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 75N95024Q00089 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 Insititute of Mental Health (NIMH) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Affinity Research Chemicals Inc, 406 Meco Dr, Wilmington, DE 19804-1112, for 5Kg of non-GMP grade methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4). 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 essential characteristics of the item that limit the availability to a sole source are: Only this suggested source can provide Methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4) in large quantity (>5kg) in 1 batch with required quality, raw analytical data, and a description of synthesis. We will need to use the same lot material from Affinity Research to avoid any problems or deviation in our further process development work due to the consistency requirement on the process development and GMP manufacturing work. If we purchase material from other vendors, we will need to purchase small amount (~100g) first, requalify (test run and analysis) the compound (which will take several months), and ask for the synthetic route method (generally vendor will not provide the synthetic route) again. There will be a risk that the material produced by other vendors cannot be used as a regulatory starting material. The material must come with detail analytical data and description of synthesis to qualify for a further process development work and as a regulatory starting material for the GMP manufcacture work. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-06 dated December 04, 2023. (iv) The associated NAICS code 325414 – Biological Product (except Diagnostic) Manufacturing and the size standard in number of employees is 1,250. (v) This requirement is for 5Kg of non-GMP grade methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4). (vi) Background: NCGC00413972 was discovered by NCATS and NCI as a first-in-class innate immune cell modulator which reprograms CD206-positive tumor associated macrophages (TAMs). NCATS TDB program is supporting preclinical and clinical development of NCGC00413972 which includes process development and GMP manufacturing of the API. Methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4) is the key intermediate for the synthesis of NCGC00413972. A 3 step synthesis has been developed based on the availability of Methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate which can be further justified as a regulatory starting material for GMP manufacturing of NCGC00413972. The acquision of 5Kg (Methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4) is critical for the further process development and cGMP manyfacture of NCGC00413972 in large scale (>2 Kg). Purpose: To obtain 5Kg of non-GMP grade methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4). Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services,qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements of the purchase description. Specific Requirements: This compound is the key intermediate and regulatory starting material for process development and GMP manufacturing 2 Kg of API. 5Kg of non-GMP grade methyl 4-(((5-phenylpyrazin-2-yl)methyl)carbamoyl)benzoate (CAS 2654074-59-4) (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery is: 6 weeks after receipt of 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) FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 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 Products and Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached. 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 (Dec 2023) NIH Invoice and Payment Provisions (APR 2022) (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 Products and Commercial Services (Nov 2023), 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 Products and Commercial Services (Nov 2023), 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 Unique 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 offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on December 27, 2023, and reference solicitation number 75N95024Q00089. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.