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

Quick Facts

Due DateOctober 18, 2018 (Thursday)
Award Amount$ 250,000 - $ 500,000
Category of Funding ActivityBusiness and Commerce
Community Development
Consumer Protection
Education
Environment
Food and Nutrition
Health
Natural Resources
Science and Technology and other Research and Development
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 - 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)

Program Description

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.

General Information

Funding Opportunity NumberRFA-FD-15-001
Funding Opportunity TitleClinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
Opportunity CategoryBusiness and Commerce
Community Development
Consumer Protection
Education
Environment
Food and Nutrition
Health
Natural Resources
Science and Technology and other Research and Development
Funding Instrument TypeGrant
Category ExplanationNot Available
Number of Awards10
Cost Sharing or Matching RequirementNo
Posted DateDecember 9, 2014 (Tuesday)
Application Due DateOctober 18, 2018 (Thursday)
***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
Application Archive DateNovember 17, 2018 (Saturday)
Total Program Funding$ 14,100,000
Award Amount$ 250,000 - $ 500,000
CFDA Number
  • 93.103 - Food and Drug Administration_Research

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 - 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)

Contact Information

Agency NameDepartment of Health and Human Services
Program Information WebsiteNIH Guide
ContactOffice: Food & Drug Administration
Vieda Hubbard
Grants Management Specialist
Phone 240-402-7588
vieda.hubbard@fda.hhs.gov

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