a- dish” applications and the evaluation of toxicity

•

Interventions that target molecular pathways or mechanisms common to multiple diseases

•

Platforms for non-antibody biologics, cell-based therapies and gene therapy discovery

•

Small molecule and biologics analytical characterization

•

Accelerated bioengineering approaches to the development and clinical application of

biomedical materials, devices, therapeutics and/or diagnostics

•

Development of novel technologies for enzyme replacement therapies (e.g.,

new cell culture/expression system) to solve major bottlenecks in rare

diseases research

•

Innovative methods to determine alternative uses for existing therapeutic interventions

for high priority areas, such as rare diseases and pain.

•

Tools and technologies that increase the predictivity or efficiency of medicinal chemistry,

biologic or other intervention optimization

•

Technologies to deliver nucleic acid therapeutics to tissues other than the liver

•

Methodologies and technologies to increase efficiencies of manufacturing therapeutics

•

Development of novel high-throughput technologies that focus on making translational

research more efficient

•

GMP production of exosome/extracellular vesicles

•

Generation of producer lines for large scale production of exosomes/extracellular vesicles

•

Extracellular RNA-based biomarkers and therapeutics of human diseases

•

Approaches to targeting the human microbiome for therapeutic or diagnostic purposes

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 146

•

Scale up, manufacturing and characterization of IPS cells

•

3D printing technologies

•

Technologies to substantially improve the efficiency and reduce the cost of clinical

grade gene therapy vector manufacturing

•

Development of in vitro human tissue models (organs, 3D printing)

•

Technologies to allow therapeutic proteins other than lysosomal enzymes to be secreted

and taken up by other cells via cross-correction

•

Novel strategies to prevent deleterious immune responses to gene therapy, to improve

efficiency genome editing and/or enzyme replacement therapy

•

Establishing more robust phenotypic screens that may help prioritize candidate

compounds for further testing

•

Innovative technology for non-small molecule delivery

•

High-throughput epigenetics screening/characterization tools and technologies

•

Microphysiological systems (MPS)/Tissue Chips, including MPS/Tissue Chips that

incorporate known functional variants, e.g., ACMG 59 or CPIC A alleles, for study

comparison using the same derived genetic background across a set of tissue chips with

the functional variant

•

Volatile organic compounds (odors, scents) as biomarkers for disease

•

Bacteriophage-based therapeutics for disease and as modulators of the microbiome and

microbiome natural products

•

High throughput Surface Plasmon Resonance devices for detecting protein small molecule

interactions

•

New class of quantum-enabled sensing technologies for advancing translational sciences (e.g.,

point of care ultrasensitive high-throughput technologies for diagnostics, and miniaturized

benchtop technologies for chemical/bioanalyte characterization).

•

Development of diagnostics or useful drug targets for rare diseases by using Pangenome

data.

Biomedical, Clinical, & Health Research Informatics

•

Searchable access to information about research resources, facilities, methods, cells,

genetic tests, molecules, biologic reagents, animals, assays, and/or technologies with

evidence about their use in research studies

•

Cloud-based tools and methods for meaningful sharing, re-use and integration of research data

•

Novel platforms, technologies and tools for: (1) enabling clinical and translational

research, particularly those with mechanisms for inclusion of patient-reported data

and (2) integration of patient data collected from multiple devices and

multiple/diverse clinical studies

•

Development of personalized phenotypic profiling (as well as personalized intervention)

based on patient-centered integration of data from multiple data sources, including

social media

•

Development of predictive models for translational science

•

Digital applications and tools (including telemedicine platforms) that facilitate/enhance

translational research and medicine in rural populations

•

Generic Disease Registry template platforms that can be reused for multiple diseases.

•

Mobile device validation tools to ensure data from different brands or versions have

compatible results.

•

Tools to assess with algorithms developed with artificial intelligence, machine learning.

•

Tools that allow for persistent identifier and attribution for data contributors that give

credit to the data producers while ensuring that shared data has not been altered

•

Patient Mobile Tool Platforms that facilitate tool developers to build “apps” that integrate

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 147

into their medical records.

•

Tools and environments that enable an easy interrogation of publicly available data

•

Innovative approaches like nanoneedles and nano particles to help improve early disease

detection and targeted therapeutic delivery

•

Tools and technologies that leverage AI and real-world data for enhanced product

evaluation and surveillance that could be used to provide a resource for rapid response to

public health needs

Clinical, Dissemination and Implementation Research

•

Tools and technologies that:

increase the efficiency of human subjects research, that facilitate the rapid

diagnosis and/or clinical trial recruitment and subject tracking, institutional review

board evaluation and/or regulatory processes

evaluate and improve the process of informed consent

address medication adherence in clinical settings

address and improve community engagement

address the rapid diagnosis and/or clinical management of rare diseases

help characterize human disease states and assist in assessing the impact of interventions

support unique approaches to advance diversity, equity and inclusion.

mine published data and generate usable knowledge and analytics to advance research

•

Increased efficiency of clinical research conduct, including but not limited to regulatory

decision support, patient eligibility analysis and recruitment and retention tracking

•

Educational tools for clinical and translational science

•

Computational or web-based health research methods, including:

Platforms for generally applicable and scalable multi-disease registries and

natural history studies

Clinical trial designs and analyses (e.g., for pragmatic clinical trials)

•

Approaches, tools, platforms and environments that:

Integrate data in novel ways for development of new biomarkers that can be

tested in translational research paradigms for which there are barriers or

bottlenecks

Engage prospective research participants who are from under-represented

communities and impacted by disparities and the digital divide

•

Strategies to enhance the quality of and accelerate the conduct of dissemination and

implementation research

•

Sustainable solutions for effective tools and environments in translational research

•

Development and validation of patient reported outcomes, clinician-reported outcomes and

biomarkers for rare diseases that are not already supported by a disease-specific NIH

Institute or Center

•

Patient empowerment tools/apps that allow users to compare their treatment and

outcomes to normative populations existing treatment guidelines

•

Telemedicine or digital health applications that focus on research in rural populations

•

Tools and technologies that enhance the quality, safety, efficiency, effectiveness of new

innovations in community settings

Contact Information

For additional information on research topics, please contact:

Krishna ‘Balki’ Balakrishnan, PhD,

MBA NCATS SBIR/STTR Acting

Program Director

National Center for Advancing Translational

Sciences, NIH Phone: 301-827-7149

Email: NCATS-SBIRSTTR@mail.nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NCATS 148

Meena U. Rajagopal, PhD

NCATS SBIR/STTR Program Officer

National Center for Advancing Translational

Sciences, NIH Phone: 301-827-1921

Email: NCATS-SBIRSTTR@mail.nih.gov

Mayra A. Alvarez Lopez, MS

NCATS SBIR/STTR Program Analyst

National Center for Advancing Translational

Sciences, NIH Phone: 301-827-7146

Email: NCATS-SBIRSTTR@mail.nih.gov

For Administrative, business management and grants policy questions, please contact:

Ms. Imoni Williams

Grants Management Specialist, SBIR/STTR Project Liaison

Phone: 301-435-2939

E-mail: imoni.williams@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NCCIH 149

NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH

(NCCIH)

Mission

The mission of NCCIH, as described in the Center’s Strategic Plan, is to define, through rigorous

scientific investigation, the usefulness and safety of complementary and integrative health

interventions and their roles in improving health and health care.

The following narrative indicates the scope of projects suitable for the Small Business Innovation

Research (SBIR)/Small Business Technology Transfer (STTR) programs that fit within the mission of

NCCIH. For additional information about areas of interest to NCCIH and a listing of NCCIH’s currently

funded applications, please visit https://www.nccih.nih.gov/research. Business concerns interested in

exploring SBIR/STTR grant opportunities with NCCIH are encouraged to visit the NCCIH SBIR

website and contact NCCIH program directors prior to submitting an application.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts defined

by the Small Business Association (SBA), which can be found on the NIH SEED website. NCCIH

policy on grant duration is described in NOT-AT-20-017.

There is an SBA-Approved Waiver Topics list, for which NCCIH generally will not fund:

•

Phase I applications greater than $325,000 total costs per year or project periods

greater than 2 years.

•

Phase II applications greater than $2,000,000 total costs for the duration of the project

or project periods greater than 3 years.

Applicants considering a requested budget greater than these limits are strongly encouraged to contact

program staff before submitting an application.

Specific SBIR and STTR Program Information

NCCIH supports the development and validation of innovative technology to advance fundamental

understanding, enhance and monitor usage, or determine the usefulness and safety of a variety of

complementary and integrative health approaches, including natural products and/or mind and body

approaches.

Specific Funding Opportunities and Programs

NCCIH does not accept applications for Phase IIB.

NOSI-AT-21-001 Development and/or Validation of Devices or Electronic Systems to Monitor or

Enhance Mind and Body Interventions (SBIR/STTR)

NOSI-AT-20-015 Methods Development in Natural Products Research (SBIR/STTR)

NIH, CDC, and FDA Program Descriptions and Research Topics

NCCIH 150

Clinical Trials

Does NCCIH accept clinical trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

For applications involving clinical studies that fall

within the NIH definition of a clinical trial, NCCIH

will not support clinical trials aiming to test

efficacy/effectiveness (meaning the study is

powered on a primary outcome that is a clinical

assessment used in clinical diagnosis of disease

or monitoring of disease severity) of an

intervention as a part of an SBIR/STTR Phase I

application. Applicants seeking to conduct

efficacy or effectiveness clinical trials should

pursue funding via other Notices of Funding

Opportunities (NOFOs) such as the Omnibus

SBIR/STTR Phase II and Fast-Track.

NCCIH recognizes a difference between “clinical

trials” that are designed to answer specific

questions about the clinical effect of

interventions and mechanistic studies that have

the primary goal of understanding how an

intervention works.

A clinical outcome study has the objective of

determining the clinical safety, tolerability,

feasibility, efficacy, and/or effectiveness of

pharmacologic, nonpharmacologic, behavioral,

biologic, surgical, or device (invasive or

noninvasive) interventions.

A mechanistic study has the objective to

understand the mechanism(s) of action of an

intervention, a biological or behavioral process,

or the pathophysiology of a disease/condition.

NCCIH continues to accept clinical trials of

all types on Omnibus SBIR/STTR Phase II

and Fast-Track applications.

See NOT-AT-19-012 for “NCCIH Policy for SBIR

and STTR Phase I Applications Proposing

Clinical Trials to the Omnibus Solicitations”

Does NCCIH accept clinical trials

through specific Notices of Funding

Opportunities?

Yes

NIH, CDC, and FDA Program Descriptions and Research Topics

NCCIH 151

Does NCCIH support clinical trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

Notice of Special Interest (NOSI): Fundamental

Science Research on Complementary and

Integrative Health Approaches, Including Natural

Products or Mind and Body Interventions

Mechanisms Underlying the Contribution of

Sleep Disturbances to Pain (R01 Clinical Trial

Optional)

Mechanisms Underlying the Contribution of

Sleep Disturbances to Pain (R21 Clinical Trial

Optional)

Center of Excellence for Research on

Complementary and Integrative Health (P01

Clinical Trial Optional)

Investigator Initiated Clinical Trials of

Complementary and Integrative Interventions

Delivered Remotely or via mHealth (R01

Clinical Trial Required)

Notice of Special Interest: Exploring the

Mechanisms Underlying Analgesic Properties of

Minor Cannabinoids and Terpenes

Research Topics

Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, special

medicinal diets, and microbiome- /microbial-based therapeutics):

•

Development and validation of technologies for standardization and characterization of

biologically active ingredients in natural products.

•

Development and validation of technologies for taxonomic identification of botanical raw

materials or detection of adulterants.

•

Development and validation of technologies for the identification and characterization of

bioactive metabolites derived from oral consumption of natural products.

•

Development and validation of methods for the sustainable production of low-yield natural

products of commercial interest.

•

Development of novel analytical tools and technologies to study the microbiome,

including its composition, genetics, and bioactivity, that can help clarify associations

between the human microbiome and brain function and health.

•

Development of gut microbiome monitoring assays for validating safety and functional

analysis of genomic and microbiota interactions.

•

Development of complementary and integrative therapeutic approaches to modify and

balance the gut microbiota in healthy populations and individuals with disrupted microbiota

and related diseases.

•

Clinical testing of natural products for the management of hard-to-treat symptoms such as

pain, sleep disorders, or mild-to-moderate anxiety and depression to allow development of an

evidence base that would accelerate U.S. Food and Drug Administration (FDA) approval of

a drug indication for the natural product.

Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, tai chi, acupuncture,

manual therapies, and music/art therapies):

NIH, CDC, and FDA Program Descriptions and Research Topics

NCCIH 152

•

Development, testing, and validation of appropriate objective and/or quantitative

measures and instruments to assess or monitor mind and body approaches in different

contexts (e.g., classrooms, families, child welfare, juvenile justice systems).

•

Development, testing, and validation of measures and tools to assess training or

fidelity of implementation of mind and body approaches in different settings (e.g., health

care, community, families, schools, child welfare, juvenile justice systems).

•

Development and testing of technologies for the implementation of mind and body

approaches in group or individual settings and/or self-care strategies. Examples may

include but are not limited to the use of mobile health technologies such as smartphone

apps, sensors, online delivery, or phone- based delivery.

•

Development and validation of methods for standardization and characterization of

the active components of mind and body approaches.

•

Development and validation of methods for standardization of multimodal interventions to

study whole person health.

•

Development and validation of imaging tools or instruments for studying manual therapies,

including but not limited to massage, acupuncture, or spinal manipulation.

•

Development and testing of innovative technologies for multisensory delivery of mind

and body approaches.

•

Development, testing, and validation of innovative technologies to enhance

sensory-based (temperature, light, olfaction, etc.) therapies.

•

Development, testing, and validation of innovative technologies to facilitate delivery of

music/art- based interventions and to identify novel outcome measures and biomarkers for

these interventions.

General Tool/Technology Development:

•

Development and validation of biomarkers that correlate with efficacy of complementary and

integrative health approaches.

•

Development and validation of standardized, reliable, and cost-effective tools that correlate

with brain imaging in response to mind and body interventions.

•

Development and validation of tools, technologies, and instruments, including gaming and

virtual reality technologies, for the accurate assessment of adherence and/or fidelity to the

use of mind and body practices and interventions.

•

Development and validation of tools to improve patient-reported outcome measures of

importance in clinical studies of complementary and integrative health approaches.

•

Development, pilot testing, and validation of wireless technologies for real-time data

collection and monitoring of brain activity or other physiological signals for mind and body

approaches.

•

Development or adaptation of biochemical or epigenetic monitoring devices for

complementary and integrative health approaches.

•

Development and validation of tools to improve biological and physiological outcome

measures for use in clinical studies of complementary or integrative health approaches.

•

Development or adaptation of technologies for objective assessment of pain with relevance

to complementary and integrative health approaches.

•

Development of sleep monitoring technologies or biomarker panels to assess sleep

deprivation, sleep deficiency, circadian rhythm dysregulation, and connection of sleep

disturbances with health risks.

•

Development and testing of in vivo labeling technology of tissues or cells responsible for

generating signals in response to different internal senses (e.g., mechanical force,

temperature, osmolarity, oxygen levels).

•

Development and testing of technology or methods for quantifying biomechanical forces

applied to internal tissues or cells.

•

Development and testing of mobile health technology or nonmobile technology and methods

to monitor or quantify physical and/or emotional well-being, breathing, or sleep.

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NCCIH 153

Contact Information

For additional information on research topics, please contact:

Emrin Horgusluoglu, PhD

Program Director, Division of Extramural Research

National Center for Complementary and Integrative Health (NCCIH)

6707 Democracy Boulevard, Suite 401

Telephone: 240-383-5302

Email: emrin.horgusluoglu-moloch@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

NLM 154

NATIONAL LIBRARY OF MEDICINE (NLM)

Mission

The National Library of Medicine (NLM) offers support for research and development projects in

biomedical informatics and data science. Biomedical informatics and data science research applies

computer and information sciences to improve the access, storage, retrieval, management,

dissemination and use of biomedical information. Grants are made to U.S. small businesses that seek

to undertake informatics research and development leading to commercialization. Critical research

areas include: representation of medical knowledge in computers; organization and retrieval issues for

image databases; enhancement of human intellectual capacities through virtual reality, dynamic

modeling, artificial intelligence, and machine learning; medical decision-making; linguistic analyses of

medical languages and nomenclatures; investigations of topics relevant to health information or library

science; biotechnology informatics issues; and informatics for disaster management. For additional

information about areas of interest to NLM and a listing of NLM funded applications, please visit

http://www.nlm.nih.gov/ep. Business concerns interested in exploring SBIR/STTR grant opportunities

with NLM are encouraged to contact the NLM representatives prior to submitting an application.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. For budgetary,

administrative, or programmatic reasons, the NLM may not fund an application or may decrease

the length of an award and/or the budget recommended by a review committee. NIH has

received a waiver from SBA, as authorized by statute, to exceed the statutory budget limitations

set by the SBA for specific topics relevant to the NLM that can be found in the SBA-Approved

Waiver Topics. Applicants with budget questions or considering requesting a budget

greater than these amounts are strongly encouraged to contact program staff before

submitting an application.

Specific SBIR and STTR Program Information

NLM Clinical Trials Topics

NLM will not accept SBIR applications that propose clinical trials, and all of the topics listed must

be for projects that do not propose clinical trials.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

NLM does not accept Phase IIB applications and does not participate in the CRP program.

Clinical Trials

Does NLM accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Yes

Does NLM accept Clinical Trials through

specific Notices of Funding

Opportunities?

Yes

Does NLM support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Yes

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NLM 155

NLM Research Topics

NLM’s SBIR/STTR grant programs are focused on areas of particular interest from small

business. The following narrative indicates the scope of projects suitable for the

SBIR/STTR program that fit within the mission of NLM. They are not listed in priority order.

Development of new, innovative tools and methods for annotating, curating, and

managing biomedical data resources

Advanced information retrieval and knowledge discovery from very large and/or

heterogeneous data sets to support biomedical research

Development of novel approaches enabling analysis and discovery at scale

across biomedical domains, research institutions, or health care sectors, including

those leveraging high-performance cloud computing and federated learning

Novel platforms, technologies, tools, and techniques enabling multimodal data

analysis to support health research or health care applications

Multi-level, reusable, data analytic models, simulations, information visualization,

and presentation approaches to enhance decisions, learning or understanding of

biological and clinical processes

Computational approaches integrating structured and unstructured data, natural

language processing, automated metadata assignment to support biomedical

research

Data science methods, approaches, or tools that enhance the quality,

confidentiality, security, and/or utility of biomedical data, including personal health

information

Artificial Intelligence techniques for characterizing and minimizing the impact of

errors, incompleteness, missingness, within health-related data sets

Novel data-driven methods to facilitate real-time decision-making in clinical

practice and public health

10.

Analytical tools, technologies, and other data-driven strategies to track disease

outbreaks, epidemics, and pandemics

11.

Tools and technologies for understanding and predicting climate and

environmental effects on human health

Contact Information

For additional information on research topics, contact:

Dr. Rebecca Moen

Program Officer

Division of Extramural Programs

National Library of Medicine

301-594-7593

Email: rebecca.moen@nih.gov

For administrative and business management questions, contact:

Ms. Samantha Tempchin

Grants Management Officer

Extramural Programs Division

National Library of Medicine

301-496-4222,

Fax: 301-402-0421

Email: samantha.tempchin@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

ORIP 156

DIVISION OF PROGRAM COORDINATION, PLANNING, AND STRATEGIC

INITIATIVES (DPCPSI), OFFICE OF RESEARCH INFRASTRUCTURE

PROGRAMS (ORIP)

Mission

ORIP supports high-quality, disease-free animal models and specialized animal research facilities to

help meet the needs of biomedical researchers to understand, detect, treat, and prevent a wide

range of human diseases. This support enables discoveries at molecular, cellular, and organ levels

that lead to animal-based studies which then are translated to patient-oriented clinical research,

aiming to find treatments to ameliorate or cure common and rare diseases. Through the small

business Phase I, Phase II, Fast-track, Direct Phase II and Phase IIB awards, ORIP is especially

interested in funding research to develop preclinical methods and technologies to reduce or replace

animal use with novel alternative methods, improve animal models of human diseases, and the

care, use, and management of laboratory animals. ORIP also encourages the development and

implementation of technologies to directly benefit the welfare of research animals and to directly

improve animal facilities that support biomedical and behavioral research.

A list of some potential ORIP program topics follows the description of our Phase IIB Competing Renewal

Awards. For additional information about ORIP, please visit our home page at https://orip.nih.gov/.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed the amounts

defined by the SBA, which can be found on the NIH SEED website. For budgetary, administrative, or

programmatic reasons, ORIP may not fund an application, may decrease the length of an award,

and/or the budget recommended by a review committee. NIH has received a waiver from SBA, as

authorized by statute, to exceed the statutory budget limitations set by the SBA for specific topics

relevant to ORIP that can be found in the SBA-Approved Waiver Topics. Applicants who have

budget questions or are considering requesting a budget greater than these amounts are

strongly encouraged to contact program staff before submitting an application.

Specific SBIR and STTR Program Information

ORIP Clinical Trials Topics

ORIP will not accept SBIR applications that propose clinical trials. All the topics listed below are for

projects that do not propose clinical trials.

Specific Funding Opportunities and Programs

In addition to the Omnibus program announcement, ORIP has targeted Notices of Funding

Opportunities (NOFOs). Please visit our ORIP Funding Opportunities webpage to view the latest

targeted NOFOs.

Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

ORIP will only accept Phase IIB SBIR Competing Renewal grant applications of ORIP-supported Phase II

awards to continue research and development of methods, technologies, tools, and devices for basic or

translational research where extraordinary time and effort are needed for completion of these projects.

The Phase IIB Competing Renewal award is intended to allow small businesses the opportunity to

NIH, CDC, and FDA Program Descriptions and Research Topics

ORIP 157

reach a stage where interest and investment by third parties would be more likely. Such products are

expected to have broad applicability, consistent with the mission of ORIP. Budgets that do not exceed

$1 M per year in total costs (for up to 2 years), may be requested for this Phase IIB Competing

Renewal opportunity; however, it is expected that, in most cases, the requested budget would not

exceed the final year budget of the applicant’s previous Phase II award. This opportunity is available

for the SBIR program only.

Please contact your Program Officer before beginning the process of preparing a Phase IIB

Competing Renewal application. In addition, prospective applicants are strongly encouraged to

submit to the Program Contact (listed after each section) a letter of intent by email that includes the

following information:

•

Descriptive title of the proposed research

•

Name, address, and telephone number of the Principal Investigator

•

Names of other Key Personnel

•

Participating organizations

•

Notice of Funding Opportunity Number (e.g., PA-22-XXX)

A letter of intent is not required, is not binding, and does not enter into the review of a subsequent

application. It is expected that only a few of ORIP SBIR Phase II awards will be eligible for a Phase

IIB Competing Renewal grant.

ORIP does not participate in the Commercialization Readiness Pilot (CRP) program at this time.

Clinical Trials

Does ORIP accept Clinical Trials

through the Omnibus/Parent Notices of

Funding Opportunities?

Does ORIP accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does ORIP support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

Research Topics

ORIP Non-Clinical Trials Topics:

Division of Comparative Medicine

Development of in vitro animal cell culture techniques, microphysiological systems

(organs- on-a-chips, organoids) or computational (in silico) methods to reduce the

number of animals used in studies and to replace certain tests conducted in animal

models with novel alternative methods (NAMS).

Development of improved reagents and cost-effective methods and technologies to

accurately screen and diagnose selected diseases of laboratory animal, and to perform

overall assessments of animal quality and health status. An urgent need currently exists

for the development of improved methods for detection of active tuberculosis in

nonhuman primates (NHPs).

Development of improved reagents, techniques, and devices/tools for genomic

and transcriptomic analysis and data mining from tissue or single cells of laboratory

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ORIP 158

animals and animal models of human diseases.

Development of new technologies for rapid or high throughput animal

characterization and deep phenotyping (at tissue, organ, cellular or molecular

levels) .

Development of nonintrusive, wearable technologies to identify or assess biomarkers in well

validated animal models.

Development of prophylactics or new therapeutic agents to prevent and/or control

infectious diseases of laboratory animals. One high priority need is to develop

methods to control and prevent monkey B virus (Macacine alphaherpesvirus-1)

infections.

Identification, development, and characterization of spontaneous (naturally

occurring) and engineered vertebrate animal models for studies of various human

diseases (excluding most random mutagenesis projects performed on rodents).

Development and refinement of high-throughput technologies, cryoprotectants and

devices for the cryopreservation, vitrification, long-term maintenance, and revival of

cells, tissues and organs, as well as laboratory animal embryos and gametes,

especially for Drosophila, aquatic models of biomedical value, swine, and NHPs.

Development of technologies, tools, and devices for the effective monitoring of

frozen, cryopreserved cells and biological materials/tissues as well as laboratory

animal embryos and gametes (including monitoring conditions during their

distribution).

Development of technologies for improved embryo transfer within a single animal

species or of intraspecific embryo transfer to allow preservation of rare or unique animal

species that may have unique value in biomedical research as animal models for human

disease.

Development of improved reagents, artificial intelligence/machine learning

technologies, tools, devices, and high-throughput technologies to perform, analyze,

capture, and process data gathered in “omics” studies (genomics, transcriptomics,

epigenomics, proteomics, lipidomics, glycomics, metabolomics, and phenomics,

among others) in normal, diseased, and intervention conditions in animal/biological

models to support or validate pre-clinical analyses.

Development of biological tools and reagents for reconstruction, remodeling, repair,

and regeneration of tissues damaged by injury or disease. Development of the

technologies and procedures to test efficacy and safety of these experiments in

animal models. Approaches to detect and track survival of implanted cells and

tissues in vivo.

Development of reagents (including antibodies), assays, and technologies that will

facilitate research using aquatic biomedical models, such as zebrafish or Xenopus,

for understanding basic aspects of development, physiology, or genetics.

Development of reagents (including antibodies), assays, and technologies that will

facilitate research using NHPs for understanding basic aspects of development,

physiology, or genetics. High priority needs include reagents for NHP species other

than the rhesus macaque.

Development of rapid and sensitive technology for the accurate detection and

diagnosis of polymicrobial infections in biomedical laboratory animal models, including

those agents involved in vertical transmission of diseases into embryos and larvae.

Technologies for improved sex determination of embryonic, neonatal, and juvenile

stages of animals, with one high priority need being nonmammalian species.

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ORIP 159

Development of rapid and sensitive technology for the detection and study of emerging

human pathogens in animal models.

Development of non-invasive, micro-sensor technologies (e.g., embedded sensors,

devices, microchips) for NHPs and other live animal models to collect data related to

neuroimaging, behavioral and cognitive assessments, metabolism, microbiomes, and

other biomedical research areas. Of special interest are wearable, swallowable

sensitive and selective probes/sensors for detecting physiological fluctuations in

living animals, with the capability of monitoring at deep tissues level.

Development of technologies for cell-based therapies that could be used as

implantable biocomputers in animal models of human disease, to perform

complex logic computations that integrated signals from multiple

metabolites/pathways. These include remote-controlled switches and natural,

nontoxic, highly soluble, and potentially beneficial to health trigger molecules.

Development of technologies and tools (biosensors, imaging approaches, and

reagents such as antibodies (especially nanobodies)), to facilitate validation

and use of multiple model organisms in research studies to enhance the rigor,

and reproducibility of animal research and their clinical and translational

research potential.

Division of Construction and Instruments

The Division of Construction and Instruments supports the development and implementation of

technologies that enhance and improve the welfare and research facilities of animal models in

biomedical and behavioral research. In particular, the areas being supported include novel tools

and equipment that improves and facilitates the care and monitoring of animals. One area of

interest is the integration of technological features for detecting, measuring, monitoring,

recording, analyzing, and reporting physiological, biobehavioral, and environmental conditions to

allow for documenting these physiological parameters and extrinsic factors and enhancing

scientific rigor and reproducibility in animal studies. Another area of interest encompasses the

improvement of laboratory equipment to maintain the environmental conditions and upkeep of the

infrastructure within animal facilities. Of special importance is the employment of green

technologies. Examples of topics of special interest include (but are not limited to) the

development of better, more reliable, and more efficient:

Equipment such as vacuum cleaners, air filters, hoods, snorkels, and autoclaves

for animal research facilities, for barrier facilities, and other facilities with special

needs and requirements.

Equipment/devices to distribute water and food and to monitor and record their

intake by research animals.

Equipment to increase the quality of life and prevent injuries of research

animals, staff, and investigators.

Technology to monitor and protect the well-being of animals, including IT-supported tools.

Equipment and its use for maintenance of disease-free colonies and healthy animals.

Equipment to disinfect devices, furnishings, and other apparatus in animal

facilities such as aquaria, cages, tunnels, and racks.

Cost-effective husbandry and colony management techniques, equipment,

and/or new approaches to improve laboratory animal welfare and assure

efficient and appropriate research use.

Specialized equipment and caging for laboratory animals to permit optimal

NIH, CDC, and FDA Program Descriptions and Research Topics

ORIP 160

environmental control, and operational efficiency, including improvements in caging,

identification/tagging of animals and remote monitoring in animal facilities.

Specialized equipment to permit integrated environmental factor measuring,

monitoring, reporting, recording and documentation (such as for air quality,

temperature, humidity, lighting, sound, and vibration level).

Contact Information

For additional information on DCM research topics, contact:

Miguel Contreras, Ph.D.

Division of Comparative Medicine,

Office of Research Infrastructure Programs,

Division of Program Coordination, Planning, and Strategic Initiatives,

Office of the Director

Phone: 301-451-7845,

Email: miguel.contreras@nih.gov mailto:contre1@mail.nih.gov

For additional information on DCI research topics, contact:

Xiang-Ning Li, Ph.D.

Director

Division of Construction and Instruments,

Office of Research Infrastructure Programs,

Division of Program Coordination, Planning, and Strategic Initiatives

Office of the Director Phone: 301-435-0766

Email: xiang-ning.li@nih.gov

For administrative and business management questions, contact:

Ms. Donna James

Grants Management Specialist,

National Heart, Lung, and Blood Institute (NHLBI),

Office of Research Infrastructure Programs (ORIP),

6705 Rockledge Drive, 202-G

Bethesda, MD 20817

Phone: 301-827-8063

Email: donna.james@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

ORWH 161

OFFICE OF RESEARCH ON WOMEN’S HEALTH

Mission

ORWH is the first Public Health Service office dedicated specifically to promoting women's

health research within and beyond the NIH scientific community. ORWH was established in

September 1990. Congress assigned a far-reaching leadership role for ORWH by mandating

that the ORWH Director:

• Advise the NIH Director and staff on matters relating to research on women's health

• Strengthen and enhance research related to diseases, disorders, and conditions that

affect women

• Ensure that research conducted and supported by NIH adequately addresses issues

regarding women's health

• Ensure that women are appropriately represented in biomedical and bio-behavioral

research studies supported by the NIH

• Develop opportunities and support for recruitment, retention, reentry, and advancement

of women in biomedical careers

• Support and advance rigorous research that is relevant to the health of women

• Ensure NIH-funded research accounts for sex as a biological variable (SABV)

ORWH crafts and implements the NIH-Wide Strategic Plan for Women's Health Research in

partnership with NIH Institutes and Centers (ICs) and co-funds research on the role of sex and

gender on health. ORWH also collaborates with NIH ICs, the NIH Office of Extramural

Research, and the NIH Office of Intramural Research to monitor adherence to NIH's inclusion

policies, which ensure that women and minorities are represented in NIH-supported clinical

research.

Budget Guidance

ORWH does not award grants but co-funds women’s health-related applications that have

received an award from one of the participating NIH Institutes and Centers (ICs) listed in the

announcement. Budgets should be discussed with Institute or Center program staff, not ORWH.

Specific SBIR and STTR Program Information

The NIH Office of Research on Women’s Health is technology agnostic and welcomes

applications focused on diseases and health conditions that predominantly affect women (e.g.,

autoimmune diseases; depressive disorders, Alzheimer’s disease (AD) and Alzheimer’s

disease-related dementias (ADRD), gender-based-violence), present and progress differently in

women (e.g., cardiovascular disease; HIV; reproductive aging and its implications), or are

female-specific (e.g., uterine fibroids; endometriosis; menopause).

Specific Funding Opportunities and Programs

In addition to the Omnibus program announcement, for a current list of funding announcements

and programmatic initiatives visit: https://orwh.od.nih.gov/research/funded-research-and-

programs/funding-opportunities-and-notices

Research Topics

NIH, CDC, and FDA Program Descriptions and Research Topics

ORWH 162

ORWH will consider co-funding for applications that have a central focus on the health of

women, as demonstrated through specific aims that EITHER explicitly address a particular

condition in women OR focus on one of the high priority topics below. In either

approach, intersectional and/or multidimensional approaches that consider the health of women

in context (e.g., projects accounting for social and structural variables—

including race, ethnicity, socioeconomic status, and State and Federal policies— that affect

women’s health) are strongly encouraged. While projects are not required to exclusively focus

on women for ORWH co-funding, studies that include more than one sex or gender should be

designed and powered to make generalizable conclusions about women and enable sex or

gender difference comparison.

ORWH intends to prioritize interdisciplinary research that:

• Addresses the influence of sex-linked biology, gender-related factors, or their

intersections on health.

• Addresses how physical, mental, and psychological health outcomes interact with

structural factors to either mitigate or exacerbate health disparities and aims to create

behavioral interventions to address these issues.

• Advances the translation of research advancements and evidence in women’s health

into practical benefits for patients and providers.

• Informs and develops multi-sector partnerships to advance innovation in women's health

research.

• Increases public awareness of the need for greater investment in and attention to

women’s health research, as well as women’s health outcomes across the lifespan.

• Advances research to reduce health disparities and inequities affecting women’s health,

including those related to race, ethnicity, age, socioeconomic status, disability, and

exposure to environmental factors and contaminants that can directly affect health.

• Increases uptake of evidence-based interventions that advance women’s health.

• Addresses topics identified in the Women’s Health Innovation Opportunity Map.

• Reduces violence, stigma, and trauma related to HIV.

• Develops woman-centered self-tests for HIV viral load monitoring, including in breast

milk.

• Develops topical microbicide agents, wearable, implantable, or insertable devices

releasing medications alone or as part of multipurpose prevention technologies (MPTs),

to prevent sexual acquisition of HIV, other sexually transmitted infections and/or

unplanned pregnancy across the lifespan including in pregnant or postpartum people.

• Promotes the use of advanced statistical modeling, data visualization, artificial

intelligence (AI), and machine learning (ML) methods for research on the health of

women.

• Develops methods, tools, or technologies to increase data sharing and improve data

management practices to align with the Findability, Accessibility, Interoperability, and

Reusability (FAIR) data principles and enhances the utility of new and existing data on

the health of women.

• Methods for integrating data science, including artificial intelligence and machine

learning, into research on the health of women.

• Develops cutting-edge computational tools and technologies to facilitate screening for

prevention, diagnosis, and treatment of diseases that affect women.

• Improves estimates of the impact of chronic conditions in women, including projects to

diagnose and reduce misclassification of female-specific and gynecologic conditions,

conditions that predominantly impact women or affect women differently, and projects to

characterize differences in chronic condition presentation by gender, race and ethnicity,

NIH, CDC, and FDA Program Descriptions and Research Topics

ORWH 163

and the various structural and social determinants that these women experience or are

affected by.

• Explores the role of hormonal fluctuations on the development of chronic conditions in

women, including the influence of age of menarche; the role of menstrual cycle

ir/regularity, length, and phase; the length of the reproductive window; the link between

adverse pregnancy outcomes and development of chronic conditions later in life; and the

effect of exogenous hormones on the development of chronic conditions

• Develops new and better approaches for addressing the symptoms that affect women

during perimenopause, menopause, and postmenopause

• Improves early and accurate detection and diagnosis of chronic conditions in women,

including the diagnosis of multiple chronic conditions

• Elucidates gender differences in access and use of health care services, including

methods for assessing discrimination (e.g., sexism, racism, ageism, and homophobia)

encountered by women when accessing health care services for chronic conditions.

Contact Information

For additional information on ORWH priorities, please contact:

Elizabeth Barr, Ph.D.

ORWH Associate Director for Interdisciplinary Research

Office of Research on Women’s Health, NIH

Phone: 301-402-7895

Email: Elizabeth.Barr@nih.gov

NIH, CDC, and FDA Program Descriptions and Research Topics

CDC 164

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

CDC is the nation’s leading science-based, data-driven, service organization that protects the

public’s health. For more than 70 years, we’ve put science into action to help children stay healthy

so they can grow and learn; to help families, businesses, and communities fight disease and stay

strong; and to protect the public’s health.

Vision

Equitably protecting health, safety, and security.

Mission

CDC works 24/7 to protect America from health, safety, and security threats, both foreign and in the

U.S. Whether diseases start at home or abroad, are chronic or acute, curable, or preventable, human

error or deliberate attack, CDC fights disease and supports communities and citizens to do the same.

CDC increases the health security of our nation. As the nation’s health protection agency, CDC

saves lives and protects people from health threats. To accomplish our mission, CDC conducts

critical science and provides health information that protects our nation against expensive and

dangerous health threats and responds when these arise.

The 2022-2027 CDC Strategic Plan advances science and health equity and affirms the agency’s

commitment to one unified vision — equitably protecting health, safety, and security. The plan

leverages five core capabilities of the agency to include: a diverse public health workforce, world-

class data and analytics, state-of-the-art laboratories, rapid response to outbreaks at their source,

and strong global capacity and domestic preparedness. Our work is underscored by the agency’s

Pledge to the American People and dedication to use timely data and science to drive and

communicate customer- centered, high-impact public health action.

Budget Guidance

Total funding support (direct costs, indirect costs, fees) normally may not exceed $306,872 for

Phase I awards and $2,045,816 for Phase II awards. These are the amounts currently defined by

the U.S. Small Business Administration (SBA), which can also be found on the CDC SBIR

website. Applicants considering a requested budget greater than these limits are strongly

encouraged to contact CDC program staff before applying. For budgetary, administrative, or

programmatic reasons, the CDC may not fund an application or may decrease the length of an

award and/or the budget recommended by a review committee. CDC has received a waiver from

SBA, as authorized by statute, to exceed the statutory budget limitations set by SBA for specific

topics relevant to CDC that can be found in the SBA-Approved Waiver Topics Over Statutory

Budget Limitations document.

Before considering and/or preparing an application to the CDC SBIR program, applicants are

encouraged to review the websites of CDC’s participating components and to contact the SBIR

program staff listed below.

Specific SBIR and STTR Program Information

CDC does not accept STTR applications.

CDC does not accept Direct to Phase IIs, Fast-Track, or Phase IIB.

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CDC 165

For additional information about CDC, please visit: http://www.cdc.gov.

Specific Funding Opportunities and Programs

Clinical Trials

Does CDC accept Clinical Trials through

the Omnibus/Parent Notices of Funding

Opportunities?

Yes

Does CDC accept Clinical Trials

through specific Notices of Funding

Opportunities?

Yes

Research Topics/Specific Areas of Interest

Additional information on the awarding components (CIOs) and their research interests is available

electronically on the home pages shown throughout the “Research Topics/Specific Areas of

Interest” sections below.

CDC encourages investigator-initiated applications that focus on support for the prevention,

detection,and response to emerging public health threats. CDC also encourages investigator-

initiated applications that align with the agency’s overall mission and the research areas of interest

of the participating CDC components below.

Contact Information

General questions about the CDC SBIR program should be directed to:

Small Business Innovation Research Program (SBIR)

Office of Science (OS)

Centers for Disease Control and Prevention (CDC)

Email: SBIR@cdc.gov

GLOBAL HEALTH CENTER (GHC)

Mission and Research Areas of Interest

CDC’s global health mission is to improve and protect the health, safety, and security of Americans

while reducing morbidity and mortality worldwide. CDC’s Global Health Center works to protect

Americans from dangerous and costly public health threats, including COVID-19, vaccine-

preventable diseases, HIV, TB, and malaria—responding when and where health threats arise.

Goals of the center include:

Protecting Americans and populations across the globe by strengthening global public health

prevention, detection, and response (Health Security)

Saving lives, improving health outcomes, and fostering healthy populations globally (Health

Impact)

Leading and influencing the advancement of global public health science and practice and

serving as a leading source of credible scientific information (Public Health Science Leadership)

GHC seeks to accomplish its goals by:

Leveraging the latest technologies and advanced analytics to accelerate public health impact

Eliminating health disparities and achieve optimal health for all

Establishing and strengthening sustainable country, regional, and international public health

systems

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CDC 166

Fostering health diplomacy in coordination with other U.S. Government agencies through its

longstanding bilateral and multilateral partnerships, engagement with the private sector, and

ongoing collaborations with academic institutions and foundations

Availing its workforce to address the most urgent global public health threats

Additionally, GHC encourages submission of research applications with innovative research

technologies designed to reduce health disparities and promote health equity.

Please visit the GHC website at: https://www.cdc.gov/GlobalHealth/.

Description of Research Areas of Interest

Areas of focus include:

Achieving an AIDS-Free generation

Innovating TB and Malaria prevention and treatment

Optimizing the impact of pneumococcal conjugate vaccine

Eradicating polio and combating vaccine-preventable diseases

Eliminating epidemic meningitis in Africa

Improving country capacity to detect and respond to outbreaks and prevent future ones

Training a multidisciplinary, global workforce

Improving in-country emergency response capacity

Maintaining a rapid response capacity at CDC to respond to international public

health emergencies

Analyzing data to best inform programming in limited resource settings

Rapidly translating data to improve public health outcomes

Examples of specific research areas of interest include, but are not limited to:

Advanced tools and techniques for detecting new microbes, biomarkers, and cases

Non-traditional surveillance tools and methods for real-time detection of emerging

public health threats, including COVID-19, vaccine-preventable diseases, HIV, TB,

and malaria

Virtual reality equipment and software to support the development of virtual

laboratory environments to assess practical laboratory skill competency

Technologies to detect diseases faster

Impact and Commercialization Potential:

This research could lead to the development of tools for the detection of diseases and improve

the ability to rapidly respond to emerging public health threats. Successful and novel innovation

that will lead to the development of these tools and technologies will have huge commercial

potential across many markets.

For GHC programmatic information, contact:

Lata Kumar, MS, MPH, MBA

Office of the Director

Center for Global Health Center

Centers for Disease Control and Prevention (CDC) Mail Stop H21-9

1600 Clifton Road NE Atlanta, GA 30329

Phone: (404) 639-7618

Email: LKumar@cdc.gov

For grants specific, administrative information, contact:

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Angie Willard, Team Lead

Office of Grant Services

Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop TV-2

2939 Flowers Road NE

Atlanta, GA 30341

Phone: 770-498-2596

Email: AEN4@cdc.gov

NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL

DISABILITIES (NCBDDD)

Mission and Research Areas of Interest

The mission of CDC’s National Center on Birth Defects and Developmental Disabilities (NCBDDD) is

to promote the health of babies, children, and adults and to enhance the potential for full, productive

living. To achieve its mission, the Center works to identif y the causes of birth defects and

developmental disabilities, helps children to develop and reach their full potential, and promotes

health and well-being among people of all ages with disabilities, including blood disorders. NCBDDD

seeks to accomplish these goals through research, partnerships, and prevention and education

programs. Our efforts in surveillance, research, and health promotion programs provide information

used to identify causes of birth defects and infant disorders, find opportunities to prevent them, and

improve the health of those with these conditions. Additionally, NCBDDD encourages submission of

research applications with innovative research technologies designed to reduce health disparities

and promote health equity.

Please visit the NCBDDD website at: http://www.cdc.gov/ncbddd/index.html.

Description of Research Areas of Interest

Goals of the center include:

Improving the health and developmental outcome of children and adults with or at

risk of disabilities

Preventing complications and improving the management of blood disorders

Addressing preventable causes of birth defects, infant disorders, and related conditions

Promoting and improving the health of people living with birth defects, infant disorders,

and related conditions

Examples of specific research areas of interest include, but are not limited to:

Improved methods for screening for newborn heart disorders

Technology-based solutions to improve access to evidence-based interventions to

manage attention-deficit/hyperactivity disorder and tic disorders

Tools and technologies to improve the life of people living with birth-defects

Technologies that improve access of individuals with intellectual disabilities to services

and evidence-based management interventions

Impact and Commercialization Potential:

This research could lead to the development of tools for the management of birth defects and

developmental disabilities, improve access to effective interventions among people with disabilities,

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and lead to the development of devices and methods for the detection and management of birth

defects. Effective tools and technologies have the potential for uptake by the intended populations

and their caregivers.

For NCBDDD programmatic information, contact:

Natalie Brown, MPH

Office of the Director

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention (CDC)

Mail Stop S107-8

4770 Buford Highway

Atlanta, GA 30341

Phone: 404-639-4601

Email: NBrown3@cdc.gov

For grants specific, administrative information, contact:

Brownie Anderson-Rana

Office of Grant Services

Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop K-75

2920 Brandywine Rd.

Atlanta, GA 30341

Phone: 770-488-2771

Email: BAndersonRana@cdc.gov

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION (NCCDPHP)

Mission and Research Areas of Interest

CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) carries

out a variety of activities that improve the nation’s health by preventing a range of chronic diseases

such as arthritis, cancer, diabetes, heart disease, obesity, and stroke, while promoting health and

wellness in the areas of reproductive health, oral health, nutrition, and physical activity. The Center’s

activities include supporting states’ implementation of public health programs; public health

surveillance; translation research; and developing tools and resources for organizations at the

national, tribal, state, and community levels. NCCDPHP has identified the following Social

Determinants of Health (SDoH) as priorities: built environment, clinical-community linkages, social

connectedness, tobacco control policy, and food and nutrition security. Additionally, the Center

encourages submission of research applications with innovative technologies designed to reduce

health disparities and promote health equity.

Please visit the NCCDPHP web site at: http://www.cdc.gov/chronicdisease/index.htm.

Description of Research Areas of Interest

The center’s areas of focus include:

Development, implementation, and promotion of effective strategies for preventing and

controlling cancer

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Prevention of diabetes and diabetes complications

Improving cardiovascular health for all, reducing the burden, and eliminating

disparities associated with heart disease and stroke

Supporting healthy eating, active living, and obesity prevention

Promoting optimal and equitable health in women and infants

Supporting efforts to protect the public’s health from the harmful effects of tobacco use

Improving symptoms and quality of life for people with conditions such as Alzheimer’s

disease, arthritis, epilepsy, and lupus

Improving oral health by promoting proven interventions

Working through schools to implement effective school-based strategies that help youth become

healthy, successful adults

Examples of specific research areas of interest include, but are not limited to:

Tools to increase access to health care, decision support tools to improve

prevention, measurement, and management of chronic diseases

Applications to improve nutrition among children and adults

Implementation tools to improve use of evidence-based interventions such as chronic

disease self-management programs

Design aids to increase physical activity through the built environment

Tools to promote physical activity and physical activity education among children

Methods to improve access to screening

Applications to reduce smoking and support quitting

Interventions to promote prevention and early detection of cancers

Impact and Commercialization Potential:

This research could lead to the development of solutions to increase uptake of prevention

interventions and increase access to screening services, as well as lead to the development of

tools to monitor and manage chronic diseases, address health disparities among specific sub-

populations, increase linkage to clinical and other support services, and result in prevention and

better management of chronic diseases. Practical, easy to use, and effective solutions will have

potential for uptake by large segments of the target populations.

For NCCDPHP programmatic information, contact:

Natalie Brown, MPH

Office of the Director

National Center for Chronic Disease Prevention and Health

Promotion

Centers for Disease Control and Prevention

(CDC)

Mail Stop S107-8

4770 Buford Highway

Atlanta, GA 30341

Phone: 404-639-4601

Email: NBrown3@cdc.gov

For grants specific, administrative information, contact:

Angie Willard, Team Lead

Office of Grant Services Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop, T2939 Flowers Road NE Atlanta, GA 30341

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Phone: 770-498-2596

Email: AEN4@cdc.gov

NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS

DISEASES (NCEZID)

Mission and Research Areas of Interest

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) aims to prevent

disease, disability, and death caused by a wide range of infectious diseases. NCEZID focuses on

diseases that have been around for many years, emerging diseases (those that are new or just

recently identified), and zoonotic diseases (those spread from animals to people). Work is guided in

part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes

and the environment. Through a comprehensive approach involving many scientific disciplines,

better health for humans and animals and an improved environment can be attained. Research to

address reducing health disparities and increasing health equity is strongly encouraged.

Please visit the NCEZID website at: http://www.cdc.gov/ncezid.

Description of Research Areas of Interest

(1)

Develop a Rapid, Portable, Point-of-Care Antifungal Therapeutic Drug Monitoring Tool

Background: Every year, an estimated 150 million severe fungal infections occur worldwide,

resulting in approximately 1.7 million deaths. Antifungals drugs for treating severe fungal infections

are limited to just 3 classes, and antifungal resistant infections are a rising global public health threat,

underscoring an urgent need to optimize antifungal use to prevent mortality and minimize resistance

selection pressure. Antifungal therapeutic drug monitoring is a critical component of individualized,

precision treatment for fungal infections and for antifungal stewardship. It can help optimize individual

patients’ antifungal treatment regimen by measuring antifungal drug concentrations in a patient's

biologic fluids and applying well-described pharmacokinetic principles to adjust drug dosing.

Infectious Diseases Society of America's Guidelines for treatment of fungal diseases like candidiasis,

aspergillosis, histoplasmosis, coccidioidomycosis, and blastomycosis recommend therapeutic drug

monitoring for certain antifungals, particularly for triazole antifungals (e.g., itraconazole, voriconazole,

Posaconazole). Antifungal therapeutic drug monitoring can help improve outcomes through

minimizing toxicity associated with supratherapeutic drug levels and prevent treatment failure from

subtherapeutic levels. Also, in vitro studies have shown that suboptimal drug levels can lead to

antifungal resistance, supporting therapeutic drug monitoring's potential role in preventing the

emergence of antifungal-resistant organisms. Measurement of antifungal concentrations is usually

performed by analytical assays, such as high-performance liquid chromatography or liquid

chromatography-mass spectrometry which are usually only available in large academic centers;

bioassays are available for certain azole antifungals (e.g., itraconazole), but are difficult to interpret

and can be inaccurate.

Recent studies suggest that antifungal therapeutic drug monitoring is underutilized, leading to missed

opportunities to address sub- and supratherapeutic drug levels and improve patient outcomes. An

analysis of a hospital discharge data set showed that only 16% of therapeutic drug monitoring-eligible

patients receiving itraconazole, Posaconazole, or voriconazole had drug level monitoring performed.

Among 55 predominately academic medical centers, only 41% of patients receiving isavuconazole,

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Posaconazole, or voriconazole for treatment or prophylaxis of invasive fungal infections had

therapeutic drug monitoring performed.

A recent survey found that there are many challenges encountered in performing antifungal

therapeutic drug monitoring; the most common being long turnaround times for send-out tests. Other

barriers noted were difficulty coordinating testing logistics, difficulty interpreting results, and cost.

Specific Research Area(s) of Interest: The major research priorities areas for NCEZID are listed below.

Investigator initiated applications that have commercial potential that fall outside these topic areas but fall

within the research mission of NCEZID will also be considered through this Omnibus solicitation.

Research to address reducing health disparities and increasing health equity is strongly encouraged.

The goals for the proposed research are to address fungal infections being treated with antifungals

requiring therapeutic drug monitoring. Prioritized antifungals would be itraconazole, voriconazole, and

Posaconazole.

Examples of specific research areas of interest include, but are not limited to:

• Development of rapid and novel strategizes for measuring in vivo antifungal level in patient for

therapeutic efficacy.

Impact: This research will lead to the development of practical, timely and innovative solutions to

address barriers to performing antifungal therapeutic drug monitoring (e.g., long turnaround times,

difficulty in coordinating logistics) to improve patient outcomes when being treated with prioritized

antifungals.

Commercialization Potential: Current antifungal therapeutic drug monitoring is limited to large academic

centers. Successful and novel innovation will improve patient outcomes and prevent toxicity and

potentially resistance while having a large market with an increasingly population susceptible to fungal

infections. Rural and urban, community and academic hospitals will be able to procure the innovative

tools.

(2)

Finding the cause of Guillain-Barré syndrome

Background: Guillain-Barré syndrome (GBS) is a rare disorder where the body’s immune system

attacks part of the peripheral nervous system, resulting in symptoms ranging from brief weakness to

devasting paralysis. The global incident rate of GBS is about 1-2 cases per 100,000 people per year,

and the CDC estimates that about 3,000 to 6,000 cases of GBS occur every year in the United

States. The cause of GBS is not fully understood, but is most frequently associated with

Campylobacter jejuni infections, with about 1 in 1,000 people with Campylobacter infection

developing GBS in the United States. Other risk factors include respiratory illnesses, viral infections,

and vaccination. Finding an accurate cause for GBS is challenging, since symptom onset can occur

weeks after the initial infection. In outbreaks of GBS that have occurred globally, determining the

cause of GBS for accurate diagnosis and surveillance has proved to be difficult, especially in regions

with limited resources.

Specific Research Area(s) of Interest: The major research priorities areas for NCEZID are listed below.

Investigator initiated applications that have commercial potential that fall outside these topic areas but fall

within the research mission of NCEZID will also be considered through this Omnibus solicitation. Research

to address reducing health disparities and increasing health equity is strongly encouraged.

The goal of the proposed research is to develop innovative methods to determine the cause of GBS.

Examples of specific research areas of interest include, but are not limited to:

• Developing cost-effective diagnostic tests for Campylobacter species from GBS patient samples.

• Enhancing surveillance by leveraging novel technologies to sequence type associated with specific

serotypes of Campylobacter jejuni.

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• Determining the cause of illness during a GBS outbreak.

Impact: This research will lead to finding innovative ideas to diagnose and perform surveillance on

illnesses with ambiguous causes that can be difficult to determine using traditional methods.

Commercialization Potential: The innovative solutions developed through this research will have

significant commercial potential in improving public’s health both domestically and globally.

(3)

Developing Novel Diagnostic Testing for Typhoid Disease

Background: Typhoid fever is a significant global health concern, particularly in regions with limited

access to healthcare facilities and resources. Traditional diagnostic methods for typhoid, such as blood

culture and serological tests, have limitations in terms of accuracy, cost, and turnaround time. Therefore,

there is an urgent need to develop novel diagnostic testing approaches that are rapid, affordable, and

highly sensitive and deployable in resource limited settings.

Specific Research Area(s) of Interest: The major research priorities areas for NCEZID are listed below.

Investigator initiated applications that have commercial potential that fall outside these topic areas but fall

within the research mission of NCEZID will also be considered through this Omnibus solicitation.

Research to address reducing health disparities and increasing health equity is strongly encouraged.

The goal of this proposal is to develop innovative methods to identify the cause of illness for suspected

Typhoid fever. The proposed test method should improve the accuracy of existing diagnostic methods

and be deployable in resource limited settings.

Examples of specific research areas of interest include, but are not limited to:

• Identify appropriate markers specific and sensitive for Salmonella enterica serotype Typhi

detection from suspected cases of typhoid fever. This may involve techniques to analyze specific

bacterial genomes or bacterial antigens.

• Design and optimize an assay based on the identified biomarkers using cutting-edge

technologies that are user-friendly, require minimal equipment, field deployable, and provide rapid

results.

Impact: This research will lead to innovative diagnostic approaches to address a challenging infectious

disease that causes illness both domestically and internationally.

Commercialization Potential: Successful approaches will lead to faster and more accurate diagnoses

and reduced disease, disability, and death and will have huge commercial potential across many

markets.

(4)

Develop new or enhanced diagnostics for Leptospira spp.

Background: Leptospirosis, caused by over 35 different species of pathogenic and intermediate

Leptospira species, is one the most common zoonotic/environmental diseases in the world. Leptospira

spp. are shed in animal urine and are capable of surviving in soil and water. Globally it is estimated that

there are up to 500,000 severe cases of leptospirosis annually, although this is likely a severe

underestimate due to non-specific clinical presentations, poor availability of reliable tests, and lack of

surveillance systems. Cases of leptospirosis increase after flooding events, tends to affect individuals in

economically poor areas, and is responsible for disproportionately high global burdens both economically

and in disability adjusted life years for affected individuals. Due to climate change and the associated

extreme weather events, it is expected that cases of leptospirosis will continue to increase at a high rate.

Specific Research Area(s) of Interest: The major research priorities areas for NCEZID are listed below.

Investigator initiated applications that have commercial potential that fall outside these topic areas but fall

within the research mission of NCEZID will also be considered through this Omnibus solicitation.

Research to address reducing health disparities and increasing health equity is strongly encouraged.

Development of better diagnostic and environmental detection tools is critical to increase positive patient

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outcomes and identify at risk populations.

Examples of specific research areas of interest include, but are not limited to:

• Development of new or enhanced diagnostics for Leptospira spp. including serological assays

with better specificity/sensitivity and are easier to transfer to partners than current assays, rapid

point of care diagnostics, and molecular assays capable of detecting intermediate pathogenic

species in addition to pathogenic species.

• Develop diagnostic tests that can easily differentiate between species and/or serovars of

Leptospira spp.

• Develop methods for better detection and genetic characterization of Leptospira spp. from

environmental matrices.

Impact: Leptospirosis is vastly underreported in the US, and cases are likely to increase due to extreme

weather events related to climate change. The proposed research should lead to practical solutions

related to the detection of these pathogens in the environment and the effective diagnosis of disease in

humans.

Commercialization Potential: Products related to the diagnosis and detection of Leptospira spp. will

have significant commercial potential both in the domestic and international markets and will improve both

surveillance and patient outcomes.

(5)

Vector Borne Diseases: Detection, Prevention, Diagnosis and Response

Background: Bacterial and viral vector borne diseases are transmitted to humans primarily through

vectors such as an infected mosquito, tick, or flea. Some of these diseases have long been present in

the United States while others have recently emerged.

Vector-borne diseases are a major public health concern. Lyme disease causes over 300,000

estimated human illnesses annually in the U.S. tick-borne rickettsial diseases, such as Rocky

Mountain spotted fever, ehrlichiosis, and anaplasmosis, are responsible for over 4,000 U.S. cases

each year, including some that result in death. Dengue fever causes millions of cases worldwide,

including thousands of cases in Puerto Rico each year. Outbreaks of arboviral diseases such as

West Nile encephalitis and Chikungunya fever have been reported in recent years. Less common,

but often deadly threats such as Yersinia pestis causes the ancient disease plague. Local plague

outbreaks occur in the southwestern U.S., and it is a significant health threat in Africa and Asia.

Specific Research Areas of Interest: The goal of this project is to encourage research that will enhance

prevention, detection, diagnosis, and response capabilities to vector borne diseases through funding

innovative solutions that address the following:

Mitigate the spread and impact of vector borne diseases

Improve our ability to prevent, detect, and respond to outbreaks of vector borne diseases

Develop diagnostic tests to differentiate among vector borne diseases

Develop vaccines effective against vector borne diseases

Impact: Given the large number of individuals affected by these diseases, and the challenges to

public health for their containment, improved detection through better diagnostic tests and improved

prevention through vaccination would have a great impact on the health of the nation. The proposed

research should lead to the development of practical solutions for the detection, prevention, and

diagnosis of vector-borne diseases.

Commercialization Potential: The products and innovations developed through this process will

have significant commercial potential and will improve public health and the healthcare system’s

response to vector-borne diseases.

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(6) Antibiotic Resistant Healthcare-Associated Infections

Background: Healthcare-associated infections (HAI) are a threat to patient safety. CDC provides national

leadership in surveillance, outbreak investigations, laboratory research, and prevention of healthcare-

associated infections. CDC uses knowledge gained through these activities to detect infections and

develop new strategies to prevent healthcare-associated infections. Healthcare-associated infections

(HAIs) can be found to effect 1 in 25 hospitalized patients on any given day in the United States, leading

to an annual burden of 722,000 infections and 75,000 deaths. Meanwhile, among 18 antibiotic resistant

(AR) organisms identified by CDC in 2013 as urgent, serious, and concerning threats, nearly half are

primarily healthcare-associated. Whereas 1 in 7 HAIs in hospitals overall are caused by AR-threat

bacteria, in some types of hospitals, AR-threat bacteria cause 1 in 4 infections. In all cases, HAIs caused

by AR-threats are more difficult to treat and some are now untreatable. There are three broad, current

strategies that clinicians and nurses need to employ to prevent these AR HAIs: following

recommendations for preventing invasive device and surgical procedure-related infections, preventing

cross-transmission of AR HAI pathogens, and practicing optimal antibiotic stewardship.

Specific Research Area(s) of Interest:

The major research priorities areas for NCEZID are listed below. Investigator initiated applications that

have commercial potential that fall outside these topic areas but fall within the research mission of

NCEZID will also be considered through this Omnibus solicitation. Research to address reducing health

disparities and increasing health equity is strongly encouraged. The goals for the proposed research are

to address antibiotic resistant healthcare-associated infections.

Examples of specific research areas of interest include, but are not limited to:

• Development of novel diagnostics that either: 1) offer a more rapid and definitive diagnosis of

whether a patient does or does not require an antibiotic (alternatively whether it is safe to stop an

antibiotic), or 2) better detect (i.e., earlier, more rapidly, and more accurately) whether a patient is

infected or colonized (and thereby may transmit) with an AR HAI pathogen.

• Novel therapeutics and preventatives based upon preservation or restoration of the human

microbiome.

• Predictive surveillance analytics that harness genomic-scale (public) data for assessing potential

trajectories and forecasting de novo risk analysis of bacterial strains/clonal types for epidemic

spread, hypervirulence, and antibiotic resistance.

Impact: This research will lead to the development of practical and innovative solutions to address the

matrix of complex problems caused by antibiotic resistant healthcare- associated infections.

Commercialization Potential: Successful and novel innovation that will reduce disease, disability, and

death will have huge commercial potential across many markets.

For NCEZID programmatic information, contact:

Amy Yang, PhD

National Center for HIV, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention (CDC)

Phone: 404-718-8836

Email: VDZ9@cdc.gov

For grants specific, administrative information, contact:

Angie Willard, Team Lead

Office of Grant Services Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop TV-2

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2939 Flowers Road NE Atlanta, GA 30341

Phone: 770-498-2596

Email: AEN4@cdc.gov

NATIONAL CENTER FOR ENVIRONMENTAL HEALTH (NCEH)

Mission and Research Areas of Interest

National Center for Environmental Health (NCEH) plans, directs, and coordinates a program to

protect the American people from environmental hazards. We promote a healthy environment

and prevent premature death, avoidable illness, and disability caused by non-infectious, non-

occupational environmental and related factors. We are especially committed to safeguarding the

health of vulnerable populations ― such as children, the elderly, and people with disabilities ―

from certain environmental hazards.

NCEH encourages submission of research applications with innovative research

technologies designed to reduce health disparities and promote health equity.

Please visit the NCEH web site at: https://www.cdc.gov/nceh/.

Description of Research Areas of Interest

The major research priorities areas for NCEH are listed below. Investigator-initiated applications

that have commercial potential that fall outside these topic areas but fall within NCEH’s research

mission will also be considered through this Omnibus solicitation. Research to address emerging

health threats, health disparities, and health equity are strongly encouraged.

(1) Tools or technologies to assess or estimate indoor air quality and health risks

Background: Poor indoor air quality resulting from high levels of dust mite allergen, mold, and

particulate matter less than 2.5 microns (PM2.5) is a well-established risk factor for development

of respiratory diseases, including asthma. Because these agents are microscopic, occupants

often do not know how to decrease exposure. Improved exposure assessment methods are an

important tool in helping individuals decrease their exposure and prevent negative health

outcomes resulting from poor indoor air quality related to these agents.

For this topic, NCEH has a specific interest in tools or technologies to assess indoor air quality

related to particulate matter (PM2.5), allergens (such as those from dust mites), and mold (which

contains allergenic and irritant components) implicated in the development or exacerbation of

asthma; and in tools or technologies to assess building-related health risks that increase

exposure to these agents.

PM2.5: Particulate matter less than 2.5 microns (PM2.5) is also microscopic and associated with

asthma attacks. PM2.5 is generated from smoke associated with cooking, hair dryers, and other

smoke generating devices, including those in an occupational setting, and can accumulate to

levels high enough to trigger asthma attacks without activating a smoke detector. An early

warning system is needed before smoke detector activation. Such an early warning system could

be connected to building systems (e.g., fans/filtration devices) which can turn on automatically to

decrease PM2.5 exposures prior to smoke detector activation to prevent the onset of asthma

attacks. For additional information about indoor air triggers such as dust mites or mold, please

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visit our web site at https://www.cdc.gov/asthma/pdfs/home_assess_checklist_P.pdf .

Dust mites: Exposure to dust mites can result in significant clinical illnesses including rhinitis,

allergic asthma, atopic dermatitis, and conjunctivitis. The disparities in childhood asthma in the

United States are well-known; approximately 16% of black children and 7% of white children have

asthma (CDC Vital Signs). In the U.S., a population-based study found that 15-20% of

participants were allergic to dust mites (Salo et al. 2011). Additional research showed that 25% of

children with asthma have allergies to dust mites (Stevenson et. al., 2001).

Furthermore, dust mite allergic sensitization varies by region, being more prevalent in the

Southeastern U.S. (Salo et al. 2014). Although present in many residences and other buildings,

dust mites are unnoticed because of their microscopic size and translucent bodies, making them

difficult to detect and remove from homes, schools, and businesses.

Mold: In 2009, the World Health Organization concluded that early mold exposure was

associated with the development of asthma in some children, particularly among children who

may be genetically susceptible to asthma development, and that selected interventions that

improve housing conditions can reduce morbidity from asthma and respiratory allergies. Mold

allergy and exposure to mold has been found to be strongly associated with childhood

emergency department visits in inner-city environments (Brosnan, 2013). Mold is also

microscopic. During investigations of possible mold-related disease (e.g., allergy, asthma, and

infections), costly and labor-intensive sampling by trained technicians and analysis in

laboratories can delay action for mold remediation due to the misidentification of “mold -like”

substances which are not mold (e.g. soot, rust, and algae).

Building related risk factors can contribute to poor health outcomes from asthma triggers:

Several well-established housing characteristics are associated with poor indoor air quality. For

example, age of housing, presence of basements, type of housing structure, number of

stories/floors, and presence of crawl spaces have been associated with greater risk of mold

exposure. Although the American Housing Survey is a large population-based survey of the

U.S., it only conducts a sample. Only tax assessor data contains this type of information for each

building across the country. With tax assessor data (not centrally managed but managed by

each county or state), geographic information system (GIS) mapping can be used to overlay

these data with health data to better elucidate the relationships and building- related risk factors

between indoor air quality and adverse health outcomes. NCEH is interested in better

understanding how the gentrification of neighborhoods can modify such relationships between

housing-related factors and adverse health.

Project Goal: The goal for the proposed research is to develop tools or technologies to assess

indoor air quality related to PM2.5, dust mite, or mold exposure, and to develop data-linkage

platforms to identify building-related features that are associated with increased risk for poor indoor

air quality from buildings within the U.S.

Examples of specific research areas of interest include, but are not limited to, the development of an:

Early warning system integrated with building systems (e.g., fans/filtration

devices) to automatically detect smoke related PM2.5 levels prior to smoke

detector activation.

Application to alert individuals that they are in a high-risk dust mite area.

Application that can view mold-like substances on a surface, and determine if the

substance is mold (e.g., using computerized image analysis).

Machine learning capable data-linkage platform that can extract building information

from tax assessor datasets and enable granular assessments of building-related risk

factors from data spanning several years.

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Impact: Asthma resulting from indoor air exposures to allergens and particulate matter is a

significant public health concern, resulting in acute and chronic clinical disease for millions of

Americans.

Innovative technologies to rapidly detect and prevent these exposures would have a beneficial

impact on public health, especially for underserved populations experiencing residential or

occupational housing inequities and at increased risk for exposure to indoor air pollution. The

technologies sought for development have the potential for commercial application across many

markets, including residential and occupational settings, schools, and healthcare facilities.

A building air quality data-linkage platform can enable more granular assessments of building-

related risk factors that decrease indoor air quality and subsequently affect health. More accurate

assessments of building-related risk factors will enable future researchers to better understand

place- based determinants of health impacting asthma and many other poor health outcomes

(e.g., cardiorespiratory disease) resulting from exposures in residential and/or occupational

settings.

Commercialization Potential: Commercial application of this technology could allow state and

local jurisdictions, businesses, and public health practitioners address housing related

environmental justice issues in a focused manner instead of only using broad levels of building

characteristics (e.g., multi-family homes vs. single-family homes).

For NCEH programmatic information, contact:

Tonia Linley

Program Specialist

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention CDC

Phone: 770-488-3593

Email: IMX9@cdc.gov or NCIPC_ERPO@cdc.gov

For grants specific, administrative information, contact:

Brownie Anderson-Rana

Office of Grant Services Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop K-75

2920 Brandywine Rd.

Atlanta, GA 30341

Phone: 770-488-2771

Email: BAndersonRana@cdc.gov

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD, AND TB PREVENTION

(NCHHSTP)

Mission and Research Areas of Interest

NCHHSTP is committed to our vision of a future free of HIV/AIDS, viral hepatitis, STDs, and TB.

We are responsible for public health surveillance, prevention research, and programs to prevent

and control HIV and AIDS, other STDs, viral hepatitis, and TB. NCHHSTP’s Strategic Plan

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articulates a vision, guiding principle, and overarching goals and strategies to influence and

enhance our programs. The three overarching goals highlighted in this plan are to decrease:

•

incidence of infection,

•

morbidity and mortality, and

•

health disparities.

Every year, millions of Americans are infected with HIV, viral hepatitis, STDs, or TB, and tens of

thousands die from their infection. Most of these infections share commonalities, from modes of

transmission to demographic, social, and economic conditions that increase risk. As a prevention

leader, NCHHSTP focuses on high impact prevention and control efforts to reduce incidence,

morbidity, mortality, and health disparities due to these infections.

Please visit the NCHHSTP website at: http://www.cdc.gov/nchhstp/.

Description of Research Areas of Interest

(1) Improved Diagnostic Tests for HIV, STDs, Hepatitis, and TB

Background: For many individuals infected with HIV, Hepatitis C, STDs and TB, they do not

receive timely diagnosis due to stigma associated with these infections. Improving diagnostic

technology and offering alternatives that can be done at the point of care or self -testing has the

potential to decrease morbidity and transmission. For individuals that are at risk and uninfected, it

allows them to focus on prevention. For those that are infected, treatment can be started earlier.

Furthermore, since many of the infections share common routes of transmission or have high rates

of infections in specific populations, there is the potential for overlapping infections also known as

syndemics.

Whereas there is tremendous value in testing and diagnosis for each of the described diseases,

some at risk individuals are never tested or do not receive their tests results and often times are

only tested for one of the diseases when testing for a combination of the diseases would be more

beneficial both for the individual and for public health. Prognostic tests (e.g., viral load, drug

resistance monitoring) also play an important role in improving health outcomes for infected

individuals.

Specific Research Areas of Interest: The major research priorities areas for NCHHSTP are

listed below. Investigator initiated applications that have commercial potential that fall outside

these topic areas but fall within the research mission of NCHHSTP will also be considered through

this Omnibus solicitation. Research to address reducing health disparities and increasing health

equity is strongly encouraged.

The major goal of the project is development of diagnostic reagents, tests or testing platforms, that will

further improve diagnosis or monitoring of HIV hepatitis C, syphilis, gonorrhea or TB. The specific area of

interest is innovative approaches or novel technology that would allow for easier screening for or

diagnosis of HIV hepatitis C, syphilis, gonorrhea or TB alone or in any combination using a single test

device or platform.

Examples of specific research areas of interest include, but are not limited to: The preferred test

format or technology would facilitate testing that allows for rapid results (preferably less than one hour), is

affordable (comparable to currently available tests) and can be performed at the point of care or by an

individual (self-test). Tests that include an option for self-collection for submission to a laboratory are also

desired. Likewise, the ability to combine detection and markers for drug resistance gonorrhea, and TB

specifically) is highly desired as it would allow for better treatment outcomes and reduce the spread of

drug resistant pathogens.

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Impact: It is known that early diagnosis and treatment of HIV infection can improve health

outcomes for individuals infected with HIV. Furthermore, such testing has the potential for

decreasing transmission of HIV. Likewise, improved diagnosis of HCV can lead to c urative

treatment. For syphilis, improved diagnostic tools have the potential to decrease congenital syphilis

and promote timely treatment to prevent spread to sexual partners. Improved TB and gonorrhea

testing that includes easy detection of drug resistance is important to prevent the spread of drug

resistant strains and improve treatment. Improving diagnosis of all of these pathogens has a

potential for a significant decrease in morbidity. Faster turnaround times, lower cost, and more

efficient detection would be highly impactful for these individuals, their partners and the

community.

Commercialization Potential: Diagnostic reagents, tests or testing platforms, that will further

improve diagnosis or monitoring of HIV, hepatitis C, syphilis, gonorrhea or TB, would be in great

demand by the healthcare and public health systems as well as other sectors engaged in using

diagnostics to treat or prevent transmission in impacted populations.

For NCHHSTP programmatic information, contact:

Amy Yang, PhD

Extramural Research Program Office

Office of the Associate Director for Science

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention (CDC)

Phone: 404-718-8836

Email: VDZ9@cdc.gov

For grants specific, administrative information, contact:

Angie Willard, Team Lead

Office of Grant Services Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop TV-2

2939 Flowers Road NE Atlanta, GA 30341

Phone: 770-498-2596

Email: AEN4@cdc.gov

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

(NCIRD)

Mission and Research Areas of Interest

The mission of the National Center for Immunization and Respiratory Diseases (NCIRD) is the prevention

of disease, disability, and death through immunization and by control of respiratory and related diseases.

NCIRD balances its efforts in the domestic and global arenas as well as accommodates the specific

needs of all populations at risk of vaccine preventable diseases from children to older adults. Research to

address reducing health disparities and increasing health equity is strongly encouraged.

Please visit the NCIRD website at: http://www.cdc.gov/ncird/.

Description of Research Areas of Interest

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(1)

Prevention and Diagnosis of Acute Respiratory Infections in the US and Globally

Background: Acute respiratory infections kill an estimated 3.9 million people annually

and in developing countries are the leading cause of mortality in children under 5 years

of age. Specific respiratory virus infections such as influenza, SARS-CoV-2, and

respiratory syncytial virus, are major contributors to this burden of disease, as are

other respiratory bacterial and viral pathogens. Respiratory virus infections are

frequent events in all age groups and impose a substantial burden on social and

healthcare delivery systems.

Specific Research Areas of Interest: The goal of this research includes, but is not limited to,

activities that support the development and evaluation of tools for: 1) the prevention of acute

respiratory infections such as pneumonia, influenza, COVID-19, and Legionnaire’s disease, 2) rapid

recognition and containment of outbreaks, and 3) advanced diagnostic technologies including point-

of-care testing, advanced molecular detection, and whole genome sequencing.

Impact: This research will lead to the development of practical solutions for the prevention and

diagnosis of vaccine preventable diseases that have a substantial impact on the economy, health,

and wellbeing of society. The goal of the research supported through this mechanism is expected to

begin shifting viral and bacterial infections from common occurrences to rare events and to reduce

the disproportionate burden of COVID-19 on populations at increased risk for infection, severe

illness, and death.

Commercialization Potential: The innovative technologies and solutions developed through this

program will make it possible to improve the public health and healthcare system’s response in a

variety of settings, thus making the commercialization potential unlimited.

For NCIRD programmatic information, contact:

Amy Yang, PhD

Extramural Research Program Office

Office of the Associate Director for Science

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention (CDC)

Phone: 404-718-8836

Email: VDZ9@cdc.gov

For grants specific, administrative information,

contact:

Angie Willard, Team Lead

Office of Grant Services Office of Financial

Resources Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop TV-2

2939 Flowers

Road NE Atlanta,

GA 30341

Phone: 770-498-2596

Email: AEN4@cdc.gov

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NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL (NCIPC)

Mission and Research Areas of Interest

For 30 years, CDC’s National Center for Injury Prevention and Control (NCIPC) has helped protect

Americans from injuries and violence. We are the nation’s leading authority on injury and violence.

We study violence and injuries and research the best ways to prevent them, applying science and

creating real-world solutions to keep people safe, healthy, and productive. NCIPC will prioritize

funding meritorious applications that address the NCIPC program topics listed in this program

announcement. NCIPC may also consider meritorious applications that address current NCIPC

research priorities.

To learn more about NCIPC, please visit the NCIPC website at: http://www.cdc.gov/injury/index.html.

Description of Research Areas of Interest

NCIPC encourages submission of research applications with innovative research technologies

designed to reduce health disparities and promote health equity.

The major research priorities areas for the NCIPC are listed below. Investigator initiated applications

that have commercial potential that are outside these topic areas but within the research mission of

NCIPC will also be considered through this solicitation. Research to address emerging health

threats, health disparities, and health equity are strongly encouraged.

To learn more about NCIPC research priorities, please visit our web site at:

https://www.cdc.gov/injury/researchpriorities/index.html.

(1)

Prevention and Management, and Recovery of Traumatic Brain Injury

Background: There were nearly 70,000 traumatic brain injury (TBI)-related deaths in 2021 and more

than 200,000 TBI-related hospitalizations. TBIs affect how the brain works and can range from mild

concussions to serious and debilitating injuries with long-term effects. They are caused by a bump, blow,

or jolt to the head or a penetrating injury (e.g., a gunshot) and are often the result of falls, firearms, motor

vehicle crashes, or assaults. While TBIs affect individuals of all ages, research suggests that some

individuals may be at greater risk for experiencing a TBI and more severe consequences of a TBI.

Individuals at higher risk often include racial and ethnic minorities, service members, people living in rural

communities, and survivors of intimate partner violence, among others.

The trajectory of recovery from a TBI is influenced by multiple factors, including the overall severity of the

injury, number of prior TBIs, and receiving an appropriate diagnosis, referrals, and tailored care.

Individuals are generally eager to return to prior activities following a TBI. However, there can be

considerable complexity in decision-making around when to return to school, work, physical activity,

driving, or other daily tasks. Careful monitoring and tracking of symptoms can help inform this dec ision-

making, as well as having access to easy-to-use evidence-based resources and supports to guide one’s

recovery path. Additionally, due to symptoms experienced and uncertainty around recovery timeline, TBI

recovery can be particularly challenging from not only a physical health perspective but also a social,

emotional, and mental health perspective (e.g., anxiety, sadness). Therefore, ensuring that strong, active

support networks exist for individuals with TBIs is a critical component of the recovery process.

Project Goal: CDC is interested in research to develop technology that can assist persons with a TBI in

better assessing when they can return to normal activities, including school, work, physical activity,

driving, and/or other daily activities. The technology can help improve understanding and confidence

among individuals with a TBI in tracking their path to recovery, as well as preventing future TBI.

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The technology could aid those who have experienced a TBI by helping them better understand what to

expect, track their symptoms throughout their recovery to help inform decision-making around returning to

activities, access recommendations each step of the way to guide them towards recovery and

reintegration in activities, and access support networks or linkage to support networks to help manage

social, emotional, and mental health during recovery. Knowledge of what to track and look for at each

step of the recovery process, support tips and information to help guide individuals (including

consideration of when to transition from rest to light, moderate, or full activity, how to handle recovery

delays, and when to seek additional healthcare), and connections to active supports and communities to

ensure care of not only physical but also social and emotional health during the recovery period are

critical needs. The technology can also help prevent future, repeated TBI by providing individuals with

information and tools centered around TBI risks and effective prevention approaches.

Given disparities in TBI, the technology should consider tailoring and framing to populations at highest

risk. These populations could include, but are not limited to, military service members and veterans, racial

and ethnic minorities, people living in rural communities, survivors of intimate partner violence, and

people of lower incomes and without access to healthcare.

For Phase I, the awardee is expected to develop, and beta test new technology designed to support

individuals on their road to recovery from a TBI. The technology should be intuitive and easy to use.

Impact and Commercialization Potential: The availability of technology that can ease one’s road to

recovery from a TBI can help improve recovery timelines and improve quality of life and social, emotional,

and mental health. Such technology can also help individuals better understand, track, manage, and

recover from their symptoms and reintegrate into normal activities, including school, work, physical

activity, driving, and other daily activities. Additionally, the availability of technology could assist in

reducing health disparities among vulnerable populations who tend to have worse health outcomes (a

greater likelihood of dying from a TBI or living with long-term problems that resulted from the injury).

Development of this technology has commercial viability. Commercial applications of this technology may

be of interest to adolescents, adults, caregivers, healthcare providers, health insurance companies, and

youth sports personnel, among others.

(2)

Technological Innovations to Reduce Deaths and Injuries from Motor Vehicle Crashes

Background: Motor vehicle crashes are a leading cause of death among those aged 1-54 years in

the United States, killing over 40,000 people every year and injuring 3 million more. Motor vehicle

crashes can result from a single or combination of environmental, human behavioral, and vehicle-

related risk factors including hazardous road conditions, driving too fast for the environment, driver

perception deficits, non-compliance with vehicle safety devices, impaired driving, lack of seat belt

use, lack of helmet use, distracted or drowsy driving, and sub-optimal vehicle performance.

Reducing any of these risk factors can lower the likelihood of a crash and increase the chance of

survival in the event of a crash.

Adaptive technologies can generate feedback loops about the road and environment, driver fitness,

and vehicle performance. Applications of these adaptive technologies in both private and commercial

vehicles can reduce risks associated with motor vehicle crashes. Currently, there are a limited

number of adaptive technologies to warn drivers of potential dangers associated with driving; most of

these technologies focus on vehicle related performance (e.g., collision warning, electronic stability

control, and lane departure warning). Innovative adaptive technologies are sought that can assist in

alerting drivers to risks associated with the road or environment and vehicle performance, and that

can facilitate drivers to modify personal risk behavior, including impaired or drowsy driving. These

adaptive technologies can result in the development of tools or systems that will reduce the

likelihood and severity of motor vehicle crashes and assist drivers in making potentially life-saving

decisions more quickly and more intuitively.

Project Goal: CDC is interested in research to address the development of improved

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technologies that have the potential to further reduce motor vehicle crashes and resulting

injuries to all road users.

These technologies can address driver risks such as excessive speed, distracted driving,

impaired driving, drowsy driving, non-compliance with use of vehicle safety equipment (e.g., seat

belts), environmental conditions (including road quality), vehicle performance and other factors

that may impact driving. Technologies could also address risks to individuals walking, biking,

riding, or rolling, such as crowdsourcing information on unsafe infrastructure (e.g., sidewalk gaps,

unsafe walking surfaces and compliance with the Americans with Disabilities Act). For Phase I,

the awardee is expected to develop and pilot test new technology designed to reduce motor

vehicle crashes and resulting injuries. Testing could also consider and explore acceptability of the

technology to road users.

Impact and Commercialization Potential: The availability of technologies to reduce motor vehicle

crashes and resulting injuries can save lives. Technologies that reduce motor vehicle crashes and

resulting injuries can help improve health equity and reduce injury disparities among vulnerable road

users. Development of these technologies has commercial viability. Commercial applications of this

technology might be of interest to motor vehicle manufacturers, insurance companies, clinicians, health

systems, departments of transportation, parents of young drivers, and all road users.

(3)

Electronic Tools to Assist Older Adults at Risk for Falls

Background: Unintentional falls are the leading cause of fatal and nonfatal injuries in older

adults aged 65 years and older. Falls result in 3 million emergency department visits and more

than 900,000 hospitalizations each year. About 38,000 older adult deaths occur each year

because of a fall. This risk of falls and their consequences is not equally distributed across the

population. Research indicates that fall risk is highest among adults of older ages (e.g., 80+),

American Indian/Alaska Native and White non-Hispanic populations, individuals with numerous

chronic health conditions (e.g., depression, diabetes, cardiovascular disease, stroke), and those

with neurological disorders (e.g., dementia, Parkinson’s disease). Falls often lead to reduced

mobility and loss of independence; therefore, reducing fall risk is conducive to maintaining

independence.

An example of a resource for information about falls prevention is CDC’s Stopping Elderly

Accidents, Deaths, and Injuries (STEADI) initiative. CDC developed the STEADI initiative based

on the American and British Geriatric Societies Guideline for the Prevention of Falls in Older

Persons to provide training, resources, and tools for healthcare providers to use to incorporate

older adult fall prevention into routine clinical care. STEADI has three core components –

SCREEN older adults at least annually to determine who is at risk for a fall, ASSESS those at

risk to determine their modifiable risk factors, and INTERVENE by recommending evidence-

based strategies for each identified risk factor. Modifiable risk factors (and associated strategies

to address them) include strength and balance limitations (physical therapy); medications with

side effects that increase risk (medication management); vision problems (vision exam), foot

problems (podiatrist exam), orthostatic blood pressure (medication management or referral to a

specialist); home hazards (home assessment with an occupational therapist), and comorbidities

(medication management or referral to a specialist).

A fourth potential core component is patient FOLLOW-UP. Older adults are more likely to follow

these recommendations with continuous follow up from their healthcare provider and when

receiving reminders and continuous ongoing support (e.g., from their network of support persons

and/or caregivers). Older adults are also more likely to follow recommended fall prevention

activities when the activities are affordable and easily accessible. Finally, recommendations

utilizing a positive framing regarding preserving mobility and thriving as we age can be

particularly effective (e.g., CDC’s “Still Going Strong” campaign). Technologies targeted at older

adult healthcare providers, as well as older adults and their families, caregivers, and support

persons may help facilitate long-term uptake of interventions and strategies to prevent falls and

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maintain mobility within a positive framing.

Project Goal: CDC is interested in research to develop technology that will help healthcare providers

incorporate STEADI-based fall prevention into their clinical practice and/or support older adults and

their families, caregivers, or support persons in understanding and supporting active implementation

of recommended strategies to reduce older adults’ fall risk, maintain mobility, and support healthy

aging.

One way this can be accomplished is through technology that incorporates elements of an evidence-

based program, such as those described in CDC’s STEADI tools and resources and inspired by a

positive, optimal mobility approach such as those used in CDC’s Still Going Strong campaign or

CDC’s MyMobility Plan tools. For example, the technology could support healthcare providers’ use of

the STEADI algorithm that guides them through the three core components.

Alternatively, the technology could integrate STEADI, Still Going Strong, MyMobility Plan, or other

patient education materials and resources to educate older adults and their families, caregivers, and

support persons about falls and how to prevent them, maintaining strength and health as one ages,

and adhering to fall prevention recommendations.

Given disparities in falls risk, the technology should consider tailoring and framing to populations at

highest risk, as noted above. For Phase I, the awardee is expected develop and beta test the

technology. The technology should incorporate applicable healthcare information privacy regulations,

be intuitive and easy to use by the target audience, and include an interface designed with the target

audience in mind.

Impact and Commercialization Potential: The availability of a technological tool to assist clinicians or

older adults, their families, and support persons in preventing falls and maintaining mobility can help

ensure that healthcare provider recommendations and evidence-based strategies are followed. By

facilitating fidelity to recommendations and improving communication about fall risk, healthy aging, and

prevention between older adults, families, and providers the expected public health benefit is a reduction

in older adult falls and increased support for healthy aging.

Development of a technological tool that reduces risk for older adult falls has commercial viability.

Commercial applications of this technology may be of interest to older adults and their families,

healthcare providers, community support staff, health insurance companies, and other stakeholders

invested in preventing older adult falls and supporting healthy aging.

(4)

Innovative Technologies to Help Prevent Drug Overdose

Background: The national drug overdose crisis continues to evolve in the United States, causing

increasing numbers of deaths and warranting innovative interventions. In 2022, over 107,000

people died from drug overdoses and 76% of those deaths involved opioids. Over 26% of

overdose deaths in 2022 involved cocaine, and almost one-third (32%) involved psychostimulants

with abuse potential (e.g., methamphetamine). Further, recent data suggest that overdoses

involving multiple substances are increasing. Given the evolving nature of the overdose crisis,

there is a need for innovative technological approaches to support the prevention of drug

overdose. These technologies can focus on: 1) using data to inform action (i.e., linking various

data platforms, including those that monitor and track nonfatal or fatal drug overdoses or

emerging drug threats to inform overdose prevention and response efforts; 2) developing or

implementing digital interventions to deliver drug overdose prevention); 3) helping people in need

of substance use treatment or harm reduction services identify and access services; and 4)

developing and implementing applications or platforms to monitor the provision of care and harm

reduction services or materials or track usage and/or outcomes.

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Innovative solutions are needed to support new opportunities to effectively leverage technology

and data systems to improve drug overdose prevention and response efforts, link and retain

people who use drugs to care and harm reduction services and monitor the provision of harm

reduction services or materials and track usage and outcomes of these services. To support

these objectives, we are soliciting proposals to create innovative and user-friendly, electronic

tools, applications, or technologies that address at least one of the following prevention activities:

Using data to inform action: Aggregate and synthesize information from

various data sources that track nonfatal or fatal drug overdoses or document

emerging drug threats (e.g., toxicology or drug seizure data) to inform and

implement overdose prevention and response efforts (e.g., using data to

identify geographical “hotspots” that can benefit from naloxone distribution,

fentanyl test strips, or overdose prevention campaigns).

Develop or implement digital drug overdose prevention: Digitally deliver

overdose prevention materials (e.g., information on how to recognize signs and

symptoms of drug overdose, how to respond to a suspected drug overdose,

where to obtain naloxone) using innovative technology.

Helping people in need of substance use treatment or harm reduction services

identify and access services: Develop or implement a mechanism for people

who use drugs (PWUD) and their family or friends to identify and access local

substance use disorder (SUD) treatment or harm reduction support services.

This could include developing an application or tool to help identify providers

based on geography or services provided or help identify and remedy barriers

to accessing services (e.g., transportation, childcare services, etc.).

Developing and implementing applications or platforms to monitor the provision

of care and harm reduction services or materials or to track usage and/or

outcomes: To better monitor the provision of care and harm reduction services

or materials to clients, develop an innovative solution to monitor metrics on

service delivery and uptake or to track usage and/or outcomes (e.g., linkage

and retention or use of services).

References:

Spencer MR, Garnett MF, Miniño AM. Drug overdose deaths in the United States,

2002–2022. NCHS data brief, no 491. Hyattsville, MD: National Center for Health

Statistics. 2024.

Specific Area of Interest/Project Goal(s): CDC is interested in research that aims to develop innovative

technologies that will leverage data to inform overdose prevention, develop or implement digital overdose

prevention materials, link people who use substances to effective substance use treatment or harm reduction

services, and develop and implement strategies to monitor the provision of care and harm reduction services

and track usage and/or outcomes of these services. The technology should use information relevant in local

communities. For example, the technology could tailor available services options including by location and

current capacity and automate referral processes to local services to provide PWUD a seamless process for

finding, contacting, and accessing services. Other examples include incorporating current characteristics of

the local epidemic into linkage messaging or a menu of locally available recovery support services such as

transportation, employment services, or housing support. Tracking usage and/or outcomes could help

enhance the technology over time by compiling data regarding most used services, gaps in available

services, reason services are sought, and outcomes of specific services.

The technology should reflect feasibility and acceptability for the population it is intended to serve: PWUD.

Therefore, the technology should be accessible for PWUD in the local area.

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The expected research outcome is the development of technology that will ultimately better track and

respond to overdoses. Projects will help tailor and deliver prevention and response efforts, connect PWUD to

locally available SUD treatment, harm reduction, and recovery support services, or help service providers

(e.g., SUD treatment providers or harm reduction services) monitor the provision or uptake or services or

track usage and/or outcomes (e.g., linkage and retention in care).

For Phase I awards, the recipient is expected to develop and beta test the new technology(ies) with the

relevant population (e.g., PWUD and at least one type of local service: SUD treatment, hard reduction

services, recovery support services). Recipients must attend to appropriate protections related to

confidentiality, personally identifiable information, health information, and SUD privacy regulations

associated with these technologies, such as those that apply to sharing protected heath data across systems

or any stigma associated with using the technology. The technology must be intuitive and easy to use.

Impact: The availability of technological tools to assist those at risk for drug overdose within

communities can help better implement effective overdose prevention and response, and ensure

that needed referrals, services, and follow-up care are received and that linkages are made in a

timely manner to effectively prevent immediate risks. By improving access to medical and non-

medical support services and near real-time data, the expected public health benefit is reduced

potential for drug overdose, and increased linkage to SUD treatment, harm reduction services, and

recovery support services that can reduce the risk of drug overdose, and a more accurate

understanding of services delivered.

Some populations, communities, and geographic areas are disproportionately impacted by

overdose and can be considered for tailored programs and interventions based on associated risk

for overdose or disparities in access to harm reduction services and SUD treatment. Further,

having a SUD is a chronic health condition, yet individuals with SUD face barriers to accessing the

care they need due to stigma and other factors. Moreover, PWUD may be more likely to have

intersecting characteristics (e.g., experiencing homelessness, being involved in the justice system)

that may be associated with poor health outcomes (such as overdose death), either by having an

increased likelihood of drug use or a reduced likelihood of receiving care if they develop an SUD.

Such characteristics may also impact accessibility to some technologies, and solutions must

incorporate meeting PWUD where they are to have the most reach. The proposed technologies

have the potential to reduce barriers to receiving overdose prevention and care among people who

use drugs, including those who have a SUD, thereby reducing health disparities among this

important population. Research suggests that some populations may have a greater risk for

experiencing disproportionate burden of drug overdose or experiencing adverse outcomes related

to drug use due to social determinants of health, indicating a potential opportunity to intervene and

support such populations. The development of innovative technologies for overdose prevention or

to support linkage to care among PWUD who experience a disproportionate burden of overdose or

experience adverse outcomes related to drug use can help prevent drug overdose and

simultaneously improve health equity.

The availability of technological tools to assist those at risk for drug overdose and those working to

prevent and respond to overdose within communities can better ensure that needed referrals,

services, and follow-up care are received and that information is shared in a timely manner to

effectively prevent immediate risks. By improving access to medical and non-medical support

services and near real-time data, the expected public health benefit is increased linkage to support

services, harm reduction services, and/or data and resources that can reduce the risk of drug

overdose.

Some populations, communities, and geographic areas are disproportionately impacted by overdose

and can be considered for tailored programs and interventions based on associated risk for

overdose or disparities in access to harm reduction services and substance use treatment. Further,

having a substance use disorder (SUD) is a chronic health condition, yet individuals with SUD face

barriers to accessing the care they need due to stigma and other factors. Moreover, PWUD may be

more likely to have intersecting characteristics (e.g., experiencing homelessness, being involved in

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CDC 187

the justice system) that may be associated with poor health outcomes (such as overdose death),

either by having an increased likelihood of drug use or a reduced likelihood of receiving care if they

develop an SUD.

The proposed technologies have the potential to reduce barriers to receiving care among people

who use drugs, including those who have a SUD, thereby reducing health disparities among this

important population. The development of innovative technologies to support linkage to care among

PWUD and population subsets of PWUD (e.g., persons who have previously experienced an

overdose; persons experiencing homelessness; justice-involved populations recently released from

incarceration; those disadvantaged by economic instability, limited education attainment, access,

and quality, and/or limited health care access and quality), can help prevent drug overdose and

simultaneously improve health equity.

Commercialization Potential: Commercial applications include technological tools developed, for

example to link people at risk for drug overdose to treatment or other services. Tools to create

connections and opportunities for data and resource sharing between PWUD and relevant services

also have commercial viability. Commercial applications of this technology may be of interest to those

at risk for overdose and their families, community support programs and staff, health insurance

companies, SUD treatment providers, harm reduction providers and other stakeholders invested in

preventing drug overdose.

(5)

Innovative Technology or Media to Prevent Violence Affecting Children/Youth

Background: Violence is a significant public health problem in the United States. In 2021, more

than 26,000 people died from homicide. Far more people experienced nonfatal violence. For

example, more than 1.4 million people were treated for nonfatal injuries from assaults in U.S.

emergency departments in 2021. Experiencing violence has a profound impact on lifelong health,

opportunity, and well-being. Violence starts early in life. In 2021, there were an estimated 4.0 million

referrals to child protective services for child abuse or neglect involving an estimated 7.2 million

children. In addition to child abuse and neglect, other forms of violence impacting children and youth,

include sexual violence, teen dating violence, youth peer violence, youth/parent suicidal behavior,

and exposure to adult intimate partner violence.

Adverse Childhood Experiences (ACEs) are potentially traumatic events that occur in childhood (0-

17 years). ACEs include experiencing violence, abuse, or neglect; witnessing violence in the home

or community; or having a family member attempt or die by suicide. Also included are aspects of the

child’s environment that can undermine their sense of safety, stability, and bonding such as growing

up in a household with substance use, mental health problems, or instability due to parental

separation or household members being in jail or prison. Common risk factors for ACEs and violence

can also start in early childhood and continue throughout the lifespan. They go beyond individual-

level factors to include family and peer relationships and other influences from schools, the

community, and society. Social determinants of health are the circumstances in which people are

born, grow up, live, work and age, and the systems put in place to deal with illness. These

circumstances are in turn shaped by a wider set of forces: economics, social policies, and politics

(see https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1). Social

determinants of health (e.g., concentrated poverty, structural racism, high rates of unemployment

and community violence, limited access to high-quality education and/or limited access to affordable,

high-quality childcare) are key drivers of health inequities among communities of color and place

them at a greater risk for experiencing violence.

The focus of CDC’s violence prevention work includes the following principles: 1. Advancing

economic, gender, and racial equity, 2. Enhancing positive relationships and environments, 3.

Addressing factors that cut across multiple forms of violence, and 4. Prioritizing efforts that

create societal- and community-level impact.

By focusing on activities that prevent multiple forms of violence, communities can achieve the greatest

impact and increase scalability of their prevention strategies. Additionally, these prevention efforts are ideally

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designed to use resources more effectively and to better address inequities by focusing on the needs of

populations at greatest risk. To help communities make decisions about violence prevention strategies, CDC

has released a series of Resources for Action documents that describe the best available evidence for

violence prevention (see https://www.cdc.gov/violenceprevention/communicationresources/pub/resource-for-

action.html). Many of the strategies in the Resources for Action documents are relevant to multiple forms of

violence, including multiple ACEs (see https://www.cdc.gov/violenceprevention/pdf/ACEs-Prevention-

Resource_508.pdf for strategies drawn from the Resources for Action documents that are relevant to

ACEs).

Broader benefits could be achieved from wider dissemination of effective violence prevention

strategies through innovative media and communication technology (e.g., mobile applications, social

media, games, and Internet-based interventions). Media and communication technology also create

the opportunity for the development of new prevention approaches based on what is known about

violence risk and protective factors and strategies that work in traditional settings. Innovative media

and communication technology can play an important role in effectively reaching populations at

greatest risk and potentially facilitate changes at multiple levels (individual, relationship, community);

however, research is needed to guide the development of technological applications for prevention

strategies.

Project Goal: CDC is interested in research to develop innovative technology or media, such as

applications for mobile devices, social media, games, or Internet-based interventions to prevent

multiple forms of interpersonal violence (e.g., child abuse and neglect, youth violence, sexual

violence, and intimate partner violence) and other ACEs affecting children or youth, particularly

among groups or communities that that are disproportionately impacted by multiple forms of

violence and poor social determinants of health (see

https://www.cdc.gov/injury/researchpriorities/index.html).

This includes, but is not limited to, new media and communication technology to do the following:

increase the accessibility of prevention approaches, modify norms about violence and bystander

behavior, enhance education and support for young children and their families, reduce stigma

and barriers to help seeking, and/or enhance young people’s skills and relationships to reduce

risk for multiple forms of violence. Additionally, CDC is interested in new media and

communication technology that could increase the adoption of community-level violence

prevention strategies and strategies that improve social determinants of health in communities

disproportionately affected by violence (e.g., housing stability, food security, education and

employment opportunities, access to quality and affordable healthcare, etc.).

The widespread use of smartphone applications, social media, and wearable technology also

provides unique opportunities for the broader dissemination, implementation, and evaluation of

evidence-base prevention strategies to significantly reduce violence, such as strategies identified in

the violence prevention technical packages used in real world settings. Applicants are encouraged

to develop technology or media that could help address poor social determinants of health that

contribute to inequities in rates of violence experienced by racial/ethnic and other groups or

communities that are disproportionately impacted by multiple forms of violence, ACEs, and/or

associated risk factors.

The prototype (e.g., developing innovative technology or media) should be informed by prior

research about violence risk and protective factors and/or evidence-based prevention strategies

and through consultation with subject matter experts in the form(s) of violence and the technology

or media selected. The awardee should describe the following: the intended audience and the

type(s) of violence addressed; goals for the product at the individual, family/relationship and/or

community level(s); the process through which the technology or media is expected to work and

the measurements and key performance indicators for tracking progress toward the goals; the

expected impacts on violence and violence-related inequities; the functionality and actions for

users to take; the estimated costs and logistics of scalability; a description of potential barriers to

implementation; and any evidence for the potential benef its from prior research.

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Impact: The results from this research will have substantial implications for either the creation of

innovative prevention approaches or for enhanced opportunities to disseminate existing

evidence- based strategies, both of which have the potential to leverage technology to improve

social determinants of health, increase health equity, and substantially reduce multiple forms of

violence (e.g., child abuse and neglect, youth violence, sexual violence, and intimate partner

violence) and other ACEs. Technological or media innovations that show effectiveness in

preventing violence affecting children and youth and communities and groups disproportionately

impacted by violence would have the potential for a range of commercial applications.

Commercialization Potential: Depending on the nature of the strategy, the intended audience, and

the costs/logistics of scalability, the product could be in demand by healthcare systems, school

systems, colleges and universities, youth serving organizations, law enforcement, public health

agencies, community groups and organizations, parents, and their children.

Visit the NCIPC homepage for more information on NCIPC’s research program areas at

http://www.cdc.gov/injury/index.html.

For NCIPC programmatic information, contact:

Tonia Linley

Program Specialist

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention CDC

Phone: 770-488-3593

Email: IMX9@cdc.gov or NCIPC_ERPO@cdc.gov

For grants specific, administrative information contact:

Angie Willard, Team Lead

Office of Grant Services

Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC)

Mail Stop TV-2

2939 Flowers Road NE Atlanta, GA 30341

Phone: 770-498-2596

Email: AEN4@cdc.gov

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

Mission and Research Areas of Interest

The National Institute for Occupational Safety and Health (NIOSH) is part of the U.S. Centers for

Disease Control and Prevention (CDC). It has the mandate to assure “every man and woman in the

Nation safe and healthful working conditions and to preserve our human resources.” NIOSH has more

than 1,500 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial

hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering.

NIOSH works closely with the Occupational Safety and Health Administration (OSHA) and the Mine

Safety and Health Administration in the U.S. Department of Labor to protect American workers.[=

For additional information about NIOSH, please visit their web site at:

http://www.cdc.gov/niosh/programs. The major research priority areas for NIOSH are listed below.

NIH, CDC, and FDA Program Descriptions and Research Topics

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Investigator initiated applications that have commercial potential that fall outside these topic areas but

fall within the research mission of the NIOSH will also be considered through this Omnibus solicitation.

Research to address emerging health threats, health disparities, and health equity are strongly

encouraged.

NIOSH typically supports Phase I awards at the maximum allowable total cost as stated in the funding

announcement. However, in most cases Phase II applications are limited to a maximum total cost of

$1M for the two-year period of performance.

(1)

Control Technology and Personal Protective Equipment for High-Risk Occupations

Background: Personal protective equipment (PPE) protects workers from death and disabling

injuries and illnesses as well as from the specific threats of exposures to certain airborne biological

particles, chemical agents, nanomaterials, splashes, noise exposures, fall hazards, head hazards,

and fires. It is estimated that 20 million workers use PPE on a regular basis to protect them from job

hazards and a total of 135,000 workers potentially could benefit from the use of PPE (Worker Health

Chartbook 2004).

Engineering controls include substitution of a safe material for a hazardous one, design changes

to equipment, or modification of work methods to eliminate or reduce hazards. Research is needed

to develop and evaluate control strategies and personal protective equipment for specific hazards

and to assure their practicality and usability in workplaces in all of the high-risk industrial sectors.

For additional information about NIOSH PPE and Engineering control programs, please visit

their web site at: http://www.cdc.gov/niosh/programs/ppt/ and

http://www.cdc.gov/niosh/programs/eng/.

Examples of specific research areas of interest include, but are not limited to:

Conduct research on the ability of existing containment and control strategies to prevent releases and

potential human exposures to engineered nanomaterials.

Develop innovative engineering control approaches and technologies for reducing respirable

crystalline silica exposures for workers involved in manufacturing, finishing, and installing natural and

engineered stone countertops.

Research should be conducted to reproduce the original human performance data using modern

advanced technology and a pool of subjects that represents the current American workforce.

Additionally, the scope of the subject pool can be expanded to encompass all workers. The

generated data would be used to confirm or adjust the parameters used for respirator approval

testing, as well as aid in the development of respirator standards used for all workers including

younger (children) workers in high risk occupations.

Conduct research to evaluate the effectiveness of personal protective equipment in protecting

workers against exposure to engineered nanomaterials. Provide data to fill knowledge gaps and

support guidance for the selection and use of gloves and protective garments to prevent exposures.

Respiratory protection research needs to be extended to a broad range of engineered nanomaterials.

Develop a heads-up display coupled with a personal noise exposure monitoring system. Personal

noise alert “badges” and personal noise dosimeters exist, but do not have an effective way to alert

the user immediately when a noise hazard occurs. A system that displays a warning within the user’s

visual field (via lights on protective eyewear, hardhat, etc.) would facilitate hazard recognition.

Develop an inexpensive hand-held earplug test device based on the NIOSH QuickFit concept.

Studies of hearing protector users have shown repeatedly that average protection values are much

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lower than the labeled Noise Reduction Ratings (NRR) determined in laboratories. A QuickFit test

system would help workers determine if their hearing protection is giving them at least 15 decibels of

attenuation.

Develop innovative engineering control approaches and technologies for reducing asphalt exposures

in roofing, and skin exposures and disease in construction workers.

Conduct research to understand PPE integration and interoperability issues. In most cases, individual

PPE are currently used without consideration for their ability to function together. Research is needed

to test interfaces among different PPE and components. Current interfaces do not provide seamless

integration of PPE components resulting in reduced comfort, fit, usability, and protection for the

wearer as well as logistical challenges for safety managers and employers.

Develop innovative educational and professional training materials suitable for today’s diverse

workplace on the role of PPE in occupational safety and health. This is especially critical for high-risk

occupations. Innovative methodologies, including social media, should be explored and evaluated to

demonstrate their effectiveness at improving workplace safety and health. For example, to what

extent can mobile application media be focused on worker safety and health to provide up-to-date

PPE information to a diverse range of employers and employees through portable communication

devices?

Conduct research on the ability of existing containment and control strategies to prevent releases and

potential human exposures to engineered nanomaterials.

Impact and Commercialization Potential: The impact of the proposed research will prevent work-

related injury, illness, and death by advancing the state of knowledge and application of personal

protective equipment. Potential products include technical methods, processes, techniques, tools, and

materials that support the development and use of personal protective equipment worn by individuals to

reduce the effects of their exposure to a hazard.

(2)

Exposure Assessment Methods for High-Risk Occupations

Background: Exposure assessment provides multi-disciplinary strategies and methods to anticipate,

recognize, evaluate, control, and confirm effective management of occupational health stressors,

exposures to those stressors, and resulting health risks. Major gaps in current approaches include:

(1) the lack of practical methods for hazard identification and measurement that can be applied at

reasonable cost in many workplaces where health stressors may exist, (2) the lack of validated,

noninvasive biological methods for monitoring relevant exposure and resulting dose, and (3) the lack

of strategies and methods for epidemiologic studies to demonstrate either a dose-response effect or

a conclusion of no association between the agent and disease in the complex environments of

today's workplaces.

For additional information about NIOSH Exposure Assessment programs, please visit their web site at:

https://www.cdc.gov/niosh/programs/exap/default.html.

Examples of specific research areas of interest include, but are not limited to:

Two areas of research are needed to support effective assessment of worker exposure to engineered

nanomaterials. 1) Real-time sensors capable of reliably detecting nanoparticles and providing

information on size distribution and count, that can be used for personal monitoring; and 2)

Development of methods that can detect and quantify the presence of engineered nanomaterials in

samples collected for the purpose of characterizing exposures. These methods need to be cost-

effective and available to the OS&H practitioner community. Broader application to general public

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health assessments should be factored into the research.

Develop new or improved methods to measure occupational health stressors such as psychological

and ergonomic factors, noise, chemicals, particles and fibers, physical agents, non-ionizing radiation,

or mixtures of stressors in the work environment. Enhanced measurement performance and

functionality can include sensitivity, selectivity, size and weight considerations, ease of use, and

capabilities to measure multiple analyses simultaneously.

Develop or adapt easy-to-use, direct-reading instruments and test kits to rapidly and inexpensively

measure exposures in a variety of workplaces. Critical applications include routine monitoring,

evaluating the success of control technologies, and supporting epidemiological studies.

Develop innovative bioaerosol samplers for collecting airborne infectious viruses onto a medium

without compromising viability or infectivity to allow exposure assessments in occupational settings.

Improve the measurement of low concentrations of chemicals and biomarkers in biological specimens

such as blood, urine, saliva, and sweat so that such concentrations can be linked to internal dose at the

intended organs, work tasks and workers can be categorized according to hazard bands and exposure

bands, and at-risk workers can be identified and protected.

Develop methods to assess mixed exposures such as chemical mixtures containing gas and particulate

matter. Develop improved understanding of dermal exposure’s contribution to exposure assessment.

Develop and apply emerging technologies including Artificial Intelligence (AI) models that support and

enhance exposure assessment data collection and analysis, particularly involving 'smart' exposure

sensors, that could inform control measures.

Develop a computerized system that can be used to predict worker noise exposure from mining

machine noise emissions. The system would include an acoustic model of mining environments and

algorithms to characterize exposure based on noise source characteristics. The main application for

this technology would be for mining machine manufacturers to evaluate the potential effects of noise

controls during the design process. If the impact of design changes on exposure reduction can be

accurately predicted without the need for extensive field measurements, innovative noise controls can

reach implementation much more quickly.

Impact and Commercialization Potential: This research will lead to the development of practical

solutions and prevention activities to address complex problems that cause occupational diseases,

injuries, and fatalities and that will lead to reductions in occupational injuries and illnesses among all

workers. This research will lead to the development and translation of exposure assessment methods

and research findings into prevention practices and products that will be adopted in occupational

settings. Potential products include technical methods, processes, techniques, tools, and materials that

support the assessment of exposure to physical, chemical, and biological hazards in the work

environment.

(3)

Work-related Injuries from Motor Vehicle Crashes

Background: The risk of injury associated with on-the-job operation of motor vehicles affects millions of

U.S. workers who work in all industries and drive all types of vehicles, and for whom driving may be a

primary or incidental job task. Motor vehicle crashes are consistently the leading cause of work-related

fatalities in the United States. From 2011 through 2022, the Bureau of Labor Statistics reported 21,046

work-related fatalities due to motor vehicle crashes, about 35% of all fatalities at work. Over the same

period, workers incurred nearly 515,000 lost-workday injuries due to these crashes. Crash-related fatalities

and serious injuries have a devastating impact on workers and their families, and on the economic health

and productivity of American businesses. Work vehicles such as large trucks also have an impact of the

safety of the motoring public.

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The NIOSH Center for Motor Vehicle Safety coordinates the CDC/NIOSH response to this pressing

worker safety issue. Many NIOSH programs include motor vehicle crashes among their top injury

prevention priorities: Traumatic Injury; Transportation, Warehousing, and Utilities; Wholesale and

Retail Trade; Oil and Gas Extraction; and Public Safety.

Examples of specific research areas of interest include, but are not limited to:

The highest priority is to develop, implement, and evaluate interventions in an effort to build the scientific

evidence base to prevent work-related motor vehicle crashes and resulting injuries. This may be achieved

by:

Developing and testing new design concepts and applications with potential for commercialization and

diffusion to employers and fleet managers.

Developing and testing novel approaches for driver training and assessment to reduce work-related motor

vehicle crashes, including training on the operation of vehicles with Advanced Driver Assistance Systems

(ADAS) or other forms of automation.

Developing and evaluating the effectiveness of technology- or management-based intervention strategies to

reduce the incidence or severity of work-related motor vehicle crashes.

Developing and evaluating engineering controls for preventing work-related crashes and injuries, with

emphasis on specialized work vehicles such as large trucks and fire apparatus.

Developing or evaluating an intervention designed to prevent crashes and injuries for a disproportionally

affected group, such as roadside assistance workers or pedestrian workers engaged in construction or

maintenance of roadways.

Developing and evaluating an easy-to-use computerized system based on readily available technology that

can automate a “fatigue detection” system capable of warning the employee driver and supervisor when the

driver may be at risk for a work-related motor vehicle crash. The system would include a statistical algorithm

capable of using Global Positioning System (GPS) data from cellular phones to characterize potential

number of hours awake within the last 24 hour-cycle. The main application for this technology would be to

allow supervisors and employee drivers to identify and respond to fatigue, thereby reducing the driver’s risk

of a fatigue-related crash.

Developing and evaluating technologies to reduce crash and crash-related injury risk among gig workers

who deliver packages, takeout food, and groceries, whose jobs are linked to a digital online platform.

Impact and Commercialization Potential: Application of evidence-based interventions is

expected to have a large impact on reducing the incidence and severity of work-related motor

vehicle crashes. This will yield substantial public health benefits and will positively affect workers’

compensation and health insurance premiums and costs. CDC/NIOSH has well-established

working relationships with employers, their trade associations, and standards-setting

organizations, and is therefore strongly positioned to communicate findings and guidance to

potential users. CDC/NIOSH also has strong infrastructure to facilitate the transfer of technology-

based interventions to the marketplace. Given the extremely short induction period between

exposure and injury occurrence, CDC can make a measurable difference in a very short period (<

4 years).

Visit the NIOSH homepage for more information on NIOSH’s research program areas

http://www.cdc.gov/niosh/homepage.html.

For NIOSH programmatic information, contact:

Steve Dearwent, PhD

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National Institute for Occupational Safety and Health (NIOSH)

Centers for Disease Control and Prevention

Mail Stop V24-4

Phone: 404-498-6382

Email: sdearwent@cdc.gov

For grants specific, administrative information, contact:

Brownie Anderson-Rana

Office of Grant Services Office of Financial Resources

Office of the Chief Operating Officer

Centers for Disease Control and Prevention (CDC) Mail Stop K-75

2920 Brandywine Rd.

Atlanta, GA 30341

Phone: 770-488-2771

Email: BAndersonRana@cdc.gov

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FDA 195

FOOD AND DRUG ADMINISTRATION (FDA)

Mission

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and

security of human and veterinary drugs, biological products, medical devices, our nation’s food

supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the

public health by helping to speed innovations that make medicines and foods more effective, safer,

and more affordable; and helping the public get accurate, science-based information they need to

use medicines and foods to improve their health.

For additional information about areas of interest to the FDA, please visit our home page at

http://www.fda.gov.

Budget Guidance

FDA will not fund:

•

Phase I applications greater than $200,000

•

Phase II applications greater than $1,500,000

Specific SBIR and STTR Program Information

FDA will not accept SBIR applications that propose clinical trials, and all of the topics listed below must be

for projects that do not propose clinical trials.

Clinical Trials

Does FDA accept Clinical Trials through

the Omnibus/Parent Notices of Funding

Opportunities?

Does FDA accept Clinical Trials

through specific Notices of Funding

Opportunities?

Does FDA support Clinical Trials

through NON-SBIR/STTR Notices of

Funding Opportunities?

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

Mission

CBER is responsible for ensuring the safety, efficacy, potency and purity of biological and related products

intended for use in the treatment, prevention or cure of diseases in humans as well as the safety of the

nation's supply of blood and blood products. The primary responsibility of CBER is to review the

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quality, safety and efficacy of vaccines, blood products, certain diagnostic products and other

biological and biotechnology-derived human products.

CBER's activities include: evaluating the quality, safety and effectiveness of biological products

before marketing, and monitoring the pre-clinical and clinical testing of new biological products;

licensing biological products and manufacturing establishments, including plasmapheresis centers,

blood banks, vaccine and biotechnology manufacturers; AIDS program and policy activities,

including research on AIDS therapeutic products, diagnostic tests and vaccines; research to

establish product standards, develop improved testing methods and assess the safety of biological

products; compliance, lot release program and post market surveillance; meeting PDUFA goals,

new research programs, and new regulatory initiatives (managed review process for all products).

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Mission

CDER develops FDA policy with regard to the safety, effectiveness, and labeling of all drugs for

human use; evaluates new drug applications and investigational new drug applications; develops

standards for the safety and effectiveness of all over-the-counter drugs; monitors the quality of

marketed drugs through product testing (bioavailability/bioequivalence testing), post marketing

surveillance, and compliance programs; develops guidelines on good manufacturing practices;

conducts research and develops scientific standards on composition, quality, safety, and efficacy of

human drugs.

Drug regulatory research as conducted in CDER is directed at the discovery of new knowledge

relevant to drug development, post marketing drug experience (patterns of drug use and safety), and

drug regulation to enhance FDA regulatory decisions. These drug regulatory decisions impact on

the development of regulations, guidelines and guidance for the regulated industry and provide

clarity and consistency in application of CDER regulatory requirements. These drug regulatory

decisions also impact public health by ensuring that marketing drugs are safe and efficacious and

that their risk: benefit profile remains acceptable during the market life of a drug. Specific areas of

research conducted by the Center include Pharmacology/toxicology, microbiology/virology, clinical

pharmacology, pediatric issues in drug therapy, post marketing drug safety, evaluation of

effectiveness of regulatory actions, patterns of drug use, including off-label, signal detection

methodologies (e.g., data mining techniques), epidemiologic studies of therapeutics using

population-based data, regulatory compliance, product quality, and active surveillance methods.

Research Topics

Research and development opportunities within the FDA that lend themselves to performance by

small businesses include, but are not limited to, the following:

Develop a system for gathering real-time data on physician prescribing behavior,

understanding and compliance with drug product labeling and frequency of off -label

prescribing.

Develop and evaluate the effectiveness of new methods and tools for managing the

known risks of marketed drug products (e.g., communicating newly identified risks to

health care practitioners and patients).

Develop methods for timely active surveillance of newly approved drug products

in large populations to identify both expected and unexpected outcomes.

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Develop methods for actively collecting information on all cases of classically drug-

associated events (e.g., acute liver failure, blood dyscrasias, severe desquamating

skin disorders) to augment the FDA’s current passive surveillance system.

Develop improved clinical markers and methods with potential for bed-side

application for detection of the early onset of adverse drug events.

Develop surrogate potency methods for biotech drug products to replace

traditional animal testing.

Development of psychochemical and in-vitro biological tests to evaluate

pharmaceutical equivalence of complex drug substances and drug products.

Research into approaches to handle informative missing patient data in clinical trials,

including innovations in study designs and statistical methods of analysis.

Statistical and computational methods and strategies for the design, analysis and

interpretation of microarray, genomic and proteonomic data.

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

Mission

The FDA is responsible for the safety of the vast range of food Americans eat; about 80 percent of all

food sold in the United States. This includes everything except for the meat, poultry, and processed egg

products that are regulated by the USDA. Consequently, CFSAN seeks research designed to

complement and accelerate efforts aimed at the detection, prevention, and control of contamination that

may be responsible for illness or injury conveyed by foods, colors, and cosmetics. CFSAN conducts

research, and develops regulations, guidance and standards related to the composition, quality,

nutrition, and safety of food, food additives, colors, and cosmetics. The Center evaluates FDA’s

surveillance and compliance programs relating to foods, colors, and cosmetics; reviews industry

petitions, and develops regulations for food standards to permit the safe use of color and food additives.

Research Topics

CFSAN maintains an active research program that is focused on the following priorities; ensuring the

safety of food, dietary supplements and cosmetics; improving nutrition; and promoting the security

and integrity of the food supply. The Center’s research activities are intended to; support the FDA’s

regulatory activities; reduce the incidence of foodborne illness by improving our ability to detect and

quantify foodborne pathogens, toxins, and chemicals that could jeopardize the safety and security of

the food supply; find new and improved ways to control these agents; and safely produce, process,

and handle food and food products. FDA is committed to reducing the incidence of foodborne illness

to the greatest extent feasible while at the same time protecting the nation's food supply. Mission-

critical knowledge gaps are addressed through translation research focused on the risks associated

with FDA regulated products throughout their life cycles, from production to consumption. Ideally

extramural research is sought that complements the Center’s intramural research efforts, and which

will enhance the Agency’s and the Nation’s ability to reduce the incidence of foodborne illness and

protect the integrity of the nation’s food supply. FDA’s mission-critical needs require that the research

not simply end with the generation of new knowledge and technologies but extend to the validation of

new approaches by using realistic conditions that accurately reflect the diversity of the food industry

and offer potential solutions that can be accept by appropriate sectors of the food industry.

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

Mission

CDRH is responsible for assuring patients and providers have timely and continued access to safe,

effective, and high-quality medical devices and safe radiation-emitting products. Towards this goal,

CDRH develops policy, conducts regulatory science, and evaluates the safety and effectiveness of

medical devices and radiation-emitting products. CDRH classifies medical devices into one of three

classes based on risk and the regulatory controls necessary to provide a reasonable assurance of

safety and effectiveness. CDRH reviews study protocols for investigational devices, applications for

authorization of medical devices, and evaluates exemption requests for investigational devices. CDRH

is integrally involved in developing national and international standards, establishing good

manufacturing practices, and driving postmarket surveillance and compliance programs. The radiation

safety programs at CDRH involve enforcement of mandatory requirements in addition to partnerships

and voluntary programs that promote the safe use of radiation-emitting products. The Center develops

and conducts research and testing programs in the areas of physical, life, and engineering sciences

related to the human health effects of radiation and medical device technologies, provides expertise

and analyses for health-risk assessments, and also develops new or improved measurement methods,

techniques, instruments and analytical procedures for evaluating product performance and reliability.

Research Topics

CDRH welcomes submissions that aid in assessment of safety, effectiveness, and performance of

medical devices and/or promote medical device innovation. Please note, we do not fund development

of any products that may eventually be regulated by the Center. Areas of interest and examples are

listed below.

A. Biocompatibility and Alternative Methods: Develop and advance reliable alternatives to

traditional in vivo biocompatibility testing approaches to characterize biological response

to extracts of medical devices and particulates, including

•

novel in vitro, ex vivo, and in silico models, microphysiological systems,

alternative assays

•

frameworks capable of leveraging clinical, animal, and material information not

obtained through biocompatibility testing to be used as a substitute or to justify

performing more focused safety analyses

•

tools for assessing toxicological risk and chemical characterization in cases

where traditional extraction methods are not feasible and/or reference standards

do not exist.

B. Digital Health and Cybersecurity: Enhance the performance of digital health technologies

and promote medical device cybersecurity, including digital health technologies that

facilitate remote clinical trials and AI/ML algorithm evaluation methodologies.

C. Electrical and electromagnetic compatibility safety evaluation methods for non-clinical

environment use taking into consideration common EM emitters such as radiofrequency

identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic

article surveillance), near-field communications (NFC) systems, wireless power transfer

(WPT), and Cellular 5G.

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D. Health Equity: Advance the development of knowledge, and safe and effective

technologies, to meet the needs of diverse patient populations and consumers,

including reducing barriers to participate in evidence generation by diverse populations

and the use of medical technologies outside a healthcare setting.

•

Health of Women: Explore unique issues related to the performance of

medical devices in women, improve analysis and communication of sex-

and gender- specific data to better assure the safe and effective use of

medical devices

•

Human Factors: Explore methodologies to test and report on usability or

user experiences with devices in diverse patient populations and

consumers.

•

Pediatric Medical Device Development: Increase and accelerate medical

device development and labelling for the unique and evolving needs of

pediatric and special populations, especially younger sub- populations such

as neonates and children. Optimize or develop infrastructure that supports

safe innovation and development of medical devices designed, evaluated,

and labelled for pediatric and special populations.

E. Sterilization: Encourage the development of new approaches to medical device

sterilization with a focus on identifying alternatives to ethylene oxide (EtO) sterilization

methods, and/or development of strategies to reduce EtO emissions.

CENTER FOR VETERINARY MEDICINE (CVM)

Mission

CVM protects human and animal health by ensuring the safety and effectiveness of animal

drugs, by ensuring the safety of animal food (and food ingredients), and by addressing safety

concerns that may arise with the use of animal devices. The Center makes timely, quality

decisions and takes regulatory actions to ensure that these products are protective of public

health, provide for quality health care of animals, minimize the transmission of diseases, and

increase the efficiency of production of animal- derived food and fiber. The Center, in partnership

with Federal and state agencies and others, ensures animal health and the safety of food derived

from animals. Regulatory decisions are supported by research, the monitoring of product safety,

and efficacy, and continuous process improvement.

Research Topics

Research and development opportunities within the Center for Veterinary Medicine that lend themselves

to performance by small businesses include, but are not limited to, the following areas of interest:

Development, for the specific purpose of obtaining approval or conditional approval, of

products for the treatment, control or prevention of diseases or conditions for which

limited approved therapeutic options are available, particularly those occurring in minor

species or small numbers of major species.

Development and validation of high throughput/screening of quantitative and qualitative

analytical methods for analyzing drugs, additives, and contaminants (chemical and

microbial) in animal tissues and feeds.

NIH, CDC, and FDA Program Descriptions and Research Topics

FDA 200

Development of methods and approaches to determine absorption, distribution, metabolism,

and excretion of drugs, food additives and contaminants (microbial and chemical) in

animals, including minor species. This includes, among other topics, 1) the development of

alternative methods, in support of replacement/reduction/refinement for activities involving

animal research, and 2) methods for the determination/validation of bioequivalence.

Development of new biomarkers and models for determining the safety and effectiveness of

veterinary drugs and food additives in animals, including minor species or development of

alternative methods to animal use.

Development of methods to determine the effects of drugs, food additives, and contaminants

(microbial and chemical) on immunological and physiological functions of animals, including

minor species.

Development/refinement of One Health approaches to monitor and minimize antimicrobial

resistance development and to support antimicrobial stewardship in animals.

Development of methodology for accelerated (short term) shelf-life stability testing for drugs

and food additives for extrapolation to real time stability testing.

OFFICE OF CRITICAL PATH PROGRAMS

Mission

The Office of Critical Path Programs, in FDA’s Office of the Chief Scientist, coordinates the cross-agency

Critical Path Initiative (CPI), FDA's strategy for transforming the way medical products are developed,

evaluated, and manufactured. CPI activities are under way throughout the Agency, from the product

centers to the Office of the Commissioner. For details, see

http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm. Collaboration is key

to the CPI initiative because bringing safe, effective, and innovative therapies to the American public

requires FDA to leverage the resources and expertise of all stakeholders, including other Federal

agencies, academia, healthcare professionals, patient and consumer groups, regulated industry, and

health-related organizations. In 2008, CPI collaborations involved 84 government agencies, universities,

industry leaders, and patient groups from 28 states and 5 countries on a raft of groundbreaking research

projects.

Research Topics

Research and development opportunities within FDA that lend themselves to performance by grantees

include, but are not limited to, the following:

Studying the immunological correlates of TB immunity and developing tools to evaluate TB

vaccine efficacy.

Developing study models for testing combination-antimicrobials as a strategy to prevent the

development of drug resistance.

Developing new approaches to preclinical safety testing.

Identifying biomarkers for safety and efficacy evaluation of medical products.

NIH, CDC, and FDA Program Descriptions and Research Topics

FDA 201

OFFICE OF ORPHAN PRODUCTS DEVELOPMENT

Mission

The Office of Orphan Products Development was established to identify and facilitate the

development of orphan products. Orphan products are drugs, biologics, medical devices and

foods for medical purposes, which are indicated for a rare disease or condition (i.e., one affecting

fewer than 200,000 people in the United States). These products may be useful in a rare

disease/disorder but lack commercial sponsorship because they are not considered commercially

attractive for marketing. A subcategory of orphan products are those marketed products in which

there is evidence suggesting usefulness in a rare disease/disorder but which are not labeled for

that disease/disorder because substantial evidence of safety and effectiveness for that use is

lacking.

Research Topics

Research and development opportunities within the FDA that lend themselves to performance by small

businesses include, but are not limited to, the following:

Development of products for the treatment of rare diseases or disorders

including but not limited to neurological, metabolic, genetic, ophthalmologic,

hematologic, and dermatological diseases or disorders for the specific purpose

of obtaining marketing licensure.

Development of products for use in diagnosis of rare diseases for which the

diagnostic tool would be used in fewer than 200,000 persons annually in the

United States.

Development of vaccines for the prevention of rare diseases to be used in

fewer than 200,000 persons annually in the United States.

For additional information on research topics and administrative and business information, contact

Kimberly Pendleton

Director, Division of Grants, Agreements, and Acquisition Support

Email: Kimberly.Pendleton@fda.hhs.gov

Food and Drug Administration

Division of Acquisition Support and Grants