Description
FDA awards Research Project (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 Food & Drug Administration’s (FDA) Center for Veterinary Medicine’s (CVM) Office of Minor Use & Minor Species Animal Drug Development (OMUMS) was created after “The Minor Use and Minor Species Animal Health Act of 2004” (MUMS act) was signed into law. The MUMS act helps make more medications legally available to veterinarians and animal owners to treat minor animal species and minor uses in major animal species (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, swine, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use is the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually in the United States.For the purposes of determining whether any particular use in a major species is a minor use, the FDA has established a specific “small number of animals” for each of the seven major animal species as follows: Horses-50,000 annually; Dogs-70,000 annually; Cats-120,000 annually; Cattle-310,000 annually; Swine-1,450,000 annually; Turkeys-14,000,000 annually; and Chickens-72,000,000 annually. Additional information about minor use and minor species is available on the FDA’s website for OMUMS. The FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants 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. The drug being studied must be designated through a formal request to FDA/CVM/OMUMS by the company developing the drug for veterinary use under their Investigational New Animal Drug File (INAD).There are two levels of funding available. Grants will be awarded up to $100,000 per year for up to 2 years, or up to $150,000 per year for up to 3 years in certain cases. Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. Study proposals for the larger grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.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.See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.