Inactive

INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The N... INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Digestive and Diabetes and Kidney Diseases (NIDDK) intends to award a purchase order without providing for full and open competition (including brand-name) to Pine Pharmaceuticals, LLC for the procurement of intravenous stable isotope (6,6 D2-Glucose) for metabolic research. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS code 325412 with a Size Standard of 1,250. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-08 Effective 10/28/2022. This acquisition is conducted under the procedures prescribed in FAR Part 13 - Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). 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 for purchases not exceeding the simplified acquisition threshold. Contracts awarded using FAR Part 13 - Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 - Competition Requirements. BACKGROUND: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. PURPOSE AND OBJECTIVES: 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 a 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 Services and Compliance (approved 10/2021), stable isotopes used in clinical human metabolic studies must meet certain specified minimum requirements. Pine pharmaceuticals was initially approved by the NIH Office of Deputy Director of Clinical Care in August 2016 and the decision re-affirmed by the NIH Sterile Products for Human Research Committee (SPHA) on July 24th, 2018. The decision to continue using the current Contractor followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of Research Support and Compliance (ORSC). A quality agreement was implemented in February 2019 and is in place between the Contractor and NIH Pharmacy and NIDDK. The objective of this requirement is to procure intravenous stable isotope (6,6 D2-Glucose) from Prime Pharmaceuticals for metabolic research. The NIDDK specifically requires the following to include specifications and packaging: Procurement of raw materials, the production of the intravenous isotope product and the microbial and analytical testing to be performed by a third-party Contractor must be included. The certificate of analysis and/or the enhanced technical data package should meet the following requirements for the most recently manufactured lot with date. The raw material D-Glucose (6,6-D2) must be obtained from Cambridge Isotope Laboratories – Catalog number: DLM-349-CTM. CONTRACTING WITHOUT PROVIDING FOR FULL AND 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 PINE PHARMACEUTICALS, LLC to be the only reasonably available source to provide the intravenous stable isotope (6,6-D2) for metabolic research the NIDDK requires. PERIOD OF PERFORMANCE: Within 60 Days After Award PLACE OF PERFORMANCE: National Institutes of Health National Institute of Digestive and Diabetes and Kidney Diseases 10 Center Drive Bethesda MD 20892 CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (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.” 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 responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.” All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, November 30, 2022, to the Contract Specialist, Kerry-Ann Chisholm, at kerry-ann.chisholm@nih.gov. Assessment of Capability - Lowest Price Technically Acceptable