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

The summary for the Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01): 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.
Federal Grant Title: Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-16-008
Type of Funding: Cooperative Agreement
CFDA Numbers: 320564
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jun 3, 2016
Original Application Deadline: Jun 3, 2016
Posted Date: Apr 1, 2016
Creation Date: Apr 1, 2016
Archive Date: Jul 3, 2016
Total Program Funding: $250,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award: none
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
State governments
Small businesses
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
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education
County governments
Private institutions of higher education
Additional Information on Eligibility
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.
Link to Full Grant Announcement
Full Announcement of RFA-FD-16-008
Grant Announcement Contact
Eric Bozoian Grants Management Specialist Phone 2404027623
[email protected]

Food and Drug Administration 240-402-7592