Bioanalytical analyses of steroid concentrations in blood samples

(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 75N95025Q00260 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 2025-05, with effective date August 7, 2025. . (iv) The associated NAICS code is 541380 and the small business size standard is 19,000.000. This requirement has a small business concern set-aside restriction. (v) This requirement is for the following: bioanalytical analyses of steroid in blood samples to support a study characterizing the impacts of menopause stage, sex hormones, and sex chromosomes on brain aging and disease (please see attached statement of work) (vi.) Biological sex influences risk for neurodegenerative diseases (NDDs), with Alzheimer's disease occurring more often in females and Parkinson's disease occurring more often in males. Here, we propose to investigate how hormonal fluctuations (associated with menopause and andropause) and sex chromosome dynamics shape both sex differences and within-sex variability in brain aging and NDD risk. We will generate new blood-based endocrine measures and integrate these data with existing intramural and published single-nucleus RNA sequencing (snRNA-seq) datasets from various brain regions to examine how menopause stage, sex hormone concentrations, and sex chromosome loss contribute brain aging in specific brain cell types. Specifically, we will measure: 1) blood steroid hormones using high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS) performed by OpAns, LLC; and 2) blood glycoproteins (FSH and AMH) using Enzyme-Linked Immunosorbent Assays (ELISAs) and an associated plate reader from Mesoscale Diagnostics, LLC. By sampling males and females across the reproductive aging period - including the menopause transition - this work can illuminate how hormonal fluctuations due to reproductive aging contribute to changes in brain gene expression in ways that may impact susceptibility to NDDs. Our findings will enhance our understanding of how sex-related mechanisms and aging interact to influence brain health, potentially revealing novel therapeutic targets for NDDs. The purpose of this acquisition is to analyze steroid concentrations in blood samples using current LC-MS/MS methodology. OpAns has a steroid panel that includes 14 compounds of interest in support of our study, characterizing the impacts of menopause stage, sex hormones, and sex chromosomes on brain aging and disease. Capabilities such as these are essential to support our research into neurogenetic disorders. We require that all samples will be analyzed at the same time. If fewer than 50 samples are requested for analysis (either initial analyses or repeat analyses due to required dilutions), a minimum batch fee corresponding to the analysis of 50 samples applies. Extrapolated concentrations can be provided for no additional fee. The government will provide vendor with an appropriate volume of blood, ~500ul would be optimal. The following will be provided once analysis is complete: An Excel data table minimally containing sample ID, matrix, and measured concentration A formal report minimally containing standard and QC performance, sample concentrations, and a brief method summary (example chromatograms can be provided for $7200. This cost has been excluded from the cost schedule). (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is one year from date of award of services. (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 (SEP 2023) FAR 52.212-3 Offeror Representations and Certifications - Commercial Items (SEP 2023) FAR 52.222-22 Previous Contracts and Compliance Reports (FEB 1999) 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 incorporated as an attachment. 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 (SEP 2023) NIH Invoicing Instructions With IPP (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. Technical capability and past performance, when combined, are significantly more important than price. (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 of the service offered to meet the Government requirement; (ii) past performance [see FAR 13.106-2(b)(3)]; and (iii) price. (b) Options. N/A (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. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (SEP 2023), 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 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. The vendor will analyze and procure data as soon as practicable and not later than one year from date of award of contract and provide the following: (a) An Excel data table minimally containing sample ID, matrix, and measured concentration and (b) A formal report minimally containing standard and QC performance, sample concentrations, and a brief method summary (example chromatograms can be provided for $7200. This cost has been excluded from the cost schedule). (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. 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 Tuesday, August 19, 2025, at 2:30pm Eastern Daylight/Standard Time and must reference solicitation number 75N95025Q00260. Responses must be submitted electronically to Tiffany Stone, Contract Specialist, at tiffany.stone@nih.gov. Fax responses will not be accepted.