Therapeutic Areas for Data Standards Development (U01)

The summary for the Therapeutic Areas for Data Standards Development (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.
Therapeutic Areas for Data Standards Development (U01): Establishing common study data standards will provide new opportunities to transform the vast and continually increasing amount of clinical study data received into useful information to speed the delivery of new therapies to patients. Standardized data elements, terminologies, and data structures enable automation of important analyses of clinical study data to support more efficient and effective regulatory decision-making. In 2011, in response to an urgent need to further standardize study data terminologies and concepts for efficacy analysis, FDA’s Center for Drug Evaluation and Research (CDER) compiled a prioritized list of disease and therapeutic areas (TAs) for which additional data standardization was needed, and made the list available on the FDA website.

The primary objective of this funding opportunity is to support projects leading to the development of specifications for TAs which capture how to structure commonly collected data and outcome measurements in disease clinical trials.
Federal Grant Title: Therapeutic Areas for Data Standards Development (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-16-020
Type of Funding: Cooperative Agreement
CFDA Numbers: 320592
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: $675,000
Maximum Federal Grant Award: $225,000
Minimum Federal Grant Award: none
Expected Number of Awards: 3
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Small businesses
For profit organizations other than small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Public and State controlled 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 Funding Announcement of RFA-FD-16-020
Grant Announcement Contact
Eric Bozoian Grants Management Specialist Phone 2404027623
[email protected]

Food and Drug Administration 240-402-7592