New Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders (U01 - Clinical Trials Not Allowed) | PAR 18 577

Opportunity Information: Apply for PAR 18 577

The funding opportunity "New Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders (U01 - Clinical Trials Not Allowed)" (PAR-18-577) is a National Institutes of Health (NIH) cooperative agreement led by the National Heart, Lung, and Blood Institute (NHLBI). Its central aim is to launch brand-new, innovative epidemiology cohort studies that will prospectively follow a large group of people over time in order to answer a broad range of research questions tied to heart, lung, blood, and/or sleep-related traits, conditions, and outcomes. A key structural requirement is scale: proposed cohorts must include at least 2,000 participants, making the intent clearly focused on creating substantial, durable population resources that can support many hypotheses rather than a narrow, single-purpose project.

The FOA is specifically geared toward the creation and establishment phase of a cohort. NHLBI is offering support for the practical and scientific building blocks needed to stand up a new cohort from the ground up, including identifying and recruiting participants, collecting detailed baseline data on all enrolled individuals, and setting up the operational infrastructure required for a high-quality long-term study. It also emphasizes biospecimen collection and storage, which signals an expectation that cohorts will be positioned for future biologic, genetic, biomarker, or other laboratory-based analyses in addition to traditional epidemiologic measurements. In parallel, the FOA highlights the need for rigorous data quality control and analytic planning, underscoring that these cohorts should produce standardized, reliable data suitable for long-term use and potentially for broad scientific collaboration.

The mechanism is a U01 cooperative agreement, which generally means NHLBI anticipates having substantial scientific and programmatic involvement during the project compared with a standard research grant. While the cohort should be designed to test and generate hypotheses related to heart, lung, blood, and sleep phenotypes, the FOA explicitly states "Clinical Trials Not Allowed," indicating the studies supported under this announcement must not be designed as clinical trials as defined by NIH. In practice, this points applicants toward observational, population-based, and epidemiologic designs where participants are followed over time without assignment to an intervention for the purpose of evaluating health outcomes.

Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, city, and township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both with and without 501(c)(3) status, other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. It also includes Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments), along with public housing authorities/Indian housing authorities. 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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

The FOA draws a clear line around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. This structure typically allows U.S.-led cohorts to incorporate international expertise, sites, or specialized capabilities when justified, while keeping the main awardee organization domestic.

From an administrative standpoint, the opportunity is categorized as discretionary funding, with a health focus under multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840). The posting indicates an original closing date of 2019-10-02 and a creation date of 2018-01-12. An explicit award ceiling is not provided in the supplied source text, and the expected number of awards is not specified there either, so applicants would typically look to the full FOA and NIH guidance for budget expectations and program priorities. Overall, the opportunity is best understood as NHLBI support to create large, well-characterized, prospective observational cohorts with strong infrastructure, robust baseline phenotyping, and biospecimen resources that can serve as foundational platforms for advancing research across heart, lung, blood, and sleep health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "New Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders (U01 - 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): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2018-01-12.
• Applicants must submit their applications by 2019-10-02. (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 18 577

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