Storage and Distribution of Clinical Agents

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Department of Health and Human Services, National Institutes of Health, at the National Cancer Institute, Pharmaceutical Management Branch and Office of Acquisitions intends to negotiate a sole source modification for a three (3) month extension to the contract with Fisher BioServices, Inc. to continue storing and distributing clinical agents for CTEP. The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is charged with providing pharmaceutical support for clinical trials sponsored and/or funded by the National Cancer Institute. The DCTD sponsors intramural and extramural research for the clinical evaluation and development of potentially effective cancer treatments. CTEP administers, coordinates, and funds these clinical trials, as well as supports other clinical research initiatives. The program fosters collaborations within the cancer research community and works extensively with the pharmaceutical and biotechnology industries. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements. Fisher BioServices, Inc. is the only responsible source and no other supplies or services will satisfy agency requirements. The Pharmaceutical Management Branch (PMB), CTEP, in providing pharmaceutical support for cancer clinical trials sponsored and funded by the DCTD, NCI, manages the Contractor who provides a facility and project team to receive, store, distribute and account for the final disposition of clinical agents for open-label and double-blind placebo-controlled clinical trials and maintains necessary records of all aspects of the process. This contract also supports agent distribution services for clinical trials of other NCI Divisions and Programs, preclinical drug development research of NCI grantees, academic institutions, Cooperative Groups, and Cancer Centers, and a compassionate-use distribution program that provides promising new agents to physicians whose patients could benefit. The NCI Clinical Repository is currently open and accessible during regular business hours (8:30 AM - 5:00 PM, Eastern Time), Monday through Friday, except for official Federal Government holidays. An occasional evening, night, or weekend emergency shipment has been necessary. Fisher BioServices, Inc. is uniquely qualified by virtue of its continued performance for this period of time and is the only source that can provide services at this time. The purpose of extending this contract is to complete the following tasks: 1)To receive, store, and distribute commercial and investigational agents consisting of chemotherapeutic agents, biologic products (e.g., cytokines, monoclonal antibodies, oncolytic viruses, gene therapy, and vaccines), small-molecule targeted agents and other therapeutic anticancer agents. 2)To receive and inspect agents from manufacturers and suppliers throughout the world. Agents shall be relabeled or supplemental labels applied as necessary to meet U.S. Food and Drug Administration (FDA) and NCI guidelines for completeness and clarity of labeling. 3)To store agents in a secure, monitored, fire protected warehouse under specified controlled temperature conditions (room temperature, refrigerated, and frozen at both 20oC and 70oC). An average of 600,000 units (vials, ampules, bottles of tablets, etc.) is maintained in storage at any one time, but can vary greatly depending on the activities of the Program. This contract requires handling, storage, shipping, and disposal of hazardous and biological materials. The proposed contract action is for supplies or services for which the Government intends to continue with one source under authority FAR 6.302. However, interested sources may identify their interest and capability must respond by submitting a capability statement (5 page limit) within 15 days of publication of this synopsis. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to Charlotte McCormack at the National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, Suite 600, Bethesda, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit their capability statements via email at mccormackc@mail.nih.gov.