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 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 Drug Administration
Grant Categories: Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Natural Resources Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-15-001
Type of Funding: Grant
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Oct 18, 2018 Application Due Date(s): February 4,
Original Application Deadline: Oct 18, 2018 Application Due Date(s): February 4,
Posted Date: December 9th, 2014
Creation Date: Oct 22, 2014
Archive Date: Nov 17, 2018
Total Program Funding: $14,100,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: $250,000
Expected Number of Awards: 10
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Public and State controlled institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
State governments
Private institutions of higher education
Special district 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
Native American tribal governments (Federally recognized)
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
Public housing authorities/Indian housing authorities
Small businesses
Independent school districts
City or township governments
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
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)


Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
U.S. Territory or Possession
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Link to Full Grant Announcement
NIH Guide
Grant Announcement Contact
Vieda Hubbard Grants Management Specialist Phone 240-402-7588
vieda.hubbard@fda.hhs.gov

Food & Drug Administration 301-443-5869
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