This is a Sources Sought Notice to determine the availability and capability of Small Businesses capable of performing Pathology and Archiving Services. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the services described herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The applicable North American Industry Classification System (NAICS) code is 541940, Veterinary Services and the size standard is $7.0 million. The U.S. Food and Drug Administration (FDA) is seeking to identify sources that can provide the services as described in this notice.

The FDA intends to establish a single award contract for Pathology and Archiving Services for a base period of one year with up to four one year option periods.

Background

The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Pathology of the Senior Science and Policy Staff (SSPS), Office of Food Additive Safety (OFAS), (hereafter referred to as Pathology), evaluates complex pathology data submitted in support of food and color additive petitions, provides pathology support to regulatory toxicological experiments utilizing laboratory animals and provides histopathological slide interpretations when requested. Pathology serves CFSAN and/or other requesting Agencies/Institutions in this regard. Pathology currently relies on extensive contractor support to provide these services and the current contractor is Experimental Pathology Laboratories, Inc. (EPL) of Sterling, VA.

Minimum Service Requirements

. Histo-technological service support including GLP complient tissue trimming, processing, routine and special staining procedures, immuno-histological staining and other specialty procedures such as Electron Microscopy, development of specialty staining procedures or morphometrics.

. Pathology expertise related such as prosector support for necropsies, pathology review functions, slide evaluation, peer review procedures, Pathology Working Group reviews (PWGs)

. Archiving support for CFSAN Pathology related materials such as glass slides, wet tissues, tissue blocks, records and also includes storage of radioactive and temperature sensitive materials for other Offices and FDA Centers (currently approximately 1,029.00 cubic ft). For the archiving phase, the facility must be maintained in compliance with Good Laboratory Practices (GLP) regulatory requirements and must be in the Washington DC metropolitan area as well as in close proximity to the Contract Histopathological Laboratory to facilitate the deposition and retrieval by contract end users of samples for which additional laboratory evaluations may become necessary after study completion.

Parties submitting capability statements are advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability of providing the required services. Respondents should limit their capability statements to no more than twenty (20) pages in length. Capability statements shall include a description of the business entity including services provided, length of time providing those services, composition and credentials of staff. Statement shall also include location and description of laboratory facility, archival areas and evidence of facility's GLP compliance. Award of contract may potentially result in relocation of delicate or otherwise "special care", archived materials from the current contractor's location in Sterling, VA. Responses to this sources sought shall also address past experience in relocating delicate or otherwise "special" care archived materials. Provide two contact names, email addresses and phone numbers for two contacts that may be contacted by the Government for contracts of Pathology services you have been awarded, and indicate period of performance, dollar amounts and a brief description of the services performed for the contracts. Potential contractors must indicate business size, proof of any set-aside status (such as 8(a), Service Disabled Veteran Owned Small Business, HUBZone) and company's DUNS number, proof of registration in the Government's System for Award Management (SAM) and provide a contact name, the mailing address, phone number, email address of point of contact for your business. Your response must reference 1116289.

Interested parties must respond with capability statements in person on or before April 23, 2013 by 1:00 PM (Central Time) Jefferson, Arkansas, at the Food and Drug Administration, Office of Acquisitions and Grants Service, Field Operations Branch, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502; Faxed to 870/543-7990 or emailed to [email protected].

 

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