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 75N95023Q00289-RFQ and the solicitation is issued as a request for quotation (RFQ). The anticipated award date is July 7, 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date 06/02/2023. (iv) The associated NAICS code is 334516 - ANALYTICAL LABORATORY INSTRUMENT 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 goal of the NCATS TDB is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). 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 Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the DPI, TDB, is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Moreover, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials. A rheometer is an analytical instrument used to measure the flow and deformation properties of materials such as fluids, semi-solids, and solids. In a formulation lab, rheometers are important for several reasons: 1. Quality Control: Rheometers can be used to evaluate the quality of raw materials and finished products by testing their viscosity, elasticity, and other physical properties. 2. Formulation Development: Rheometers can help formulation scientists develop new products by providing insights into the flow and deformation properties of different materials and how they interact with each other. 3. Process Optimization: Rheometers can be used to optimize manufacturing processes by providing real-time data on material behavior during processing. 4. Regulatory Compliance: Rheometers can be used to ensure compliance with industry standards and regulations by testing the physical properties of materials according to specific requirements. Thus, NCATS DPI TDB requires a rotational rheometer to measure the flow and deformation properties of materials such as fluids, semi-solids, and solids in the formulation lab. (vi) The Purchase Description (PD) with a description of the products to be acquired is included as an attachment to this Solicitation. The Formulation Lab within Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI), within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase a NETZSCH Kinexus Prime Pro+ Rheometer with accessories, installation, and warranty (brand-name or equal). (vii) The NCATS DPI TDB Formulation Laboratory is under construction. Therefore, delivery is expected to be performed in September 2023. Delivery shall be 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). Installation shall be performed by personnel authorized by the manufacturer to perform installation activities. The installation shall occur at a date and time scheduled by NCATS, no later than sixty (60) days from delivery. (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 (Mar 2023) 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 52.225-13, 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 (Jun 2023) Invoice and Payment Provisions with and without IPP (Mar 2023) The following clauses is attached and in included in full text: FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Oct 2022), Alternate III (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 (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. 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 proposing on an equal product 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. All quotations must be received by 9 a.m., Eastern Time, on June 30, 2023, and reference Solicitation Number 75N95023Q00289-RFQ. 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 (Jun 2023) FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Oct 2022), Alternate III (Jan 2021). Invoice and Payment Provisions with and without IPP (Apr 2022)