Recertification/Recrystallization of TRV734

INTRODUCTION 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). The National Institute on Drug Abuse (NIDA), Contracts Management Branch Blue intends to solicit by a request for quotation from Trevena, Inc. for award on or around August 16, 2018. The Behavioral Neuroscience Research Branch and Clinical Pharmacology and Therapeutic Research Branch within the NIDA Intramural Research Program (IRP) are investigating biased agonists at the mu opioid center, which represent a novel class of medications that may be useful for the treatment of opioid use disorders. The purpose of this acquisition is to obtain recertification and/or recrystallization of a supply of the biased mu agonist TRV734 for use in clinical trials. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 325412 with a Size Standard of 1,250 employees. This acquisition is set aside for small businesses. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: 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). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-97, dated January 24, 2018. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The purpose of this acquisition is to obtain recertification of a supply of TRV724 and, if that recertification is unsuccessful, to recrystallize the supply to GMP standards for use in a clinical trial. PROJECT REQUIREMENTS: This project requires the retesting of an existing supply of TRV724 to ensure that it meets GMP standards for administration in humans. If this retesting is successful, the Contractor will deliver the supply of TRV724 to IRP. If this testing is unsuccessful, the vendor will recrystallize the supply of TRV724 to meet the certification standard and will deliver the recertified supply to IRP. 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, MED Associates, Inc. is the only vendor in the marketplace that can provide the services required by NIDA. In accordance with FAR part 10, extensive 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 all of the requirements. Therefore, only Trevena, Inc. is capable of meeting the needs of this requirement. The intended source is: Trevena, Inc. 955 Chesterbrook Blvd Suite 200 Chesterbrook, PA 19087 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 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIHDA201800401. Responses must be submitted electronically to Kenneth Janosko, Contract Specialist, at kenneth.janosko@nih.gov. U.S. Mail and Fax responses will not be accepted.