The FDA IMEDS-Methods Research Grant program, under the Reagan-Udall Foundation, aims to support the FDA’s Sentinel Initiative in enhancing post-market drug safety monitoring. Researchers will focus on developing new analytic methodologies in areas such as bias reduction, data utility, risk/benefit assessment, and supporting investigators with access to electronic healthcare data. The program seeks to improve post-marketing surveillance tools and promote their adoption by industry, government, and academic researchers. Grant applications are welcome until June 15, 2015, to advance methods research for enhancing drug safety evaluation in large databases.
Opportunity ID: 275869
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-010 |
| Funding Opportunity Title: | IMEDS- Methods Research Agenda |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Community Development Education Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 15, 2015 |
| Last Updated Date: | Apr 15, 2015 |
| Original Closing Date for Applications: | Jun 15, 2015 |
| Current Closing Date for Applications: | Jun 15, 2015 |
| Archive Date: | Jul 15, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $1 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligibility is limited to the Reagan Udall Foundation. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians that have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel distributed database. In addition, through the Reagan-Udall Foundation partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government and industry so that the findings and tools developed through its research agenda will be promulgated and adopted. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Section 905 of the Food and Drug Administration Amendments Act (FDAAA) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption.
Research Objectives IMEDS plans to conduct methods research in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. |
| Link to Additional Information: | Federal Register |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 240-402-7588 Email:vieda.hubbard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Opportunity Number corrected | Apr 15, 2015 | |
| Apr 15, 2015 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-010 |
| Funding Opportunity Title: | IMEDS- Methods Research Agenda |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Community Development Education Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 15, 2015 |
| Last Updated Date: | Apr 15, 2015 |
| Original Closing Date for Applications: | Jun 15, 2015 |
| Current Closing Date for Applications: | Jun 15, 2015 |
| Archive Date: | Jul 15, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $1 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligibility is limited to the Reagan Udall Foundation. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians that have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel distributed database. In addition, through the Reagan-Udall Foundation partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government and industry so that the findings and tools developed through its research agenda will be promulgated and adopted. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Section 905 of the Food and Drug Administration Amendments Act (FDAAA) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption.
Research Objectives IMEDS plans to conduct methods research in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. |
| Link to Additional Information: | Federal Register |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 240-402-7588 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD015-010 |
| Funding Opportunity Title: | IMEDS- Methods Research Agenda |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Community Development Education Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 15, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 15, 2015 |
| Archive Date: | Jul 15, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $1 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligibility is limited to the Reagan Udall Foundation. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians that have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel distributed database. In addition, through the Reagan-Udall Foundation partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government and industry so that the findings and tools developed through its research agenda will be promulgated and adopted. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Section 905 of the Food and Drug Administration Amendments Act (FDAAA) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA’s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption.
Research Objectives IMEDS plans to conduct methods research in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. |
| Link to Additional Information: | Federal Register |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 240-402-7588 Email:vieda.hubbard@fda.hhs.gov |
Related Documents
Folder 275869 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc.pdf
Folder 275869 Full Announcement-2 -> rfa-fd-15-010 ruf occ clearance.pdf
Packages
| Agency Contact Information: | Vieda Hubbard Grants Management Specialist Phone 240-402-7588 Email: vieda.hubbard@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 | PKG00216150 | Apr 15, 2015 | Jun 15, 2015 | View |
Package 1
Mandatory forms
275869 RR_SF424_2_0-2.0.pdf
275869 PHS398_ResearchPlan_2_0-2.0.pdf
275869 PHS398_CoverPageSupplement_2_0-2.0.pdf
275869 RR_Budget_1_3-1.3.pdf
275869 RR_KeyPersonExpanded_2_0-2.0.pdf
275869 RR_OtherProjectInfo_1_3-1.3.pdf
275869 PerformanceSite_2_0-2.0.pdf
Optional forms
275869 PlannedReport-1.0.pdf
275869 PHS398_CumulativeInclusionReport-1.0.pdf
275869 RR_SubawardBudget30_1_3-1.3.pdf
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