National NeuroHIV Tissue Consortium (NNTC) - Clinical Sites

INTRODUCTION PURSUANT TO RFO 5.101 — PRESOLICITATION NOTICE, THIS IS A NOTICE OF A PROPOSED CONTRACT ACTION. THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE MODIFICATION UNDER CONTRACT PROGRAM NO. 75N95023C00014 WITH CALIFORNIA UNIVERSITY SAN DIEGO (UCSD) AND 75N95024C00027 WITH WASHINGTON UNIV (WASHU). The National Institute of Mental Health (NIMH) at the National Institutes of Health (NIH) intends to modify Contract No. 75N95023C00014 (UCSD) and 75N95024C00027 (WASHU) titled National NeuroHIV Tissue Consortium (NNTC) - Clinical Sites to increase the task 2 costs of each contract by modification as follows: A modification to Contract No. 75N95023C00014 (UCSD) to increase the contract value by $269,941.00 from $13,504,478.00 to $13,774,419.00 during Option Period Three (3) through 8/22/2027. A modification to Contract No. 75N95024C00027 (WASHU) to increase the contract value by $543,301.63 from $7,778,864.00 to $8,322,165.63 for Option Period Two (2) through 9/22/2027. There are no other changes. The increase to the contract will allow for the continuation of work begun under these National NeuroHIV Tissue Consortium (NNTC) - Clinical Sites contract and prevent any delays or disruption of support services. The National NeuroHIV Tissue Consortium (NNTC) Clinical Site contracts 75N95023C00014 (California University San Diego) and 75N95024C00027 (Washington University) are for clinical research studies focused on mental health and neurocognitive outcomes in people with HIV. The site recruits, clinically assesses, and longitudinally follows a well-characterized participant cohort, and collects, stores, and distributes CNS and peripheral nervous system tissues, cerebrospinal fluid, and other biospecimens in close coordination with the NNTC Data Coordinating Center. The site also contributes specialized neuropsychiatric expertise critical to understanding the behavioral and psychiatric dimensions of CNS complications in people with and without HIV. Data and specimens generated from this cohort advance NeuroHIV science and inform broader questions about how immune dysregulation and psychosocial stress shape brain health, directly supporting the NIMH mission under 42 U.S. Code § 285p and § 285p-2. The scope supports these objectives; however, an increased need focused on Task 2 is necessary to meet NIH priorities related to research toward an HIV cure. Continuation for the recruitment of new participants from these sites is necessary as they already have extensive NeuroHIV characterization, allowing specialized assessments aligned with the HIV cure research agenda, including viral reservoir assays and other cure-relevant measures, to be integrated efficiently without duplicating baseline evaluations. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees REGULATORY AUTHORITY The resultant modification will include all applicable provisions and clauses of the Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26. STATUTORY AUTHORITY This modification is conducted under the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION Background: The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. To fulfill this vital public health mission, the Institute supports biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the causes, diagnosis, treatment, management, and prevention of mental illnesses. This approach aims to turn scientific breakthroughs into real-world benefits for all people impacted by mental illnesses. The NNTC was established in 1998 to support researchers around the world who wish to further NIMH’s understanding of HIV-associated central nervous system dysfunction–including cognitive, neurologic, and mental health outcomes. In 2023, the NNTC, became jointly funded by NIMH, National Institute on Drug Abuse (NIDA), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute on Aging (NIA). This consortium provides clinical data, biological data, and post-mortem tissue specimens to investigators interested in studying HIV-associated CNS comorbidities in the context of anti-retroviral therapy, as well as investigators who are advancing efforts toward a cure for HIV. Specifically, the NNTC collects, stores, and distributes high quality and well characterized biospecimens, including brain, peripheral tissues, blood, and cerebrospinal fluid, that have been donated by people with HIV and people without HIV. In addition to biospecimens, the NNTC longitudinally collects and distributes prospective neuromedical, neuropsychological, neuroimaging, and other clinical data from study volunteers. To ensure uniformity across the NNTC’s clinical sites, detailed pathological evaluations of brain, spinal cord, and peripheral organs are conducted post-mortem, and samples are banked according to strict protocols. Prospective clinical measures are also harmonized across clinical sites. UCSD and WashU are ongoing established clinical sites under this NNTC contract program and serves as critical resources for catalyzing high priority research in NeuroHIV, including studies to understand the mechanisms of HIV neuropathogenesis, aging with long-term HIV and ART, and research towards an HIV cure. The NNTC shall collect, store, and provide clinical data and well characterized biological specimens, including post-mortem tissue from study volunteers and/or organ donors with HIV as well as HIV-negative controls. Goals and Objectives: This NNTC clinical sites continues to functions as a part of the NNTC, a national resource that provides clinical data and biological specimens to NeuroHIV investigators interested in conducting research on Human Immunodeficiency Virus (HIV) associated CNS co-morbidities in the context of antiretroviral therapy (ART), as well as investigators who are advancing efforts toward a cure for HIV. The Contractor shall collect antemortem neuromedical and neuropsychiatric clinical data from volunteers who are both living with HIV and are HIV negative, and who have indicated a willingness to participate in organ donation. The Contractor is responsible for the following task areas: Task 1 -Distribution of existing specimen resources Task 2- (optional task) Recruitment, clinical assessment, and follow-up of the NNTC cohort Task 3 (optional task) - Collection, maintenance, and distribution of newly acquired specimen resources. The clinical sites also work cooperatively with a DCC to provide the clinical data and specimen resources to research investigators. The NNTC DCC is being contracted under a separate contract. These contracts with UCSD and WashU is part of a strategy by the NIH to maximize availability of post-mortem human biospecimens to the research community while simultaneously achieving greater efficiency and better coordination of brain and tissue repository resources. NIMH, NINDS, NIDA, and NIA seek to continue to support the collection and distribution of central nervous system (CNS) and peripheral nervous system (PNS) biospecimens and antemortem clinical data for research on NeuroHIV. The objective of this initiative is to provide access to post-mortem brains, related biospecimens and relevant clinical data from donors with HIV as well as HIV negative controls. The objectives also include facilitating proactive involvement of the HIV advocacy and patient communities, and more efficiently acquiring, processing, characterizing, curating, storing, and distributing biospecimens for research with the ultimate goal of reducing the burden of NeuroHIV specifically and HIV more broadly. In order to do so, the NIH will continue to support collection sites through contracts (i.e., the NNTC) to provide services that will actively acquire, process, store, curate, preserve, and distribute central nervous system, clinical data and related biological specimens to qualified investigators Period of Performance: The period of performance of Contract No. 75N95023C00014 (UCSD) shall be extended with an increased/renegotiated contract value through 8/22/2026. Contract No. 75N95024C00027 (WASHU) shall be extended with an increased/renegotiated contract value through 9/22/2027. CLOSING STATEMENT This synopsis is not a request for competitive proposals, and the Government is not committed to award a contract pursuant to this announcement. However, interested parties may respond by identifying their interest, submitting capability statements, and or submitting objections to the proposed contract modification. The Government will consider responses; however, a determination by the Government to proceed with the proposed contract modification is solely within the discretion of the Government. Any potential offeror must have an active registration in the System for Award Management (SAM) www.sam.gov. In addition, the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. A determination by the Government not to compete this proposed modification based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. All responses must be received by 9:00 a.m. Eastern Daylight Time, August 22, 2026, and reference notice number 75N98026R00139. Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov. Fax responses will not be accepted. Contracting Office Address: National Institutes of Health Office of Acquisitions and Logistics Management (OALM) 6701 Rockledge Dr, RKL2, 4th floor Bethesda, MD 20817 All responsible sources may submit a capability statement which shall be considered by the agency.