Pathology and Veterinary Support for Preclinical Toxicology Studies

The Toxicology and Pharmacology Branch (TPB) of the Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) is seeking a Contractor to furnish services, qualified personnel, equipment, and facilities, not otherwise provided by the Government, to provide pathology support for toxicology and other in vivo studies. Another important activity for the pathology contractor is to provide an independent verification (pathology peer review) of the pathology findings from toxicology studies.


Project Requirements

Typical tasks to be performed will include, but not be limited to, the following:

• Pathology peer review of toxicology studies conducted by another contractor
• Necropsy and pathology support for in vivo studies. (Travel will be required)
• Immunohistochemical localization and semi-quantitation of molecular targets/biomarkers of interest from in vivo and in vitro studies
• Human (and animal, if applicable) tissue binding specificity studies of therapeutic antibodies per FDA guidelines (contractor prepares a study protocol)
• Processing of human biopsies/samples into slides, stain (routine, immunohistochemical or specialty), histologic evaluation and interpretation of results (no diagnosis)
• Storage of pathology materials from pharmacology and toxicology studies including slides, blocks, fixed tissues and frozen specimens
• Storage of pathology materials from other sources such as studies at an outside investigator's lab
• Establishing a repository database that has a format compatible with seamless migration of data to a variety of other databases
• Maintaining and promptly updating the repository database


Anticipated Period of Performance

The anticipated period of performance will consist of five (5) years, from August 13, 2010 through August 12, 2015.

Mandatory Qualification Criteria

Supporting documentation demonstrating compliance with the Mandatory Qualification Criteria listed below must be included with the initial proposal submission.

1) The offeror must demonstrate that they are in compliance with the FDA's current Good Laboratory Practice Regulations (GLPs);

2) The offeror shall provide documentation of board certification by the American College of Veterinary Pathologists for contributing pathologists.

NAICS for this acquisition is 541712.

The solicitation, which is being issued as a 100% small business set-aside, is scheduled for release on or about April 7, 2010. The RFP may be accessed through the NCI Office of Acquisitions homepage located as http://rcb.cancer.gov/rcb-internet/index.jsp. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation as well as any amendments. ALL OFFERORS WILL BE RESONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN ADDITIONAL, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO COLLECT CALLS WILL BE ACCEPTED. ANY QUESTIONS SHALL BE SUBMITTED IN WRITING TO THE CONTRACT SPECIALIST.