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

Post Date

May 22nd 2009

Application Due Date

July 1st 2009

Funding Opportunity Number

RFA-FD-09-008

CFDA Number(s)

93.103

Funding Instrument Type(s)

Grant

Funding Activity Categories

Business and Commerce
Consumer Protection
Education
Employment, Labor and Training
Health
Housing
Science and Technology and other Research and Development

Number of Awards

10

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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

Funding

• Estimated Total Funding:

  $750000

• Award Range:

  $50000 - $100000

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Marc Pitts
  Electron Research Administration Liaison
  Phone 301-827-7162

• Agency Mailing Address:

  Marc.Pitts@FDA.HHS.GOV

• Agency Email Address:

  Marc.Pitts@FDA.HHS.GOV

• More Information:

  NIH GUIDE FOR GRANTS & CONTRACT