Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

The summary for the Clinical Studies of Safety and Effectiveness of Orphan Products 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.
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01): The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a "rare disease or condition" and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Federal Grant Title: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Information and Statistics Natural Resources Regional Development Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-13-001
Type of Funding: Grant
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Oct 16, 2014
Original Application Deadline: Oct 16, 2014
Posted Date: Dec 10, 2012
Creation Date: Nov 01, 2012
Archive Date: Nov 15, 2014
Total Program Funding: $14,100,000
Maximum Federal Grant Award: $400,000
Minimum Federal Grant Award: $200,000
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 - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - 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
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
Grant Announcement Contact
Vieda HUBBARD Grants Management Specialist Phone 301-827-7177

vieda.hubbard@fda.hhs.gov [vieda.hubbard@fda.hhs.gov]
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