6,6 D2-Glucose 72.9 mg/ml

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), Laboratory of Bioorganic Chemistry intends to award a purchase order without providing for full and open competition to Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150 to acquire 6,6 D2-Glucose 72.9 mg/ml. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 with a Size Standard 1,250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-07 effective 07-02-2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States DESCRIPTION OF REQUIREMENT To engage Pine Pharmaceuticals in a term-limited contract for the procurement of intravenous stable isotopes for metabolic research. Pine Pharmaceuticals, under the directive of the NIH SPHA executive committee, will be responsible for sourcing the raw material, manufacturing the sterile intravenous isotope product, and submitting and releasing the product to the NIH CC Pharmacy after microbial and analytical testing. The contractor shall provide the following: Item # Description Quantity 6,6 D2-GLUCOSE 72.9 MG/ML (30 ML) VIAL 60 6,6 D2-GLUCOSE 72.9 MG/ML (30 ML) VIAL 60 6,6 D2-GLUCOSE 72.9 MG/ML (30 ML) VIAL 60 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 as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined that Pine Pharmaceuticals Pine Pharmaceutical, LLC is the only contractor/ vendor that is currently approved for the procurement of intravenous stable isotopes for metabolic research at the NIH CC. This approval was obtained from the NIH CC Pharmacy and the NIH SHPA executive committee on July 24, 2018 and the approval renewed in June 2019. The approval follows an external audit of the Pine Pharmaceuticals facility, a review of Pine’s response to recent FDA inspection in June 2018 and a review of alternatives for isotope procurement (including using a Contract Management Organization or CMO). This NIH executive committee directed-process constitutes the basis for using Pine Pharmaceuticals and the sole-source justification. 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, 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 to this notice shall be submitted electronically by 11:00 AM Eastern Standard Time, on August 5, 2020.