This grant is for the continued support and implementation of the National Evaluation System for Health Technology (NEST) through the operations of the NEST Coordinating Center (NESTcc). The primary purpose is to ensure the sustainable operations of NESTcc, aligning with the commitments outlined in the Medical Device User Fee Act (MDUFA) IV and future MDUFA V agreements between the FDA and industry. This initiative aims to strengthen the national system for evaluating health technology, fostering collaboration and achieving key performance goals. The funding will enable NESTcc to further its mission of improving the quality and safety of medical devices through robust real-world data collection and analysis.
Opportunity ID: 329766
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-008 |
| Funding Opportunity Title: | Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) – (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition |
| 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: | Nov 09, 2020 |
| Last Updated Date: | Nov 09, 2020 |
| Original Closing Date for Applications: | Jan 08, 2021 |
| Current Closing Date for Applications: | Jan 08, 2021 |
| Archive Date: | Feb 07, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $50,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Medical Device Innovation Consortium |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this announcement is to continue to support the implementation of the National Evaluation System for health Technology (NEST) through operations of the NEST Coordinating Center (NESTcc) toward sustainable operations to coincide with the stated purposes and goals listed in Section IV.H of the Medical Device User Fee Act Performance Goals and Procedures, letter MDUFA IV Commitment Letter and future commitments under MDUFA V agreements between FDA and industry |
| Link to Additional Information: | Funding Opportunity Annoucement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Kiara Fowler
Grants Management Specialist Phone 2404023099 Email:kiara.fowler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Kiara Fowler Grants Management Specialist Phone 2404023099 Email: kiara.fowler@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 | RFA-FD-21-008 | FORM F | PKG00264048 | Nov 09, 2020 | Jan 08, 2021 | View |
Package 1
Mandatory forms
329766 RR_SF424_2_0-2.0.pdf
329766 PHS398_CoverPageSupplement_5_0-5.0.pdf
329766 RR_OtherProjectInfo_1_4-1.4.pdf
329766 PerformanceSite_2_0-2.0.pdf
329766 RR_KeyPersonExpanded_2_0-2.0.pdf
329766 RR_Budget_1_4-1.4.pdf
329766 PHS398_ResearchPlan_4_0-4.0.pdf
329766 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
329766 RR_SubawardBudget30_1_4-1.4.pdf
329766 PHS_AssignmentRequestForm_3_0-3.0.pdf
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