Opportunity Information: Apply for PAR 23 036

The funding opportunity titled "Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 23 036) is a discretionary NIH grant program run under the National Institutes of Health, with a focus that aligns specifically with the National Heart, Lung, and Blood Institute (NHLBI) mission. Its central purpose is to encourage researchers to make strong, targeted use of human datasets that already exist, rather than generating new primary data, in order to answer important new questions in heart, lung, and blood diseases and sleep disorders. The emphasis is on well-focused secondary analyses that can produce meaningful advances, including the testing of novel scientific ideas or the development and evaluation of new models, systems, tools, methods, or technologies that could have a significant impact on biomedical or biobehavioral research in these topic areas.

A key point in this announcement is that it uses the NIH R21 mechanism, which is commonly designed for exploratory, developmental, or early-stage projects that can open up new directions. In practice, that means the program is oriented toward innovative analyses that may be higher-risk than standard hypothesis-testing projects, but that also have the potential for high reward if they reveal new mechanisms, new associations, new predictive approaches, or new analytic methods. At the same time, the "Clinical Trial Not Allowed" designation makes it clear that applicants should not propose prospective interventional studies where participants are assigned to an intervention. The work should remain within the boundaries of analyzing existing human data resources, which can include clinical, epidemiologic, cohort, registry, claims, biobank-linked, digital health, or other previously collected datasets, as long as the proposed activities are truly secondary analysis rather than new participant enrollment and intervention.

The opportunity is positioned to stimulate creative reuse of valuable data that may already be publicly available, available through controlled-access repositories, or held by institutions and consortia, with the expectation that applicants will bring a compelling scientific rationale and a rigorous analytic plan. The program language also highlights not only testing new scientific ideas but also exploring or validating "new models, systems, tools, methods, or technologies." That can reasonably include, for example, innovative computational or statistical approaches, data integration strategies, algorithm development or refinement, novel phenotyping approaches, or other analytic innovations, provided they are grounded in a specific use case and are likely to move the field forward in areas relevant to NHLBI. The goal is not simply to reanalyze data in a routine way, but to use existing datasets to generate insights or capabilities that would be difficult to obtain otherwise and that could meaningfully influence future research or understanding of disease and health.

Eligibility is broad, which is typical for many NIH funding opportunities, and it is explicitly inclusive of a wide range of organization types. Eligible applicants include various levels of government (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, and Native American tribal governments (federally recognized). It also includes public housing authorities and Indian housing authorities, Native American tribal organizations that are not federally recognized tribal governments, and a wide range of nonprofit entities (both 501(c)(3) organizations and nonprofits without 501(c)(3) status, as long as they are not institutions of higher education). For-profit organizations are also eligible (other than small businesses), as are small businesses, and a general "other" category, which reinforces the open nature of the applicant pool. In addition, the announcement explicitly calls out several "other eligible applicants" categories to emphasize inclusivity and participation across different institution types and geographies. These include 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, Indian/Native American Tribal Governments other than federally recognized, and non-U.S. entities (foreign organizations). The inclusion of foreign organizations indicates that the program can support internationally based applicants, assuming they meet NIH and program requirements and can justify the relevance and feasibility of their work.

From an administrative standpoint, the opportunity is categorized under the "Health" funding activity area and lists multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting the NIH/NHLBI programmatic areas that may support awards under this announcement. The original closing date is listed as 2026-01-07, which signals that the opportunity remains active through that date according to the provided source data. The award ceiling and expected number of awards are not specified in the provided listing, which often means applicants should rely on the full NIH funding opportunity announcement and standard NIH policy guidance for typical R21 budgeting practices, while also paying attention to any institute-specific budget or project period constraints that may be described in the complete announcement.

In plain terms, this grant is aimed at investigators who can take existing human data relevant to cardiovascular, pulmonary, hematologic, or sleep health and use it in a fresh, carefully designed way to answer an important question or to create a useful new analytic approach. The program is designed to get more scientific value out of datasets that already exist, accelerate discovery without the time and cost of new data collection, and support innovative, potentially field-shifting secondary analyses, while staying firmly outside the scope of conducting a clinical trial.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed)" 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 2022-11-28.
  • Applicants must submit their applications by 2026-01-07. (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.
Apply for PAR 23 036

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FAQs: Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed) - PAR 23 036

What is the official title and funding opportunity number?

The opportunity is titled "Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed)" and the Funding Opportunity Number is PAR 23 036.

Which agency runs this grant program?

This is a discretionary NIH grant program under the National Institutes of Health (NIH), with a focus aligned specifically with the National Heart, Lung, and Blood Institute (NHLBI) mission.

What is the main purpose of this funding opportunity?

The purpose is to encourage researchers to make strong, targeted use of existing human datasets (rather than collecting new primary data) to answer important new questions in heart, lung, and blood diseases and sleep disorders.

What types of projects is the program trying to support?

The program emphasizes well-focused secondary analyses that can lead to meaningful advances, including testing novel scientific ideas or developing and evaluating new models, systems, tools, methods, or technologies that could significantly impact biomedical or biobehavioral research in the covered topic areas.

What does "secondary analysis of existing datasets" mean in this context?

It means using human data that have already been collected (for example, through prior studies or routine systems) and conducting new analyses to address new questions. The intent is reuse of existing data resources rather than enrolling participants to generate new data.

What kinds of datasets can be used?

The opportunity indicates that existing human datasets may include clinical, epidemiologic, cohort, registry, claims, biobank-linked, digital health, or other previously collected datasets, as long as the proposed work is truly secondary analysis.

Do datasets need to be publicly available?

Not necessarily. The program notes that datasets may be publicly available, available through controlled-access repositories, or held by institutions and consortia.

What does the R21 mechanism imply about the type of research expected?

The announcement uses the NIH R21 mechanism, which is commonly used for exploratory, developmental, or early-stage projects. This typically aligns with innovative or potentially higher-risk approaches that could open new directions, but that may not fit a standard, lower-risk hypothesis-testing format.

Is this opportunity intended for high-risk/high-reward work?

Yes. The description emphasizes innovative analyses that may be higher-risk than standard projects, but with the potential for high reward if they uncover new mechanisms, associations, predictive approaches, or analytic methods.

Are clinical trials allowed under this opportunity?

No. The announcement is explicitly labeled "Clinical Trial Not Allowed," meaning applicants should not propose prospective interventional studies where participants are assigned to an intervention.

What kinds of human-subjects activities would likely be outside the scope of this grant?

Prospective interventional studies that assign participants to an intervention are outside scope. The work should remain within the boundaries of analyzing existing human data resources, not enrolling participants for a new intervention study.

Can applicants propose creating new analytic tools or methods?

Yes. The program language specifically highlights exploring or validating "new models, systems, tools, methods, or technologies" and gives examples consistent with innovative computational or statistical approaches, data integration strategies, algorithm development or refinement, and novel phenotyping approaches, as long as they are grounded in a specific use case relevant to NHLBI areas.

Is routine reanalysis of a dataset the goal?

No. The opportunity frames the goal as going beyond routine reanalysis by using existing datasets to generate insights or capabilities that would be difficult to obtain otherwise and that could meaningfully influence future research or understanding of disease and health.

What research areas are in scope?

Projects should be relevant to heart, lung, and blood diseases and sleep disorders, consistent with the NHLBI mission focus described in the opportunity.

What type of funding activity area is this listed under?

The opportunity is categorized under the "Health" funding activity area.

Who is eligible to apply?

Eligibility is broad and includes many organization types such as: 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; and Native American tribal governments (federally recognized). It also includes public housing authorities and Indian housing authorities; Native American tribal organizations that are not federally recognized; nonprofits (both 501(c)(3) and nonprofits without 501(c)(3) status, as long as they are not institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible applicants as listed in the announcement.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible.

Are nonprofits eligible even if they do not have 501(c)(3) status?

Yes. The listing includes nonprofits without 501(c)(3) status (as long as they are not institutions of higher education).

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The opportunity explicitly includes non-U.S. entities (foreign organizations) among the eligible applicant categories, indicating that internationally based applicants may be supported if they meet NIH and program requirements and can justify relevance and feasibility.

Are U.S. territories or possessions included in eligible applicants?

Yes. U.S. territories or possessions are explicitly listed among the "other eligible applicants" categories.

Does the opportunity encourage participation from specific institution types?

Yes. The listing calls out multiple "other eligible applicants" categories, including 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); faith-based or community-based organizations; eligible federal agencies; and regional organizations.

What are the CFDA numbers associated with this opportunity?

The listing includes multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, and 93.840.

What is the application closing date shown in the provided information?

The original closing date shown is 2026-01-07, indicating the opportunity remains active through that date based on the provided source data.

Is the award ceiling provided?

No. The award ceiling is not specified in the provided listing.

Is the expected number of awards provided?

No. The expected number of awards is not specified in the provided listing.

If award amounts are not listed here, how should applicants interpret budget expectations?

Because the award ceiling is not specified in the provided listing, applicants are expected to rely on the full NIH funding opportunity announcement and standard NIH policy guidance for typical R21 budgeting practices, while also paying attention to any institute-specific budget or project period constraints that may be described in the complete announcement.

Why does this program emphasize existing datasets instead of new data collection?

The program is designed to get more scientific value out of datasets that already exist, accelerate discovery without the time and cost of new data collection, and support innovative, potentially field-shifting analyses while staying outside the scope of conducting a clinical trial.

What is a good fit in plain terms?

A strong fit is an investigator-led project that uses existing human data relevant to cardiovascular, pulmonary, hematologic, or sleep health in a fresh and carefully designed way to answer an important question or to create and demonstrate a useful new analytic approach.

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