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Next Generation Sequencing System

Active

75F40126Q134622Federal

Response Deadline08/05/2026, 06:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The U.S. Food and Drug Administration, through its Office of Acquisition Grant Services under the Department of Health and Human Services, is seeking proposals for a Next Generation Sequencing System under solicitation number 75F40126Q134622. The solicitation, posted on July 28, 2026, requires responses to be submitted by August 5, 2026, at 6:00 PM Eastern Time. This is a combined synopsis and solicitation with no set-aside designation, and it falls under NAICS code 334516 for Medical Equipment and Supplies Manufacturing. The contract will be executed by the FDA Office of Acquisition Grant Services located in Rockville, Maryland, with the required system to be delivered and performed in Jefferson, Arkansas, ZIP code 72079. Primary point of contact for all inquiries is Nick Sartain, reachable at 301-796-1988 or nick.sartain@fda.hhs.gov. All interested parties must review the full combined synopsis/solicitation document via the provided SAM.gov webpage to understand technical specifications, evaluation criteria, and submission requirements.

General Info

FDA seeks next-generation sequencing system delivery to Arkansas by August 5, 2026, via SAM.gov solicitation.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

334516 - Analytical Laboratory Instrument ManufacturingView NAICS

Place of Performance

Jefferson, AR, 72079, USA

Set-Aside

NONE

Documents

(1)

combined+synopsis-solicitation+134622+sequencing+system.pdf

PDF

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Timeline

PhaseCombined Synopsis

PostedJul 28

Combined Synopsis

Response DeadlineAug 5

Submission deadline

Response Deadline

08/05/2026, 06:00:00 PM UTCin 8 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeRockville, MD, 20852, USA

Organization / Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

View Agency Profile

Office AddressRockville, MD, 20852, USA

Contacts

Nick Sartain

contact@example.gov

+1 (555) 000-0000

Full Description

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See attached combined synopsis/solicitation.

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CDRH Clinical Study Service ContractThe U.S. Food and Drug Administration’s Center for Devices and Radiological Health is soliciting commercial clinical study services under solicitation number 75F40126Q00193, with proposals due by August 4, 2026. The contract is a Firm Fixed Price (FFP) award for remote performance of a clinical study involving the collection, annotation, and delivery of 12-lead ECG data from 150 subjects in the base year and 35 subjects per optional year, alongside the development of a synthetic retrospective dataset of at least 4,000 subjects to support the validation of an FDA-developed ECG signal transformation framework for AI/ML-enabled cardiovascular devices. Performance is scheduled to begin September 30, 2026, with up to four one-year optional extensions through September 29, 2031. All deliverables, including approved study protocols, de-identified datasets, monthly progress reports, and a final public-ready dataset, must comply with FDA and IRB requirements, HIPAA standards for de-identification, and FDA-approved data collection procedures. The contract requires continuous monitoring of signal quality, synchronization of FDA-approved ECG devices, and collection of comprehensive metadata during resting, supine conditions. Offerors must demonstrate extensive experience in AI and machine learning applications for 10 or more years, a proven history analyzing wearable datasets, affiliation with a hospital within 10 miles of Silver Spring, Maryland, and a track record of conducting at least five clinical studies involving both healthy and unhealthy subjects, including publications in prestigious journals. Proposals must be submitted electronically via email to Natalie.Brown@fda.hhs.gov by the deadline, formatted into two volumes: a Technical Approach detailing methodology and personnel resumes, and a Price volume using the provided attached Price Sheet, which currently contains no populated values. All offerors must have an active UEI in SAM.gov, maintain compliance with employment eligibility, anti-trafficking, and cybersecurity regulations, and adhere to clauses covering whistleblower protections, subcontractor exclusions, paid sick leave, and data safeguarding. Payment must be processed exclusively through the U.S. Treasury’s Invoice Processing Platform, with no physical delivery or FOB terms applicable. The government will evaluate proposals based on technical merit and overall advantage, not solely on price, and will select the offeror best positioned to deliver high-quality, compliant clinical data under strict oversight. Security clearances are not required, but robust data protection measures

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

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Procure a new WD-XRF for Color Certification Analysis.The FDA Office of Acquisition and Grant Services is seeking to procure a new wavelength-dispersive X-ray fluorescence (WD-XRF) spectrometer to sustain the mission-critical Color Certification Program under 21 CFR Part 74. This instrument is essential for high-throughput analysis of elemental impurities in certifiable color additives, enabling accurate certification or rejection decisions, supporting regulatory sample analysis with unknown elemental compositions, and advancing research into improved analytical methods. The acquisition is not subject to any set-aside provisions and falls under NAICS code 334516, targeting advanced analytical instrumentation specifically designed for precise elemental detection in complex matrices. The solicitation, designated OC-2026-134665, was posted on July 27, 2026, with proposals due by August 7, 2026. Performance of the contract will occur at College Park, Maryland, while the contracting office is located in Rockville, Maryland. Bidders must provide equipment with guaranteed service support, including timely maintenance and repair capabilities to ensure uninterrupted operational continuity. Primary point of contact for inquiries is David Seid, reachable via phone or email through the FDA’s HHS domain. The contract is being procured through a combined solicitation process, and all responses must meet the technical and service requirements to support the FDA’s regulatory and scientific obligations.

Analytical Laboratory Instrument Manufacturing

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BRAND NAME AGILENT OPENLAB CDS AND ECM SOFTWARE MAINTENANCEThe Office of Pharmaceutical Quality Research within CDER relies on the Agilent OpenLab CDS and ECM software systems as essential tools for managing and analyzing chromatographic data from HPLC systems used in critical research and regulatory studies. These systems are central to evaluating product and process design impacts on pharmaceutical quality, making uninterrupted functionality and timely updates imperative to the office’s mission. A maintenance service contract is required to ensure continuous software support, including patches, updates, and resolution of technical issues, to maintain data integrity and operational efficiency in daily workflows. The solicitation for this maintenance contract, identified by number 75F40126Q00330, was posted on July 27, 2026, with responses due by August 3, 2026. It is a combined solicitation with no set-aside designation and falls under NAICS code 334516 for laboratory analytical instrument manufacturing. The contract will be managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, with performance taking place in St. James, Maryland. All inquiries and communications should be directed to Tiffany Hatcher at the provided contact details based in Rockville, Maryland.

Analytical Laboratory Instrument Manufacturing

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