SOURCES SOUGHT
66 -- Capillary Array and BigDye Terminator Kits
- Notice Date
- 3/31/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1164765
- Archive Date
- 4/28/2016
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a 24-capillary 50cm array and BigDye Terminator kits. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Facility for Biotechnology Resources (FBR) within CBER provides capillary DNA sequencing services to CBER scientists. Several critical steps in sequencing include a) high quality template DNA preparation; 2) sequencing reaction by incorporation of fluorescent nucleotides into the growing DNA chains in a thermocycler, 3) precipitation and removal of free dye before subjecting DNA to the sequencer. Advances in DNA sequencing technology enable scientists to rapidly determine the genomic makeup of various organisms, detect mutations and polymorphisms associated with diseases, define genetic variations of pathogens and their infectivity, reveal patterns of gene expression (transcriptomes), elucidate functions of various RNA species, etc. The extent of achievement relies significantly on the availability of modern DNA sequencers. Scientists in the CBER conduct research as well as perform regulatory functions. To meet the needs of their DNA sequencing needs, FBR uses two Applied Biosystems' (ABI, Now Life Technologies Corp., a subsidiary of Thermo Fisher Scientific) capillary DNA sequencers, the 3500xl Genetic Analyzers (SN: 25355-101 and SN: 22315-080) for sequencing analysis. The DNA sequencers run sequencing analysis on a daily basis. These sequencers use BigDye chemistry and a 24-capillay array to achieve sequencing analysis. The number of samples for DNA sequencing submitted to FBR varies, but in general falls in the range between 60 and 400 per day. There is thus a need of constant supply of the capillary array and BigDye Terminator (BDT) kits, both proprietary products of life Biotechnologies Corp., and is anticipated that this is not available from other vendors. Information is requested on a brand name or equal basis. Performance requirements: a. The BigDye reagent kit is prepared for capillary DNA sequencers ABI 3500xl. It shall contain all four nucleotides (A, T,C, G) and the corresponding fluorescent dideoxy analogs, thermo stable DNA polymerase, and adequate buffer composition enabling DNA synthesis using plasmid or PCR-amplified product as a template. b. It shall contain all reagents needed to complete the sequencing cycles, including an adequate ratio of labeled to non-labeled nucleotides that enable sequencing up to 1000 bases. c. The 24-capillary 50cm array shall fit ABI 3500xl Genetic Analyzer sequencers (SN: 25355-101 and SN: 22315-080) seamlessly, and is supplied in pre-assembled set of 24 capillaries per array, with a built-in frame for easy installation. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery date is within 15 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, Silver Spring, MD 20993. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before April 13, 2016 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1164765. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1164765/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04069404-W 20160402/160331235427-1370d692ab012474ad3410747341336f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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