Inactive

COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Synthesis and bioanalytical analysis of small molecules and microbiome conjugates (i) This is a combined synopsis/solicitation for commercial items ... COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Synthesis and bioanalytical analysis of small molecules and microbiome conjugates (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; quotes are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95022R00033 and the solicitation is issued as a for quotes (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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 22-2022/01-14-2022. (iv) The associated NAICS code is 541990, All Other Professional, Scientific and Technical Services This requirement is a small business set-aside. (v) This requirement is for support services for the projects focused on the therapeutic areas of the microbiome, neurodegeneration, and addiction. (vi) Background: NCATS needs medicinal chemistry services from a CRO that has concomitant capability of bioanalytical services. Iterative synthesis of rounds of analogs from multiple different series emerging from programs from the therapeutic areas of the microbiome, addiction, and neurodegenerative disorders will be required. Prior experience in medicinal chemistry campaigns and exposure to assays to the microbiome therapeutic area is required. In addition, capability of determining metabolites after compound incubation in assays is also required. Capability to generate in vitro ADME data in quick turnaround time as well mass spec capabilities to detect drug-conjugates from microbiome and microsomal assays is required. The services will augment existing medicinal chemistry campaigns within NCATS Purpose: The purpose and overall goal of this contract is to obtain support services for the projects focused on the therapeutic areas of the microbiome, neurodegeneration, and addiction. Prior experience and exposure to medicinal chemistry campaigns and mass spec based assays in the microbiome therapeutic area are required. 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 Statement of Work. Contractor shall ship 10 mg of analogs in iterative rounds of medicinal chemistry to NCATS. Depending on complexity of synthesis 50-100 analogs have to be synthesized. Simultaneously, contractor shall synthesize and ship 250 mg to 5 gram quantities of at least 5 intermediates that can be utilized for diversification at NCATS. In addition custom synthesis of prior art compounds from literature may also be required. Microsome stability for select compounds will be required. Metabolite identification and drug conjugate additions from microsome and microbiome assays for select compounds will be required. Deliverables: Intermittently and depending on complexity of synthesis a total of at least 50-100 analogs in 10-30 mg quantities with >95% purity as characterized by LCMS; as well at least 5-10 intermediates 250 to 5 gram quantities. LCMS and 1H NMR of key intermediates and analogs. Bioanalytical assay results of select compounds. Due within three (3) to four (4) months after receiving request from government. Reporting Requirements: Contractor shall present progress reports and meeting every 3-4 weeks with the Program Office. Reports shall cover progress in the synthesis of analogs, discussion of issues with synthesis and possible solutions, and the prioritization of compounds to be synthesized. Reports will also contain data from bioanalytical experiments. Government Responsibilities: NCATS will design and supply lists of analogs and intermediates for synthesis. NCATS will suggest candidates for bioanalytical experiments. Data Rights, Publications and Confidentiality of Information: Contractor shall not publish any information without informing NCATS. All information is confidential and NCATS will solely determine date for publication or publicity or patenting. Data will belong to NCATS. All information shared between NCATS and contractor is confidential. The time or method for publication will be determined by NCATS. (vii) Period of Performance: Twelve (12) months from date of award. The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is March 2022 through March 2023. (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 Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.225-2, Buy American Certificate (Feb 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (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 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. Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The Dun & Bradstreet Number (DUNS), 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 11:00 a.m., Eastern Daylight/Standard Time, on Friday, February 18, 2022, and reference Solicitation Number 75N95022R00033. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.