Solubility stability and toxicology studies are needed to advance NIH developed novel drug candidates into the clinical arena

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 JAI RESEARCH FOUNDATION for solubility stability and toxicology studies which are needed to advance NIH developed novel drug candidates into the clinical arena. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 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 The NIDDK Laboratory of Bioorganic Chemistry, Molecular Recognition Section Needed for the continuation of drug candidates evaluated in the following NIH publication: Chen Z, Janes K, Chen C, Doyle T, Bryant L, Tosh DK, Jacobson KA, Salvemini D. Controlling murine and rat chronic pain through A3 adenosine receptor activation. FASEB J. 2012 May; 26 (5):1855-65 Our requests are for CRO services to characterize the ADME-tox of experimental drug-like substances needed for possible translational research. This is essential to determine if a particular compound or substructure within a compound is suitable for progression into more advanced testing. These standard preclinical tests are needed for anticipated - derisking (i.e. detect obvious liability in potential drug candidates) in coming months. The objective is to have eight of our novel drugs tested for safety solubility and bioavailability. Preclinical testing is needed for drug discovery projects. These are standard tests that are predictive of safety for new drug substances. Specifically, the NIDDK requires the following: Task Area 1 - The samples will be tested on site at the Jai Research Foundation facility in Valvada, INDIA. The sample will be supplied by NIH and shipped via NIH shipping and FedEx at room temperature. The company will be responsible for the customs clearance. Sample will be shipped in several groupings for a total of 8.. 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 JAI RESEARCH FOUNDATION to be the only reasonably available source to provide solubility stability and toxicology studies which are needed to advance NIH developed novel drug candidates into the clinical arena. This testing must be consistent with all previous testing. This is the second set done by JAI RESEARCH FOUNDATION who has provided data consistent with the previous vendor that we can no longer use due to price and billing issues. Any competitive vendor must abide by the exact protocols used by JRF. Any deviance from these established protocols will require further testing to ensure that data from many years ago can be compared to the data generated in this request. PERIOD OF PERFORMANCE Within 12 Months of Award Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 8 Center Drive Bethesda MD 20814 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 contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable