This grant, offered by the Medical Device Regulatory Department, is designed to foster innovative research and infrastructure development concerning medical countermeasures (MCM) and associated devices. Its primary purpose is to advance and apply novel methodologies for bridging premarket and postmarket evidence on device safety and effectiveness, including patient-centered outcomes across the total product life cycle. The funding will support high-quality independent research to inform regulatory decisions for MCM-priority medical devices and radiological health, while also developing and evaluating robust postmarketing surveillance systems. Furthermore, the initiative seeks to promote communication with stakeholders and conduct educational outreach regarding innovative MCM medical device surveillance and scientific strategies, ultimately enhancing public health preparedness and response capabilities.
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Education Health 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: | 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: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments 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) City or township governments State governments Public and State controlled institutions of higher education |
| 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: | Full Announcement RFA-FD-12-010 NIH Guide |
| 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 |
|---|---|---|
Related Documents
Folder 155593 Other Supporting Documents-SF424 RR Guide for Applications 1 -> sf424_rr_guide_general_adobe_verb.pdf
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 | PKG00108090 | Apr 01, 2012 | Apr 30, 2012 | View |
Package 1
Mandatory forms
155593 RR_SF424_1_2-1.2.pdf
155593 PerformanceSite_1_4-1.4.pdf
155593 RR_OtherProjectInfo_1_3-1.3.pdf
155593 RR_KeyPersonExpanded_1_2-1.2.pdf
155593 RR_Budget-1.1.pdf
155593 PHS398_CoverPageSupplement_1_4-1.4.pdf
155593 PHS398_ResearchPlan_1_3-1.3.pdf
155593 PHS398_Checklist_1_3-1.3.pdf
Optional forms
155593 RR_SubawardBudget30-1.2.pdf
155593 PHS_CoverLetter_1_2-1.2.pdf
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