The FDA Center for Drug Evaluation and Research is offering a grant to accelerate the creation of data standards for human drug development. The grant aims to establish national, consensus-based standards for clinical studies on drugs and biologics. Applicants can address challenges in data standards development or focus on standardization in specific clinical areas. Applications are due by May 15, 2018.
Opportunity ID: 301705
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-18-015 |
| Funding Opportunity Title: | Data Standards for Clinical Research and Drug Development (U24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Mar 15, 2018 |
| Last Updated Date: | Apr 09, 2018 |
| Original Closing Date for Applications: | May 15, 2018 |
| Current Closing Date for Applications: | May 15, 2018 |
| Archive Date: | Jun 14, 2018 |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $750,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) County governments City or township governments Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The FDA Center for Drug Evaluation and Research is encouraging applications for projects to expedite development of data standards and terminologies to support human drug development and evaluation. The primary objective is to support research and the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts, domains, or therapeutic areas where standardization is needed. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| In the section “Components of Participating Organizations” the organization listed was “Center for Biologics Evaluation and Research (CBER)”. This is incorrect – an error during posting. It should read "Center for Drug Evaluation and Research (CDER)." | Apr 09, 2018 | |
| Change in Eligibility Criteria | Apr 09, 2018 | |
| Mar 15, 2018 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-18-015 |
| Funding Opportunity Title: | Data Standards for Clinical Research and Drug Development (U24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Mar 15, 2018 |
| Last Updated Date: | Apr 09, 2018 |
| Original Closing Date for Applications: | May 15, 2018 |
| Current Closing Date for Applications: | May 15, 2018 |
| Archive Date: | Jun 14, 2018 |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $750,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) County governments City or township governments Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The FDA Center for Drug Evaluation and Research is encouraging applications for projects to expedite development of data standards and terminologies to support human drug development and evaluation. The primary objective is to support research and the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts, domains, or therapeutic areas where standardization is needed. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-18-015 |
| Funding Opportunity Title: | Data Standards for Clinical Research and Drug Development (U24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 09, 2018 |
| Last Updated Date: | Mar 15, 2018 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 15, 2018 |
| Archive Date: | Jun 14, 2018 |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $750,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal governments (Federally recognized) County governments City or township governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The FDA Center for Drug Evaluation and Research is encouraging applications for projects to expedite development of data standards and terminologies to support human drug development and evaluation. The primary objective is to support research and the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts, domains, or therapeutic areas where standardization is needed. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-18-015 |
| Funding Opportunity Title: | Data Standards for Clinical Research and Drug Development (U24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Mar 15, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 15, 2018 |
| Archive Date: | Jun 14, 2018 |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $750,000 |
| Award Floor: | $250,000 |
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 Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The FDA Center for Drug Evaluation and Research is encouraging applications for projects to expedite development of data standards and terminologies to support human drug development and evaluation. The primary objective is to support research and the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts, domains, or therapeutic areas where standardization is needed. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@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 | RFA-FD-18-015 | FORM E | PKG00239297 | Mar 15, 2018 | May 15, 2018 | View |
Package 1
Mandatory forms
301705 RR_SF424_2_0-2.0.pdf
301705 PHS398_CoverPageSupplement_4_0-4.0.pdf
301705 RR_OtherProjectInfo_1_4-1.4.pdf
301705 PerformanceSite_2_0-2.0.pdf
301705 RR_KeyPersonExpanded_2_0-2.0.pdf
301705 RR_Budget_1_4-1.4.pdf
301705 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
301705 RR_SubawardBudget30_1_4-1.4.pdf
301705 PHS_AssignmentRequestForm_2_0-2.0.pdf
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