National Institute on Drug Abuse, Contracts Management Branch, 6001 Executive Blvd., Room 3105, MSC 9543, Bethesda, MD 20892-9543

R -- CLINICAL TRIAL NETWORK (CTN) ADMINISTRATIVE SUPPORT CENTER DUE 032300 POC Kenneth E. Goodling, Contracting Officer, Phone: (301) 443-6677 E-MAIL: Click here to contact the Contracting Officer., kg25d@nih.gov. The National Institute on Drug Abuse (NIDA) is seeking information in the form of capability statements from interested Small Businesses (SIC Code 8742, small business size standard is 500 employees) on a potential project for a Clinical Trials Network Administrative Support Center. The project is to provide resources to support the newly established Clinical Trials Network (CTN) Office. In an effort to dramatically improve drug abuse treatment throughout the country, NIDA established the CTN in September 1999 with the award of five Regional Research and Training Centers (RRTCs). It is anticipated that another 5-6 RRTCs will be awarded in FY 2000 with an eventual goal of 20-30 RRTCs nationwide. Each RRTC is affiliated with 10-15 Community-based Treatment Programs (CTPs). Multi-site clinical trials will be performed in these CTPs. This project is to support the work of the CTN in designing and implementing clinical trials to evaluate the effectiveness of science based behavior therapies and/or safe and effective pharmacological therapies. For medication trials, the work may include preparing protocols, regulatory documents, and monitoring/site-visiting clinical trials to assure that pertinent Good Clinical Practice (GCP) and FDA regulations are met. Data reports and other documents will be submitted to FDA in support of INDs and NDAs. The organization also will compile and edit data, perform statistical analysis, prepare reports to support the CTN Data Safety Monitoring Board (DSMB), as well as provide other logistical and meeting support services as needed by the CTN Office. No actual clinical or laboratory studies will be conducted under this project. Organizations should demonstrate capability to administer and coordinate the interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both government and commercial that the organization has performed, references, i.e., names, titles, telephone numbers and any other information which would serve to document the organizations capability, e.g. awards, commendations, etc. This is not a request for proposals. This notice is for information purposes only and does not commit the Government to any contractual agreement. Any proprietary information should be so marked. Interested organizations submitting a capability statement in response to this sources sought announcement are required to identify their size status. Written capability statements must be submitted no later than March 23, 2000 to the NIDA Contracts Management Branch at the address indicated at the beginning of this announcement. See Note 25. Posted 03/09/00 (W-SN432795). (0069)

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