Plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217 ) using the Lumipulse assays on the Fujirebio G1200 in the Baltimore Longitudinal Study of Aging (BLSA)
(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... (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 75N95025Q00186 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; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, 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 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, intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Johns Hopkins Bayview Medical Center, 5200 Eastern Avenue, Room 5100, MFL Center Tower, Baltimore, MD 21224 for plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217 ) using the Lumipulse assays on the Fujirebio G1200 in the Baltimore Longitudinal Study of Aging (BLSA). This acquisition is conducted as non-competitive for a commercial product or commercial service and is conducted pursuant to FAR 13.106-1(b)(1). (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 621511 and the small business size standard is $41.5 million. (v) This requirement is for the following services: Contractor shall analyze serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays on 4000 samples from BLSA study participants. The contractor will use senior research specialists to perform the assays on the Fujirebio G1200 analyzer. The data shall be compiled and sent to The National Institute on Aging (NIA) after completion of the assays. (vi) The National Institute on Aging (NIA) requires quantification of the-state-of-art assays for plasma abeta42, abeta40, ptau217 using Lumipulse assays. These biomarkers will be assayed using stored specimens from participants in the Baltimore Longitudinal Study of Aging (BLSA). This procurement is for the services of the Senior research specialist to perform the Lumipulse assays on the Fujirebio G1200 instrument. This project requires the use of high throughput equipment and sensitive assays for the identification of these biomarkers. For continuity of research, the assays must be performed in a similar way to prior assays in serum/plasma from BLSA participants. The contractor shall build upon assessments already performed. These biomarkers will provide important insights into the biological underpinnings of cognitive impairment and AD/Alzheimer’s Disease and Related Dementias (ADRD) years before any symptoms would be apparent. New insights may lead to early identification of those most likely to show cognitive decline, as well as novel treatments to help prevent or delay AD/ADRD. The government will provide the serum/plasma samples to be assayed and the necessary kits and materials to perform the assays. The contractor shall deliver an electronic copy of the results of the analysis within one (1) year from the date of receipt of the contract. The contractor shall provide a written progress report once the samples have been analyzed that will cover measurements for each sample, problems encountered, problem resolution, and unresolved problems. Please see Statement of Work. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is May 1, 2025, to April 30, 2026. (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 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 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). 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). (ix) 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: 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)]. Technical and past performance, when combined, are significantly more important than cost or price. 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. (x) 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. (xi) 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. (xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii) 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. Please be advised that the National Institutes of Health (NIH) is a Federal agency. Your mass-market commercial sales and/or license agreement terms and conditions may include provisions that are customarily found in the commercial sector but which are not appropriate for a contract with a Federal agency. Specifically, NIH considers any provision in your mass-market commercial sales and/or license agreement terms and conditions to be inappropriate and unenforceable that: (1) Contravenes a right granted NIH under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan), (2) Violates the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Prompt Payment Act, Contract Disputes Act, Freedom of Information Act, Principles of Federal Appropriations Law), (3) Departs from reasonable consumer expectations, or (4) Violates fundamental public policy. NIH shall assume that you are in agreement with the statements herein if you submit a quotation/proposal and accept NIH's order/contract. 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 9:00 a.m., Eastern Daylight Time, on Friday, April 11, 2025, and reference Solicitation Number 75N95025Q00186. Responses must be submitted electronically to Emily Palombo, Contract Specialist, at Emily.palombo@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.
Data sourced from SAM.gov.
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