Inactive

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 (INCLUDING BRAND-NAME). The Nat... 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 (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 on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases 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 (Potassium palmitate U-13C) 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 (FAC) FAC 2021-02 effective November 23, 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). 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. 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 generation of knowledge that may not be possible by any other method. Prior to 2015, all intravenous sterile isotopes used for metabolic research at the NIH Clinical Center (CC) were produced and dispensed by the NIH CC Pharmaceutical Development Service (PDS). After the PDS closure in June 2015, NIDDK investigators worked with the NIH CC Pharmacy and developed a standard operating procedure (SOP) for procuring intravenous isotope compounding at Pine Pharmaceutical LLC, an FDA-registered 503b compounding pharmacy. 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 Pine Pharmaceuticals, LLC followed extensive year-long vetting and an external audit commissioned by the NIH CC Office of Research Support and Compliance (ORSC). This requirement is for the acquisition of the intravenous stable isotope of palmitate (U-13C-palmitate) from Pine Pharmaceuticals for 3 batches deliverables (i.e. a batch of U-13C-palmitate will be delivered ~ every 4 month). Specifically, the NIDDK requires the following: This requirement includes the procurement of raw materials, the production of the intravenous isotope product at Pine and the microbial and analytical testing to be performed by a third-party vendor. These stable isotopes are needed for metabolic research protocols that are IRB-approved. The NIH SHPA executive committee directive in July 2018 mandated that these isotopes must be obtained from Pine Pharmaceuticals, LLC per an existing quality agreement signed between NIH, NIDDK and Pine Pharmaceuticals, LLC. 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 PINE PHARMACEUTICALS, LLC to be the only reasonably available source to provide the Intravenous Stable Isotope (Potassium palmitate U-13C) for Metabolic Research the NIDDK requires. PINE PHARMACEUTICALS, 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 needed for this statement of work (SOW).is the manufacturer and the only authorized dealer for providing maintenance for this instrument. PERIOD OF PERFORMANCE Within 12 Months of Award Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & 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 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 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 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 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 Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov . Assessment of Capability Lowest Price Technically Acceptable