National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- CLINICAL AND REGULATORY AFFAIRS SUPPORT CONTRACT SOL NIH-NIAID-DMID-00-21 DUE 062099 POC Ms. Nancy M. Hershey, Contracting Officer, 301-496-0193 The Clinical and Regulatory Affairs Branch (CRAB), Division of Microbiology Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), has a requirement to provide regulatory support services for the operations of the Clinical and Regulatory Affairs Branch. The purpose of the RFP is to seek responsible offerors for data and document collection and compilation for regulatory filing (pre-IND, IND) with the U.S. Food and Drug Administration (FDA); technical review and report preparation; clinical site monitoring activities; final container packaging, purchase, labeling, storage, distribution and tracking of investigational products; storage of biological samples; implementing and maintaining computer information systems; providing administrative coordination and general logistic support for regulatory activities, and other services as required. To this end, this solicitation is to support activities of the CRAB, DMID, NIAID, NIH, and the clinical research and development of vaccines and therapeutics for a wide variety of diseases including those bacterial, viral and parasitic origin. It is anticipated that one (1) cost-reimbursement, completion type contract will be awarded for a period of seven years, beginning approximately March 1, 2000. RFP-NIH-NIAID-DMID-00-21 will be available electronically on or about March 15, 1999, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page by using the following electronic address and instructions: NIAID/CMB Home Page (via the World Wide Web): Access by using http://www.niaid.nih.gov/contract and select the "RFPs" link and then select "RFP-NIH-NIAID-DMID-00-21." Please note that the RFP for this acquisition has been revised to include only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, the Technical Evaluation Criteria, and the proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due June 20, 1999. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. Point of Contact: Nancy Hershey, Contracting Officer Electronic mail address: nh11x@nih.gov Telephone: (301) 496-0193 Fax: (301) 402-0972 No collect calls will be accepted. Posted 02/25/99 (W-SN302510). (0056)

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