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

Opportunity Information: Apply for RFA FD 15 001

The Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) is designed to promote the development of products for rare diseases or conditions where current treatments are lacking or where the new product could be a significant improvement over existing options. The FDA offers funding for clinical studies that investigate the safety and effectiveness of these products, with the ultimate goal of aiding in their market approval. Applicants must provide a detailed Background and Significance section in their applications, which should include evidence that the condition being studied qualifies as rare and an explanation of how the study will contribute to product approval or provide critical data for development.

• The Food Drug Administration in the business and commerce community development consumer protection education environment food and nutrition health natural resources science and technology and other research and development sector is offering a public funding opportunity titled "Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
• This funding opportunity was created on Oct 22, 2014 and posted on Dec 9, 2014.
• Applicants must submit their applications by Oct 18, 2018 Application Due Date(s) February 4, 2015 February 3, 2016 February 1, 2017 February 7, 2018. Resubmission Due Date(s) October 15, 2015 October 14, 2016 October 16, 2017 October 15, 2018). This FOA uses non standard due dates. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
• The funding agency has allocated a total of $14,100,000.00 to eligible and selected applicants.
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• The number of recipients for this funding is limited to 10 candidate(s).
• Eligible applicants include: Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education County governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification).
• 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)

Apply for RFA FD 15 001

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