{"canonical":"https://abierto.us/opportunities/cder2026133117","key":"CDER2026133117","url":"https://abierto.us/opportunities/cder2026133117","title":"FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal","solicitation_number":"CDER-2026-133117","notice_type":"k","open":false,"response_deadline":"2026-06-26T16:00:00Z","first_posted":"2026-06-16","last_posted":"2026-06-16","department":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","subagency":"FOOD AND DRUG ADMINISTRATION","office":"FDA OFFICE OF ACQ GRANT SVCS","naics":"334516","psc":"6640","set_aside":null,"place_state":"MD","place_county":"24031","place_county_name":"Montgomery County","place_city":"2472450","place_city_name":"Silver Spring","winner":null,"award_amount":null,"publications":[{"notice_id":"f8159aeb3a864bfb85526f7d66b8c965","title":"FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal","solicitation_number":"CDER-2026-133117","notice_type":"k","base_type":"k","posted":"2026-06-16","posted_at":null,"due_at":"2026-06-26T16:00:00Z","due_date":"2026-06-26","cancelled":null,"archived":null,"archive_date":"2026-07-11","award_number":null,"awardee_name":null,"amount":null,"link_sam":"https://sam.gov/workspace/contract/opp/f8159aeb3a864bfb85526f7d66b8c965/view","enriched":false,"history":[]}],"latest_notice_id":"f8159aeb3a864bfb85526f7d66b8c965","first_type":"k","notices":[{"dates":{"posted":"2026-06-16","response_deadline":{"raw":"2026-06-26T12:00:00-04:00","utc":"2026-06-26T16:00:00Z","date":"2026-06-26","time":"12:00:00","utc_offset_seconds":-14400}},"links":{"sam":"https://sam.gov/workspace/contract/opp/f8159aeb3a864bfb85526f7d66b8c965/view"},"naics":{"codes":["334516"],"primary":"334516"},"title":"FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal","agency":{"office":{"code":"75F401","name":"FDA OFFICE OF ACQ GRANT SVCS"},"subtier":{"code":"7524","name":"FOOD AND DRUG ADMINISTRATION"},"department":{"code":"075","name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF"},"office_address":{"zip":"20852","city":"Rockville","state":"MD","country":"USA"},"organization_type":"OFFICE"},"status":{"active":false,"archive_date":"2026-07-11","archive_type":"auto15"},"contacts":[{"name":"Brandon Rafus","role":"primary","email":"brandon.rafus@fda.hhs.gov"}],"base_type":{"code":"k","label":"Combined Synopsis/Solicitation"},"notice_id":"f8159aeb3a864bfb85526f7d66b8c965","provenance":{"extract":{"url":"https://s3.amazonaws.com/falextracts/Contract%20Opportunities/Archived%20Data/FY2026_archived_opportunities.csv","etag":"\"d9374b90a938e9923d910594731b7b57-106\"","fetched_at":"2026-09-16T16:22:53.920682Z","row_sha256":"4bbcc07f03d0a7a1a3237bbb4935b87b6a1dfd5615f1bb217c344196a599f24c","last_modified":"2026-09-13T14:50:39Z"},"updated_at":"2026-09-16T16:22:53.920682Z","first_seen_at":"2026-09-16T16:22:53.920682Z"},"description":{"text":"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.","origin":"extract"},"notice_type":{"code":"k","label":"Combined Synopsis/Solicitation"},"schema_version":1,"solicitation_number":"CDER-2026-133117","place_of_performance":{"city":{"name":"Silver Spring"},"state":{"code":"MD"},"country":{"code":"USA"}},"product_service_code":"6640"}],"due_at":"2026-06-26T16:00:00Z","due_date":"2026-06-26","closes_at":"2026-06-26T16:00:00Z","awardable":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG ADMINISTRATION","office_key":"o-75F401","office_name":"FDA OFFICE OF ACQ GRANT SVCS","state":"MD","county":"24031","county_name":"Montgomery County","city":"2472450","city_name":"Silver Spring","country":"USA","winner_key":null,"amount":null,"linked_awards":0,"cancelled":false,"archived":false,"updated_at":"2026-09-16T21:18:12.857524Z","principal_notice_id":"f8159aeb3a864bfb85526f7d66b8c965","description":{"text":"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.","html":null,"origin":"extract"},"contacts":[{"name":"Brandon Rafus","role":"primary","email":"brandon.rafus@fda.hhs.gov"}],"place_of_performance":{"city":{"name":"Silver Spring"},"state":{"code":"MD"},"country":{"code":"USA"}},"office_address":{"zip":"20852","city":"Rockville","state":"MD","country":"USA"},"naics_codes":["334516"],"award":null,"attachments":[],"awards":[],"related":[{"key":"75F40126Q000430","latest_notice_id":"88bce0d89f7948c39aeef0d6ca3581d6","title":"Vanquish Neo System and Ion Chromatography system","solicitation_number":"75F40126Q000430","notice_type":"o","first_type":"o","first_posted":"2026-09-10","last_posted":"2026-09-16","notices":2,"due_at":"2026-09-21T14:30:00Z","due_date":"2026-09-21","closes_at":"2026-09-21T14:30:00Z","awardable":true,"open":true,"dept_key":"d-075","dept_name":"HEALTH AND HUMAN SERVICES, DEPARTMENT OF","sub_key":"s-7524","sub_name":"FOOD AND DRUG 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