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

The summary for the Minor Use Minor Species Development of Drugs; Research Project Grant (R01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.
Minor Use Minor Species Development of Drugs; Research Project Grant (R01): 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.
Federal Grant Title: Minor Use Minor Species Development of Drugs; Research Project Grant (R01)
Federal Agency Name: Food Drug Administration
Grant Categories: Other
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-15-004
Type of Funding: Grant
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jan 13, 2018
Original Application Deadline: Jan 13, 2018
Posted Date: Mar 11, 2015
Creation Date: Mar 11, 2015
Archive Date: Feb 12, 2018
Total Program Funding: $3,000,000
Maximum Federal Grant Award: $150,000
Minimum Federal Grant Award: $0
Expected Number of Awards: 10
Cost Sharing or Matching: No
Category Explanation
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.
Applicants Eligible for this Grant
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Native American tribal governments (Federally recognized)
State governments
Special district governments
Private institutions of higher education
Small businesses
Independent school districts
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
County governments
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Link to Full Grant Announcement
NIH Guide for Grants and Contracts
Grant Announcement Contact
Oluyemisi (Yemisi) Akinneye Grants Management Specialist Phone 240-402-7560
Oluyemisi.Akinneye@fda.hhs.gov

Food & Drug Administration 301-443-5869
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