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

Post Date

April 15th 2016

Application Due Date

October 15th 2018

There are two deadlines for this RFA. October 14, 2016 and October 15, 2018, by 11:59 PM Eastern Time.

Funding Opportunity Number

RFA-FD-16-043

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Health

Number of Awards

5

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

Funding

• Estimated Total Funding:

  $2000000

• Award Range:

  $None - $400000

Grant Description

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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Daniel Lukash
  Grants Management Specialist
  Phone 240-402-7596

• Agency Mailing Address:

  daniel.lukash@fda.hhs.gov

• Agency Email Address:

  daniel.lukash@fda.hhs.gov

• More Information:

  Full Announcemnet of RFA-FD-16-043