Opportunity Information: Apply for PAR 21 088
The NHLBI Program Project Applications opportunity (P01 Clinical Trials Optional), Funding Opportunity Number PAR-21-088, is a National Institutes of Health discretionary grant mechanism designed to support large, coordinated research programs that align with the National Heart, Lung, and Blood Institute mission. It funds research on fundamental biology and disease processes involving the heart, blood and lymphatic vessels, lungs, and blood, with explicit inclusion of areas such as transfusion medicine, blood resources, and sleep disorders. The scope also extends to mission-relevant work in implementation science, health disparities, and translational research, as long as the overall program remains tightly connected to NHLBI priorities.
A central feature of this grant is that applicants must propose a minimum of three interrelated research projects that collectively address a single complex biomedical theme or overarching research question. The emphasis is not on assembling several independent studies under one umbrella, but on building an integrated program where the projects are scientifically connected, mutually reinforcing, and stronger together than they would be as separate applications. To support this kind of collaboration, the application may include shared core units when justified. These cores are intended to create efficiencies by sharing specialized resources, personnel, space, instrumentation, data capabilities, or other infrastructure that would be duplicative or less cost-effective if each project operated entirely on its own.
NHLBI frames the P01 mechanism as a way to accelerate discovery and progress by encouraging genuine collaboration and thematic integration. The institute’s rationale is that coordinated teams working on complementary aims can advance knowledge more effectively than a collection of unrelated projects that happen to be funded at the same time. In that same spirit, NHLBI signals particular interest in program projects that pursue new scientific directions, including topics, approaches, or investigator groups that may not have traditionally been supported by the institute. The announcement also highlights the program project setting as a training ground for leadership, giving emerging scientific leaders exposure to the responsibilities and structure of managing a multi-project research program. Relatedly, applicants are given an explicit opportunity to include at least one project led by an Early Stage Investigator (ESI), reinforcing the goal of cultivating new leadership and broadening participation.
Clinical trials are optional under this announcement, meaning applicants can propose clinical trial work if it is appropriate for the integrated program, but they are not required to do so. Regardless of whether clinical trials are included, every project in the program must remain clearly interrelated and must contribute to the shared central theme within NHLBI’s scientific mandate.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions when categorized separately); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations other than federally recognized governments. The announcement also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined under the NIH Grants Policy Statement, which generally means discrete project elements performed outside the U.S. can be included when they are well-justified and add unique scientific value.
Administrative details provided in the source data include the agency (National Institutes of Health), the activity focus (health), and CFDA program numbers listed as 93.233 and 93.837 through 93.840. The record shows an original closing date of 2023-09-25 and a creation date of 2020-12-02. The award ceiling and expected award count are not specified in the provided summary, indicating applicants would need to refer to the full FOA and NIH budget policy guidance for limits and expectations.Apply for PAR 21 088
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Program Project Applications (P01 Clinical Trials Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
- This funding opportunity was created on 2020-12-02.
- Applicants must submit their applications by 2023-09-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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): NHLBI Program Project Applications (P01 Clinical Trials Optional) - PAR-21-088
What is this funding opportunity?
This opportunity is the NHLBI Program Project Applications mechanism (P01 Clinical Trials Optional) under Funding Opportunity Number PAR-21-088. It is a discretionary grant mechanism from the National Institutes of Health (NIH) designed to support large, coordinated, multi-project research programs that align with the mission of the National Heart, Lung, and Blood Institute (NHLBI).
What is the purpose of the P01 Program Project mechanism?
The P01 mechanism is intended to accelerate discovery and progress by supporting genuinely collaborative, thematically integrated research programs. NHLBI emphasizes that coordinated teams working on complementary aims can advance knowledge more effectively than a set of unrelated projects funded independently.
What research areas does NHLBI consider within scope for this program?
The scope includes research on fundamental biology and disease processes involving the heart, blood and lymphatic vessels, lungs, and blood. The description explicitly includes transfusion medicine, blood resources, and sleep disorders. It also allows mission-relevant work in implementation science, health disparities, and translational research, as long as the overall program remains tightly connected to NHLBI priorities.
How many projects are required in a P01 application?
Applicants must propose a minimum of three interrelated research projects that collectively address a single complex biomedical theme or overarching research question.
Do the projects need to be related, or can they be separate studies under one umbrella?
The projects must be scientifically connected and mutually reinforcing. The emphasis is not on combining independent studies into one application, but on creating an integrated program where the projects are stronger together than they would be as separate applications.
What is meant by a "single complex biomedical theme" or "overarching research question"?
Based on the opportunity description, the central expectation is that all proposed projects contribute to one shared, program-wide scientific theme or overarching question that fits NHLBI's scientific mandate. Each project should contribute meaningfully to that shared theme and be interrelated with the other projects.
Can a P01 application include shared core units?
Yes. The application may include shared core units when justified. These cores are intended to create efficiencies by sharing specialized resources, personnel, space, instrumentation, data capabilities, or other infrastructure that would be duplicative or less cost-effective if each project operated independently.
What is the purpose of including cores in a P01 program?
Cores exist to support the integrated nature of the program by providing shared capabilities across projects and improving efficiency. They are meant to reduce duplication and improve cost-effectiveness across the multi-project program.
Are clinical trials required under PAR-21-088?
No. Clinical trials are optional under this announcement. Applicants may propose clinical trials if they are appropriate for the integrated program, but clinical trials are not required.
If clinical trials are included, do they still need to fit the overall program theme?
Yes. Whether or not clinical trials are proposed, every project in the program must remain clearly interrelated and must contribute to the shared central theme within NHLBI's scientific mandate.
Does NHLBI encourage new research directions or unconventional teams?
Yes. NHLBI signals particular interest in program projects that pursue new scientific directions, including topics, approaches, or investigator groups that may not have traditionally been supported by the institute.
Is there an emphasis on leadership development or training in this program?
Yes. The program project setting is highlighted as a training ground for leadership, giving emerging scientific leaders exposure to the responsibilities and structure involved in managing a multi-project research program.
Can an Early Stage Investigator (ESI) lead a project within the P01?
Yes. Applicants are given an explicit opportunity to include at least one project led by an Early Stage Investigator (ESI), reflecting the program's interest in cultivating new leadership and broadening participation.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include:
- State, county, city or township, and special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions when categorized separately)
- For-profit organizations (other than small businesses)
- Small businesses
- Public housing authorities / Indian housing authorities
- Native American tribal governments (federally recognized)
- Tribal organizations other than federally recognized governments
- U.S. territories or possessions
- Eligible federal agencies
- Regional organizations
- Faith-based or community-based organizations
- Historically Black Colleges and Universities (HBCUs)
- Hispanic-serving Institutions
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Are foreign institutions eligible to apply as the applicant organization?
No. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations under this opportunity.
Can a U.S.-based applicant include foreign components or work performed outside the United States?
Yes. Non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined under the NIH Grants Policy Statement. This generally means discrete elements performed outside the U.S. can be included when well-justified and when they add unique scientific value.
Which agency is offering this grant?
The agency is the National Institutes of Health (NIH), and the program is associated with the National Heart, Lung, and Blood Institute (NHLBI).
What is the general activity focus area for this opportunity?
The activity focus is health.
What CFDA program numbers are associated with this opportunity?
The provided summary lists CFDA program numbers 93.233 and 93.837 through 93.840.
What was the original closing date listed in the provided information?
The record shows an original closing date of 2023-09-25.
What is the creation date listed for this opportunity record?
The record shows a creation date of 2020-12-02.
Is the award ceiling provided in the summary?
No. The award ceiling is not specified in the provided summary. Applicants would need to refer to the full Funding Opportunity Announcement (FOA) and NIH budget policy guidance for budget limits.
Is the expected number of awards provided in the summary?
No. The expected award count is not specified in the provided summary, so applicants would need to consult the full FOA for details (if provided there).
What should applicants do if they need details that are not in this summary (like budget limits or number of awards)?
The provided information indicates that some administrative details (such as the award ceiling and expected award count) are not included in the summary. Applicants would need to refer to the full FOA and NIH budget policy guidance to understand limits and expectations.
What is the key thing reviewers or NHLBI are looking for in a P01 program design?
Based on the description provided, a key expectation is tight thematic integration: at least three interrelated projects that are scientifically connected, mutually reinforcing, and clearly aligned with NHLBI priorities. The program should function as a coordinated whole, potentially supported by shared cores that improve efficiency.
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