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NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: The Role of Mitochondrial Genetic Variation in Dementia (i) This is a combined synopsis/solicitation for commercial products and commercial serv... NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: The Role of Mitochondrial Genetic Variation in Dementia (i) This is a combined synopsis/solicitation for commercial products and commercial services 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 75N95025Q00174 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial product or commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Products and Commercial Services; and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is 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 AND OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute on Aging (NIA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Johns Hopkins University, 3910 Keswick Road N4327-B, Baltimore, MD, 21211-2226 for laboratory analysis of mitochondrial genetic variation in dementia patient samples. This acquisition is conducted as non-competitive for a commercial product or commercial service and is conducted pursuant to FAR Subpart 13.5—Simplified Procedures for Certain Commercial Products and Commercial and FAR 13.501, Special Documentation Requirements, in accordance with 41 United States Code (U.S.C.) 1901 Simplified acquisition procedures. Pursuant to FAR Subpart 13.501(a)(1)(iii) the justification (excluding brand-name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-03, with effective date 01/17/2025. (iv) The associated NAICS code is 541380 and the small business size standard is $19M. (v) This requirement is for the following services: The Contractor will perform digital polymerase chain reaction (PCR) to assess mtDNA mutations in dementia patients. Contractor will supply 570 brain tissue samples (2 brain regions, frontal and occipital cortices) from dementia patients. Contractor will extract DNA from patient tissue using Qiagen- QIAmp DNA mini extraction kits and then perform Illumina short-read sequencing using the Twist Bioscience Mitochondrial Panel to assess mtDNA mutations. A monochrome qPCR assay using the Applied Biosystems ViiA 7 Real-time PCR System is needed to assess mtDNA copy number in patient samples. The Contractor will provide dedicated staff and reagents to process samples for mtDNA sequencing and mtDNA copy number analyses, and to analyze the resulting data. The Contractor will ship 570 frozen brain samples to NIA in a state that is compatible with to proteomics, cardiolipins mass spectrometry including oxidized cardiolipins, and long-read RNA sequencing assays. (vi) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is twelve months with one twelve month option period. (vii) 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 https://www.acquisition.gov/caac-letters (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Nov 2024) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and Disclosures (Dec 2023) FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION Feb 2025) CAAC_Letter_2025-01_Supplement-1.pdf and CAAC_Letter_2025-02_Supplement-1.pdf FAR 52.217-5, Evaluation of Options (July 1990). FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) 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 https://www.acquisition.gov/caac-letters (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). FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions below 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 ( Jan 2025) (DEVIATION Feb 2025) Per CAAC Letters 2025-01 and 2025-02, FAR 52.222-21, Prohibition of Segregated Facilities and FAR 52.222-26 - Equal Opportunity will not be considered when making award decisions or enforce requirements. FAR 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014). HHSAR 352.239-78, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION). HHSAR 352.239-79, Information and Communication Technology Accessibility (Feb 2024) (DEVIATION). FAR DEVIATION STATEMENT: The CAAC Letter 2025-01 -Supplement 1 and CAAC Letter 2025-02-Supplement 1 are applicable to this acquisition. System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM. The mentioned CAAC Letters may be accessed electronically at this address: CAAC Letters | Acquisition.GOV. The following invoice instruction is included and will be incorporated in the final award: NIH Invoicing Instructions with IPP (Mar 2023). (viii) The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services (Nov 2021), applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) technical capability; (ii) past performance; (iii) price. Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (ix) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION Feb 2025), 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. See DEVIATION STATEMENT above regarding applicable CAAC Letters. (x) 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. (xi) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xii) 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 product selected as compared with that of a comparable product, 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 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 9:00a.m., Eastern Standard Time, on March 31, 2025, and reference Solicitation Number 75N95025Q00174. Responses must be submitted electronically to Kevin Alvarez, Contracting Officer, kevin.alvarez@nih.gov. A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement. Fax responses will not be accepted.