SOURCES SOUGHT
66 -- Test Kits for use with Vitek2oThe laboratories shall be able to use the cards with the VITEK2® Instrument
- Notice Date
- 2/15/2011
- Notice Type
- Sources Sought
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFI-1081925
- Archive Date
- 2/23/2011
- Point of Contact
- Linda Troutman-Robinson, Phone: 3018277168, Doreen Williams,
- E-Mail Address
-
linda.t.robinson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(linda.t.robinson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Document Type: RFI#1081925 Release Date: February 15, 2011 Response Date: February 22, 2011 at 4:30pm local time via email to Linda.Troutman@fda.hhs.gov Contracting Office Address: Food and Drug Administration, Linda Troutman, Contract Specialist Description of Services/Supplies: Test Kits for use with Vitkek2® Instrument This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. According to FAR Part 10, Market Research, the results of the market research will be used to: i) Determine if sources capable of satisfying the agency's requirements exist; (ii) Determine if commercial items or, to the extent commercial items suitable to meet the agency's needs are not available, nondevelopmental items are available that- (A) Meet the agency's requirements; (B) Could be modified to meet the agency's requirements; or (C) Could meet the agency's requirements if those requirements were modified to a reasonable extent; (iii) Determine the extent to which commercial items or nondevelopmental items could be incorporated at the component level; (iv) Determine the practices of firms engaged in producing, distributing, and supporting commercial items, such as type of contract, terms for warranties, buyer financing, maintenance and packaging, and marking; (v) Ensure maximum practicable use of recovered materials and promote energy conservation and efficiency; and (vi) Determine whether bundling is necessary and justified. (vii) Assess the availability of electronic and information technology that meets all or part of the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at 36 CFR Part 1194. The extent of market research will vary, depending on such factors as urgency, estimated dollar value, complexity, and past experience. The contracting officer may use market research conducted within 18 months before the award of any task or delivery order if the information is still current, accurate, and relevant. Market research involves obtaining information specific to the item being acquired and should include- (i) Whether the Government's needs can be met by- (A) Items of a type customarily available in the commercial marketplace; (B) Items of a type customarily available in the commercial marketplace with modifications; or (C) Items used exclusively for governmental purposes; (ii) Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs; (iii) Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products or services are made; (iv) The requirements of any laws and regulations unique to the item being acquired; (v) The availability of items that contain recovered materials and items that are energy efficient; (vi) The distribution and support capabilities of potential suppliers, including alternative arrangements and cost estimates; and (vii) Size and status of potential sources. Mission and Objectives: The FDA field laboratories require various test kits for the identification of pathogens in food and environmental samples. The test cards shall be compatible for use with the VITEK2® instrumentation exiting in the field laboratories. RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be:  identified with the RFI number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability: Specification Questionnaire: Is your company capable of providing test kits compatible for use with the VITEK2® instrument? Do your test kits meet the GN card specification? • GN Cards o For the in vitro identification of Enterbacteriaceae and a select group of glucose nonfermenting gram-negative organisms. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain APPA, ADO, PYRA, IARL, DCEL, BGAL, H2S, BNAG, AGLTP, DGLU, GGT, OFF, BGLU, DMAL, DMAN, DMNE, BXYL, BALAP, PROA, LIP, PLE, TYRA, URE, DSOR, SAC, DTAG, DTRE, CIT, MNT, 5KG, ILATK, AGLU, SUCT, NAGA, AGAL, PHOS, GLYA, ODC, LDC, 0DEC, IHISA, CMT, BGUR, 0129R, GGAA, IMLTA, ELLM, ILATA o The laboratories must be able to use the cards with the VITEK2® instrutment. Do your test kits meet the GP card specifications? • GP Cards o For the identification of enterococci, streptococci, staphylocci, and a select group of gram-positive organisms. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain AMY, PIPLC, DXYL, ADH1, BGAL, AGLU, APPA, CDEX, ASPA, BGAR, AMAN, PHOS, LEUA, PROA, GBURR, AGAL, PYRA, BGUR, ALAA, TYRA, DSOR, URE, POLYB, DGAL, DRIB, ILATK, LAC, NAG, DMAL, BACI, NOVO, NC6.5, DMAN, DMNE, MBDG, PUL DRAF, 0129R, SAL, SAC, DTRE, ADH2S, OPTO. o The laboratories must be able to use the cards with the VITEK2® instrument. Do your test kits meet the BCL card specifications? • BCL Cards o For the identification of Gram-positive microorganisms of the family Bacillaceae. o Each card must contain 64 WELLS o Each card must contain a pre-inserted transfer device o Each card must contain a unique barcode identifier o Each card must be covered with a labeled foil seal containing the lot number and expiration date o Reactive ingredients must contain BXYL, LYSA, ASPA, LEUA, PHEA, PROA, BGAL, PURA, AGAL, ALAA, TYRA, BNAG, APPA, CDEX, DGAL, GLYG, INO, MDG, ELLM, MDX, AMAN, MTE, GLYA, DMAN, DMNE, DMLZ, NAG, PLE, IRHA, GGLU, BMAN, PHC, PVATE, AGLU, DTAG, DTRE, INU, DGLU, DRIB, PSCNA, NACL6.5, KAN, OLD, ESC, TTZ, POLYBR. o The laboratories must be able to use the cards with the VITEK2® instrument. Part B. Size of Business State whether your company is a large business, small business (and also state your socioeconomic status in accordance with FAR Part 19), College/University, or a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission, objectives, and scope of work, what dollar value range would you determine to be the most accurate rough estimate. Under $150,000.00 Over $150,000.00 and Under $500,000.00
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFI-1081925/listing.html)
- Place of Performance
- Address: Multiple Locations, United States
- Record
- SN02380327-W 20110217/110215234347-649b68507b2a3a8c0ae351e218e240bc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |