A -- NHLBI Gene Therapy Resource Program (GTRP) - Pharmacology/Toxicology Core Laboratory

The National Heart, Lung, and Blood Institute anticipates that request for proposals (RFP) NHLBI-HV-07-02 will be available on or about December 9, 2005. The objective of the RFP is to establish a Pharmacology/Toxicology Core Laboratory (PTCL) for a new five-year study, NHLBI Gene Therapy Resource Program (GTRP). The purpose of the program is to facilitate the translation of basic research in gene therapy to clinical application in the areas of heart, lung, and blood diseases. The GTRP will provide resources in the areas of preclinical and clinical-grade vector production in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, the GTRP will provide funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP will consist of a clinical coordinating center that will oversee and coordinate the logistics of the core laboratories and provide regulatory assistance for clinical trials; a preclinical-grade vector production core laboratory; a clinical-grade vector production core laboratory for adeno-associated virus (AAV); a clinical-grade vector production core laboratory for lentivirus; and a pharmacology/toxicology core laboratory. The PTCL will 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide and maintain a Manual of Procedures (MOP), 3) develop, in collaboration with the SC, a customer satisfaction survey for investigators to evaluate the quality and acceptability of the product and timeliness of the service provided, 4) develop, in collaboration with the Clinical Coordinating Center (CCC), maintain and update a secure and password protected web site page and provide updates to the CCC as needed, 5) conduct preclinical vector toxicology testing and biodistribution studies using all types of gene therapy vectors in accordance with Good Laboratory Practices (GLP) in small and/or large animals, and applicable Federal and State regulations, for use by NHLBI-funded investigators, 6) maintain an established facility to support rodent, non-human primate (NHP), and large animal pharmacology/toxicology and biodistribution studies 6) adhere to the treatment of animals in accordance with IACUC (Institutional Animal Care and Use Committee) guidelines, 7) monitor facilities to ensure quality control of pharmacology/toxicology studies and that a regulatory framework is established to ensure consistent data quality. Develop plans to facilitate rapid communication of adverse toxicological results to the CCC and NHLBI and maintain and make available for review, as necessary, records of monitoring activities, and 8) prepare materials for and participate in site visits to the contractor?s facilities and ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits. This announcement is not a request for proposals (RFP) and, although one award is anticipated, the Government is not committed to award a contract pursuant to this announcement. The RFP will be available on the FedBizOpps web page at http://fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. It is also offerors? responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. Letters of intent are due no later than January 31, 2006. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541710.