This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on June 16, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal
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The Center for Drug Evaluation and Research (CDER) is seeking commercial parts and consumables for three Nova BioProfile Flex 2 instruments under a combined synopsis/solicitation issued as a full and open competition. The requirement is for brand name or equal components compatible with the specific serial-numbered instruments: T262230070C, T26817050C with its external sampling module T2761720PC, and T26A200050C. All supplied items must be new, unused, defect-free, and not sourced from the grey market or refurbished; they must also retain at least 75% to 80% of their original shelf life upon delivery. The parts must function without any modification to the instruments as configured in the FDA facility and are used for automated bioanalysis, measuring pH, dissolved gases, metabolites, osmolality, and cell density across three distinct operational settings: a microbioreactor system for 48 vessels, an automated sampling setup for 5L glass bioreactors, and a pilot biomanufacturing lab. Items requiring refrigeration or classified as flammable must be shipped and delivered following manufacturer guidelines and applicable DOT/IATA regulations, and all packaging and marking must comply with government standards, including the contract number and contractor name. The contract is a Firm Fixed-Price (FFP) Purchase Order with a period of performance of 12 consecutive months following award, with four phased delivery windows spanning approximately 300 days, and all deliveries are FOB destination. The award will be made on a Lowest Price Technically Acceptable (LPTA) basis, where technical acceptability is a pass/fail gate determined by full compliance with all salient characteristics and requirements. Failure to meet any one requirement disqualifies the quote. Offerors must be the manufacturer or an authorized reseller, provide SAM.gov registration verification, include their Unique Entity ID and current address, and complete required representations and certifications either via SAM.gov or manually. Submissions must be emailed by 12:00 p.m. Eastern Time on June 26, 2026, using a specified subject line and formatted as Microsoft Word or Excel files without macros, passwords, or executables. Invoices must be submitted electronically through the Invoice Processing Platform (IPP), include an invoice log addendum with payment tracking details, and comply with FAR 32.905(b). The contract incorporates
General Info
Agency
NAICS
Place of Performance
Silver Spring, MD, USASet-Aside
Timeline
Submission Closed
Organization & Contact Information
Full Description
Request for Quotation: FDA-RFQ-CDER-2026-133117 BioProfile FLEX2 Parts and Components-Brand Name or Equal
Notice of Combined Synopsis/Solicitation – This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.
Background – The Center for Drug Evaluation and Research (CDER) requires operational parts and consumables for three (3) currently owned Nova BioProfile Flex 2 instruments. To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components listed in the Statement of Work (SOW) that must be compatible with the corresponding three (3) NOVA BioProfile Flex 2 instruments:
Main FLEX2 instrument 1: Serial Number- T262230070C
Main FLEX2 instrument 2: Serial Number- T26817050C
External sampling module for instrument 2: T2761720PC
Main FLEX2 instrument 3: Serial Number- T26A200050C
Please note Main FLEX2 instrument 2 has two serial numbers because it has an additional module added which has its own Serial Number. The offeror is also expected to adhere to the:
the established delivery times as expressed in Section 5.1 of the attached combined solicitation/synopsis the fullest extent practicable.
Minimum Salient Characteristic Requirements:
1. Compatibility is needed for three currently owned Nova BioProfile Flex 2 instruments as described in this Section (Section 5). The Contractor shall identify the following salient characteristics for BioProfile Flex-2 commercial parts and consumables or equal
2. Instrument identity: Manufacturer (Nova Biomedical), instrument name and model (BioProfile FLEX 2), and all three serial numbers of the government-owned instruments
3. Instrument function: Automated bioanalysis system for cell culture monitoring, measuring parameters such as pH, dissolved gases, metabolites, osmolality, and cell density
4. Compatibility requirement: All parts and consumables supplied must be fully compatible with and functional in the Nova BioProfile FLEX 2 as configured at the FDA facility, without modification to the instrument
5. Quality standard: All items must be new, unused, and free from defects; grey market and refurbished products are unacceptable
6. Shelf life: All items must arrive with at least 75% to 80% of their total shelf life remaining upon delivery
7. Cold chain: Items requiring refrigeration or classified as flammable must be shipped and delivered in accordance with manufacturer specifications and applicable DOT/IATA regulations
8. Authorization: Offeror must be the manufacturer or an authorized reseller of the items quoted
Place of Performance:
Food and Drug Administration
Attn: Erica Berilla
10903 New Hampshire Ave
Bldg. 52/72 RM 2232
Silver Spring, MD 20903
Period of Performance:
12 consecutive months commencing upon date of Award.
Please see the attached Statement of Work and Corresponding Justification for reference/utilization. Quotes are due by email on or before June 26, 2025, by 12:00 P.M. (Eastern Daylight Time) and should be sent to brandon.rafus@fda.hhs.gov.
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