Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 Clinical Trials Not Allowed) | RFA CA 23 043

Opportunity Information: Apply for RFA CA 23 043

The funding opportunity titled "Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 Clinical Trials Not Allowed)" (RFA-CA-23-043) is a National Cancer Institute (NCI), NIH Notice of Funding Opportunity designed to make one non-competitive, single-source cooperative agreement award to continue operating and supporting the AIDS and Cancer Specimen Resource (ACSR). It is a reissue of an earlier solicitation (RFA-CA-18-012) and is structured specifically to solicit an application from a named institute (listed in the NOFO text as "(-----institute name-----)"), signaling that NCI intends to fund a single awardee to maintain continuity of this established national and international resource. The application due date listed is 2024-01-09, and the funding mechanism is a UM1 cooperative agreement, meaning NCI will have substantial scientific and programmatic involvement in the project compared with a typical research grant.

At its core, the ACSR exists to solve a practical bottleneck in HIV and HIV-associated cancer research: access to well-characterized human biospecimens linked to meaningful clinical and epidemiologic data. The ACSR functions as an international repository that aggregates and curates specimens spanning multiple phases of the HIV epidemic, including materials collected in the pre-cART era as well as in the post-cART era. This time depth matters because antiretroviral therapy has changed immune function, viral dynamics, cancer risks, and outcomes, so having specimens across eras enables researchers to ask questions that would otherwise be impossible. The repository also emphasizes geographic breadth and diversity, including specimens from the United States, sub-Saharan Africa, and Latin America, and from people with diverse genetic backgrounds and environmental exposures. That breadth supports research that is more generalizable and better suited to understanding how HIV and malignancies behave in different populations and settings.

The specimens in the ACSR are drawn from multiple participant groups to support a wide range of study designs. Collections include materials from people with HIV (PWH), individuals at risk of acquiring HIV, and HIV-uninfected controls, which is important for comparative work and for disentangling effects attributable to HIV infection from other confounders. The specimens come from participants enrolled in clinical trials, observational cohort studies, and other research efforts conducted by HIV investigators and consortia. Beyond passively receiving samples, the ACSR also uses informed, prospective curation strategies aimed at collecting the kinds of specimens the research community is likely to need most, rather than relying solely on opportunistic acquisitions.

A major feature of the ACSR model is access. The NOFO states that specimens and associated data are made available to the broader research community at no cost. This is intended to lower barriers for both clinician investigators and basic scientists, accelerate hypothesis testing, enable validation studies, and encourage use by researchers who may not have the infrastructure or patient access to build their own large specimen collections. In practice, resources like this typically support studies ranging from biomarker discovery and validation to viral oncology, immunology, tumor genomics, translational pathology, and investigations into cancer prevention, screening, treatment response, and mechanisms of oncogenesis in the context of HIV.

In addition to its general mission as a community resource, the ACSR has a formal operational role as the biorepository for the AIDS Malignancy Consortium (AMC). The AMC is an NCI-funded multicenter clinical trials group focused on treatment and prevention research for HIV-associated malignancies. Under this NOFO, continuing ACSR support includes maintaining biorepository capabilities that serve AMC trials, including coordination for multiple repository sites. The description indicates the ACSR is currently supporting two domestic biorepositories along with biorepository capacity in sub-Saharan Africa and Latin America for AMC needs, underscoring that the award supports not only specimen storage but also the logistics, harmonization, and data/specimen management required for multicenter clinical research networks.

From an eligibility and competition standpoint, this is not an open, fully competitive opportunity. It is explicitly described as a non-competitive single-source solicitation intended for a particular institute, with the expectation of a single award. The NOFO also states that non-U.S. (foreign) organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement are allowed, which is consistent with the ACSR's international specimen footprint and the need to interact with, collect from, or coordinate activities in other countries under appropriate NIH policy and oversight.

Administratively, the opportunity is categorized as discretionary and uses a cooperative agreement funding instrument, with activity categories listed under education and health and CFDA numbers including 93.393, 93.394, 93.395, 93.396, and 93.399. The "Clinical Trials Not Allowed" designation indicates the award itself is not intended to run clinical trials; instead, it supports the infrastructure and operations of a biospecimen and data repository and its service role for the wider research community and the AMC clinical trials network. Overall, the NOFO is best understood as a continuity mechanism to keep a specialized, high-value national and international specimen resource operating, expanding strategically, and delivering curated specimens and linked data to accelerate research on HIV and HIV-associated cancers.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 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): 93.393, 93.394, 93.395, 93.396, 93.399.
• This funding opportunity was created on 2023-11-02.
• Applicants must submit their applications by 2024-01-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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