Evaluation of Semaglutide Safety and Tolerability in Adults with Cocaine Use Disorder with and without HIV and Assessment of Long-Acting Stimulants to Reduce Harm and HIV Transmission in Methamphetamine Use Disorder

This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED.

The NIH Clinical Center, Office of Purchasing and Contracts, intends to negotiate and award a contract, a three-year period of performance, to the University of Maryland Medical Center 22. S. Greene St., Baltimore, MD 21201. The scope of activities for this contract shall focus on the development and conduct of two clinical research studies using novel treatments for methamphetamine use disorder and cocaine use disorder in the Baltimore/Washington, DC region.

These studies support NIH’s HIV and HIV-related research priorities developed by the Office of AIDS Research. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690 with a Size Standard of $16.5 million.

REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 2, 2023. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

DESCRIPTION OF REQUIREMENT The anticipated start date is September 30, 2024. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, they address the priority to reduce the incidence of HIV and address HIV-associated comorbidities, coinfections, and complications.

In accordance with FAR part 10, extensive market research was conducted to reach this determination. Additionally, knowledgeable individuals in the Government and Industry were contacted for market research purposes. None of the subject matter experts contacted were able to identify any contractor. Finally, a review of both the GSA Advantage and Dynamic Small Business Search returned no results. APPLICABLE CLAUSES AND PROVISIONS The provision at FAR clause 52.215 and other HHSAR and NIH clauses are applicable.

The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include:

unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Susan Nsangou, Contracting Officer, susan.nsangou@nih.gov. US Mail and Fax responses will not be accepted.