This National Institutes of Health grant aims to establish a robust National Medical Device Postmarket Surveillance System through collaborative partnerships. It supports the development and application of advanced epidemiologic methodologies to comprehensively understand medical device performance and clinical outcomes in real-world use settings. Key objectives include creating new data collection and analysis systems for proactive risk identification, systematic evidence updates, and visual analytics. Furthermore, the grant seeks to develop approaches that integrate postmarket information into regulatory decision-making across the entire device lifecycle and to foster access to high-quality data sources essential for thorough device evaluation.
Opportunity ID: 235342
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 5 |
| Posted Date: | May 22, 2013 |
| Last Updated Date: | Apr 19, 2016 |
| Original Closing Date for Applications: | Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is June 24, 2013, by 11:59 PM Eastern Time. The next application due date(s) are: April 30, 2014, 2015, 2016, 2017 by 11:59 PM Eastern Time. |
| Current Closing Date for Applications: | May 13, 2016 May 13, 2016 by 11:59 PM eastern Time. |
| Archive Date: | Jun 12, 2016 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Special district governments Small businesses State governments For profit organizations other than small businesses Private institutions of higher education Independent school districts County 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) Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Officer Email:Lisa.Ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Updated application due date. | Apr 19, 2016 | |
| Notice of Change to Application Due Dates and Expiration Date for PAR-13-232 | Apr 19, 2016 | |
| Updated first application due date. The first application due date is July 5, 2013, by 11:59 PM Eastern Time. | Apr 12, 2016 | |
| The first application due date is now July 1, 2013. | Jun 10, 2013 | |
| May 29, 2013 |
DISPLAYING: Synopsis 5
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 5 |
| Posted Date: | May 22, 2013 |
| Last Updated Date: | Apr 19, 2016 |
| Original Closing Date for Applications: | Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is June 24, 2013, by 11:59 PM Eastern Time. The next application due date(s) are: April 30, 2014, 2015, 2016, 2017 by 11:59 PM Eastern Time. |
| Current Closing Date for Applications: | May 13, 2016 May 13, 2016 by 11:59 PM eastern Time. |
| Archive Date: | Jun 12, 2016 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Special district governments Small businesses State governments For profit organizations other than small businesses Private institutions of higher education Independent school districts County 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) Native American tribal organizations (other than Federally recognized tribal governments) |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Officer Email:Lisa.Ko@fda.hhs.gov |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Apr 19, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2016 The next application Due date is May 13, 2016 by 11:59 PM Eastern Time. |
| Archive Date: | May 15, 2016 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments City or township governments Independent school districts Native American tribal governments (Federally recognized) Private 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 Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Grants Management Specialist Email:Martin.Bernard@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 12, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is July 5, 2013, by 11:59 PM Eastern Time. The next application due date(s) are: April 30, 2014, 2015, 2016, 2017 by 11:59 PM Eastern Time. |
| Archive Date: | May 30, 2017 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments City or township governments Independent school districts Native American tribal governments (Federally recognized) Private 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 Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jun 10, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is July 1, 2013, by 11:59 PM Eastern Time. The next application due date(s) are: April 30, 2014, 2015, 2016, 2017 by 11:59 PM Eastern Time. |
| Archive Date: | May 30, 2017 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments Independent school districts City or township governments Native American tribal governments (Federally recognized) Private institutions of higher education State governments 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 |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership 2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings;3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance;4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-232 |
| Funding Opportunity Title: | Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic Methodologies through Multi-stakeholder Partnership (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Business and Commerce Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 29, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Apr 30, 2017 This FOA has multiple receipt dates. The first application due date is June 24, 2013, by 11:59 PM Eastern Time. The next application due date(s) are: April 30, 2014, 2015, 2016, 2017 by 11:59 PM Eastern Time. |
| Archive Date: | May 30, 2017 |
| Estimated Total Program Funding: | $1,100,000 |
| Award Ceiling: | $1,100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Special district governments City or township governments Native American tribal governments (Federally recognized) Independent school districts Private institutions of higher education State governments 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 |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 1) To support implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnership
2) To develop new epidemiologic methodologies or to apply existing methodologies in new ways to provide a comprehensive understanding of medical device performance and clinical outcomes associated with device use in real-world use settings; 3) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification , periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance; 4) To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle ; and 5) To support the development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes. |
| Link to Additional Information: | Link to Full Announcement of PAR-13-232 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Lisa Ko Grants Management Officer Email: Lisa.Ko@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 | ADOBE-FORMS-C | Use for due dates after 7/5/2013 | PKG00187811 | Oct 28, 2013 | May 13, 2016 | View |
Package 1
Mandatory forms
235342 RR_SF424_2_0-2.0.pdf
235342 PHS398_ResearchPlan_2_0-2.0.pdf
235342 PHS398_CoverPageSupplement_2_0-2.0.pdf
235342 RR_Budget_1_3-1.3.pdf
235342 RR_KeyPersonExpanded_2_0-2.0.pdf
235342 RR_OtherProjectInfo_1_3-1.3.pdf
235342 PerformanceSite_2_0-2.0.pdf
Optional forms
235342 PlannedReport-1.0.pdf
235342 PHS398_CumulativeInclusionReport-1.0.pdf
235342 RR_SubawardBudget30_1_3-1.3.pdf
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