National Cancer Institute, Research Contracts Branch, TBS, 6120 Executive Blvd, EPS/Rm 603 Bethesda, MD 20892-7220

R -- STORAGE AND DISTRIBUTION OF CLINICAL DRUGS SOL NCI-CM-87028-28 DUE 080698 POC Carolyn E. Barker, Contract Specialist, (301) 496-8620 or Dorothy M. Coleman, Contracting Officer, (301) 496-8620 WEB: Research Contracts Branch Solicitation Website, http://rcb.nci.nih.gov/RFP.HTM. E-MAIL: Carolyn E. Barker, barkerc@rcb.nci.nih.gov. The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute's Division of Cancer Treatment and Diagnosis (DCTD) is seeking an organization to provide for the storage, and distribution for their repository of clinical drugs. This contract provides for the receipt, storage, inventory control, distribution, and disposition of investigational chemical agents, biological response modifiers, other therapeutic biologic anticancer agents, and vaccines used in NCI-sponsored clinical trials. Large shipments of many thousands of units of drugs are received from manufacturers and packagers throughout the world, and inspected on arrival. Frequently, relabeling or application of supplemental labels is necessary to meet U.S. FDA and NCI guidelines for completeness and clarity of labeling. Drugs are stored and inventoried in a large, secure, fire-protected warehouse under specified temperature conditions. At any one time, approximately 450,000 units (vials, ampules, bottles of tablets, etc.) are on hand in the repository. Upon receipt of an approved Clinical Drug Request from the NCI, repository staff repackage the specified amount of each drug in such a way that the shipment will reach the researcher in good condition. Dry ice shipments, wet ice shipments, expedited deliveries and emergency shipments are often necessary. Shipments are made to investigators throughout the United States and the world. In addition, this contract effort provides pharmaceutical support for randomized double-blind clinical trials of a number of agents with potential usefulness in treatment and/or prevention of cancer. Pharmaceutical manufacturers supply unlabeled bottles of solid oral dosage forms, and this contractor provides the storage, patient-specific blinded labeling, and distribution to individual clinical sites. In total, this contractor will be required to label, dispense, and ship approximately 260,000 patient-specific bottles of study medication over the duration of this contract. THE FOLLOWING MANDATORY QUALIFICATION CRITERIA must be met at the time of receipt of Final Proposal Revisions by the Contracting Officer: (a) The organization must possess an Evironmental Protection Agency (EPA) Generator of Hazardous Waste permit and any state and local permits (if necessary), for generation and transportation of waste drugs for disposal, storing toxic/hazardous substances, and storing and distributing investigational drugs for the life of the contract, and (b) All pharmacists performing work under the contract shall be concurrently licensed in the state (or District of Columbia) in which the respository is located. It is anticipated that a single cost-reimbursement completion type award will be made for a seven-year period of performance with incremental funding each year. To assist in the preparation of a proposal, the Government considers the effort to be approximately 20,800 hours annually based on 2,080 hours per FTE. This is a recompetion of Contract N02-CM-47201 currently being performed by McKesson BioServices, Inc. The solicitation is scheduled for electronic release approximately June 22, 1998. The RFP may be accessed through the Research Contracts Branch Home Page by using the following internet address: http://rcb.nci.nih.gov/RFP.HTM 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: Carolyn E. Barker, Contract Specialist @ e-mail: BARKERC@RCB.NCI.NIH.GOV; FAX: 301-402-6699; TELE: 301-496-8620. No collect calls will be accepted. (0152)

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