Plasma assays of neurodegeneration using Lumipulse G1200 and Quanterix HD-X in the Baltimore Longitudinal Study of Aging (BLSA)

(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 75N95023Q00459 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date June 2, 2023. (iv) The associated NAICS code 541380 - Testing Laboratories and the small business size standard is $19 million. This requirement is full and open with no set-aside restrictions. (v) This requirement is for the following services: Plasma assays of neurodegeneration using Lumipulse G1200 and Quanterix HD-X in the Baltimore Longitudinal Study of Aging (BLSA). Background Information: Evidence from autosomal dominant Alzheimer's disease (AD) research suggests that soluble forms of phosphorylated tau may have downstream effects on neurodegenerative processes and cognitive decline. Recent data suggest that pTau217 may be particularly sensitive to the development of brain amyloid. The purpose of this procurement is to perform assays for biomarkers of AD (ABeta, pTau217), neuroinflammation (GFAP) and neuronal injury (NfL) in longitudinal biospecimens from participants in the BLSA who have scores on the phenotypic metric of aging index or proteomics data. These data will be used by investigators in the Laboratory of Behavioral Neuroscience and Translational Gerontology Branch to leverage the wealth of available neuroimaging, cognitive, and clinical data in the BLSA. Specifically measures of ABeta and pTau217 will be used to stratify participants to determine the likelihood that participants are in a preclinical phase of AD. These measures will also be used continuously alone and in combination with biomarkers of inflammation and neuronal injury to further understand the causes of cognitive and brain changes in healthy individuals and those with a variety of comorbidities. 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. These biomarkers will provide important insights into the biological underpinnings of cognitive impairment and AD/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. (vi) Specific Requirements: The National Institute on Aging (NIA) requires state-of-art assay kits for quantification of serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays and NfL and GFAP using Quanterix SIMOA 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 technicians/ specialists to perform the assays on the Lumipulse G1200 instrument and the Quanterix Simoa assays on the HD-X instrument. Contractor shall analyze serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays and NfL and GFAP using Quanterix SIMOA assays on 4500 samples from BLSA study participants. The contractor will use technicians/specialists to perform the assays on the Lumipulse G1200 and the Quanterix Simoa HD-X analyzer. Level Of Effort: Senior technician(s)/ specialist(s). 50% effort Government Responsibilities: The government will provide the serum/plasma samples to be assayed and the necessary kits and materials to perform the assays. Deliverables: 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. Reporting Requirements: The contractor is required to 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. Key Personnel: Technicians/ specialists with experience running assays on the Lumipulse G1200 instrument and the Quanterix HD-X instrument. Data Rights: The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of - unlimited rights is contained in Federal Acquisition Regulation (FAR) 27.401, - Definitions. FAR clause 52.227-14, - Rights in Data-General, is hereby incorporated by reference and made a part of this contract/order. Publications and Publicity: The contractor will work with the National Institute on Aging on publications. Any publications are required to follow the National Institute on Aging publication procedures. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months. (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 (Mar 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022) FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) 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. 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 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (June 2023) NIH Invoice and Payment Provisions (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)]. 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) 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 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 11:00 A.M. Eastern, on August 25, 2023, and reference Solicitation Number 75N95023Q00459. Responses must be submitted electronically to Hashim Dasti, Contract Specialist, at contact@example.gov. Fax responses will not be accepted.