Inactive

This ammendmant 1 dated 4/8/2022 includes all soliciation attachments for 75N950022Q00191 All other terms and conditions of the solicitation remain unchanged. This is a combined synopsis/solicitation ... This ammendmant 1 dated 4/8/2022 includes all soliciation attachments for 75N950022Q00191 All other terms and conditions of the solicitation remain unchanged. 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 75N95022Q00191 and the solicitation is issued as arequest 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 the brand-name manufacturer, Gibco, or authorized resellers for the Gibco Cell Culture Medium, Substrate, and Supllements. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) 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, or industrial mobilization). Cells require a variety of medium, substrate, and supplements to nurture based on the type of cell, while other supplements are used for differentiation. The National Center for Advancing Translational Sciences (NCATS), Stem Cell Translation Laboratory (SCTL) requires an assorted cell culture medium, substrate, and supplements to achieve its goals. NCATS opened the SCTL in 2017 with innovative laboratory technologies featuring advanced equipment and resources not available to most laboratories. The focus of the SCTL is to bring iPSC-derived cells closer to clinical applications and serve as a reference center for iPSC research and application. Ongoing research projects in SCTL focus on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. To achieve these aims for supporting stem cell pluripotency maintenance, multi-lineage differentiation and 3-D culture, SCTL performed rigorous internal tests of a variety of stem cell culture systems. Gibco cell culture medium, substrate, and supplements meets the SCTL’s specific requirement for its ongoing research projects. The cell culture medium used for the ongoing research projects by its Scientists in the NCATS SCTL must meet specific measurements of purity and consistency from batch to batch to provide consistent cell growth and viability. Numerous batches of cells have already been grown using these Gibco medium and supplements by its NCATS Scientists. To ensure the integrity and consistency of the results of its ongoing research projects and the predictable growth resulting in successful assays performed at NCATS, SCTL requires an assortment of Gibco (brand-name) cell culture medium, substrate, and supplements that are manufactured at a cGMP-compliant facility, registered with the FDA as a medical device manufacturer, certified to ISO 13485 standards. These brand-name cell culture medium have already been used by NCATS for the majority of cells used in its assays since it’s inception. Re-optimization of all existing assays would need to be performed if another manufacturer’s medium were to be introduced, and would therefore incur tremendous costs, time and material resources to the government. Soliciting on a brand-name only basis still allows for authorized resellers identified through the market research conducted to compete for this proposed procurement opportunity. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-04, with effective date 01/30/2022. (iv) The associated NAICS code 325414 Biological Product (except Diagnostic) Manfacturing and the small business size standard 1,250 employees. This requirement is full and open (brand-name only) with no set aside restrictions. (v) This requirement is for Gibco Cell Culture Medium, Substrate, and Supplements (Brand-Name Only). (vi) The brand name media and supplements required include the following: Manufacturer Name: Gibco Manufacturer Product Number: A1370701 Product Name: CTS (Cell Therapy Systems) N-2 Supplement Quantity: 100 bottles Manufacturer Name: Gibco Manufacturer Product Number: A1516401 Product Name: Essential 6 Medium Quantity: 100 bottles Manufacturer Name: Gibco Manufacturer Product Number: A1569601 Product Name: Geltrex HESC Qualified Quantity: 50 bottles See Attached Purchase Description (PD). (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is 14 days after receipt of order (ARO). Delivery will be f.o.b. destination. The place of delivery and acceptance will be 9800 Medical Center Drive, Rockville, MD 20850. The building and room number shall be specified at time of purchase order award. (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) 52.211-6 Brand Name or Equal (AUG 1999) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.225-4, Buy American-Free Trade Agreements-Israel Trade Act Certificate (Feb 2021), Alternate I (JAN 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 pursuant to 4.2103 Procedures and submit applicable completed copies as separate documents with their offer. 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; and c. 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) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. 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. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. The Unique Entity Identification (UEI) from SAM.gov, 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 questions must be received by 9:00 AM, Eastern Daylight/Standard Time, on Tuesday, April 12, 2022, and reference Solicitation Number 75N95022Q00191. Questions may be submitted electronically to Chandani Hangilipola, 301-480-7089, chandani.hangilipola@nih.gov & Rieka Plugge, 301-827-7515, rieka.plugge@nih.gov All offers/quotations must be received by 9:00 AM, Eastern Daylight/Standard Time, on Monday, April 18, 2022 and reference Solicitation Number 75N95022Q00191 Responses must be submitted electronically to Chandani Hangilipola, 301-480-7089, chandani.hangilipola@nih.gov & Rieka Plugge, 301-827-7515, rieka.plugge@nih.gov Fax responses will not be accepted.