National Cancer Institute, Research Contracts Branch, TCS, 6120 Executive Blvd, EPS/Room 603 MSC 7220, Bethesda MD 20892-7220

R -- OPERATION AND SUPPORT OF THE CTEP PROTOCOL & INFORMATION OFFICE (PIO) SOL N01-CM-77016-26 DUE 051396 POC Carolyn L. Swift, Contracting Officer, (301) 496-8620, (301) 402- 6699 FAX, or E-mail SWIFTC@RCB.NCI.NIH.GOV. The Cancer Therapy Evaluation Program (CTEP) is responsible for the administration and coordination of the majority of the extramural clinical trials supported by the Division of Cancer Treatment, Diagnosis, and Centers (DCTDC). It is also responsible for the development of over 200 investigational agents for which the Division has filed Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). As the sponsor of these agents, DCTDC is not only responsible for the writing and filing of the IND, but is also responsible for monitoring the safety and efficacy of the agents used in the trials it sponsors. This includes tracking the progress of the studies both administratively and scientifically, reporting adverse reactions in a timely manner, and preparing an annual report to the FDA. The Protocol and Information Office (PIO) is responsible for ensuring that protocols for investigational drugs are monitored within guidelines and regulations established by the FDA. The contractor shall assist the CTEP Protocol and Information Office (PIO) in the various clinical research responsibilities pertaining to Investigational New Drug Applications and will also provide general administrative support for IND sponsorship activities. Specifically the Contractor shall operate and staff, on government site in Rockville, Maryland, the PIO which is responsible for: 1) managing the protocol submission and review process, 2) maintaining the official records of all CTEP sponsored protocols, amendments, and protocol related communications, 3) protocol distribution, 4) managing and maintaining up-to-date information and records of all protocols in the CTEP Information Management System database, 5) indexing and scanning of documents in the CTEP imaging system, 6) generating on line queries, providing standard/customized reports, and 7) tracking the progress of each protocol as well as clinical trial monitoring data. The Contractor shall also maintain off-Government site office and storage space for all closed protocols. This acquisition is being offered for competition limited to eligible 8(a) concerns. The Standard Industrial Classification (SIC) code is 7375. RFP N01-CM-77016-26 will be issued upon written request to Carolyn Swift, Contracting Officer, on or about May 13, 1996 with a due date for receipt of proposals on or about July 8, 1996. Interested 8(a) firms should request a copy of the solicitation as expeditiously as possible since the solicitation will be issued without further notice upon SBA acceptance of the requirement for the section 8(a) program. Requests may be made by FAX:(301) 402-6699 or E-mail at SWIFTC@RCB.NCI.NIH.GOV NO collect calls will be accepted (0122)

Loren Data Corp. http://www.ld.com (SYN# 0069 19960502\R-0002.SOL)