Media for SelecT automated cell culture system

(i)   This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.(ii)   The solicitation number is 75N95022Q00285 and the solicitation is issued as a  request for quotation (RFQ).  This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;  and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf

of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a Firm Fixed Price Purchase Order without providing for full and open competition (including brand-name) to Thermo Fisher Life Technologies, 3175 Staley Road, Grand Island NY 14072 for Media must be compatible with SelecT automated cell culture system.This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).The rationale for the sole source justification is Life Technologies is the sole source provider of the required 5L bags Essential 6 Medium. It’s the only company to focus exclusively on kinases. Additionally it is essential for SCTL to continue using this exact brand of cell culture media to maintain continuity within the experiments conducted since its start.(iii)    The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 22-2022/01-14-2022.(iv)    The associated NAICS 334516 – Analytical Laboratory Instrument Manufacturing and the small business size standard 1,000. (v)     This requirement is for the purchase of 15 of ME17436L1 5L bags Essential 6 Medium(vi)    - All items must come from the same manufacturer to ensure consistency of the   additives, agents, and vitamins across all   mediaMust be manufactured at a cGMP-compliant facilityRegistered with the FDA as a medical device manufacturerCertified to ISO 13485 standardsThe Essential 6 Medium is a proprietary formula to GibcoBackground: The National Institutes of Health (NIH), Stem Cell Translation Laboratory (SCTL)  request 15, 5L bags Essential 6 Medium as part of the overall mission of the Helping to End Addiction Long-term (HEAL) Initiative to focus on the development of human cell-based models of opioid misuse and addiction, and of pain. The SelecT was purchased in 2017 and has been in constant use since calibrated and optimized.NCATS CRM performed rigorous internal tests of a variety of stem cell culture systems from several vendors and concluded that Essential 6 stem cell culture system meets our specific requirement, including stem cell pluripotency maintenance, multi-lineage differentiation and 3-D culture. Any cell culture media used in this context must meet specific measurements of purity and consistency from batch to batch to provide consistent cell growth and viability. The above list of cell culture media meets the specifications. In addition, numerous batches of cells have been grown using these medium and the result was consistent, predictable, growth resulting in successful assays performed at NIH NCATS.These media and supplements are used routinely to support the growth of cells in culture medium, is a key and critical component of most cell culture efforts. By nature, these cell culture media are highly variable. Due to its complexity, the precise composition of these cell culture media varies depending on its grade, supplier and lot. Cells that thrive in cell culture media supplemented with one type of the requested media may suffer a loss of viability when switched to a different source of media. One way in which to decrease variation is to purchase high quality media exclusively from one manufacturer. As a manufacturer, Life Technologies produces a high-quality product that processes serum using a “true pool” processing method to increase consistency and minimize variability. Furthermore, all production steps are documented, and products are rigorously tested to ensure quality. It is essential for SCTL to continue using this exact brand of cell culture media to maintain continuity within the experiments conducted since its start.Purpose:SCTL uses the CompacT SelecT automated cell culture system (SelecT) to achieve industrial scale production, and ensure consistent quality between batches of stem cells produced in the lab. Cells require a variety of media and supplements to nurture based on the type of cell, while other supplements are used for differentiation. The SelecT requires the Essential 6 Medium to be in a bulk format to integrate into the system properly.Project Requirements:All items must come from the same manufacturer to ensure consistency of the additives, agents, and vitamins across all mediaMust be manufactured at a cGMP-compliant facilityRegistered with the FDA as a medical device manufacturerCertified to ISO 13485 standardsThe Essential 6 Medium is a proprietary formula to Gibco(vii)   The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 06/30/2022 – 07/22/2022, delivery date is 50 days after vendor receives the order The place of delivery and acceptance will be 9800 Medical Center Drive, Rockville, MD 20850.(viii)  The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:  https://www.acquisition.gov/browse/index/far   https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html   (End of provision)The following provisions apply to this acquisition and are incorporated by reference:FAR 52.204-7, System for Award Management (Oct 2018)FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021)FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021)FAR 52.225-2, Buy American Certificate (Feb 2021)FAR 52.225-4, Buy American-Free Trade Agreements-Israel Trade Act Certificate (Feb 2021)HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:https://www.acquisition.gov/browse/index/far   https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html  (End of clause)The following clauses apply to this acquisition and are incorporated by reference:FAR 52.204-13, System for Award Management Maintenance (Oct 2018)FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached.HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2022)NIH Invoice and Payment Provisions (Feb 2021)(ix)   The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:a. Technical capability of the item offered to meet the Government requirement;b. Price; andc. Past performance [see FAR 13.106-2(b)(3)].(x)    The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.(xi)   The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.(xii)   There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.(xiii)  The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.(xiv)  Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.The Uique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.All quotations must be received by 11:00 a.m., Eastern Daylight/Standard Time, on June 24 ,2022, and reference Solicitation Number 75N95022Q00285. Responses must be submitted electronically to Morgen Slager, at morgen.slager@nih.gov. U.S Mail and Fax responses are not accepted.