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, t