Opportunity Information: Apply for FOR FD 21 004
This funding opportunity, titled "Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed" (Opportunity Number FOR-FD-21-004), is a grant program run by the U.S. Food and Drug Administration (FDA) through its Center for Veterinary Medicine (CVM). The purpose is to support research projects that help move certain veterinary drugs toward FDA approval when the intended market is small, specialized, or otherwise unlikely to attract enough private investment on its own. In practical terms, the program targets "MUMS" products, meaning drugs intended either for minor uses in major animal species (for example, a less common disease or limited production class within cattle, swine, chickens, etc.) or for use in minor species (species that are not considered major, such as many aquaculture species, sheep and goats in some regulatory contexts, and various other less-common domestic or captive animals). The main goal is to generate credible safety and effectiveness data that can be used to satisfy FDA requirements for approving a new animal drug for these limited-use situations.
The FDA has specific statutory authority to issue these grants to help cover (or "defray") the costs of qualified testing needed for approval. That means the work proposed under the award is expected to be directly relevant to regulatory decision-making, not just basic discovery research. Projects should be designed to produce study results that are suitable for inclusion in an approval package, such as well-justified safety studies, effectiveness studies, or other structured data collection that FDA can rely on when evaluating whether a designated MUMS drug should be approved for its specific intended use.
A key feature of this opportunity is that it is built around the FDA's MUMS designation framework. To be eligible, the drug must already have a formal minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for a specific intended use. This requirement ties the grant to a clearly defined regulatory pathway and ensures that the funded work addresses a recognized MUMS need rather than a broadly defined or speculative use case. The legal basis for this designation and program structure is section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and the implementing regulations at 21 CFR part 516.
Another major eligibility requirement is that the sponsor pursuing approval must have already opened an Investigational New Animal Drug (INAD) file with FDA/CVM. An INAD is essentially the regulatory file used to manage communications, study plans, and data submissions while a new animal drug is still under investigation. By requiring an active INAD, FDA is signaling that applicants should already be engaged in the formal drug development and review process, with an identified product, a defined indication, and an organized development plan.
The NOFO also places strong emphasis on protocol readiness and FDA alignment before an application is even submitted. Specifically, FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol in advance. This step is important because it helps prevent situations where a study is funded but later deemed unsuitable for regulatory use due to design flaws, endpoints that do not support the claim, inappropriate target animal population selection, or other issues that could limit the data's value for approval. In effect, the program expects applicants to do the upfront regulatory coordination so that, once funded, the study can proceed in a way that will actually advance an approval decision.
While the funding announcement references an R01 research project format, the listed funding instrument type is a cooperative agreement, which typically implies more substantial FDA involvement than a standard grant. In cooperative agreements, the agency often has an active role in overseeing progress, providing input, or coordinating aspects of the project to ensure the work remains aligned with program goals and regulatory expectations. The activity category is listed under areas like agriculture, consumer protection, and food and nutrition, reflecting the FDA/CVM mission to protect animal health, human food safety (where applicable), and the public interest connected to veterinary drug use.
In terms of who can apply, the eligible applicant categories are broad on paper and include various levels of government, public and private institutions of higher education, tribal governments and organizations, nonprofits with or without 501(c)(3) status, and for-profit entities including small businesses. However, the practical eligibility is narrower than the generic list because the program is restricted to parties actually developing a veterinary drug or organizations formally partnering with such developers as research collaborators. In other words, an academic lab or nonprofit could be eligible if it is working as a research partner to the drug sponsor and the sponsor has the required designation and INAD in place. The applicant organization ultimately needs to be situated in a real regulatory development effort, not operating independently of a sponsor seeking FDA approval.
The title includes "Clinical Trials Not Allowed," which signals that the award should not propose human clinical trials, and that the supported research is focused on veterinary drug development studies and related regulatory-grade testing rather than human-subject research. The studies contemplated here are generally the kinds of target-animal safety and effectiveness investigations that support veterinary labeling claims and approval, conducted under conditions and data standards suitable for FDA evaluation.
Administrative details provided in the source information include a creation date of May 25, 2021, and an expectation of about six awards. The award ceiling is listed as 0 in the provided extract, which usually means the ceiling was not specified in that data snapshot or is defined elsewhere in the full announcement. The opportunity is issued by the Department of Health and Human Services (HHS), FDA, and is associated with CFDA number 93.103.
Overall, the program is best understood as a targeted regulatory-science funding mechanism to push forward drug approvals for smaller veterinary markets that might otherwise remain underserved. It is designed for applicants who are already on the FDA development pathway for a MUMS-designated product, have engaged FDA review offices early, and can carry out studies that FDA can realistically use as part of an approval decision for the specific minor use or minor species indication.Apply for FOR FD 21 004
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on May 25, 2021.
- Applicants must submit their applications by Archiving forecast. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| AAV Vector manufacturing for diseases affecting very small populations Apply for FOR FD 21 007 Funding Number: FOR FD 21 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases Apply for FOR FD 21 006 Funding Number: FOR FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U01) Clinical Trial Not Allowed Apply for RFA FD 22 004 Funding Number: RFA FD 22 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Conformance with the Egg Regulatory Program Standards (U2F) (Clinical Trial Not Allowed) Apply for RFA FD 22 006 Funding Number: RFA FD 22 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Research to support the development of alternatives to antimicrobials for use in food-producing animals Apply for PAR 22 087 Funding Number: PAR 22 087 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Innovative ways to provide education on antimicrobial stewardship practices in animals. Apply for PAR 22 108 Funding Number: PAR 22 108 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Revision Applications - Development and Maintenance of the Animal Feed Regulatory Program Standards Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 010 Funding Number: RFA FD 22 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 22 009 Funding Number: RFA FD 22 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Revision Applications - Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 019 Funding Number: RFA FD 22 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| Retail Food Safety Regulatory Association Collaboration (U18) (Clinical Trial Not Allowed) Apply for RFA FD 22 008 Funding Number: RFA FD 22 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Renewal - Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 22 025 Funding Number: RFA FD 22 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal- Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trail Not Allowed Apply for RFA FD 22 024 Funding Number: RFA FD 22 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Funding Opportunity Title Innovation Award: Minority Health and Health Equity (U01) Clinical Trials Optional Apply for RFA FD 22 005 Funding Number: RFA FD 22 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Optional Apply for RFA FD 22 020 Funding Number: RFA FD 22 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed Apply for RFA FD 23 003 Funding Number: RFA FD 23 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Clinical Trials Not Allowed Apply for RFA FD 23 020 Funding Number: RFA FD 23 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 027 Funding Number: RFA FD 23 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $565,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 019 Funding Number: RFA FD 23 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Renewal-Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 23 032 Funding Number: RFA FD 23 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal-Local Food Producer Outreach, Education and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 23 031 Funding Number: RFA FD 23 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
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