Minor Use Minor Species Development of Drugs; Research Project Grant (R01)

Food and Drug Administration

Description

The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in the areas representing the investigators’ specific interest and competencies based on the mission of FDA. FDA Awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization. The Office of Minor Use & Minor Species Animal Drug Development (OMUMS) was created to promote the development of drugs intended for minor use in major species of animals or for use in minor species of animals (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, pigs, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use in a major species is one that involves use of a drug in no more than the following number of animals of a major species in the United States on an annual basis: Horses-50,000; Dogs-70,000; Cats-120,000; Cattle-310,000; Pigs-1,450,000; Turkeys-14,000,000; Chickens-72,000,000. Additional information about OMUMS is available on FDA’s Website at www.fda.gov/cvm/minortoc.htm. The primary goal of FDA’s OMUMS grant program is to support the development of drugs intended for minor use or intended for use in minor species. Only animal drugs that have qualified for designation in accordance with the provisions of 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to defray the costs of qualified safety and effectiveness testing, or expenses incurred in the development of processes and procedures associated with manufacture of a designated MUMS drug. However, this FOA only relates to grants to defray 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. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the application’s “Background and Significance” section. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Marc Pitts <br/>Electron Research Administration Liaison <br/>Phone 301-827-7162
Marc.Pitts@FDA.HHS.GOV