Opportunity Information: Apply for PAR 21 343
The NIH funding opportunity "Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)" (PAR-21-343) is a discretionary National Institutes of Health program that uses a cooperative agreement mechanism (U01) to support collaborative translational research. The central aim is to speed up the path from basic biological discoveries to real-world clinical applications that improve human health. In practical terms, NIH is looking for strong, well-justified projects that can plausibly advance understanding of a significant disease process or generate clear clinical value, such as new therapeutic interventions, diagnostic approaches, or prevention strategies. Projects are expected to fit within the research interests and priorities of the participating NIH Institutes and Centers, meaning applicants should be prepared to show alignment with the missions and scientific goals of the relevant NIH components.
A defining feature of this opportunity is its emphasis on partnerships that bridge NIH intramural and extramural research. The program is designed to broaden and strengthen translational research collaborations by bringing together NIH intramural investigators (researchers working within NIH laboratories and clinics) and extramural investigators (researchers working in institutions outside of NIH). The NIH Clinical Center is a key asset in this program: the award is intended to help external teams access and use the Clinical Center's distinctive infrastructure and capabilities to conduct clinical research in collaboration with NIH intramural partners. In other words, the Clinical Center is not just a setting for patient studies; it is part of the value proposition of the grant, offering specialized resources and an environment built specifically for complex clinical research efforts that may be difficult to execute elsewhere.
Because the funding mechanism is a cooperative agreement, applicants should expect a more hands-on partnership with NIH compared to a standard research project grant. While the specific degree of NIH involvement varies by project, U01 awards generally reflect substantial programmatic collaboration, coordination, or technical input from NIH staff during the life of the award. The "Clinical Trial Optional" designation signals that proposed projects may include a clinical trial, but they do not have to; the program can support translational clinical research with or without an interventional trial component, as long as the work leverages collaboration with NIH intramural investigators and makes meaningful use of the NIH Clinical Center where appropriate.
Eligibility is broad and includes a wide range of domestic applicant types across government, academia, nonprofit, and industry. Eligible applicants listed include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The opportunity also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), tribal governments and organizations (including those other than federally recognized), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This wide eligibility reflects NIH's intent to draw high-quality translational collaborations from many sectors and communities, including organizations positioned to engage diverse populations or address health needs that are often underrepresented in clinical research.
Key administrative details in the source data include the sponsoring agency (National Institutes of Health), the funding instrument type (cooperative agreement), and an award ceiling of $500,000. The opportunity lists an original closing date of 2024-04-18 and a creation date of 2021-11-19. It is associated with multiple CFDA numbers, indicating that multiple NIH Institutes/Centers may participate and support awards under their respective authorities. Overall, this program is best understood as an NIH-supported pathway for extramural investigators to team up with NIH intramural scientists and make serious use of the NIH Clinical Center to move promising translational ideas toward clinical impact, whether by clarifying disease mechanisms in humans, validating clinically useful biomarkers, developing or testing interventions, or building prevention strategies grounded in strong biological rationale.Apply for PAR 21 343
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Opportunities for Collaborative Research at the NIH Clinical Center (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): 93.121, 93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.853, 93.855, 93.865, 93.867.
- This funding opportunity was created on 2021-11-19.
- Applicants must submit their applications by 2024-04-18. (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: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the NIH funding opportunity PAR-21-343?
PAR-21-343 is an NIH discretionary funding opportunity titled "Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)." It supports collaborative translational research intended to accelerate the path from basic biological discoveries to clinical applications that improve human health.
What is the main goal of this program?
The central aim is to speed translation from biological discovery to real-world clinical value. NIH is looking for projects that can plausibly advance understanding of a significant disease process or produce clear clinical value, such as new therapeutic interventions, diagnostic approaches, or prevention strategies.
What funding mechanism is used?
This opportunity uses a cooperative agreement mechanism (U01). A cooperative agreement generally involves substantial NIH involvement during the project period compared to a standard research grant.
What does "cooperative agreement" mean for applicants and awardees?
Because this is a U01 cooperative agreement, applicants should expect a more hands-on partnership with NIH. While the exact level of involvement can vary by project, U01 awards commonly include programmatic collaboration, coordination, or technical input from NIH staff throughout the life of the award.
Are clinical trials required under this opportunity?
No. The opportunity is labeled "Clinical Trial Optional," which means proposed projects may include a clinical trial, but they do not have to. Projects can support translational clinical research with or without an interventional trial component.
What kinds of research projects does NIH want to fund through PAR-21-343?
NIH is seeking strong, well-justified translational research projects that can move promising ideas toward clinical impact. Examples described in the opportunity include work that clarifies disease mechanisms in humans, validates clinically useful biomarkers, develops or tests interventions, or builds prevention strategies grounded in strong biological rationale.
How important is collaboration between intramural and extramural investigators?
This is a defining feature of the program. The opportunity is designed specifically to bridge NIH intramural investigators (within NIH laboratories and clinics) and extramural investigators (outside NIH), strengthening translational collaborations between these groups.
What role does the NIH Clinical Center play in these projects?
The NIH Clinical Center is a core asset of this program. The award is intended to help external teams access and use the Clinical Center's infrastructure and capabilities to conduct clinical research in collaboration with NIH intramural partners. The Clinical Center is positioned as part of the value proposition of the grant, especially for complex clinical research that may be difficult to execute elsewhere.
Does the project need to use the NIH Clinical Center?
The opportunity emphasizes making meaningful use of the NIH Clinical Center where appropriate, as it is central to enabling collaborative clinical research with NIH intramural investigators.
Do proposed projects need to align with specific NIH priorities?
Yes. Projects are expected to fit within the research interests and priorities of participating NIH Institutes and Centers. Applicants should be prepared to show alignment with the missions and scientific goals of the relevant NIH components.
Who is the sponsoring agency for this grant opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the award ceiling listed for this opportunity?
The source information lists an award ceiling of $500,000.
Who is eligible to apply?
Eligibility is broad and includes many domestic organization types across government, academia, nonprofit, and industry, as well as additional categories specifically highlighted in the opportunity.
Which government entities are eligible applicants?
Eligible government applicants include state governments, county governments, city or township governments, and special district governments.
Are educational institutions eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are nonprofit organizations eligible to apply?
Yes. Eligible applicants include nonprofits with 501(c)(3) status (other than institutions of higher education) and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations other than small businesses, and small businesses.
Are minority-serving institutions and tribal entities included in the eligible applicant types?
Yes. The opportunity explicitly highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and tribal governments and organizations (including those other than federally recognized).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among eligible applicant categories, along with regional organizations.
Can foreign organizations apply?
Yes. The eligibility list includes non-U.S. entities (foreign organizations).
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed among the additional eligible applicant categories.
What is the listed closing date for this opportunity?
The source information lists an original closing date of 2024-04-18.
When was this opportunity created?
The source information lists a creation date of 2021-11-19.
What does it mean that multiple CFDA numbers are associated with this opportunity?
The opportunity is associated with multiple CFDA numbers, which indicates that multiple NIH Institutes and Centers may participate and support awards under their respective authorities.
What makes this opportunity different from a typical NIH research grant?
Two differentiators are emphasized: (1) it is a U01 cooperative agreement with substantial NIH involvement, and (2) it is built around collaborative translational research that bridges NIH intramural and extramural investigators while leveraging the NIH Clinical Center's specialized infrastructure and clinical research environment.
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