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.Apply for PAR 21 340
- 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.
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Frequently Asked Questions (FAQs)
What is NIH funding opportunity PAR-21-340?
PAR-21-340 is an NIH discretionary grant opportunity titled "Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science for UM1 CTSA Hub Awards (RC2 Clinical Trials Not Allowed)." It supports existing CTSA Program Hubs in developing and demonstrating specialized, high-impact innovations that address persistent bottlenecks in clinical and translational science.
What is the main goal of this grant?
The main goal is to accelerate the development and real-world demonstration of distinctive capabilities, platforms, and shared resources that can remove critical barriers slowing or limiting clinical and translational science. The focus is on producing validated, transferable solutions that could later be adopted or adapted by other CTSA hubs.
Who is this opportunity intended for?
This is a limited competition opportunity intended specifically for institutions that already hold UM1 Clinical and Translational Science Awards (CTSA) Hub awards under PAR-21-293. Applicants are expected to be existing CTSA hubs proposing targeted innovations that leverage their current infrastructure and expertise.
Is this a limited competition opportunity?
Yes. The opportunity is limited competition and is tied to institutions that already have UM1 CTSA Hub awards under PAR-21-293.
What funding mechanism does PAR-21-340 use?
PAR-21-340 uses the NIH RC2 grant mechanism.
Are clinical trials allowed under this opportunity?
No. The announcement explicitly states "Clinical Trials Not Allowed," meaning the proposed work cannot include NIH-defined clinical trials, even if they are small, pilot, or feasibility studies.
If clinical trials are not allowed, what types of projects can be supported?
The opportunity can support a wide range of clinical and translational science innovation activities that do not meet the NIH definition of a clinical trial. Examples mentioned include 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, and regulatory and ethics process innovations.
What makes a project a good fit for a Specialized Innovation Program (SIP)?
A strong SIP is expected to target a clear translational science barrier and deliver a high-impact innovation that goes beyond routine hub operations, standard capacity building, or incremental improvements. It should be timely, leverage the hub's unique strengths, and move beyond concepts or prototypes toward a demonstrated solution validated in a realistic setting.
Does this grant fund routine CTSA hub operations or standard capacity building?
No. The program is not intended to fund routine hub operations, standard capacity building, or incremental improvements. It is designed to support specialized, high-impact innovations and their real-world demonstration.
Why does the program emphasize real-world demonstration?
The emphasis on demonstration reflects the program's intent to move beyond early concepts and prototypes toward solutions that have been implemented and tested in realistic conditions. The expectation is that applicants will generate evidence, practical implementation know-how, and outputs that could support broader dissemination across the CTSA consortium.
Is the intent for the innovation to stay within one hub, or to be shared?
The intent is not for innovations to remain isolated local improvements. Successful SIPs are expected to generate transferable capabilities, practical implementation lessons, and a credible pathway for adoption or dissemination to other CTSA hubs.
What kinds of translational science bottlenecks is this opportunity trying to address?
The opportunity targets persistent bottlenecks that limit the speed, quality, efficiency, equity, or overall effectiveness of translation from discovery to clinical and public health impact. Projects should tackle critical gaps or roadblocks in clinical and translational science.
Who is the sponsoring agency for this grant?
The sponsoring agency is the National Institutes of Health (NIH).
What is the CFDA number for this opportunity?
The CFDA number provided is 93.350, which corresponds to the Clinical and Translational Science Awards program area.
What is the maximum award amount (award ceiling) listed?
The award ceiling shown is $500,000, indicating NIH expects a focused, high-leverage innovation effort rather than a large-scale, long-term buildout.
When was this opportunity created?
The listing indicates the opportunity was created on 2021-09-17.
What was the original closing date listed for this opportunity?
The original closing date listed is 2023-11-07.
Does the provided information specify how many awards NIH expects to make?
No. The provided source snippet does not specify the expected number of awards.
What types of U.S. organizations are listed as eligible applicants in the provided information?
The provided information lists public and state-controlled institutions of higher education as eligible applicants, consistent with many CTSA hubs being housed at public universities.
Are foreign institutions eligible to apply as the applicant organization?
No. Foreign institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply as applicant components?
No. Non-U.S. components of U.S. organizations are not eligible to apply as applicant components.
Are any international activities allowed at all?
Yes, the provided information states that "foreign components" are allowed as defined by the NIH Grants Policy Statement. This generally means limited, well-justified parts of the project may occur outside the U.S. when scientifically necessary, while the applicant organization remains U.S.-based and otherwise eligible.
How does a "foreign component" differ from a foreign institution applying?
A foreign institution cannot be the applicant, and non-U.S. components of a U.S. organization cannot serve as applicant components. However, a "foreign component" may be included as part of the project when justified and scientifically necessary, under NIH policy, while the primary applicant remains an eligible U.S.-based organization.
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