Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)

The summary for the Natural History Studies for Rare Disease Product Development: 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.
Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01): The objective of FDA's Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States (US) is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the US per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. Additional information may be required upon request, for example, regarding population estimate and rationale.

Federal Grant Title: Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-16-043
Type of Funding: Cooperative Agreement
CFDA Numbers: 321125
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Oct 15, 2018 There are two deadlines for this RFA
Original Application Deadline: Oct 15, 2018 There are two deadlines for this RFA
Posted Date: Apr 15, 2016
Creation Date: Apr 15, 2016
Archive Date: Nov 14, 2018
Total Program Funding: $2,000,000
Maximum Federal Grant Award: $400,000
Minimum Federal Grant Award: none
Expected Number of Awards: 5
Cost Sharing or Matching: No
Applicants Eligible for this Grant
County governments
For profit organizations other than small businesses
Public and State controlled 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)
Small businesses
Independent school districts
Special district governments
Public housing authorities/Indian housing authorities
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Native American tribal organizations (other than Federally recognized tribal governments)
City or township governments
Link to Full Grant Announcement
Full Announcemnet of RFA-FD-16-043
Grant Announcement Contact
Daniel Lukash Grants Management Specialist Phone 240-402-7596
daniel.lukash@fda.hhs.gov

Food and Drug Administration 240-402-7592
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