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 75N95023Q00605 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 Center for Advancing Translational Sciences (NCATS) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Kansas University Biopharmaceutical Innovation & Optimization Center., McCollum Laboratories, 2097 Constant Avenue, Lawrence Ks, 66047 for services in testing Solid Dosage Form Strategy Options for GPR110 agonist A8 (NCGC00248435). 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 solid dosage form of NCGC00248435, that limit the availability to a sole source are continuity of study. This requirement involves careful handling of a compound that is sensitive to air and light. Only this suggested source can furnish the requirements, to the exclusion of other sources, because of the expertise and experience needed to handle such demanding requirements in the handling of the compound. Switching vendors would cause delay in work and an uncertainty in the formulation used in testing. Any change in the formulation would cause a loss of data previously obtained using the compound. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04 dated June 2, 2023. (iv) The associated NAICS code 541380 – Testing Laboratories and Services and the size standard in number of employees is $16.5. (v) This requirement is for the services in testing for Solid Dosage Form Strategy Options for GPR110 agonist A8 (NCGC00248435). (vi) Background: The National Institutes of Health (NIH), The National Center for Advancing Translational Sciences (NCATS) has discovered a compound (NCATSNCGC00248435) that has shown efficacy in various animal models of disease such as retina damage, diabetic retinopathy, multiple sclerosis, etc. There is a need to evaluate the compound’s efficacy and potential as a preclinical candidate. Purpose: The purpose of this requirement is to acquire services in testing for Solid Dosage Form Strategy Options for GPR110 agonist A8 (NCGC00248435). 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. Specific Requirements: Phospholipids, drug, and polymer which can act as a solid carrier will be dissolved/emulsified and spray-dried to generate a powder, done with and without antioxidants; resulting materials will be evaluated for preliminary solid properties amenable to further processing, dissolution to release drug, short term stability. Drug, with or without will be adsorbed to various silicates in suspension or emulsion and spray dried to generate a solid, done with and without antioxidants; resulting materials will be evaluated for preliminary solid properties amenable to further processing, dissolution or desorption to release drug, short term stability. A final report with feasibility for each method summarizing the results will be provided. (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated Period of Performance is 180 days (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 (MAR 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 Items (DEC 2022). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) 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 52.204–27, Prohibition on a ByteDance Covered Application (Jun 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 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 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) 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 August 16, 2023, and reference solicitation number 75N95023Q00605. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.