DHHS, National Institute on Drug Abuse, Contracts Management Branch, OPRM, Parklawn Building, Room 10-49, 5600 Fishers Lane, Rockville, Maryland 20857

R -- CLINICAL OPERATIONS - REGULATORY AFFAIRS SOL N01DA-5-8051 DUE 042595 POC Point of Contact, Kenneth E. Goodling, Contract Specialist (301) 443-6677 The National Institute on Drug Abuse is soliciting proposals from qualified organizations having the capability to provide regulatory affairs resources supporting the conduct of Phase I and II clinical trials for the treatment of cocaine and opiate addiction under the current Food and Drug Admistration regulations and Good Clinical Practice guildelines. The work shall involve: a) to provide regulatory affairs support to the Clinical Operations Contracts; b) to ensure regulatory compliance during protocol development and review; c) to ensure regulatory compliance during conduct of each clinical trial; d) to provide a regulatory strategy plan for each compound under development; e) to plan, compile and file regulatory submissions; f) to interact with regulatory and government agencies; and g) to prepare written study summary reports of adequate quality to support NDA submissions. The nature of the clinical trials shall be to determine the tolerated dose range, the dosing regimen, the safety profile and estimates of pharmacokinetic and pharmacodynamic parameters and to evaluate the efficacy of the investigational compounds or marketed medications. The offeror must be highly experienced in the field of regulatory science and providing regulatory affairs support for Phase I and II clinical trials. It is estimated that a 4.5 year contract will result from this procurement. Estimated issuance date of RFP No. N01DA-5-8051 is February 24, 1995 and responses are due to be received in the Contracting Office 60 calendar days thereafter. Written requests for copies of the solicitation will be honored if received within fifty calendar days after issuance of the solicitation. Written requests received after this period will be filled on a first-come, first-served basis until the supply is exhausted; however, there is no assurance that copies requested after the fiftieth day will reach the requestor before the due date for receipt of responses. Written requests shall be forwarded to the attention of the Contract Specialist. (0033)

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