SOLICITATION NOTICE
65 -- Induced pluripotent stem cell (iPSC) derived human neurons and astrocytes. (Brand-Name)
- Notice Date
- 5/26/2023 7:21:04 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00352
- Response Due
- 5/31/2023 6:00:00 AM
- Archive Date
- 06/15/2023
- Point of Contact
- Renato Gomes
- E-Mail Address
-
renato.gomes@nih.gov
(renato.gomes@nih.gov)
- Description
- �(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 75N95023Q00352 and the solicitation is issued as a request for quotation (RFQ). The anticipated award date is May 31, 2023. 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 purchase order without providing for full and open competition (including brand-name) to FUJIFILM CELLULAR DYNAMICS, INC., 465 SCIENCE DR., MADISON, WI 53711, 608-310-5100 for Induced pluripotent stem cell (iPSC) derived human neurons and astrocytes. 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 brand-name justification is based on vendor previous supply of iPSC derived human neurons and astrocytes. NCATS has extensively characterized them in current assay protocol with a robust HTS compatible neuronal spheroid model using iPSC derived neurons (glutamatergic, GABAergic, and dopaminergic) and iPSC derived astrocytes for robust cultures for investigating viral infection. (iii)������ The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-02, with effective date 03/16/2023. �(iv)����� The associated NAICS code is 325414 Biological Product (except Diagnostic) Manufacturing and the small business size standard is 1,000 employees. This requirement is not set-aside 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 and conducts collaborative research projects across the preclinical phases of the translational science spectrum, using both internal and contract resources to advance them. The NCATS DPI ETB�s goal is to uncover new small molecule therapeutics and advance the process of therapeutic development through a model of collaborative research. For each collaboration, external disease experts team with the ETB�s drug discovery teams, who provide access to small molecule screening, medicinal chemistry and informatics expertise. Moreover, 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 tasked with identifying and developing antivirals for a variety of viruses of outbreak and pandemic potential, including a number of neurotrophic viruses (e.g. encephalitic bunyavirales viruses, flaviviruses, alphaviruses). NCATS has developed a robust HTS compatible neuronal spheroid model using iPSC derived neurons (glutamatergic, GABAergic, and dopaminergic) and iPSC derived astrocytes for robust cultures for investigating viral infection. NCATS has developed this model specifically using FujiFilm/CDI iPSC derived neurons and astrocytes. Thus, NCATS DPI ETB requires Induced pluripotent stem cell (iPSC) human cell-derived differentiated cells for high-throughput screening (HTS) for fluorescent imaging plate reader (FLIPR) and functional screening as well as viral infections. (vi)������ The Purchase Description (PD) with a description of the products to be acquired is included as an attachment to this Solicitation. The Early Translation Branch (ETB), under the Division of Preclinical Innovation (DPI), within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase Induced pluripotent stem cell (iPSC) derived human neurons and astrocytes for high-throughput screening (HTS) for fluorescent imaging plate reader (FLIPR) and functional screening as well as viral infections for use in DPI- Antiviral Program for Pandemics (APP) Biology Antiviral Drug Development IDDA DPI (8051491). (vii)����� The Government anticipates award of a firm fixed-price purchase order for this acquisition, and delivery shall be within thirty (30) days after receipt of order (ARO), FOB Destination to 9800 Medical Center Drive, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays). (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 (Dec 2023) 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 (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.225-2 Buy American Certificate (Oct 2022) 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 (Mar 2023) The following clauses is attached and in included in full text: FAR 52.225-2 Buy American Certificate (Oct 2022) (ix)������ The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to Fujifilm Cellular Dynamics, provided it is technically acceptable and at a fair and reasonable price. If multiple quotations are received, the Government may perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation. The evaluation shall compare: Technical capability of the item offered to meet the Government requirement in accordance with the requirements specified in the Statement of Work, Price, and Past Performance as defined under FAR 13.106-2(b)(3). An award will be made to the vendor whose quotation is most advantageous to the Government. The government reserves the right to select a response that provides benefit to the government that exceeds the minimum; the government is not required to select a response that exceeds the minimum; responses may exceed the requirements; each response must meet the solicitation requirement statement at a minimum; 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 (Dec 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 (Dec �2022), 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. 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)���� 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 solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product. 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 Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the service. 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. 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 May 31, 2023, and reference Solicitation Number 75N95023Q00352. 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 (Mar 2023) FAR 52.225-2 Buy American Certificate (Oct 2022) Invoice and Payment Provisions with and without IPP (Apr 2022)
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/36060c9dc78f4207aa34f80621802998/view)
- Place of Performance
- Address: Rockville, MD 20850, USA
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN06696390-F 20230528/230526230108 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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