November 21, 2014
The Food and Drug Administration (FDA) will publish a New Funding Opportunity Announcement (FOA) entitled “Minor Use Minor Species Development of Drugs; Research Project Grant (R01)” in early 2015. The new FOA will replace #RFA-FD-12-003, which is set to expire on January 17, 2015. The grant program was established by the Minor Use and Minor Species Animal Health Act of 2004, and is administered by the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) at the FDA Center for Veterinary Medicine (CVM).
The new FOA will contain open dates (earliest submission dates) and application due dates for a three year period from 2015 to 2018. The first two anticipated open periods for submission of grant applications will be Early Summer 2015 and Late Fall 2015. The new FOA will be found in its entirety on www.grants.gov.
The FOA issued by FDA/CVM solicits Research Project (R01) grant applications from institutions or organizations that propose to develop, or support the development of, new animal drugs intended for minor use in major species or intended for use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated intended use.