Longitudinal Study of Sex Differences in Autoantibodies and Autoimmune Diseases with Aging

Note: Response due date is revised to September 14, 2023 (5pm - EDT). Item vii description is revised (in italic) to incorporate additional antibody assays - See attached revised SOW Title: Longitudinal Study of Sex Differences in Autoantibodies and Autoimmune Diseases with Aging. (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 75N95023Q00565-RFQ, and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a 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 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 is 541380 - Testing Laboratories, and the small business size standard is $16.5 million. This requirement is full and open with no set-aside restrictions. (v) The purpose of this requirement is to procure service to perform multiplex antibody assays using a high throughput immunoproteomics approach to assess subclinical and preclinical autoimmune diseases and investigate their longitudinal change in an individual and investigate their association with aging and age-related diseases in the Baltimore Longitudinal Study of Aging (BLSA). (See attached statement of work). (vi) The contractor shall construct and perform ANA testing for ~1,500 blood samples using indirect immunofluorescence assay, which is the gold standard test to detect these autoantibodies. The contractor shall utilize HEp-2 cells, containing important autoantigens, grown on glass slides, overlaid with patient serum, and then incubated with a fluorescein-conjugated antibody to detect autoantibodies. Fluorescence shall be examined under an ultraviolet microscope, and the ANA titer will be reported based on the dilution prior to an endpoint where less than half of the cells show detectable fluorescence. The titer and the patterns of cellular fluorescence will be analyzed, which are strongly associated with various autoimmune diseases. The number and type of samples are subject to change as data are generated. (See attached 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 September 20, 2023, thru September 19, 2025. In addition to providing a quotation for ANA testing for ~1,500 blood samples using indirect immunofluorescence assay, the offeror's quotation shall include pricing for the following antibody assays: Reflex ANA testing for up to 15,900 samples Rheumatoid factor by turbidometry for up to 17,400 samples CCP antibody (IgG/IgA) for up to 17,400 samples Anti-thyroperoxidase antibody for up to 17,400 samples Anti-tissue transglutaminase IgA up to 17,400 samples (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). 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 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021). FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Dec 2022). FAR clause 52.227-14, Rights in Data-General (May 2014). 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, 52.204-26, and 52.222-52 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). FAR 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014). 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 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; (b) price, and (c) past performance [see FAR 13.106-2(b)(3)]. Technical capability and past performance, when combined, are significantly more important than 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 (Dec 2022), 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 (Dec 2022), applies to this acquisition. (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 September 14, 2023, at 5:00 pm, Eastern Daylight Time (revised), and reference Request for Quotation Number 75N95023Q00565. Responses must be submitted electronically to Iris Merscher, Contract Specialist, at e-mail address contact@example.gov.