DHHS/PHS/FDA/Office of Facilities, Acquisitions, And Central Services, Division Of Contracts and Program Management, HFA-511(ITCB), 5600 Fishers Lane, Rockville, MD 20857

R -- OPERATION AND MANAGEMENT OF THE CENTER FOR DRUG EVALUATION AND RESEARCH DOCUMENT CONTROL ROOMS SOL 223-98-5522 DUE 050198 POC Leonard Grant, Contract Specialist, (301)443-1555, Dennis Hunt, Contracting Officer, (301)443-1555 The contractor will manage and operate the document control rooms for the Center for Drug Evaluation and Research (CDER), FDA. This will include receiving, processing, distribution, filing, and storing of all incoming submissions and outgoing documents pertaining to Investigational New Drug Applications, New Drug Applications, the abbreviated format of the aforementioned documents, Adverse Drug Reaction Reports, and Drug Master Files. The contractor will abstract and code data from submissions and input data into existing Management Information System. To improve information management and access to the CDER community, an Electronic Document Room (EDR) will be developed. The EDR has three goals, (1) To reduce paper processing and management activities; (2) To maintain an archival copy of documents from which data can be accessed years from now in an efficient manner; (3) To deliver the information directly to the reviewer's desktop computer. The work will be conducted in Government facilities. An Indefinite Quantity/Fixed Price/Time and Materials contract will be awarded to provide support for a period of five years. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. See Note-1. Written requests for a copy of the solicitation shall be sent to the FDA at the address show above or transmitted by FAX to Leonard Grant on (301)827-0966. Telephonic requests will not be accepted. (0062)

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