Food and Drug Administration Research (93.103)
Food and Drug Administration Research (Assistance Listing 93.103) is run by the Food and Drug Administration, part of the Department of Health and Human Services. It awarded $1.2 billion in 940 grants from fiscal 2021 to 2025, about $1.3 million per award on average. 54 funding opportunities are open or forecast now.
The typical award was $499,996. Half of the 940 awards fell between $200,000 and $1.3 million, and they ranged from $4,040 to $87.7 million.
- Awarded, FY 2021 to 2025$1.2 billion
- Grant awards940
- Typical award$499,996
- Awarded in FY 2025$213 million
- Size rank236 of 1,823
- Type of assistanceCooperative agreements (discretionary grants), project grants (discretionary)
Key findings
- Annual funding rose from $203 million in fiscal 2021 to $213 million in fiscal 2025.
- It is the 236th largest of 1,823 federal grant programs by five-year awards.
- The 20 largest recipients received 44% of the money.
- Awards went to recipients in 51 states and territories.
What the program funds
To assist institutions and organizations, to establish, expand, and improve research, demonstration, education and information dissemination activities; acquired immunodeficiency syndrome (AIDS), biologics, blood and blood products, therapeutics, vaccines and allergenic projects; drug hazards, human and veterinary drugs, clinical trials on drugs and devices for orphan products development; nutrition, sanitation and microbiological hazards; medical devices and diagnostic products, radiation emitting devices and materials; food safety and food additives. These programs are supported directly or indirectly by the following Centers and Offices: Center for Biologics Evaluation and Research (CBER); Center for Drug Evaluation and Research (CDER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), National Center for Toxicological Research (NCTR), the Office of Orphan Products Development (OPD), the Center for Tobacco Products (CTP), and Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC). Small Business Innovation Research (SBIR) Programs: to stimulate technological innovation; to encourage the role of small business to meet Federal research and development needs; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation by minority and disadvantaged persons in technological innovation. Funding support for scientific conferences that are relevant to the FDA scientific mission and public health are also available.
Open and forecast opportunities
- Minor Use Minor Species Development of Drugs (R01)
- Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed
- NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens
- NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)
- Laboratory Flexible Funding Model (LFFM)
- Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
- Animal and Veterinary Innovation Centers (U18)
- Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
- Vet-LIRN Capacity-Building Project and Equipment Grants (U18)
- Development and Maintenance of Human and Animal Food Rapid Response Teams
- National Produce Safety Partnership Program
- Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs
- African Medical Devices Regulatory Harmonization Program
- Manufactured Foods Flexible Funding Model (MF-FFM)
- Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed
- Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
- Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
- Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
- Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
- Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
- Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
- Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
- Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed
- Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
- Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed
Past notices
Of 187 notices posted under this program since 2021, most went up in January (39), May (37) and February (22).
- RFA-FD-26-014: Federal and University Partnership to Improve the Safety of Seafood from the Gulf of America
- RFA-FD-26-013: Cooperative Agreement to Support Shellfish Safety Assistance Project
- RFA-FD-26-011: Research, Education, and Outreach on Botanical Natural Products
- RFA-FD-26-009: Education and Outreach to Tribal Producers through the Tribal Food Safety Alliance
- RFA-FD-26-012: Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
- RFA-FD-26-003: Retail Food Safety Regulatory Association Collaboration
- RFA-FD-26-004: Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers
- RFA-FD-26-007: Pathways for Regulatory Innovation and Strategic Modernization (PRISM)
- RFA-FD-25-005: Establishing the Integrated Food Safety System (IFSS) Regulatory and Laboratory Training System (RLTS) National Coordination Center (NCC) and Learning Management System (LMS)
- RFA-FD-25-016: FDA's Integrated Food Safety System Training Delivery and Development
- RFA-FD-25-022: Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs
- RFA-FD-25-015: Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional
- RFA-FD-25-023: Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities
- RFA-FD-25-019: Food Safety Capacity and Infrastructure Building (U2F)
- RFA-FD-25-021: Conformance with the Egg Regulatory Program Standards
Rules from the program listing
Who can apply
Applicants should review the individual funding opportunity announcement issued under this CFDA program to see which applicant organizations are eligible to apply.
What the money can and cannot pay for
Research grants are awarded to eligible institutions in the name of a principal investigator for applications that are responsive to programmatic requirements as stated in the Funding Opportunity Announcement (FOA). Funds are to be used for costs as identified in the FOA and as directly allocable, necessary and reasonable to carry out the proposed research aims and objectives. Small Business Innovation Research (SBIR) Phase I grants are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. SBIR Phase II grants for this program are for the competitive continuation of the research initiated in Phase I, and are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. Conference grants provide partial support for domestic scientific conferences related to the FDA mission. Funding restrictions are noted in the Funding Opportunity Announcement and the Terms and Conditions of award.;
Matching requirements
This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.
Deadlines
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the application deadline information.
Award range and average, in the agency's words
Varies by grant mechanism and program specific requirements.
Funding history and past recipients
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
Who usually wins
Nonprofits received 35% of the money, colleges and universities 33% and state and local governments 25%.
| Recipient type | Awards | Amount | Share |
|---|---|---|---|
| Nonprofits | 191 | $408 million | 35% |
| Colleges and universities | 320 | $386 million | 33% |
| State and local governments | 293 | $297 million | 25% |
| Small businesses | 82 | $49.9 million | 4.2% |
| Other | 43 | $36.4 million | 3.1% |
| Businesses | 11 | $3.6 million | 0.3% |
By state
50 states have a page for this program: those that received at least $1 million or 10 awards.
| State | Awards | Amount |
|---|---|---|
| Arizona | 20 | $102 million |
| California | 66 | $95.7 million |
| Pennsylvania | 58 | $83.3 million |
| Maryland | 41 | $80.1 million |
| Virginia | 30 | $79.7 million |
| North Carolina | 39 | $69.1 million |
| Colorado | 19 | $61.6 million |
| New York | 53 | $51.9 million |
| Texas | 37 | $42.6 million |
| Minnesota | 31 | $37.7 million |
| Massachusetts | 39 | $37.5 million |
| Ohio | 30 | $32.9 million |
| Michigan | 27 | $31.6 million |
| District of Columbia | 25 | $30.5 million |
| Illinois | 28 | $28.0 million |
| Connecticut | 18 | $23.6 million |
| Washington | 23 | $23.1 million |
| Florida | 23 | $22.9 million |
| Mississippi | 12 | $20.3 million |
| Tennessee | 16 | $18.5 million |
| Kentucky | 16 | $12.8 million |
| Wisconsin | 19 | $12.8 million |
| Arkansas | 16 | $12.2 million |
| Indiana | 16 | $11.6 million |
| Iowa | 21 | $11.2 million |
| New Jersey | 14 | $11.1 million |
| Georgia | 15 | $10.2 million |
| Missouri | 13 | $10.0 million |
| Kansas | 17 | $8.8 million |
| South Carolina | 10 | $6.9 million |
| Rhode Island | 7 | $6.7 million |
| Alabama | 10 | $6.5 million |
| West Virginia | 10 | $6.2 million |
| Oregon | 8 | $5.8 million |
| New Hampshire | 3 | $5.6 million |
| Delaware | 2 | $4.9 million |
| Louisiana | 11 | $4.7 million |
| Hawaii | 6 | $4.4 million |
| New Mexico | 7 | $3.8 million |
| Alaska | 4 | $3.4 million |
| Vermont | 3 | $3.3 million |
| Utah | 6 | $3.2 million |
| Oklahoma | 7 | $2.6 million |
| Nevada | 3 | $2.6 million |
| Nebraska | 8 | $2.3 million |
| South Dakota | 7 | $2.2 million |
| Idaho | 1 | $1.7 million |
| Maine | 4 | $1.6 million |
| Montana | 2 | $1.4 million |
| Puerto Rico | 2 | $1.3 million |
| North Dakota | 6 | $520,317 |