D-GLUCOSE (U-13C6, 99%), MICROBIOLOGICAL/PYROGEN TESTED

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE Solicitation: NIMH23004475 Title: D-GLUCOSE (U-13C6, 99%), MICROBIOLOGICAL/PYROGEN TESTED INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH) intends to intends to solicit by a request for quotation from Cambridge Isotope Laboratories, Inc. for award on or around May 24, 2023. The purpose of this purchase order will be to provide the National Institute of Mental Health (NIMH) D-GLUCOSE (U-13C6, 99%), MICROBIOLOGICAL/PYROGEN TESTED. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325199 – All Other Basic Organic Chemical Manufacturing with a Size Standard of 1250 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2023-02 dated February 14, 2023. STATUTORY 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). DESCRIPTION OF REQUIREMENT Purpose and Objectives The Magnetic Resonance Spectroscopy Core of the Molecular Imaging Branch (MIB) of the National Institute of Mental Health (NIMH) requires 250 gm of [U-13C6] glucose for studying metabolism in human brain. Stable isotopes have been used safely in clinical research for decades and have contributed insights into human metabolism. Magnetic Resonance Spectroscopy (MRS) Section and Core have been conducting research projects using carbon-13 (13C) labeled glucose to study brain metabolism of healthy volunteers for more than ten years. Common MRS detect signals from protons which are dominant nuclei in living tissues. 13C MRS detects signals of carbons instead of protons which provides different information of metabolism. Because natural abundance of 13C is only one percent, signals from natural 13C is too weak to be detected. Thus, we need to administrate 13C enriched chemicals into human subjects to increase 13C signal intensity. In an ongoing project, [U-13C6] glucose will be used. The glucose will be prepared into 20% solution for oral administration. Each human study will use 40-50 grams of [U-13C6] glucose depending on the body weight of the subject. With the administration of 13C labeled glucose, we should be able to measure 13C signals in a reasonable scan time. The objective for this procurement is to purchase 250 gm of [U-13C6]glucose. The manufacture should produce the isotope product and ship the product to the NIH Clinical Center Pharmacy after microbial and analytical testing. Delivery or Deliverables 30 days ARO. 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, compliance with he NIH Pharmacy standard/procedure, 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.www.sam.gov.” All responses must be received by Monday, May 22, 2023 at 4:30 p.m. , Eastern Standard Time , and reference number NIMH23004475 . Responses may be submitted electronically to Robin Knightly, Contracting Officer, at [email protected] . Fax responses will not be accepted. Extensions to the deadline will not be granted. Please contact Robin Knightly, Contracting Officer, at [email protected] or (301) 827-5302 with any questions.