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PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING... PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS 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, Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition (Including brand-name) to Cambridge Isotope Laboratories, Inc. 3 Highwood Dr. Tewksbury, MA 01876 to procure Deuterium oxide (D, 70%, Microbiological/Pyrogen Tested). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 with a Size Standard 1250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2024-05 effective 05/22/2024. 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 The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. A single batch of deuterium oxide (D, 70%, Microbiological/Pyrogen Tested, 300 bottles with a fill volume of 50ml of deuterium oxide (catalog #: DLM-2259-70-0, lot # PR-34301). Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. In many cases, stable isotopes allow generation of knowledge that may not be possible by any other method. Under the directive of the NIH Sterile Products for Human Administration (SPHA) executive committee and the NIH Office of Research Support and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet outlined minimum requirements REQUIRED FEATURES AND SPECIFICATIONS A single batch of deuterium oxide (D, 70%, Microbiological/Pyrogen Tested, 300 bottles with a fill volume of 50ml of deuterium oxide (catalog #: DLM-2259-70-0, lot # PR-34301) will be delivered in October 2024. The procurement and packaging of raw materials with the following items: Certificate of Analysis to meet the following requirements below: Intended for nonsterile / oral use (Raw) Must have a lot specific Certificate of Analysis (COA) COA and/or previously obtained Enhanced Data Package must contain the following: 1. Lot number 2. Identity 3. Chemical purity 4. Appearance 5. Isotopic enrichment 6. Total impurities %, including heavy metals and total organic carbon 7. Statement that material is not derived from animal/human source or Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy testing results 8. All test results shall meet or exceed the vendor’s published specifications including MPT grade materials testing for S. aureus, P. aeruginosa, E. coli, Salmonella sp., aerobic bacteria, yeast, and mold, and for bacterial endotoxins. 9. Meet USP <1111> standards for non-sterile drugs – (microbial enumeration that includes TAMC, TCYMC, and an absence of E. coli) 10. Additional requirements for aqueous raw materials include: 11. The FDA guidance regarding liquid non-sterile preparations and Burkholderia cepacia complex (BCC) (2) see USP <60> 12. Bacterial Endotoxin testing (USP <85>), FDA Pyrogen and Endotoxin Testing (June, 2012 Guidance) 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 Cambridge Isotope Laboratories, Inc is the only vendor that can provide the Deuterium oxide (D, 70%, Microbiological/Pyrogen Tested). Cambridge Isotope Laboratories is the preferred vendor for the procurement of these raw material and oral stable isotopes for metabolic research at the NIH CC. Cambridge Isotopes quoted under their OM BPA HHSN263201600088B. There are only two sources for isotopes, Cambridge Isotope Laboratories and Millipore Sigma. Millipore Sigma has not undergone the evaluation needed by the NIH CC Pharmacy and the NIH Office of Research Support and Compliance; we are not approved to use Millipore Sigma. These guidelines are set by NIH CC Pharmacy and the NIH Office of Research Services and Compliance. Cambridge Isotope Laboratories is the only vendor capable of proving the needed isotopes. 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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. 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 Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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 (75N94024Q00120) shall be submitted electronically by 11:00 AM Eastern Standard Time, on June 11, 2024.