Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) - (U01) Clinical Trial Optional | RFA FD 21 008

Opportunity Information: Apply for RFA FD 21 008

This funding opportunity, titled "Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) - (U01) Clinical Trial Optional," is a cooperative agreement released by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). The central aim is to continue supporting the National Evaluation System for health Technology (NEST) by funding the ongoing operations of the NEST Coordinating Center (often referred to as NESTcc). In practical terms, the award is meant to keep the national infrastructure moving forward that helps generate and organize better evidence about medical devices, especially evidence drawn from real-world clinical use, so FDA and other stakeholders can make more informed decisions across a device's full lifecycle.

The program is closely tied to the Medical Device User Fee Act (MDUFA) performance goals and procedures, specifically the MDUFA IV Commitment Letter and anticipated future commitments under MDUFA V. That linkage matters because MDUFA agreements reflect negotiated priorities between FDA and industry, including timelines and performance goals. By explicitly aligning the continuation of NESTcc operations with those commitments, the opportunity signals that the funded work is expected to support FDA's broader device evaluation goals, including more efficient and higher-quality evidence development and assessment methods that can complement traditional clinical trials.

Administratively, this is a discretionary grant using a cooperative agreement mechanism (U01). A cooperative agreement typically means FDA expects to have substantial involvement in the funded project's direction, oversight, or collaboration compared to a standard grant. The listing indicates "Clinical Trial Optional," which generally means the recipient may propose work that includes clinical trial components if appropriate, but a clinical trial is not required to meet the intent of the announcement. The funding opportunity number is RFA-FD-21-008, and it is associated with CFDA number 93.103, reflecting FDA-related assistance programs.

In terms of scale and competitiveness, the opportunity anticipates a single award (ExpectedAwards: 1) with a very large maximum funding level (AwardCeiling: $50,000,000). That combination suggests FDA was seeking one central awardee to operate as the national coordinating hub rather than funding multiple smaller, separate centers. Eligibility is described broadly as "Others," with additional details referenced in the full announcement's eligibility section, which typically means the applicant pool could include certain non-profits, academic institutions, consortia, or other qualifying entities capable of serving as a national coordinating organization.

Key dates in the source information show the notice was created on November 9, 2020, with an original application closing date of January 8, 2021. The activity category is listed under "Food and Nutrition," which is an administrative classification used in some federal listings; however, the substance of the project is clearly focused on medical device evidence generation and evaluation systems rather than nutrition programming.

Overall, the opportunity is best understood as continued federal support for a national coordinating center responsible for advancing NEST toward sustainable operations, while meeting the objectives FDA laid out under MDUFA performance commitments. The award is designed to keep the NESTcc functioning as the backbone organization that coordinates partners, data approaches, and evaluation activities needed to strengthen how medical device safety and effectiveness evidence is developed and used in the United States.

• The Department of Health and Human Services, Food and Drug Administration in the food and nutrition sector is offering a public funding opportunity titled "Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) - (U01) Clinical Trial Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Nov 09, 2020.
• Applicants must submit their applications by Jan 08, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $50,000,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 21 008

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