Minor Use Minor Species Development of Drugs (R01)
About
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.
The Minor Use Minor Species Development of Drugs (R01) grant program, administered by the FDA's Center for Veterinary Medicine, supports research and development of new animal drugs for specialized veterinary applications. This program funds qualified safety and effectiveness testing for drugs intended for minor uses in major animal species or for use in minor species—areas that typically receive limited pharmaceutical development due to market constraints. The grant is designed for institutions, organizations, and research entities actively developing veterinary drugs or partnering with drug developers. Applicants must have an open Investigational New Animal Drug (INAD) file with FDA/CVM and hold a designated minor use or minor species status from the Office of Minor Use and Minor Species Animal Drug Development (OMUMS). This grant represents a critical funding opportunity for veterinary pharmaceutical innovators addressing underserved animal health needs. If your organization is committed to advancing veterinary medicine in specialized treatment areas and meets the FDA's designation requirements, this R01 grant can substantially reduce development costs and accelerate your path to FDA approval. The program welcomes applications from faith-based organizations, community-based organizations, regional organizations, and non-domestic entities, making it accessible to diverse research partners globally focused on veterinary drug innovation.
Funding Facts
● Applications openDeadline
January 29, 2027
Award Amount
Up to $250K
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $250K
Deadline
2027-01-29
Grant Type
federal
Application Cycle
Competitive, with deadline of January 29, 2027
Best For
Veterinary drug developers, research institutions, and organizations with FDA-designated minor use or minor species drugs requiring safety and effectiveness testing
Eligibility
• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)
Frequently Asked Questions
Who is eligible for Minor Use Minor Species Development of Drugs (R01)?
Eligible applicants include institutions and organizations developing designated new animal drugs or serving as research partners with drug developers. Your organization must have an open Investigational New Animal Drug (INAD) file with FDA/CVM and hold a minor use or minor species designation from OMUMS for your specific drug and intended use. The program accepts faith-based organizations, community-based organizations, regional organizations, and non-domestic (foreign) entities. For detailed eligibility verification and current requirements, consult the official FDA/CVM website or contact the administering agency directly.
How much funding does Minor Use Minor Species Development of Drugs (R01) provide?
Grant awards range up to $250,000, though specific amounts vary based on the scope and nature of proposed safety and effectiveness testing. The actual funding level depends on your research protocol, study design, and FDA/CVM review and concurrence of your proposed study plan. For precise funding details for your specific application, contact FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) or visit the official grant announcement.
How do I apply for Minor Use Minor Species Development of Drugs (R01)?
To apply, ensure your organization has: (1) an open INAD file with FDA/CVM; (2) a minor use or minor species designation from OMUMS for your drug and intended use; and (3) FDA/CVM's Office of New Animal Drug Evaluation (ONADE) review and concurrence of your proposed study protocol. Application submission follows standard federal grant processes. Visit the official FDA/CVM Notice of Funding Opportunity (NOFO) and grants.gov for complete application instructions, forms, deadlines, and submission procedures.
What can Minor Use Minor Species Development of Drugs (R01) funding be used for?
Grant funds specifically support qualified safety and effectiveness testing required to meet FDA approval requirements for designated new animal drugs for minor uses in major species or for use in minor species. Allowable costs cover research activities that generate safety and efficacy data necessary for New Animal Drug Application (NADA) submissions. Funding defrays expenses associated with conducting FDA-compliant studies that satisfy regulatory standards. For detailed information on allowable costs and budget categories, refer to the official NOFO and federal grant guidelines.
Last updated: July 5, 2026