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 CLARIVATE ANALYTICS (US) LLC for the acquisition of access to a comprehensive database that contains as much as information as is available concerning pharmacokinetic and toxicity information for our 101 compounds. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 511210 with a Size Standard of $41.5. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 Effective July 12, 2021. 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 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Base: POP September 15, 2021 – September 14, 2022 Option 1*: POP September 15, 2022 – September 14, 2023 Option 2*: POP September 15, 2023 – September 14, 2024 Option 3*: POP September 15, 2024 – September 14, 2025 Option 4*: POP September 15, 2025 – September 14, 2026 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 5 Memorial Drive Bethesda MD 20892 DESCRIPTION OF REQUIREMENT 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. _________________________ Hydroxyurea is the only compound approved by the FDA for inhibiting sickle cell hemoglobin polymerization, the cause of the pathology in sickle cell disease. The goal of the Eaton Lab’s drug development is to find additional and more effective drugs. The Eaton Lab has discovered 101 compounds from the Calibr ReFrame Library of Scripps Institute that inhibit sickling and are therefore potential drugs to treat sickle cell disease. To determine whether the compound should be pursued, it is essential to determine whether the concentrations that can be achieved in human serum without toxicity are comparable to the concentrations that inhibit sickling in our assay. Therefore, we require a comprehensive database that contains as much as information as is available concerning pharmacokinetic and toxicity information for our 101 compounds. Without access to the pharmacokinetic and toxicity information of our 101 compounds from these databases, we are unable to determine whether a compound that inhibits sickling in our assay is a potential drug to treat sickle cell disease. PURPOSE AND OBJECTIVES The objective of this request it to obtain subscriptions to comprehensive databases that contains pharmacokinetic and toxicity information for the 101 compounds the Eaton Lab has discovered from the Calibr ReFrame Library of Scripps Institute that inhibit sickling and thus, are potential drugs to treat sickle cell disease. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS Independently, and not as an agent of the Government, the contractor shall provide the following: a Cortellis Drug Discovery Intelligence term and OFF-X (Translational Safety/Toxicology) Subscription. 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 CLARIVATE ANALYTICS (US) LLC to be the only reasonable available source to provide Purchase of a Cortellis Drug Discovery Intelligence term and OFF-X (Translational Safety/Toxicology) Subscription. This acquisition was pursued on a sole source basis centered on the Eaton Lab having discovered 101 compounds from the Calibr ReFrame Library of Scripps Institute that inhibit sickling and are therefore potential drugs to treat sickle cell disease. To determine whether the compound should be pursued, it is absolutely essential to determine whether the concentrations that can be achieved in human serum without toxicity are comparable to the concentrations that inhibit sickling in our assay. Therefore, the NIDDK requires a comprehensive database that contains as much information as possible on pharmacokinetic and toxicity information for our 101 compounds. The Cortellis Drug Discovery Intelligence database contains the required pharmacokinetic information, while the OFF-X (Translational Safety/Toxicology) Subscription database contains the required toxicology information for our sickle cell drug development project to make further progress. Failure to procure these reagents from CLARIVATE ANALYTICS (US) LLC would result in a significant loss of research. 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 responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, August 2, 2021 to the Contracting Officer, Amber Harris, at
[email protected]. Assessment of Capability Lowest Price Technically Acceptable