SOLICITATION NOTICE
A -- Preclinical Pharmacology and Toxicology Studies
- Notice Date
- 11/15/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-25002-02
- Archive Date
- 3/20/2003
- Point of Contact
- James Chestnut, Contract Specialist, Phone (301) 496-8604, Fax (301) 402-8579, - Gary Topper, Contracting Officer, Phone (301) 435-3793, Fax (301) 402-8579,
- E-Mail Address
-
jc572n@nih.gov, gt22b@nih.gov
- Description
- Request for Proposal (RFP) N01-CN-25002-02, titled: Preclinical Pharmacology and Toxicology Studies. The National Cancer Institute, Division of Cancer Prevention (NCI/DCP) is seeking proposals from qualified organizations who have the ability to evaluate the toxicology and pharmacology of potential cancer preventive agents and to establish collaborative groups to conduct these studies. The studies will include, for example, evaluation of mutagenicity, acute and subchronic and chronic toxicity, carcinogenicity, teratogenicity and reproductive effects, pharmacokinetics and supporting analytical methods validation, pharmacological effects on gene and protein expression, and specialized studies such as immunological, neurological, and other assessments as necessary. The studies will be used to qualify agents for clinical studies and in many cases to support Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for phase 1 - 3 clinical studies and New Drug Applications (NDA) to the FDA. The agents to be studied shall include agents developed by the pharmaceutical and other industries and provided to the NCI for collaborative development as well as commercially available agents, agents developed by the NCI, and agents nominated by academic investigators through the RAPID program (http://www.cancer.gov/prevention/rapid/). Offerors must demonstrate the ability to conduct toxicological and pharmacological evaluations of potential cancer preventive agents in accordance with the Code of Federal Regulations Good Laboratory Practices Act and other regulations applicable to pharmaceutical and/or dietary supplement / nutriceutical product development and commercialization. Offerors need to provide evidence of their knowledge of drug development, preferably in disease prevention or related to noncytotoxic therapeutic agents intended for prolonged administration, and expertise in laboratory animal husbandry and toxicological / pharmacological studies. Offerors must demonstrate their own expertise and access to expertise in such areas as in vitro cell culture techniques for mutagenicity testing, animal husbandry, veterinary medicine and clinical and anatomic pathology, analytical chemistry, statistical analyses, molecular biology, and other potentially relevant laboratory methodologies. Contracts awarded as a result of this RFP will replace the Master Agreement for Preclinical Toxicology of Chemopreventive Agents. Contracts will be awarded to Offerors who demonstrate ability in four primary task areas: (1) GENOTOXICITY TESTING, (2) GENERAL TOXICOLOGY IN EXPERIMENTAL ANIMALS, (3) REPRODUCTIVE TOXICITY STUDIES IN RODENTS AND RABBITS and (4) SPECIALIZED STUDIES. Contracts awarded as a result of this solicitation will be Cost-Reimbursement Completion Type using managed Work Assignments. The Project Officer will initiate Work Assignments which are then forwarded to the Principal Investigator stating the Period of Performance, specific work to be performed and deliverables. Within a specified period the contractor will submit to the Project Officer a detailed description of the technical approach and an estimate of the required costs and effort. The costs of a Work Assignment will not exceed the funds currently allocated for this contract. With the concurrence of the Project Officer and approval by the Contracting Officer, the Work Assignment shall commence. Offerors will have the flexibility to subcontract with additional vendors to provide specific technical expertise that is needed for the individual Work Assignments. The duration of each study will depend on the scope and complexity of the project. This will be specified in each Work Assignment. The contractor selected shall bear the expense of providing the agent for testing except in cases where NCI wants an agent tested that is not available to the contractor. The Work Assignment shall specify whether the contractor or NCI shall provide the agent. It is anticipated that four (4) awards will be made and the contracts will be incrementally funded for a period of performance of five (5) years. Offerors must submit proposals that address all four (4) task areas in order to be considered for award. The code for this project based on the North American Industry Classification System (NAICS) is 541710. It is anticipated that this RFP will be available ELECTRONICALLY by 12/05/2002. The RFP will be available on the Research Contracts Branch (RCB) web site at: http://rcb.nci.nih.gov . Click on ?Current Request for Proposals.? It is the offeror?s responsibility to monitor the above referenced Internet Site for release of this RFP and amendment(s). POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPIES OF THE SOLICITATION AND AMENDMENT(S). Point of Contact is James N. Chestnut, Contract Specialist, Prevention, Control and Population Science Section, Research Contracts Branch, National Cancer Institute, 6120 Executive Blvd, EPS, Room 6004, MSC7195, Bethesda, MD 20892-7195. Phone: (301)496-8604; FAX: (301)402-8579. All questions should be directed via EMAIL to Mr. Chestnut at jc572n@nih.gov. All request for information should reference RFP N01-CN-25002-02. NO COLLECT CALLS WILL BE ACCEPTED. See Note 26.
- Record
- SN00205698-W 20021117/021115213216 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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