The FDA Center for Drug Evaluation and Research (CDER) is offering this grant to expedite the development of crucial data concepts and terminology, specifically aimed at supporting human drug development and evaluation processes. This grant is for the purpose of fostering non-proprietary, consensus-based, national data standards, which are essential for use in clinical studies involving human drugs and biologics. Projects supported by this initiative may focus on finding innovative solutions to general data standards development and implementation challenges that hinder progress. Alternatively, applicants can concentrate on specific clinical concepts or domains where robust standardization is critically needed. The overall goal is to enhance data interoperability and streamline the entire clinical research and drug development lifecycle.
Opportunity ID: 91494
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-209 |
| Funding Opportunity Title: | Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Information and Statistics Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | Development of data concepts and terminology to support human drug development and evaluation |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | May 03, 2011 |
| Last Updated Date: | Dec 20, 2012 |
| Original Closing Date for Applications: | Jun 16, 2011 |
| Current Closing Date for Applications: | Jun 02, 2011 The revised date reflects the correct close date for the receipt date of June 1, 2011. |
| Archive Date: | Nov 16, 2013 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 Public and State controlled institutions of higher education Private 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 (CDER) is encouraging grant applications for programs to expedite development of data concepts and terminology to support human drug development and evaluation. The primary objective is to support the development of non-prietary, 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 or domains where standardization is needed. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| PLEASE NOTE: This Program Announcement will be withdrawn/terminated and replaced with a new Request for Applications (RFA)in FY 2013. At this time the last receipt date for which applications were accepted was November 15, 2012. No applications will be accepted for the initially projected June 1, 2013 and November 15, 2013 receipt dates. | Dec 20, 2012 | |
| Dec 20, 2012 | ||
| May 18, 2011 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-209 |
| Funding Opportunity Title: | Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Information and Statistics Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | Development of data concepts and terminology to support human drug development and evaluation |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | May 03, 2011 |
| Last Updated Date: | Dec 20, 2012 |
| Original Closing Date for Applications: | Jun 16, 2011 |
| Current Closing Date for Applications: | Jun 02, 2011 The revised date reflects the correct close date for the receipt date of June 1, 2011. |
| Archive Date: | Nov 16, 2013 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 Public and State controlled institutions of higher education Private 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 (CDER) is encouraging grant applications for programs to expedite development of data concepts and terminology to support human drug development and evaluation. The primary objective is to support the development of non-prietary, 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 or domains where standardization is needed. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-209 |
| Funding Opportunity Title: | Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Information and Statistics Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | Development of data concepts and terminology to support human drug development and evaluation |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 20, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 02, 2011 The revised date reflects the correct close date for the receipt date of June 1, 2011. |
| Archive Date: | Nov 16, 2013 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have 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 (CDER) is encouraging grant applications for programs to expedite development of data concepts and terminology to support human drug development and evaluation. The primary objective is to support the development of non-prietary, 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 or domains where standardization is needed. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-11-209 |
| Funding Opportunity Title: | Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Information and Statistics Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | Development of data concepts and terminology to support human drug development and evaluation |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 18, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 16, 2011 |
| Archive Date: | Jul 16, 2011 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $50,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have 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 (CDER) is encouraging grant applications for programs to expedite development of data concepts and terminology to support human drug development and evaluation. The primary objective is to support the development of non-prietary, 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 or domains where standardization is needed. |
| Link to Additional Information: | NIH Guide published April 28, 2011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys M. Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gmbohler@fda.hhs.gov |
Related Documents
Folder 91494 Other Supporting Documents-Supplemental Funds 1 -> additional supplemental funds available for par.pdf
Packages
There are no packages on this grant.
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