Inactive

(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 annou... (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 75N95022Q00547 and the solicitation is issued as a request for quotation (RFQ). The anticipated award date is September 16, 2022. 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-07, with effective date August 10, 2022. (iv) The associated NAICS code is 325414 - Biological Product (except Diagnostic) Manufacturing and the small business size standard is 1,250 employees. This requirement is not restricted to small business. (v) The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum. NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug (IND)-enabling development. The APP is also tasked with identifying and developing antivirals for a variety of viruses of outbreak and pandemic potential, including a number of viruses that cause vascular damage (e.g. bunyavirales viruses, flaviviruses, alphaviruses). NCATS DPI will use 2d and 3d spheroid liver models to screen for antivirals within APP against select virus panels using the cryopreserved primary human hepatocytes. Primary human hepatocytes have critical characteristics and properties not present in immortalized or cancer liver cell lines. Culturing primary human hepatocytes as spheroids extends their lifespan by up to 4 fold. (vi) The Purchase Description (PD) with a description of the products to be acquired is included as an attachment to this Solicitation. The Division of Preclinical Innovation (DPI) within the National Center for Advancing Translational Sciences (NCATS) seeks cryopreserved, primary human liver cells (non-fetal) for use in DPI-APP_Biology Antiviral Drug Development IDDA DPI (8051491). (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date within three (3) weeks 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. (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 52.211-6, Brand Name or Equal (Aug 1999) FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (May 2022) FAR 52.214-34 Submission of Offers in the English Language (Apr 1991) FAR 52.214-35 Submission of Offers in U.S. Currency (Apr 1991) FAR 52.225-25 Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications (Jun 2020) 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 Products and Commercial Services (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2021) Alternate I (Jan 2021) FAR 52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021) 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 Products and Commercial Services (May 2022) Invoice and Payment Provisions with and without IPP (Apr 2022) The following clauses is attached and in included in full text: FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Feb 2021) Alternate I (Jan 2021) (ix) The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, provides the best value, considering price and other factors in this solicitation. The evaluation will compare: (a) Technical capability of the service offered to meet the Government requirement; (b) Price; and (c) Past Performance as defined under FAR 13.106-2(b)(3). If only one quotation is received it will be evaluated on the preceding basis. Responses may exceed capability or performance characteristics of the solicitation’s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation’s requirements if it provides a benefit to the Government; and the Government is not requesting or accepting alternate proposal(s). (x) The Offerors are to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2022), with offers. If the offeror has completed FAR provision 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 Products and Commercial Services (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. This COVID-19 requirement will be funded with COVID-19 funds at time of award. The following language is applicable and shall be included in the resultant COVID-19 award. “HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System.” The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. (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. The quote must be for a firm-fixed-price total amount inclusive of all costs and fees and include. any other information or factors that may be considered in the award decision. 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 ID 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 quotations must be received by 9 a.m., Eastern Time, on September 7, 2022, and reference Solicitation Number 75N95022Q00547. Responses must be submitted electronically to Renato Gomes at renato.gomes@nih.gov. Fax responses will not be accepted. Attachments: Purchase Description 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) Addendum to FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Products and Commercial Services (May 2022) FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Feb 2021) Alternate I (Jan 2021) Invoice and Payment Provisions with and without IPP (Apr 2022)