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

Department of Health and Human Services

 
Synopsis
       


The synopsis for this grant opportunity is detailed below, following this paragraph. This synopsis contains all of the updates to this document that have been posted as of 04/16/2010 . If updates have been made to the opportunity synopsis, update information is provided below the synopsis.

If you would like to receive notifications of changes to the grant opportunity click send me change notification emails . The only thing you need to provide for this service is your email address. No other information is requested.

Any inconsistency between the original printed document and the disk or electronic document shall be resolved by giving precedence to the printed document.

Description of Modification

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’T SUBMIT YOUR ADOBE – FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/6/2011

Document Type: Modification to Previous  Grants Notice
Funding Opportunity Number: RFA-FD-10-001
Opportunity Category: Discretionary
Posted Date: Apr 16, 2010
Creation Date: Mar 25, 2011
Original Closing Date for Applications: May 14, 2010    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.
Current Closing Date for Applications: May 14, 2010    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’T SUBMIT YOUR ADOBE – FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/5/2011
Archive Date:
Funding Instrument Type: Grant
Category of Funding Activity: Agriculture
Business and Commerce
Consumer Protection
Education
Employment, Labor and Training
Environment
Health
Regional Development
Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 10
Estimated Total Program Funding: $750,000
Award Ceiling: $100,000
Award Floor: $50,000
CFDA Number(s): 93.103  --  Food and Drug Administration_Research
Cost Sharing or Matching Requirement: No

Eligible Applicants

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 of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization*Federal Government Agencies (that are not part of HHS)

Agency Name

Food & Drug Administration

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’s “Background and Significance” 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.

Link to Additional Information

NIH Guide for Grants and Contracts

If you have difficulty accessing the full announcement electronically, please contact:

Vieda Hubbard
Grants Management Specialist
Office of Acquisitions & Grants Services, FDA
5630 Fishers Lane, Room 1079
Rockville, MD 20857

Phone: (301) 827-7177
Fax: (301) 827-7039
Email: Vieda.Hubbard@fda.hhs.gov
Vieda.Hubbard@fda.hhs.gov

Synopsis Modification History

The following files represent the modifications to this synopsis with the changes noted within the documents. The list of files is arranged from newest to oldest with the newest file representing the current synopsis. Changed sections from the previous document are shown in a light grey background.

File Name Date
Modification #4 Apr 21, 2010
Modification #3 Apr 21, 2010
Modification #2 Apr 16, 2010
Modification #1 Apr 16, 2010
Original Synopsis Apr 16, 2010