AN41--R&D Placebo DEHA/PG Rx Study

Closed Special Notice Posted

Solicitation number
36C24625Q0864
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs Network Contracting Office (NCO) 6 at Durham Veterans Affairs Medical Center has issued a Special Notice announcing their intent to enter into a sole source procurement with Campbell University for research and development services. The notice pertains to a contract for over-encapsulation and analytic testing of study medication and placebo for a clinical research trial. The procurement falls under NAICS code 541715 for Research and Development in the Physical, Engineering, and Life Sciences and is classified as an Advisory and Assistance contract. The government intends to negotiate with Campbell University under FAR 13.501 authority without conducting a competitive procurement process. This represents a sole source procurement opportunity rather than an open competitive solicitation.

The primary objective of this procurement is to support a double-blind, placebo-controlled clinical research trial designed to evaluate the efficacy of pregnenolone versus placebo in improving symptoms of anxiety and depression among Iraq/Afghanistan-era Veterans. The contractor will be responsible for manufacturing and delivering both the study medication and matching placebo to the Durham VA Health Care System. The proposed contract includes a one-year base period of performance with four additional one-year option periods. Interested parties may submit capability statements and express their interest by emailing Keicha.Passley@va.gov no later than 8:00 AM EST on July 8, 2025, with all information to be provided at no cost to the government. The government retains sole discretion in determining whether to proceed with the proposed contract based on any responses received, and this notice explicitly states that no solicitation will be made available and telephone inquiries will not be accepted.

Notice text

INTENT TO SOLE SOURCE

The Department of Veterans Affairs Network Contracting Office (NCO) 6, Durham Veterans Affairs Medical Center (VAMC) intends to enter into a sole source procurement with Campbell University,143 Main St, Buies Creek , North Carolina 27506.

NAICS 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The proposed contract action is for over-encapsulation, and analytic testing of the study medication and placebo. This is a double-blind, placebo-controlled clinical research trial to determine the efficacy of pregnenolone (vs placebo) to improve symptoms of anxiety and depression in Iraq/Afghanistan-era Veterans. The contractor shall manufacture and deliver the study medication and matching placebo to the Durham VA Health Care System.

The Government intends to solicit and negotiate with only one source under the authority of FAR 13.501. This Advisory and Assistance contract is intended to be for a period of performance of one year, with four 1-year option periods. This notice of intent is NOT a request for quotation. Interested parties may identify their interest in the requirement and capabilities to 8Keicha.Passley@va.gov no later than 8:00 AM EST, July 8, 2025. Telephone inquiries will not be accepted. All information shall be furnished at no cost or obligation to the government.

No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the government not to complete this proposed contract based upon responses to the notice is solely within the discretion of the Government.

Files

File Type Posted
36C24625Q0864.docx DOCX document

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