Funding-Minor Use Minor Species Development of Drugs; Research Project Grant (R01); August 14, 2015

Agency

U.S. Food and Drug Administration  (FDA)
Center for Veterinary Medicine (CVM)

Description

This Funding Opportunity Announcement (FOA) 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 new animal drugs intended for minor use in major species or intended for use in minor species. 

• The FDA is authorized to provide grants only to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in or substantially contribute to FDA approval or conditional approval of a new animal drug.
• Only companies developing drugs for veterinary use or parties working as research partners with such companies are eligible for grants.
• Only studies in support of new animal drugs that such companies have had designated for specified intended uses by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS), 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, are eligible for grants.
• Qualified studies eligible for funding include those intended to support target animal safety or effectiveness, environmental safety, or human food safety.
• The protocol for a proposed study must be accepted by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) prior to application submission.
• In addition to studies intended to directly establish target animal safety or effectiveness, the following manufacturing studies supportive of target animal safety or effectiveness are eligible for funding, provided a protocol has been accepted by

FDA/CVM/ONADE:

• A study to evaluate the stability of a MUMS drug
• A study to validate analytical methods associated with the manufacture of a MUMS drug
• A study to determine the homogeneity/segregation of an animal feed bearing or containing a MUMS drug
• A study to validate analytical methods for an animal feed bearing or containing a MUMS drug.
• In addition to studies intended to directly establish human food safety, a separate study to validate an analytical method prior to the conduct of an in-life human food safety study is eligible for funding, provided a protocol has been accepted by FDA/CVM/ONADE.
• Applicants must include an explanation of how the proposed study will contribute to FDA approval or conditional approval of the product in the application’s “Significance” section of the Research Strategy (PHS 398 Research Plan).

All funded studies are subject to the requirements of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. 

Activity Code: R01 Research Project Grant

Announcement Number: RFA-FD-15-004

Closing Date: August 14, 2015; January 15, 2016; August 12, 2016; January 13, 2017; August 11, 2017; January 12, 2018

Link to Full Announcement

http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-004.html