This grant is for advancing the post-market surveillance of medical devices. Its primary purpose is to develop new and adapt existing methodologies for collecting and linking registry data related to medical devices. Furthermore, the grant aims to create novel frameworks that enable these registry data infrastructures to serve multiple functions beyond just surveillance, including device tracking through Unique Device Identifiers (UDI), facilitating prospective embedded studies, and supporting quality improvement initiatives. Ultimately, this funding seeks to establish specialized registries and consortia in key medical device areas. This will facilitate the implementation of new registry methodologies, strategically expanding the reach and effectiveness of both US and international post-market surveillance systems.
Opportunity ID: 231113
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-202 |
| Funding Opportunity Title: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Apr 19, 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 May 31, 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: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Small businesses City or township 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) Public housing authorities/Indian housing authorities County governments Special district governments Private institutions of higher education For profit organizations other than small businesses |
| 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 address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and(3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system. |
| Link to Additional Information: | Link to Full Announcement PAR-13-202 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 |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update to application due date. | Apr 19, 2016 | |
| The original due date of April 29, 2016 is no longer valid.
The next application due date(s) is: May 13, 2016 by 11:59 PM Eastern Time. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application by the due date. |
Apr 19, 2016 | |
| First application due date is now June 14, 2013. | Apr 18, 2016 | |
| May 29, 2013 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-202 |
| Funding Opportunity Title: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Apr 19, 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 May 31, 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: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Small businesses City or township 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) Public housing authorities/Indian housing authorities County governments Special district governments Private institutions of higher education For profit organizations other than small businesses |
| 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 address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and(3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system. |
| Link to Additional Information: | Link to Full Announcement PAR-13-202 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 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-13-202 |
| Funding Opportunity Title: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 19, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2016 This FOA has multiple receipt dates. The first application due date is June 14, 2013, by 11:59 PM Eastern Time. The next application due date(s) is: May 13, 2016 by 11:59 PM Eastern Time.
The original due date of April 29, 2016 is no longer valid. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application by the due date. |
| Archive Date: | May 30, 2017 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Special district governments Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities |
| 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 address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and(3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system. |
| Link to Additional Information: | Link to Full Announcement PAR-13-202 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-13-202 |
| Funding Opportunity Title: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 18, 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 June 14, 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: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Special district governments Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities |
| 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 address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and(3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system. |
| Link to Additional Information: | Link to Full Announcement PAR-13-202 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-13-202 |
| Funding Opportunity Title: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| 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 May 31, 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: | $300,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Special district governments Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities |
| 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 address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and
(2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and (3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system. |
| Link to Additional Information: | Link to Full Announcement PAR-13-202 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 Specialist 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 6/14/2013 | PKG00187790 | Oct 28, 2013 | May 13, 2016 | View |
Package 1
Mandatory forms
231113 RR_SF424_2_0-2.0.pdf
231113 PHS398_ResearchPlan_2_0-2.0.pdf
231113 PHS398_CoverPageSupplement_2_0-2.0.pdf
231113 RR_Budget_1_3-1.3.pdf
231113 RR_KeyPersonExpanded_2_0-2.0.pdf
231113 RR_OtherProjectInfo_1_3-1.3.pdf
231113 PerformanceSite_2_0-2.0.pdf
Optional forms
231113 PlannedReport-1.0.pdf
231113 PHS398_CumulativeInclusionReport-1.0.pdf
231113 RR_SubawardBudget30_1_3-1.3.pdf
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