Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF AUGUST 28,1995 PSA#1419

Contracts Management Branch, NICHD, National Institutes of Health, Executive Building, Suite 7A-07, 6100 Executive Blvd., MSC 7510, Bethesda, Maryland 20892-7510

A -- MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY SOL RFP-NICHD-CD-95-19 due 110895. Contact Karlene Ruddy, Contract Specialist, 301-496-4611. The Contraceptive Development Branch of the Center for Population Research, NICHD, has a requirement for the maintenance and operation of a synthetic chemical facility for the synthesis of anti-fertility agents on a laboratory scale (1-5 grams) as well as on a relatively large scale (1,000 grams). The maximum quantities of any final product to be prepared by multistep synthesis via batchwise operations will not normally exceed 1000 grams. It is desirable that Offerors have expertise in the synthesis of a variety of optically active steroids, steroid-protein conjugates as immunogenic agents for radioimmunoassay as well as their tracers to be radiolabelled with 3H and 125I, a wide variety of unnatural amino acids including resolutionwork, stereoselective synthesis, and determination of their optical purity, radiolabelled compounds for metabolism studies, heterocyclic, carbocyclic and other non-steroidal compounds which may be of significance to the contraceptive development program. In addition, the capability to perform High Performance Liquid Chromatograhy (HPLC) analysis for the detection and quantification of circulating drugs in serum, urine and feces from animals, and to perform analytical work in order to access the purity of compounds, is also desirable. Specific assignment of compounds and quantities to be prepared will be determined by the Project Officer. Major emphasis will be on the preparation of experimental compounts on a laboratory scale (1-5 grams). As minimum requirements, organizations must have the following in-house equipment (or indications of anticipated purchase of same): Ultraviolet, infrared and 1Hand 13C nuclear magnetic resonance spectrometers (90-100 MHZ), mass spectrometer, polarimeter, gas chromatography, analytical high performance liquid chromatography preferably equipped with an integrator and preparative high performance liquid chromatography which can provide gram quantities of purified compounds. The Government does not intend to furnish any of the above equipment or facilities. The offeror's facilities must meet requirements for current Good Manufactuing Practices (cGMP) and must meet requirements in compliance with OSHA for protection of its workers. The offeror must have (1) a nuclear license to handle radioactive materials and (2) a controlled substance license to handle androgens. The offeror must have in-house capabilities for a relatively large scale synthesis and FIVE (5) FULL TIME SUPPORTING TECHNICAL STAFF (CHEMISTS PREFERABLY WITH a B.S. or M.S. DEGREE) who will devote 100% of their time to the project. NO SUBCONTRACTING will be permitted. The above minimum requirements must be met at time of proposal submission. The Government estimates the total level of effort to be approximately 5.25 person years annually. It is desirable that the Principal Investigator is an established synthetic organic chemist and/or medicinal chemist in the synthesis of a variety of steroidal drugs and optically active, unnatural amino acids with a Ph.D. degree and will devote a minimum of 25% of her/his time to this project. All responsible sources may submit a proposal which shall be considered by the agency. It is anticipated that ONE (1) cost-reimbursement incrementally funded type contract will be awarded as a result of the RFP for a period of sixty (60) months, beginning August 1, 1996. The RFP represents a recompetition of contract N01-HD-1-3137 for the ``Maintenance and Operation of a Synthetic Chemical Facility'' being performed by the Southwest Foundation for Biomedical Research, San Antonio, Texas. This announcement is not a request for proposals (RFP). RFP-NICHD-CD-95-19 will be issued on or about September 14, 1995. Proposals will be due approximately 60 days thereafter. Copies of the RFP may beobtained by sending a written request to the address listed above. Requests may also be made by FAX (301) 402-3676. (236)

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