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 and Drug Administration, which is the U.S. government agency offering this grant.
Minor Use Minor Species Development of Drugs; Research Project Grant (R01): 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.
Federal Grant Title: Minor Use Minor Species Development of Drugs; Research Project Grant (R01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Business and Commerce Consumer Protection Education Employment Labor and Training Health Housing Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-09-008
Type of Funding: Grant
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jul 01, 2009
Original Application Deadline: Jul 01, 2009
Posted Date: May 22, 2009
Creation Date: May 22, 2009
Archive Date: Jul 31, 2009
Total Program Funding: $750,000
Maximum Federal Grant Award: $100,000
Minimum Federal Grant Award: $50,000
Expected Number of Awards: 10
Cost Sharing or Matching: No
Applicants Eligible for this Grant
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 tribal governments) - Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Hispanic-serving Institutions* Historically Black Colleges and Universities (HBCUs)* Tribally Controlled Colleges and Universities (TCCUs)* Alaska Native and Native Hawaiian Serving Institutions * For-Profit Organizations (Other than Small Businesses)* Indian/Native American Tribally Designated Organizations* U.S. Territory or Possession Indian/Native American Tribal Governments (Other than Federally Recognized)* Non-domestic (non-U.S.) Entities (Foreign Organizations) * Eligible Agencies of the Federal Government - Agencies that are part of HHS may not apply * Faith-based or Community-based Organizations
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
Marc Pitts Electron Research Administration Liaison Phone 301-827-7162

Marc.Pitts@FDA.HHS.GOV [Marc.Pitts@FDA.HHS.GOV]
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