The Food and Drug Administration intends to issue a sole source award to Experimental Pathology Laboratory. This is NOT a request for competitive quotes. CFSAN Pathology (hereafter referred to as PATHOLOGY in this document) of the Senior Science and Policy Staff (SSPS), Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN) evaluates complex pathology data submitted in support of food and color additive petitions, provides pathology support to toxicological experiments utilizing laboratory animals and provides histopathological slide interpretations when requested. When the PATHOLOGY offices and laboratory moved to College Park, along with other CFSAN offices in 2002, no space was provided at the College Park site to accommodate the PATHOLOGY Archives. Therefore, the Pathology Archive materials needed to be contracted out to an off-site location. In the spring of 2003, the archiving needs that pertained to specimens and files of the PATHOLOGY Archives were added to the PATHOLOGY service contract needs as the previous PATHOLOGY service contract was re-competed in full and open competition and awarded to Experimental Pathology Laboratories (EPL) under Contract No. 223-03-2480. In the summer of 2003, a contract modification was necessary in order to accommodate the archiving of radioactive and non-radioactive samples as well as samples that needed to be retained refrigerated or frozen (temperature sensitive) for the Office of Cosmetics and Colors. Therefore PATHOLOGY relies today exclusively on Experimental Pathology Laboratory services contract for technical support of any kind. In addition the archiving needs of PATHOLOGY have expanded in volume and complexity as mentioned above, accommodating Good Laboratory Practices (GLP) required needs for other CFSAN program offices or FDA Centers such as the storage of radioactive and frozen samples mentioned above. This contract enabled the small staff of pathologists within CFSAN PATHOLOGY to continue to provide CFSAN’s program offices / other FDA Centers the needed pathology support and fulfill other pathology related functions effectively. Moving samples out of the archive and set-up in new facility would be: 1. cost and time extensive to the 2. the cost may outweigh actual worth of the samples and 3. jeopardize the intrinsic worth the samples hold as shared resource to other FDA Centers who do not have Pathology unit additionally, the samples may be lost or damaged during the moving process The vendor has worked extensively in these areas and thus possesses an understanding of the procedures, problems and timeliness aspect to these projects. Having the same vendor continue to do this will ensure that critical work is not interrupted and is completed in a manner that furthers the mission of FDA. The proposed source is for commercial services for which the Government intends to solicit and negotiate with only one source. This action is proposed on a sole source basis because it is a follow-on contract where the vendor has developed procedures that help expedite critical requests and there being a substantial duplication of cost to the government. The proposed award is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 5 days of this announcement. A determination by the Government not to compete the proposed contracts based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be sent via email to
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