This grant opportunity from FDA aims to develop data standards for therapeutic areas to improve the efficiency of regulatory decision-making and accelerate the delivery of new therapies to patients. By establishing common study data standards, projects funded under this initiative will focus on structuring collected data and outcome measurements in disease clinical trials. The ultimate goal is to transform clinical study data into valuable information, enhancing the efficacy and speed of bringing new treatments to the market. Applications are accepted until June 3, 2016.
Opportunity ID: 282710
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-020 |
| Funding Opportunity Title: | Therapeutic Areas for Data Standards Development (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 03, 2016 |
| Current Closing Date for Applications: | Jun 03, 2016 |
| Archive Date: | Jul 03, 2016 |
| Estimated Total Program Funding: | $675,000 |
| Award Ceiling: | $225,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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. |
| Link to Additional Information: | Full Funding Announcement of RFA-FD-16-020 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Eric Bozoian
Grants Management Specialist Phone 2404027623 Email:eric.bozoian@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Eric Bozoian Grants Management Specialist Phone 2404027623 Email: eric.bozoian@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00222279 | Apr 04, 2016 | Jun 03, 2016 | View |
Package 1
Mandatory forms
282710 RR_SF424_2_0-2.0.pdf
282710 PHS398_CoverPageSupplement_3_0-3.0.pdf
282710 RR_OtherProjectInfo_1_3-1.3.pdf
282710 PerformanceSite_2_0-2.0.pdf
282710 RR_KeyPersonExpanded_2_0-2.0.pdf
282710 RR_Budget_1_3-1.3.pdf
282710 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282710 RR_SubawardBudget30_1_3-1.3.pdf
282710 PHS_Inclusion_Enrollment_Report-1.0.pdf
282710 PHS_AssignmentRequestForm-1.0.pdf
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