STUDIES THAT INVOLVES THE EVALUATION OF THE TOXIC AND CARCINOGENIC POTENTIAL OF SELECTED CHEMICAL AGENTS USED AS DIETARY SUPPLEMENTS AND/OR HERBAL MEDICINE Release Date: July 31, 2000 NOTICE: ES-00-004 RFP: NIH-ES-00-28 National Institute of Environmental Health Sciences The NIEHS is soliciting offers for a contract that involves the evaluation of the toxic and carcinogenic potential of selected chemical agents used as dietary supplements and/or herbal medicine. This project includes 90-day and 2-year studies of Chromium Picollinate, Goldenseal, Milk Thistle, Thujone, and Androstenedione. The base contract will consist of Phase 1 for all five chemicals to include those work activities associated with the determination of bulk chemical purity and identity, and validation of dose formulation/analysis methods, any health and safety concerns that must be addressed before study start, and only those other aspects specifically included in Phase 1. Upon successful completion of Phase 1, the Government may unilaterally exercise options for the conduct of 90-day and 2-year studies specified in Phase 2 and 3. These studies shall be conducted according to the Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and Physical Agents in Laboratory Animals for the National Toxicology Program dated August, 1992, with subsequent revisions. Offerors shall have a working laboratory involved in conducting studies by gavage administration in place by the date of proposal submission. The Principal Investigator, Toxicologist, Chemist, Health and Safety Officer and Quality Assurance Officer shall be employees of the contract laboratory (i.e., not consultants or subcontractors). The daily interaction and constant coordination of efforts needed amongst these discipline areas throughout the in-life portion of the studies makes it critical that they be physically and organizationally together. Award of one cost-reimbursement, completion type contract on May 31, 2001 on level of effort is 1,400 labor hours for the base contract and 127,250 labor hours for all options. The estimated period of performance is approximately seven months for the base contract and four years four months if all options are exercised. Interested organizations should request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which will include only the Statement of Work, deliverables and reporting requirements, special requirements, mandatory qualifications, and technical evaluation criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP by written, telephonic (919) 541-7596), or telefax request (919) 541-2712. The electronic version of the CBD synopsis and the RFP (which will be available on or about July 31, 2000 with the NTP specifications) will be available on the Internet at: http://www.niehs.nih.gov/dert/rcb/rfp.htm. All responsible sources may submit a proposal which shall be considered by the Agency. Expected release date of the RFP is July 31, 2000 with proposals due September 30, 2000. Request should reference RFP NIH-ES-00-28 and should be forwarded to: National Institute of Environmental Health Sciences Research Contracts Branch, DERT Attn: Jacqueline A. Osgood 79 T. W. Alexander Drive, 4401 Building P.O. Box 12874 Research Triangle Park, NC 27709
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