Minor Use Minor Species Development of Drugs (R01)

About this funding opportunity

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.

Topic areas: Agriculture and Food, Public Policy and Governance, Life Sciences and Health.

Funding amount

This grant provides Up to $250K in funding, up to $250K per award.

Deadline

Applications are due Jan 29, 2027. Confirm the exact closing time on the official program page before applying.

Who can apply

This opportunity is open to the following applicant types:

• NGOs
• SME
• Public Authorities
• University
• Large Company
• Other

Eligibility

• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Agency

Minor Use Minor Species Development of Drugs (R01) is administered by Food and Drug Administration (FDA), listed via Grants.gov.