Minor Use Minor Species Development of Drugs (R01)
Open Posted
- Opportunity number
- PAR-24-216
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $250,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Consumer Protection
- Agriculture
- Food and Nutrition
- Eligible applicants
-
- Public or Indian Housing Auth.
- Tribal Organizations (Not Federally Recognized)
- County Governments
- State Governments
- Non-501(c)(3) Nonprofits
- 501(c)(3) Nonprofits
- Independent School Districts
- For Profit Organizations
- Tribal Governments (Federally Recognized)
- Other
- Higher Education Inst. (Private)
- Small Businesses
- Higher Education Inst. (Public)
- Special District Governments
- City/Township Governments
- Points of contact
-
- Terrin Brown terrin.brown@fda.hhs.gov (240) 402-7610
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is soliciting Research Project (R01) grant applications to develop or support development of designated new animal drugs for minor uses in major species or use in minor species (MUMS), with applications due January 29, 2027.
Eligibility is restricted to entities developing drugs for veterinary use or research partners of such entities. The applicant organization seeking approval of the new animal drug must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and hold a minor use or minor species designation granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for the drug for a specified intended use, in accordance with section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before submission of a grant application.
Eligible applicant categories include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, state and local governments, tribal governments (federally recognized), county governments, city/township governments, special district governments, independent school districts, and public or Indian housing authorities.
The program funds qualified safety and effectiveness testing costs that satisfy FDA approval requirements for MUMS-designated drugs. Grants are issued under CFDA 93.103 (Food and Drug Administration Research), which operates under the Department of Health and Human Services. Applications must follow NIH PHS SF424 (R&R) procedures and formats.
Synopsis
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS).
The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs.
Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.
The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.
FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.
Eligibility
• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)
Files
| File | Type | Posted |
|---|---|---|
| PKG00286737.pdf |
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