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OpenR01

Minor Use Minor Species Development of Drugs (R01)

Food and Drug Administration · Other Federal · PAR-24-216

Source: Grants.gov · View original posting ↗

Award
Up to $250K
Deadline
Jan 29, 2027
Letter of intent
Mechanism
R01
Duration
Expected awards
Funding cycle
Standard NIH dates
Open date
May 29, 2024
Total funding
$250K total
Clinical trial
Unspecified
Established investigatorGovernmentHigher educationSmall businessNonprofitForeign entities

Research areas

Therapeutics & drug discovery

Auto-classified from the title and description (keyword-based) — may be imperfect.

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.