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)
ID: 75N95025Q00186Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, USA

NAICS

Medical Laboratories (621511)

PSC

MEDICAL- LABORATORY TESTING (Q301)
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a contractor to perform plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217) using Lumipulse assays on the Fujirebio G1200 for the Baltimore Longitudinal Study of Aging (BLSA). The contractor will analyze approximately 4,000 serum/plasma samples, employing senior research specialists to ensure continuity and consistency with prior assays, ultimately contributing to the understanding of cognitive decline and Alzheimer’s disease. This procurement is critical for advancing research on early identification and treatment of Alzheimer’s and related dementias, with a contract period anticipated from May 1, 2025, to April 30, 2026. Interested parties must submit their proposals by 9:00 a.m. EDT on April 11, 2025, to Emily Palombo at emily.palombo@nih.gov.

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    The government document outlines the representation requirements regarding telecommunications and video surveillance services or equipment in contracts involving federal agencies, following Section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019. It specifies that offerors must declare whether they will provide "covered telecommunications equipment or services" as part of their offered products or services to the government. The document details definitions and factors related to the terms used, prohibition clauses on covered equipment, and required disclosures based on the representations made by the offeror. If an offeror states they will or do use such covered telecommunications items, they must provide extensive information, including the identity of the producing entity and the nature of the proposed use. This document serves to ensure compliance with national security measures, protecting against potential risks associated with certain telecommunications technologies within government contracts.
    The provision 52.204-26 outlines requirements regarding "covered telecommunications equipment or services" in the context of federal contracting. It defines relevant terms and mandates that Offerors check the System for Award Management (SAM) for entities that cannot receive federal awards related to such equipment or services. Offerors must provide a representation indicating whether they supply or utilize covered telecommunications equipment as part of their products or services for government contracts. This requirement supports compliance with the prohibition on contracting for certain telecommunications and video surveillance services known to pose risks to national security. Thus, this provision aims to safeguard government contracting processes by ensuring that agencies do not engage with companies that may compromise security due to the use of prohibited technologies.
    The document serves as an addendum to FAR 52.212-4, addressing the order of precedence for resolving inconsistencies in government contracts pertaining to commercial items. It outlines the hierarchy of documents, starting with the schedule of supplies/services, followed by specific clauses and agreements relevant to commercial supplier agreements. These agreements are defined as terms commonly offered by vendors, significant for IT acquisitions, and apply to all formats and delivery mechanisms. It clarifies that when the U.S. Government is the end user, certain provisions are incorporated, including governance by federal law, limitations on binding government personnel, and restrictions on automatic renewals. Additionally, it establishes rules regarding dispute resolution, indemnification issues, and conditions for audits. The document emphasizes that modifications requiring governmental consent must be properly documented and enforces the principle that rights and obligations cannot be assigned without government approval. This summary highlights key legal frameworks that govern commercial supplier agreements in federal contracting, ensuring clarity and enforceability for both suppliers and government entities.
    The document outlines the Federal Acquisition Regulation (FAR) clauses applicable to the contracting of commercial products and services, as mandated by various statutes and executive orders. Key clauses incorporated by reference include those relating to contractor ethics, whistleblower protections, Executive Order compliance, and various contracting rules to enhance the utilization of small businesses, particularly in set-asides for HUBZone and veteran-owned firms. Notably, the contract requires adherence to terms prohibiting subcontractor sales restrictions, the requirement for reporting executive compensation and first-tier subcontract awards, and the implications of compliance with the Federal Acquisition Supply Chain Security Act. Additional provisions concerning labor standards, employment eligibility verification, and minimum wage requirements reflect an ongoing commitment to ethical labor practices and transparency in government contracting. The purpose of these clauses is to ensure that contractors comply with established laws and regulations, promoting fair competition and protecting the rights of workers, while simultaneously advancing government objectives in contracting practices, especially regarding small and disadvantaged businesses.
    The document outlines the certification requirements for offerors seeking exemption from the Service Contract Labor Standards (SCLS) for certain services in government contracts, as stipulated by federal regulation 52.222-52. Offerors must certify that their services are regularly offered to non-governmental customers at established prices and that employees will spend minimal time (less than 20%) on government contracts. Additionally, the compensation plan for service employees must be consistent with that for commercial clients. If the offeror meets these criteria, the contracting officer may decide that SCLS does not apply to the offeror, resulting in the exclusion of certain labor standards clauses from the contract. Conversely, failing to certify compliance will prevent contract award or require immediate communication with the contracting officer regarding wage determinations. This provision emphasizes the importance of compliance with federal contracting regulations and informs offerors about their obligations concerning labor standards in government-related services.
    This document outlines the Invoice and Payment Provisions applicable to federal contracts, specifically those under the National Institutes of Health (NIH). Key provisions emphasize the detailed requirements for submitting invoices, which must include specific identification details such as the Contractor's information, unique invoice numbers, relevant contract numbers, and descriptions of services or supplies provided. Invoices must be submitted electronically via the Department of Treasury’s Invoice Processing Platform (IPP). The payment timeframe stipulates that payments will occur within 30 days after receiving a proper invoice or government acceptance of delivered services, with expedited terms for perishable goods. Interest penalties may apply for late payments when certain conditions are met. Additionally, the document mandates accelerated payments to small business subcontractors within 15 days after the contractor receives government payments and specifies that electronic submission of payment requests is required unless an alternative method is authorized. This summary encapsulates the document's structure, emphasizing the requirements for invoices, payment timelines, and provisions promoting small business assistance within the context of government contracting processes.
    The National Institute on Aging (NIA) seeks to quantify Alzheimer’s disease (AD) biomarkers using Lumipulse assays on stored plasma samples from the Baltimore Longitudinal Study of Aging (BLSA). This procurement will employ a Senior Research Specialist to carry out assays for abeta42, abeta40, and pTau217 on 4,000 samples, aiming to enhance understanding of cognitive decline and AD through these biomarkers. The data will assist researchers in identifying participants who may be in the preclinical phase of AD and will be used alongside other clinical data. The contractor is required to deliver results electronically within one year and provide a progress report detailing sample analyses and any issues encountered. The NIA will retain unlimited rights to all deliverables produced under the contract. The project's period spans from May 1, 2025, to April 30, 2026, and is characterized as high-throughput research critical for early detection and treatment of cognitive impairments associated with Alzheimer's and related dementias.
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