SOURCES_SOUGHT_ANNOUNCEMENT_-_1150143.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY.

THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION.

THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR

PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), has issued this sources sought announcement on behalf of the Center for the Biologics Evaluation and Research (CBER), Facility for Biotechnology Resources (FBR) to determine if there are existing small business sources capable of providing Reagent Sequencing Kits and 24-Capillary Arrays Sequencing Kits.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 325414 – Biological Product (except Diagnostic) Manufacturing; with a Small Business Size Standard of 500 employees, and believe that your firm would be able to provide the FDA with the services described below, please submit an email to lilliam.maldonado-gutierrez@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: FDA/CBER/FBR requires Reagent Sequencing Kits and 24-Capillary Arrays Sequencing Kits.

The capillary DNA sequencing kits shall be compatible with the Applied Bio Systems (ABI), 3500xl Genetic Analyzer. The 24-capillary array shall fit ABI 3500xl Genetic Analyzer sequencers (S/N: 25355- 101 and S/N 22315-080) seamlessly, and supplied in pre-assembled set of 24 capillaries per array, with a built-in frame for easy installation.

Minimum Requirements:

Reagent Kit (Qty 4) Cycle Sequencing Kit Compatible with ABI 3500 XL Genetic Analyzer Kit shall contain sufficient reagents for 1000 reactions.

Shall be used with Fluorescent Dye Terminator Sequencing

Capillary Array (Qty 3) Capillary Array Direct sequencing kits Compatible with ABI 3500 XL Genetic Analyzer Kit shall contain sufficient reagents for 24 reactions.

Shall be used with Fluorescent Dye Terminator Sequencing

Period of Performance: Sixty (30) calendar days after receipt of contract award.

Place of Performance:

Food and Drug Administration

Center for the Biologics Evaluation and Research 10903 New Hampshire Avenue Building 52 Silver Spring, MD 20993

Service Records and Reports

Responses to this sources sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product and service. Though the target audience is small business manufacturers or small businesses capable of providing service from another small business manufacturer or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, 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.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service to include date of sale, description, dollar value, client name, client address, client 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.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the supply the responding firm is regularly engaged in manufacturing and/or selling.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 6, 2015 by 1:00 PM (Central Time) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn:

lilliam.maldonado-gutierrez, 3900 NCTR Road, HFT-320, Bldg. 50, Rm 434 Jefferson, AR 72079-9502 or email Lilliam.maldonado-gutierrez@fda.hhs.gov. Reference: FDA-15-223-1150143.

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).

Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.