Minor Use Minor Species Development of Drugs (R01)
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Oct 19, 2026
Can you apply?
This grant is for institutions and organizations developing new animal drugs for minor uses in major species or any uses in minor species. Organizations must be directly developing drugs for veterinary use or working as research partners with drug developers. Applicants must have an open Investigational New Animal Drug (INAD) file with FDA/CVM and hold an FDA/CVM minor use or minor species designation for the specific drug and intended use. FDA/CVM's Office of New Animal Drug Evaluation must review and approve the study protocol before submission.
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Program 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.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Federal Application for Grants and Cooperative Agreements)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Investigational New Animal Drug (INAD) file documentation
- FDA/CVM minor use or minor species designation letter
- Study protocol with FDA/CVM Office of New Animal Drug Evaluation concurrence
- Institutional biosafety documentation (if applicable)
Program contact
- 👤 Terrin Brown Grantor
- 📧 terrin.brown@fda.hhs.gov
- 📞 2404027610
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$137,050,554
-
$76,105,626
-
$53,144,194
-
$52,672,417
-
$38,251,997
-
$36,000,000
-
$35,391,995
-
$32,562,281
-
$30,732,300
-
$25,132,999
Top States by Funding
- AZ 4 awards $149.9M
- CA 9 awards $114.6M
- MD 7 awards $112.8M
- VA 7 awards $104.5M
- PA 11 awards $86.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who is eligible to apply for this grant?
Organizations developing veterinary drugs or research partners working with drug developers. Your organization must have an open INAD file and FDA/CVM minor use/minor species designation for your specific drug.
Do I need FDA approval before applying?
Yes. FDA/CVM's Office of New Animal Drug Evaluation must review and concur with your study protocol before you submit the application.
What can the grant fund?
Costs of safety and effectiveness testing required to meet FDA approval requirements for minor use or minor species drugs.
When is the deadline?
The fixed deadline is January 29, 2027.
What is the funding amount?
The total funding pool is $250,000 for this round of awards.
💡 Tips for applicants
- Start FDA/CVM protocol review process well before the January 2027 deadline. Approval takes time.
- Develop a clear testing plan that directly addresses FDA approval requirements. Focus on safety and effectiveness data.
- Partner with experienced veterinary researchers if you lack in-house expertise. FDA values rigorous study design.
- Budget realistically for all required safety and effectiveness testing. Underestimation causes problems later.
- Obtain your minor use or minor species designation before beginning the full application process.
⚠️ Common mistakes
Applications without FDA/CVM protocol approval or minor use/minor species designation are rejected immediately. Study protocols that lack rigor or don't align with FDA approval standards are unfunded. Applicants underestimate testing costs, leading to incomplete or failed research.
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