Limited Competition: Renewals of, and Revisions and Resubmissions to, the Longitudinal Early-onset Alzheimers Disease Study (LEADS) Cooperative Agreement (U01 Clinical Trial Not Allowed) | PAR 19 338

Opportunity Information: Apply for PAR 19 338

This funding opportunity, issued by the National Institutes of Health (NIH), is a limited competition cooperative agreement (U01) tied specifically to the Longitudinal Early-onset Alzheimers Disease Study (LEADS). The goal is not to launch an entirely new, open competition program, but to support the continuation or modification of work already connected to LEADS through allowable application types. In practice, it is meant for organizations that are already positioned to renew an existing LEADS award, submit a resubmission of a prior application, or propose a revision to an active award. The FOA is explicitly marked as "Clinical Trial Not Allowed," which means applicants must design the work so it does not meet NIH's definition of a clinical trial (for example, it cannot prospectively assign human participants to interventions to evaluate effects on health-related outcomes). The activity area is health, under CFDA 93.866, and the funding mechanism is a cooperative agreement, which typically involves substantial NIH programmatic involvement in the direction, coordination, or oversight of the project compared with a standard research grant.

The announcement invites three main types of applications: renewals, resubmissions, and revisions. A renewal generally proposes to extend the scope and duration of an ongoing, previously funded project for a new project period, building on progress made in the prior award. A resubmission is typically a revised version of an application that was previously submitted and reviewed but not funded, updated to address reviewer concerns and strengthen the proposal. A revision (often called an administrative supplement or competing revision depending on the context) requests changes to an existing award such as adding activities, expanding aims, or adjusting the approach, while remaining within the overarching goals of the parent project. One key restriction highlighted in the FOA is that revision applications cannot request funding past the current project end date of the parent award, meaning any added work must fit within the remaining timeline of the active award rather than extending it.

Eligibility is broad across U.S.-based organizational types typically permitted under NIH policy, including state, county, city or township governments; special district governments; independent school districts; public and state-controlled colleges and universities; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not higher education institutions if applying under the nonprofit category); for-profit entities (other than small businesses); and small businesses. The FOA also explicitly calls out additional eligible applicant categories commonly emphasized by NIH to encourage broad participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Foreign eligibility is limited in a way that is typical for many NIH opportunities with U.S.-centered infrastructure needs. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization. In addition, non-domestic components of U.S. organizations are not eligible to apply. At the same time, the FOA allows foreign components as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant may include a foreign site or foreign collaborators as part of the project when scientifically justified and compliant with NIH policy, even though a foreign institution cannot serve as the primary applicant.

Administratively, the opportunity number is PAR-19-338 and it was created on August 9, 2019. The original closing date listed is July 5, 2022. The listing does not provide an award ceiling or the number of expected awards in the provided source fields, so applicants would typically look to the full FOA text and NIH institute guidance for budget expectations, allowable costs, and the anticipated scale of support. Since this is a cooperative agreement, applicants should also expect that NIH will have defined expectations for coordination and governance (for example, participation in steering committees, common data elements, harmonized protocols, centralized data sharing, or other collaborative requirements), especially because LEADS is a longitudinal study where consistency across sites and over time is often essential.

In summary, this is a targeted NIH funding opportunity to sustain or appropriately modify the LEADS cooperative agreement effort focused on longitudinal research in early-onset Alzheimers disease, limited to renewals, resubmissions, and revisions rather than brand-new, unrelated proposals. It supports a wide range of U.S. organizations, bars foreign institutions from applying as the lead, allows foreign components when justified, and requires that proposed work remain non-clinical-trial in nature and, for revisions, stay within the existing parent award end date.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Renewals of, and Revisions and Resubmissions to, the Longitudinal Early-onset Alzheimers Disease Study (LEADS) Cooperative Agreement (U01 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): 93.866.
• This funding opportunity was created on 2019-08-09.
• Applicants must submit their applications by 2022-07-05. (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 19 338

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