Opportunity Information: Apply for PAR 21 179
The Minor Use Minor Species Development of Drugs (R01) opportunity (PAR 21-179) is a discretionary funding program run by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), specifically the Center for Veterinary Medicine (CVM). Its purpose is to support research projects that move certain veterinary drugs closer to FDA approval when the intended market is too small to easily justify the cost of development. The program focuses on MUMS products, meaning either drugs intended for a minor use in a major animal species (for example, a narrowly used treatment in cattle, swine, chickens, turkeys, dogs, cats, or horses) or drugs intended for a minor species (such as fish, sheep, goats, rabbits, honey bees, zoo animals, and many other less-common species). The core idea is to help fill gaps where animal health needs exist but private investment may be limited because the population affected is relatively small.
Funding is aimed at qualified safety and effectiveness testing that can be used to meet FDA requirements for approval of new animal drugs that have received MUMS designation. In practical terms, that means the grant is meant to pay for research steps that generate data regulators can actually use, rather than basic exploratory science. Projects should be positioned to produce credible, well-controlled evidence that supports safety and/or effectiveness for the drug’s specific intended use, with the expectation that this work will contribute to a future approval package.
Eligibility is broad in the sense that many types of organizations can apply, including state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (including small businesses); and other entities as described in the NOFO’s additional eligibility language. Even with this broad list, the program has an important limiting condition: only entities that are developing veterinary drugs, or groups formally partnering as research collaborators with those developers, are eligible for funding. The intent is to ensure the funded work is tightly connected to an active drug development program and can realistically be incorporated into an FDA regulatory submission.
There are also several required regulatory readiness steps that must already be in place before a grant application can be submitted. The organization pursuing eventual approval of the new animal drug must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM. In addition, the drug and its specific intended use must already have a formal minor use or minor species designation from CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS), under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and the designation regulations at 21 CFR Part 516. Finally, CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed the proposed study protocol and concurred with it before the applicant submits the grant application. This pre-review requirement is a key feature of the program because it helps ensure that the studies being funded are designed in a way that will be acceptable for regulatory decision-making.
The award mechanism is a cooperative agreement, which generally indicates that FDA expects to have substantial involvement during the project rather than acting only as a passive funder. The opportunity is categorized under Agriculture, Consumer Protection, and Food and Nutrition, and is associated with CFDA number 93.103. The published maximum award amount is $500,000, and the opportunity anticipated about six awards. The opportunity was created on February 18, 2021, with an original closing date listed as February 3, 2024.Apply for PAR 21 179
- 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)" 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 Feb 18, 2021.
- Applicants must submit their applications by Feb 03, 2024. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- 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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| Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products (U01) Clinical Trials Not Allowed Apply for RFA FD 21 031 Funding Number: RFA FD 21 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trials Not Allowed Apply for RFA FD 21 032 Funding Number: RFA FD 21 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| An evidence-based clinical practice guideline for dental pain (surgical and non-surgical) Apply for FOR FD 20 001 Funding Number: FOR FD 20 001 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Apply for FOR FD 20 006 Funding Number: FOR FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) Apply for FOR FD 20 018 Funding Number: FOR FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed Apply for FOR FD 20 011 Funding Number: FOR FD 20 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for FOR FD 20 007 Funding Number: FOR FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Incorporating cost effectiveness & societal outcomes into FDA opioids model (U01) Apply for FOR FD 20 008 Funding Number: FOR FD 20 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products Apply for FOR FD 20 009 Funding Number: FOR FD 20 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Drug Development Science Support (U01) Apply for FOR FD 20 010 Funding Number: FOR FD 20 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed Apply for FOR FD 21 004 Funding Number: FOR FD 21 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| 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 |
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