Pharmacology and Histology Studies

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Charles River Laboratories, Inc. for Pharmacology and Histology Studies. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541380 - Testing Laboratories with a Size Standard of $16.5 million. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-06 dated May 26, 2022. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people's lives. Included in this process is the development of unique small molecules as potential anticancer agents or as potential for regenerative medicine. Evaluating the efficacy of pharmacological agents in living animals is a critical step in translating the efficacy observed for these small molecules in biochemical and cellular systems to an agent that may be suitable for further development in humans. The objective of this requirement is the first step in that process: the treatment of mice with the small molecules, followed by an examination of the organ systems in the mice for the key biomarkers that may show efficacy. This requirement is for the treatment of the mice and collection of the organ systems. The biomarker analysis is to be performed at NCATS. The requirement is for two (2) sets of Pharmacology and Histology studies. Specific Requirements: Study 1: 1. Formulation and administration of 6 small molecule agents to 12 CD-1 mice (2 mice per agent) 2. Formulation and administration of 1 control placebo to 2 CD-1 mice. 3. Euthanization of the mice after 4 to 24 hours. 4. Collection of select organ systems from the mice for all samples. 5. Flash freezing and shipment of the organ systems to NCATS for analysis. 6. Shipment to NCATS will be by World Courier (preferred) Study 2: 1. Formulation and administration of 6 small molecule agents to 18 CD-1 mice (3 mice per agent) 2. Formulation and administration of 1 control placebo to 3 CD-1 mice. 3. Euthanization of the mice after 4 to 24 hours. 4. Collection of select organ systems from the mice for all samples. 5. Flash freezing and shipment of 50% of the organ systems to NCATS for analysis. 6. Formalin fixation and paraffin embedding of the remaining 50% of the collected organ systems, followed by shipment to NCATS for analysis. 7. Shipment to NCATS will be by World Courier (preferred) ESTIMATED PERIOD OF PERFORMANCE: Within four (4) months from the contract award and receipt of first batch of material. 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. Specifically, Charles River Laboratories, Inc. is the only vendor in the marketplace that can provide the services required by NCATS . The intended source is: Charles River Laboratories, Inc. 251 Ballardvale St. Wilmington, MA 01887 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: 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 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NCATS-22-005187. Responses must be submitted electronically to Sarah Adan, Contract Specialist, at contact@example.gov and Valerie Whipple, Contracting Officer, at contact@example.gov. U.S. Mail and fax responses will not be accepted.