NOTICE OF INTENT to Sole Source.docx

NOTICE OF INTENT TO SOLE SOURCE

1. SOLICITATION NUMBER: 75N95022Q00400

2. TITLE: Manipulating Ghrelin signaling via GOAT inhibition in alcohol use disorder.

3. NAICS Code: 541380 - Testing Laboratories

4. RESPONSE DATE:

July 27, at 10:00 am Eastern Time.

5. PRIMARY POINT OF CONTACT:

Polina Klimenkova polina.klimenkova@nih.gov Phone: 301-443-6677

6. DESCRIPTION:

The National Institute on Drug Abuse (NIDA) intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1 (b) Soliciting from a single source. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). This contract will be awarded to Alcami Carolinas Corporation, 2320 Scientific Park DR, Wilmington, North Carolina 28405, to perform the stability testing on the ongoing study drug GLWL-01 in relation to alcohol related behavior.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under 541380 with a Size Standard of $16.5 mil.

DESCRIPTION OF REQUIREMENT

The National Institute on Drug Abuse, Intramural Research Program (NIDA IRP) Translational Addiction Medicine Branch, Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section (TAMB/CPN) conducts addiction-related translational research. TAMB/CPN requires the continuance of the proof of concept human laboratory study testing the potential early signal of efficacy of GLWL-01 in relation to alcohol related behavior. Therefore, stability testing on the study drug GLWL-01 will need to be performed so that the drug may be recertified to extend its expiration date and allow the study to proceed uninterrupted and preserve the safety and integrity of the research.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted and compelling urgency. This study is currently active, enrolling research participants. The study drug, GLWL-01 is set to expire by August 2022. It is critical that stability testing be performed so that the drug may be recertified to extend its expiration date so that the study may proceed uninterrupted and preserve the safety and integrity of the research. Safety and stability testing of the study drug, GLWL-01 must be performed by the same company (Alcami) that conducted the initial tests to confirm continuity and consistency in methodology, assay analyses, processes and procedures are maintained. Using different company will jeopardize the research integrity of this work.

In accordance with FAR part 10, the market research was conducted to reach this determination. Specifically, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. Finally, a review of the GSA Advantage, and previous government acquisitions returned no results that meet the requirement. Therefore, only ALCAMI CAROLINAS CORPORATION is capable of meeting the needs of this requirement.

The intended source is:

ALCAMI CAROLINAS CORPORATION

2320 Scientific Park DR Wilmington, North Carolina, 28405

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.

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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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.

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 Unique Entity ID Number (UEI), 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. FAR clauses 52.212-4, Contract Terms and Conditions – Commercial Items and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items apply to this acquisition.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95022Q00400. Responses must be submitted electronically to Polina Klimenkova, Contract Specialist, at polina.klimenkova@nih.gov.