OpportunityTitle: Minor Use Minor Species Development of Drugs; Research Project Grant (R01)
AdditionalInformationOnEligibility: Hispanic-serving Institutions of Higher Education&#149;Historically Black Colleges and Universities (HBCUs)&#149;Tribally Controlled Colleges and Universities (TCCUs) &#149;Alaska Native and Native Hawaiian Serving Institutions  Faith-based or Community-based Organization*Federal Government Agencies (that are not part of HHS)
Description: This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. 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. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the application&#146;s &#147;Background and Significance&#148; section. All funded studies are subject to the requirements of 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.
GrantorContactEmailDescription: Vieda.Hubbard@fda.hhs.gov
GrantorContactText: Vieda Hubbard &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Office of Acquisitions &amp; Grants Services, FDA &lt;br/&gt;5630 Fishers Lane, Room 1079 &lt;br/&gt;Rockville, MD 20857 &lt;br/&gt; &lt;br/&gt;Phone: (301) 827-7177  &lt;br/&gt;Fax:     (301) 827-7039 &lt;br/&gt;Email:  Vieda.Hubbard@fda.hhs.gov  &lt;br/&gt;
CloseDateExplanation: This FOA has Multiple Receipt Dates.     The first Application Receipt/Due Date is 05/14/2010.     The Second Application Receipt/Due Date is September 3, 2010.    The Third Application Receipt/Due Date is February 4, 2011.     The Fourth and Final Receipt/Due Date is August 5, 2011.     ATTENTION: AS OF MAY 7, 2011 APPLICANTS WILL NO LONGER BE ABLE TO SUBMIT GRANTS USING THE ADOBE-FORMS-A TEMPLATE PACKAGE. THIS PACKAGE WILL EXPIRE.     IF YOU DON&#146;T SUBMIT YOUR ADOBE &#150; FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/5/2011