JOFOC_Part 6_NNTC_fs_Redacted.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health Office of the Director Bethesda, Maryland 20892

[Last Updated: 6/01/2026.]

Justification for Other than Full and Open Competition (JOFOC)

FAR 6.103 - 6.302-1

1. Acquisition Title: National NeuroHIV Tissue Consortium (NNTC) - Clinical Site (UCSD & WashU)

Division: National Institute of Mental Health (NIMH), HIV Neuropathogenesis, Genetics, and Therapeutics Branch

Contracting Activity: National Institutes of Health (NIH), Office of the Director (OD), Office of Acquisition (OA)

Author(s): , NIH OD Contracting Officer (CO) and , NIMH Contracting Officer’s Representative (COR)

Basis for approval under FAR 6.104(c): Individual Basis.

2. Nature and/or Description of the Action being Approved: The HIV Neuropathogenesis, Genetics, and Therapeutics Branch within the NIMH requires a modification to contract no. 75N95023C00014 with the University of California San Diego (UCSD) and contract no. 75N95024C00027 with Washington University (St. Louis) for an increase of support to Task 2 for the recruitment, clinical assessment, collection of biospecimens and NNTC cohort follow-up during the following contracted option periods for exercising and shall use fiscal year 2026 appropriated funds. As such, it is proposed to execute:

1) a modification is executed 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 and

2) a modification is executed 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 is proposed.

These National NeuroHIV Tissue Consortium (NNTC) Clinical Site contracts are clinical research study 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.

While the existing scope supports these objectives, it is insufficient to meet NIH priorities related to research toward an HIV cure. We are requesting exercise of the next option year along with a bilateral contract modification to recruit new participants from the site who 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. This option year exercise and modification qualify for class approval under the exempted category covering clinical research studies, including natural history studies at NIH and NIH-funded institutions, which are approved to proceed regardless of initiation date. The cohort constitutes an ongoing natural history study, and the proposed assessments extend that longitudinal characterization within the same participant population and study framework.

3. Description of Supplies and/or Services: 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.

The NNTC also includes a data coordinating center, which works with each clinical site to manage data and brain banking operations. The coordinating center serves as a data repository, provides biostatistical expertise, and expands coordination and distribution capability. Each NNTC site is required to adhere to the highest ethical standards regarding specimen procurement, data sharing, consent, protection of human subjects, and donor anonymity.

The established NNTC Clinical sites ensuring geographic diversity are critical resources and shall continue collecting, storing, and providing clinical data and well characterized biological specimens, including antemortem/ postmortem tissue from study volunteers and/or organ donors with HIV as well as HIV-negative controls.

In accordance with the Statement of Work, the contracted clinical sites task responsibilities include the following.

Task 1: Maintenance and distribution of biospecimen resources from the cohort and postmortem tissue Task 2: Recruitment, clinical assessment, collection of biospecimens and follow-up of NNTC cohort Task 3: Postmortem autopsies and characterization

4. Statutory Authority Cited and Rationale: FAR 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements, and no other type of supplies or services will satisfy agency requirements. Authority: 41 U.S.C. 3304(a)(1). Ongoing support with the current contractors (UCSD & WashU) shall provide continuity and readiness that is essential for maintaining seamless processing of the critical task areas, ensuring no gap. There remains uniformity across the NNTC’s clinical sites for detailing pathological evaluations of brain, spinal cord, and peripheral organs that are conducted post-mortem, and samples are banked according to strict protocols that exist. An increase to task area 2 under the current contracts, avoiding unacceptable delays in filling NIMH requirements and avoiding substantial duplication of costs to the Government that is not expected to be recovered through competition significantly outweighs the benefits of competition at this time. Therefore, it is recommended to sole source via modification and obtain a fair and reasonable price/cost.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts: Not applicable.

6. Actions to Increase Competition:

a. A Notice Was Published: A notice was published to SAM.gov on 8/03/2026, as required by FAR 5.201(a).

b. Responses Were Not Received: There were no responses received to the above-mentioned notice.

c. Sources Expressing Interest: There were no sources that expressed in writing an interest in the acquisition.

d. Actions to Foster Competition for Future, Similar Requirements: NIMH in coordination with the NIH OA is in the early acquisition planning phases for the anticipated recompetition for the NNTC DCC and clinical site contract programs for award in fiscal year 2028. Actions will be taken to the maximum extent possible to increase competition before subsequent acquisition of the supplies or services is required. With the anticipated competitive follow-on, significant market research in accordance with RFO Part 10 and departmental and agency (HHS and NIH) policy shall be conducted to address any efforts that will be underway to facilitate a full and open competition.

7. Market Research: Given the timeframe of the need abbreviated market research was considered based on limited to readily available historical and commercial information, estimated dollar value, complexity, and past performance experience. At this time there are no other contractors other than the current clinical sites that can realistically fill NIH's broad range of needs within the current scope of the contracted requirements or do so with minimal loss of resources and disruption to critical ongoing research programs provided under these contracts.

Consistent with RFO/FAR Companion Part 10 principles, extensive market research for the follow-on competitive acquisition will be conducted and documented in accordance to support the planned recompete effort and maximize competition to the extent practicable.

8. Procurement History:

Contractor: University of California San Diego (UCSD)

Contract Number: 75N95023C00014 Award Date and Period of Performance:

Base Period: 08/23/2023 - 08/22/2024 Option Period One (1): 08/23/2024 - 08/22/2025 Option Period Two (2): 08/23/2025 - 08/22/2026 Option Period Three (3): 08/23/2026 - 08/22/2027 Option Period Four (4): 08/23/2027 - 08/22/2028

Value (including base and all options): $13,504,478.00 Competitive Status: Full and Open Competition Authority formerly relied upon if Not Competed: N/A

Contractor: Washington University (St. Louis)

Contract Number: 75N95024C00027 Award Date and Period of Performance:

Base Period: 09/23/2024 - 09/22/2025 Option Period One (1): 09/23/2025 - 09/22/2026 Option Period Two (2): 09/23/2026 - 09/22/2027 Option Period Three (3): 08/23/2027 - 08/22/2028

Value (including base and all options): $7,778,864.00 Competitive Status: Full and Open Competition Authority formerly relied upon if Not Competed: N/A

9. Additional Information or Other Facts: None.