Minor Use Minor Species Development of Drugs (R01)
Description
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
See official grant page for eligibility requirements
Industry Tags
About This Grant
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.
Funding Information
- Award Ceiling
- $250,000
- Estimated Total Program Funding
- $250,000
Eligibility Overview
This opportunity from Food and Drug Administration is open to eligible applicants nationwide. Organizations working in Federal are especially encouraged to review the requirements.
Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:
- Nonprofits and 501(c)(3) organizations
- Small businesses and startups (especially for SBIR/STTR programs)
- State, local, and tribal governments
- Colleges, universities, and research institutions
- Individuals (for select programs in education, arts, and research)
Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.
How to Apply
- 1
Review the full opportunity
Read the complete Notice of Funding Opportunity (NOFO) for this Food and Drug Administration program on its official page (https://www.grants.gov/search-results-detail/354573).
- 2
Confirm eligibility
Check that your organization meets every requirement set by Food and Drug Administration — applicant type, location, registration status, and any prior-award restrictions.
- 3
Prepare required documents
Gather your budget narrative, needs statement, organizational details, SAM.gov registration, and any required certifications.
- 4
Submit before the deadline
This opportunity closes on January 29, 2027. Submit at least 48 hours early — portal systems are often slow near closing time.
Grant Writing Tips
Proposals for federal programs such as those from Food and Drug Administration are competitive — these tips can strengthen your application:
- ✓Start your application at least 4 weeks before the deadline — rushed proposals score lower.
- ✓Tailor your needs statement to match the funder's stated priorities, using their exact language where possible.
- ✓Have a colleague outside your team review your budget narrative before submitting — fresh eyes catch errors reviewers penalize.
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Frequently Asked Questions
Who is eligible for Minor Use Minor Species Development of Drugs (R01)?
This opportunity from Food and Drug Administration is open to eligible applicants nationwide. Organizations working in Federal are especially encouraged to review the requirements. Always confirm the full eligibility criteria on the official listing before applying.
How much funding does Minor Use Minor Species Development of Drugs (R01) provide?
Minor Use Minor Species Development of Drugs (R01) provides awards of up to $250,000.
When is the deadline for Minor Use Minor Species Development of Drugs (R01)?
The application deadline for Minor Use Minor Species Development of Drugs (R01) is January 29, 2027. Submit at least 48 hours early to avoid last-minute portal issues.
How do I apply for Minor Use Minor Species Development of Drugs (R01)?
Apply for Minor Use Minor Species Development of Drugs (R01) through the official grant page (https://www.grants.gov/search-results-detail/354573). Confirm your eligibility and prepare your application materials before the deadline.
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