Minor Use Minor Species Development of Drugs (R01)
Funds safety and effectiveness testing to support FDA approval of designated minor-use or minor-species new animal drugs for eligible veterinary drug developers and their research partners.
⚑ Applicant or research partner must be tied to a veterinary drug development effort with an FDA/CVM-opened INAD file and FDA/CVM minor-use/minor-species designation for the drug and intended use. · FDA/CVM Office of New Animal Drug Evaluation must have reviewed and concurred with the proposed study protocol before submission. · Eligible applicants are limited to entities developing veterinary drugs or their research partners; foreign organizations are explicitly eligible. · R01 grant with award ceiling of $250,000.
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 40 partial | technical depth: minor; funds applied research |
| IPPRA | 30 weak | outside portfolio topics; social/behavioral work is none; funds applied research; university can only partner, not lead; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
| Tom Love Innovation Hub | 30 weak | funds applied research; deep-tech content |
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
• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)
Apply
View on Grants.gov → CONTACT: Terrin Brown Grantor <terrin.brown@fda.hhs.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · HHS services agencies (SAMHSA / HRSA / CDC / ACF) conventions SEE AN HHS EXAMPLE →
Funder-faithful document skeletons — HHS services agencies (SAMHSA / HRSA / CDC / ACF)'s document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.