Minor Use Minor Species Development of Drugs (R01)

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Description

This grant opportunity, offered by the FDA Center for Veterinary Medicine (CVM), supports research projects (R01) that develop or facilitate the development of new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The program aims to defray the costs of qualified safety and effectiveness studies required for FDA approval or conditional approval of MUMS-designated drugs.

Eligible projects must focus on generating data that will directly support FDA approval or conditional approval of a drug for a MUMS-designated use. The applicant must have an open Investigational New Animal Drug (INAD) file and a MUMS designation for the drug and intended use, and the proposed study protocol must be reviewed and concurred by FDA/CVM's Office of New Animal Drug Evaluation (ONADE) prior to application.

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Due Dates

• Upcoming Application Deadlines:

  • July 25, 2025
  • January 30, 2026
  • July 24, 2026
  • January 29, 2027

• Letter of Intent Deadlines:

  • June 20, 2025 (for July 25, 2025 application)
  • December 26, 2025 (for January 30, 2026 application)
  • June 19, 2026 (for July 24, 2026 application)
  • December 25, 2026 (for January 29, 2027 application)

Note: Late applications will not be accepted. All applications are due by 11:59 PM Eastern Time on the listed dates.

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Funding Amount

• Maximum Award: $250,000 total costs (direct + indirect) per year.
• Project Duration:
  • Most studies: 1 year.
  • Long-term toxicological studies: up to 3 years (with noncompetitive renewals dependent on performance, compliance, and funding).
• Budget Justification: Applicants must justify the need for more than one year of support if applicable.

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Eligibility

• Eligible Applicants:

  • Public and private institutions of higher education
  • Nonprofits (with or without 501(c)(3) status)
  • For-profit organizations (including small businesses)
  • State, county, city, township, and special district governments
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • Native American tribal governments and organizations
  • Faith-based and community-based organizations
  • Regional organizations
  • Non-domestic (non-U.S.) entities (foreign organizations)

• Program-Specific Requirements:

  • The applicant (or research partner) must be developing or supporting the development of a MUMS-designated new animal drug.
  • The applicant must have:
    • An open INAD file with FDA/CVM.
    • A MUMS "designation" for the drug and intended use from FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS).
    • FDA/CVM/ONADE concurrence on the proposed study protocol before application submission.
  • The study protocol must be submitted under an active INAD and support the development of the MUMS-designated drug toward FDA approval or conditional approval.
  • Applicants must remain in compliance with INAD and designation regulations throughout the project period.

• Eligible Studies:

  • Studies supporting target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies (e.g., stability, analytical method validation, homogeneity/segregation of animal feed).
  • Analytical method validation studies prior to in-life human food safety studies (with FDA protocol concurrence).

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Application Process

• Application Submission:

  • Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
  • All required registrations (SAM, eRA Commons, Grants.gov) must be completed before submission.
  • Follow the NIH How to Apply - Application Guide except where the NOFO provides specific instructions.

• Required Attachments:

  • Appendix 1: The FDA/CVM/ONADE-concurred study protocol (unaltered).
  • Appendix 2: Protocol concurrence letter or reference with submission identifier.
  • Appendix 3: If the applicant is not the drug sponsor, a letter documenting the relationship between the sponsor and applicant.
  • Appendix 4: Letter from the product supplier confirming availability of the investigational product.

• Page Limits:

  • Specific Aims: 1 page.
  • Research Strategy: 12 pages (does not include the protocol, which is a separate appendix).

• Budget:

  • Provide a detailed budget and justification for each year requested.
  • Indirect costs: If no negotiated rate, a de minimis rate of 10% MTDC is allowed; foreign organizations are limited to 8% MTDC.

• Human Subjects/Vertebrate Animals:

  • Complete the PHS Human Subjects and Clinical Trials Information form if applicable.
  • Animal studies must comply with OLAW requirements.

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Additional Information

• No resubmissions are permitted for this NOFO.
• No cost sharing is required.
• Data Management and Sharing Plan is not required for this NOFO.
• Foreign organizations are eligible and must follow HHS grants policy for foreign entities.
• Performance and financial reporting is required annually.

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External Links

• Full Funding Opportunity Announcement (PAR-24-216)
• FDA Office of Minor Use and Minor Species Animal Drug Development (OMUMS)
• NIH How to Apply - Application Guide
• FDA Minor Use/Minor Species Designations List
• Grants.gov Opportunity Listing

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Contact Information

For additional details, see the Agency Contacts section of the NOFO.