Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed) | PAR 21 340

Opportunity Information: Apply for PAR 21 340

The NIH funding opportunity PAR-21-340, titled "Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)," is a discretionary grant program designed to help existing CTSA Program Hubs build and prove out specialized, high-impact innovations that can remove persistent bottlenecks in clinical and translational science. The core idea is not to fund routine hub operations, standard capacity building, or incremental improvements, but to accelerate the development and real-world demonstration of distinctive capabilities, platforms, and shared resources that a hub is uniquely positioned to create. These Specialized Innovation Programs (SIPs) are meant to tackle critical gaps or roadblocks that are limiting the speed, quality, efficiency, equity, or overall effectiveness of translation from discovery to clinical and public health impact.

This is a limited competition opportunity tied specifically to institutions that already hold UM1 Clinical and Translational Science Awards (CTSA) Hub awards under PAR-21-293. In practical terms, applicants are expected to be CTSA hubs proposing targeted innovations that leverage their existing infrastructure and expertise, while clearly showing why the proposed SIP is both timely and high impact. A strong application would typically make a compelling case that the hub can rapidly implement and test a novel approach, resource, or platform, demonstrate its utility in a realistic setting, and generate evidence and implementation know-how that other CTSA hubs could later adopt or adapt. The emphasis on demonstration matters: the program is intended to move beyond concepts and prototypes toward validated solutions that can serve as a foundation for broader dissemination across the CTSA consortium.

The funding mechanism is an NIH RC2 grant, and the announcement explicitly states "Clinical Trials Not Allowed." That means the proposed work cannot include NIH-defined clinical trials, even if they are small or feasibility-oriented. The program can still support a wide range of clinical and translational science innovation activities, such as developing informatics tools, data interoperability resources, recruitment and retention infrastructure, novel research workflow platforms, new models for community-engaged research operations, quality systems for multi-site research, regulatory and ethics process innovations, or specialized capabilities that speed translation while protecting participants and improving rigor. The unifying theme is that the innovation should address a clear translational science barrier and produce outputs that can realistically be taken up by other hubs in the future.

From an eligibility standpoint, the opportunity lists public and state-controlled institutions of higher education as eligible applicants, consistent with many CTSA hubs being housed at public universities. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply as applicant components. However, "foreign components" are allowed as defined by the NIH Grants Policy Statement, which generally means limited, well-justified elements of the project may occur outside the U.S. when scientifically necessary, while the applicant organization remains U.S.-based and otherwise eligible. This distinction matters for hubs that collaborate internationally, because it allows certain kinds of cross-border contributions without making a non-U.S. institution the applicant or a formal non-domestic organizational component of the U.S. applicant.

Key administrative details from the source information include the sponsoring agency, the National Institutes of Health (NIH), and the CFDA number 93.350, which corresponds to the Clinical and Translational Science Awards program area. The opportunity was created on 2021-09-17, with an original closing date listed as 2023-11-07. The award ceiling is shown as $500,000, signaling that NIH expects proposals to be scoped to a focused, high-leverage innovation effort rather than a large-scale, long-term center-like buildout. The listing does not specify the expected number of awards in the provided source snippet, which often means applicants need to consult the full funding announcement for the most current expectations on award counts, budget periods, and any additional constraints.

Overall, this grant opportunity is aimed at pushing CTSA hubs to create and test specialized solutions to common translational science problems, with a strong expectation that successful SIPs will not remain isolated local improvements. Instead, they should generate transferable capabilities, practical implementation lessons, and a credible pathway for adoption or dissemination to other CTSA hubs, strengthening the national clinical and translational research ecosystem without conducting clinical trials under this specific award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
• This funding opportunity was created on 2021-09-17.
• Applicants must submit their applications by 2023-11-07. (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 $500,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for PAR 21 340

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