The Department of Health is offering a grant to fund projects that focus on advancing innovative methodologies in medical device epidemiology for medical countermeasure-associated devices. The grant aims to bridge premarket and postmarket evidence gaps, conduct high-quality independent research, develop postmarketing surveillance systems, and enhance communication with stakeholders. Researchers will contribute to medical device regulatory decision-making and promote patient-centered outcomes across the total product life cycle. The closing date for applications is April 30, 2012.
Opportunity ID: 155593
General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-FD-12-010 |
| Funding Opportunity Title:: | Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | 1 |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 1 |
| Posted Date:: | Mar 19, 2012 |
| Last Updated Date:: | |
| Original Closing Date for Applications:: | Apr 30, 2012 |
| Current Closing Date for Applications:: | Apr 30, 2012 |
| Archive Date:: | May 30, 2012 |
| Estimated Total Program Funding:: | $ 2,680,000 |
| Award Ceiling:: | $490,000 |
| Award Floor:: | $1 |
Eligibility
| Eligible Applicants:: | Special district governments |
| Additional Information on Eligibility:: | Non-doemstic (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. Advance and apply innovative methodological solutions to bridge premarket and postmarket evidence of medical countermeasures (MCM)-related device safety and effectiveness, including evidence synthesis, and evaluation of medical device patient-centered outcomes across the total product life cycle (TPLC).
2. Conduct highest quality independent research to contribute to medical device regulatory decision-making for MCM-priority medical devices and radiological health. 3. Advance development, implementation, and evaluation of postmarketing surveillance systems and their application to MCM-priority medical device regulatory science. 4. Promote communication with stakeholders and educational outreach of innovative MCM medical device surveillance and scientific strategies |
| 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: | PKG00108090 |
| Opening Date: | Apr 01, 2012 |
| Closing Date: | Apr 30, 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] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00108090 | Apr 01, 2012 | Apr 30, 2012 | View | Lisa Ko | Organization Applicants |