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This grant aims to develop registries and consortia to enhance post-market surveillance of medical devices by implementing new methodologies and addressing gaps within the current system. The goal is to broaden the scope of postmarket surveillance both in the US and internationally by developing innovative registry data collection methods, tracking devices through Unique Device Identifiers, and utilizing the infrastructure for various purposes. Applications are open until June 25, 2012.
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Opportunity ID: 170816
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-FD-12-028 |
| Funding Opportunity Title:: | Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | 2 |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 1 |
| Posted Date:: | May 15, 2012 |
| Last Updated Date:: | |
| Original Closing Date for Applications:: | Jun 25, 2012 |
| Current Closing Date for Applications:: | Jun 25, 2012 |
| Archive Date:: | Jul 25, 2012 |
| Estimated Total Program Funding:: | $ 250,000 |
| Award Ceiling:: | $125,000 |
| Award Floor:: | $0 |
Eligibility
| Eligible Applicants:: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility:: | Awards made under this announcement will be supported using Critical Path funds as described in Section 566 of the Federal Food Drug and Cosmetic Act (FD&C Act). Section 566(b) of the FD&C Act defines eligible entities as (A) an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965 [20 USC § 1001]) or a consortium of such institutions; or (B) an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 [26 USC § 501(c)(3)] and exempt from tax under section 501(a) of such Code [26 USC § 501(a)]. |
Additional Information
| Agency Name:: | Food and Drug Administration |
| Description:: | (1) 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, and
(2) 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 (3) 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. |
| Link to Additional Information:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | |
| Competition Title: | |
| Opportunity Package ID: | PKG00121991 |
| Opening Date: | May 21, 2012 |
| Closing Date: | Jun 25, 2012 |
| Agency Contact Information:: | Lisa Ko |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00121991 | May 21, 2012 | Jun 25, 2012 | View | Lisa Ko | Organization Applicants |
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