SOLICITATION NOTICE
A -- Preclinical Efficacy and Intermediate Endpoint Assays
- Notice Date
- 10/6/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- RFP-N01-CN-55006-72
- Response Due
- 12/15/2004
- Archive Date
- 12/30/2004
- Description
- Request for Proposals (RFP) N01-CN-55006-72, entitled: Preclinical Efficacy and Intermediate Endpoint Assays. The mission of the Chemopreventive Agent Development Research Group, Division of Cancer Prevention (DCP), National Cancer Institute is to identify safe and effective agents for the prevention of human cancers and to develop and qualify these agents for clinical trials. The DCP is seeking proposals from qualified organizations that have the ability to establish the efficacy of potential cancer preventive agents or agent combinations in a variety of in vivo assays, to identify and validate surrogate intermediate endpoints for clinical trial use, and to establish collaborative groups to conduct these studies. The studies will assess the potential of various agents to inhibit, reverse, or delay early carcinogenesis by evaluating the effects of these selected agents on a variety of cancers and endpoints, measuring cancer incidence, multiplicity, tumor size and latency. In addition other studies would address the identification and validation of surrogate intermediate endpoints in animal models for use in clinical trials. 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/) The specific goals of this RFP are: 1) To establish the efficacy of potential cancer preventive agents (or combinations of agents) in various in vivo carcinogenesis assays, measuring the inhibition, reversal, or delay of the carcinogenesis process and, 2) To identify and validate surrogate intermediate biomarkers for future use in clinical trials using in vivo assays of experimental carcinogenesis. Contracts will be awarded to the offerors who demonstrate the ability to conduct both efficacy and intermediate endpoint bioassays 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 must demonstrate that they have knowledge of drug development, preferably in disease prevention, and expertise in laboratory animal cancer chemoprevention bioassay methods and intermediate endpoint biological, molecular assay, or imaging techniques. Offerors need to provide evidence of their own expertise and access to expertise in such areas as molecular biology, pathology, imaging, statistical analyses, analytical chemistry, and other potentially relevant laboratory methodologies. Offerors must submit a proposal that addresses both task areas, that is, Preclinical Efficacy and Intermediate Endpoint Assays. Only those proposals from offerors who demonstrate the capability to perform both Preclinical Efficacy and Intermediate Endpoint Assays will be considered for potential award. Contracts awarded as a result of this solicitation will replace the current Efficacy Studies of Chemopreventive Agents in Animal Models and Preclinical Evaluation of Intermediate and their Modulation by Chemopreventive Agents Master Agreement Pools. Multiple prime contracts will be awarded on a cost-reimbursement completion type basis, with managed Work Assignments. Currently, awards have been made to Fox Chase Cancer Center, N01-CN-43309 and Washington University, N01-CN-43308. The purpose of this solicitation is to add additional prime contractors. It is anticipated that up to 1-2 awards may be made and that these contracts will be incrementally-funded with a period of performance of four (4) years. 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 intermediate biomarker assay or the laboratory animal model and will be specified in each Work Assignment. The contractor selected shall be responsible for providing the chemopreventive agent except in instances when the NCI wants an agent tested that may not be available to the contractor. In such cases, the Government shall bear the expense of providing an agent. The specific work assignment shall specify whether the contractor shall be expected to provide the agent. The North American Industry Classification System (NAICS) code is 541710. The RFP will be issued ELECTRONICALLY on or about October 19, 2004. 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 internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of Contact: Jacqueline Ballard, Contracting Officer, Prevention, Control and Population Sciences Section (PCPSS), Research Contracts Branch (RCB), NCI, 6120 Executive Boulevard, Room 6000, MSC 7195, Bethesda, Maryland 20892-7195. Phone: (301) 435-3795; fax: (301) 402-8579; ALL QUESTIONS/INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO JACQUELINE BALLARD, CONTRACTING OFFICER, at: ballardj@mail.nih.gov/ . All requests for information should reference RFP No. N01-CN-55006-72. No collect calls will be accepted. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.
- Record
- SN00690015-W 20041008/041006211643 (fbodaily.com)
- Source
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