Minor Use Minor Species Development of Drugs (R01)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you're developing a veterinary drug for a neglected animal indication and have FDA's MUMS designation in hand, this grant covers the expensive testing needed to prove safety and efficacy.
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What this is
This is a competitive grant program for veterinary drug developers pursuing FDA approval under the MUMS (Minor Use Minor Species) pathway. Funding covers qualified safety and efficacy testing costs required for FDA approval. You must already have obtained a formal MUMS designation from FDA/CVM and have an open Investigational New Animal Drug (INAD) file; additionally, FDA/CVM's Office of New Animal Drug Evaluation must have reviewed and approved your study protocol before you can apply. This is highly specialized funding for a narrow but important regulatory niche.
Who can apply
You must be developing or partnering with a veterinary drug developer; hold a formal FDA minor use or minor species designation; have an open INAD file with FDA/CVM; and have FDA/CVM's Office of New Animal Drug Evaluation pre-approval of your study protocol. Eligible organizations include nonprofits, small businesses, for-profits, universities, government entities, and tribal organizations.
Eligible applicant types
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- County governments
- Public housing authorities/Indian housing authorities
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- State governments
- Public and State controlled institutions of higher education
- Private institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
- Independent school districts
- Special district governments
- Native American tribal governments (Federally recognized)
- City or township governments
Full description — from the agency
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.
Topics: veterinary drug development · minor use minor species · FDA approval · animal drug testing · INAD filing · safety efficacy testing
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.