NIA Limited Competition: Renewals of, and Revisions to, Existing Alzheimer's Disease Patient Registry Cooperative Agreement Awards (U01 - Clinical Trial Not Allowed) | PAR 18 715

Opportunity Information: Apply for PAR 18 715

This funding opportunity, titled "NIA Limited Competition: Renewals of, and Revisions to, Existing Alzheimer's Disease Patient Registry Cooperative Agreement Awards (U01 - Clinical Trial Not Allowed)" (PAR-18-715), is a National Institute on Aging (NIA) notice that is intentionally narrow in scope. It is not an open call for brand-new Alzheimer’s disease patient registry projects. Instead, it is a limited competition designed specifically for organizations that already hold certain NIA-supported Alzheimer’s Disease Patient Registry cooperative agreement awards identified in the FOA (the eligible awards are described in the announcement's Part 2, Section I). Those current awardees are being invited to submit applications either to renew their existing cooperative agreements, to request revisions to them, or potentially to do both, depending on what the FOA permits and what the program staff advise.

The mechanism is a Cooperative Agreement (U01), which means the work is expected to involve substantial scientific and/or programmatic involvement by the NIH compared with a typical research project grant. In practical terms, the registry activities, deliverables, timelines, governance, and coordination with NIA priorities are usually more structured under a U01, and NIH program staff often play an active role in shaping or overseeing key aspects of the effort. The activity area is health, and the relevant CFDA number is 93.866, which is associated with NIH/NIA research support.

A key restriction is that the opportunity is "Clinical Trial Not Allowed." That label signals that applications submitted under this FOA should not propose clinical trials as defined by NIH. The focus is on patient registry-related infrastructure, operations, data collection/curation, follow-up, data sharing, coordination, and similar registry functions rather than interventional testing of treatments or prevention strategies. Applicants typically need to be careful that any human-subjects activities described remain within registry and observational boundaries and do not cross into interventional trial territory.

Eligibility is also tightly defined. The eligible applicant type listed includes public and state-controlled institutions of higher education, but the defining eligibility feature is really the "limited competition" requirement: only existing Alzheimer’s Disease Patient Registry U01 awardees covered by the FOA can apply for renewal and/or revision. On the international side, the announcement makes clear that non-domestic (non-U.S.) entities (foreign institutions) cannot apply as the main applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, "foreign components" are allowed as NIH defines them in its Grants Policy Statement. In other words, while the primary applicant must be eligible and U.S.-based, the project can still include certain foreign elements (for example, a specific collaboration or performance site abroad) if they meet NIH policy requirements and are justified in the application.

The FOA strongly encourages potential applicants to contact their current program officer before submitting. That is more than a courtesy in a limited competition renewal/revision context: it is often essential for confirming that the planned submission fits the FOA’s intent, that the proposed changes are appropriate for a revision or renewal, and that the applicant is using the right application approach (for example, distinguishing between a competitive renewal versus a revision request, aligning proposed aims with current cooperative agreement expectations, and ensuring the scope remains consistent with what the U01 mechanism and "clinical trial not allowed" designation permit).

From the posted opportunity metadata, the issuing agency is the National Institutes of Health, the original closing date listed is 2021-05-07, and the opportunity was created on 2018-03-21. The award ceiling and expected number of awards are not specified in the provided source details, which often means applicants need to consult the full FOA text (and potentially speak with the program officer) for budget expectations, project period limits, and anticipated funding levels. Overall, the opportunity is best understood as a continuation and adjustment pathway for a defined set of existing NIA-funded Alzheimer’s patient registry cooperative agreements, rather than a general Alzheimer’s registry funding announcement open to the broader research community.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIA Limited Competition: Renewals of, and Revisions to, Existing Alzheimer's Disease Patient Registry Cooperative Agreement Awards (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 2018-03-21.
• Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for PAR 18 715

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