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

Post Date

December 9th 2014

Application Due Date

October 18th 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

Funding Opportunity Number

RFA-FD-15-001

CFDA Number(s)

93.103

Funding Instrument Type(s)

Grant

Funding Activity Categories

Business and Commerce
Community Development
Consumer Protection
Education
Environment
Food and Nutrition
Health
Natural Resources
Science and Technology and other Research and Development

Number of Awards

10

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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)

Funding

• Estimated Total Funding:

  $14100000

• Award Range:

  $250000 - $500000

Grant 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 рrare disease or conditionс and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Vieda Hubbard
  Grants Management Specialist
  Phone 240-402-7588

• Agency Mailing Address:

  vieda.hubbard@fda.hhs.gov

• Agency Email Address:

  vieda.hubbard@fda.hhs.gov

• More Information:

  NIH Guide