This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on April 20, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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RFQ 75F40126Q00091 Dual Dissolution

Closed

75F40126Q00091Federal

Submission Closed05/08/2026, 04:00:00 PM UTC

Contract Overview

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

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NAICS: 334516

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about 19 hours ago

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AI Contract Overview

The FDA San Juan Medical Products Laboratory is soliciting a firm-fixed-price contract for the procurement, delivery, installation, and validation of a modern, dual bathless dissolution system with integrated autosampler, PC workstation, and controller software to replace its obsolete analytical equipment. The new system must fully comply with regulatory and quality standards including cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, 21 CFR Part 11, and support analytical protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program, and the Federal Contract Compliance program. The contract requires the equipment to be new, serialized, and accompanied by manufacturer certification, with delivery inside the FDA San Juan facility, installation, IQ/OQ validation, onsite training for up to five users, and comprehensive user manuals. A minimum three-year warranty covering parts, labor, travel, and software updates is mandated, including a 72-hour onsite response time. The entire delivery and installation process must be completed within six to eight weeks after award. The procurement is conducted under NAICS code 334516 and is set aside for total small business participation. Evaluation will be based on a balanced trade-off between technical approach and price, with the technical proposal addressing compliance with specifications, delivery schedule, warranty, training, and documentation quality. Pricing submissions must be itemized and fair, although no option periods are included. Invoices will be submitted electronically via the Department of Treasury’s Invoice Processing Platform. The contract incorporates standard FAR and federal Health and Human Services acquisition regulations, emphasizing domestic end products under Buy American provisions, and includes security prohibitions relevant to information systems but no specific clearance requirements. Offerors must submit proposals in two volumes—technical and price—meeting page limits and deadlines, with no discussions planned prior to award. The Government will perform inspection and acceptance at the San Juan laboratory, based on successful installation, validation, and compliance with the stated regulatory and quality standards.

General Info

Procurement of dual bathless dissolution system with installation, validation, training, three-year warranty, FDA compliance.

Agency

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

NAICS

334516 - Analytical Laboratory Instrument ManufacturingView NAICS

Place of Performance

San Juan, PR, 00901, USA

Set-Aside

NONE

Documents

(3)

SOW for Dual Dissolution Bath with Autosampler System - San Juan Medical Products Laboratory

PDF•sow

RFQ 75F40126Q00091 Dual Dissolution Bath with Autosampler System

PDF•rfq

Attachment 2 - Pricing Sheet

XLSX•pricing-sheet

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedApr 20

Combined Synopsis

Response DeadlineMay 8

Deadline has passed

Submission Closed

05/08/2026, 04:00:00 PM UTC

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Organization & Contact Information

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

Erika Crawford

contact@example.gov

+1 (555) 000-0000

Full Description

The FDA San Juan Medical Products Laboratory (SJNLMP) requires the replacement of its obsolete dissolution bath systems used for routine sample analysis. The replacement system must maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards for analytical equipment under existing accreditation.

The laboratory analyzes medical product samples using established protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program (DOD SLEP), and the Federal Contract Compliance (FCC) program. To maintain modern analytical capabilities, SJNLMP requires a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components, as the previous system has been discontinued by the manufacturer.