Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)

Post Date

April 1st 2016

Application Due Date

June 3rd 2016

Funding Opportunity Number

RFA-FD-16-008

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $250000

Grant Description

Electronic data standards are needed for the animal efficacy studies and natural history studies for Animal Rule applications (see 21 CFR 314.600-650 for drugs and 21 CFR 601.90-95 for biological products). CDER is seeking organization(s) to refine and complete its preliminary work in this area and to publish a complete set of voluntary consensus standards for these studies, incorporating the relevant current electronic data standards from Standard for Exchange of Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM) and creating any new standards needed to characterize data from these studies.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Eric Bozoian
  Grants Management Specialist
  Phone 2404027623

• Agency Mailing Address:

  eric.bozoian@fda.hhs.gov

• Agency Email Address:

  eric.bozoian@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-16-008