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

A -- CARDIOVASCULAR AND SAFETY EVALUATIONS OF POTENTIAL MEDICATIONS TO REDUCE DRUG USE DUE 022400 POC Kenneth E. Goodling, Contracting Officer, Phone: (301) 443-6677 E-MAIL: Click here to contact the NIDA Contracts Office., 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 8731, small business size standard is 500 employees) concerning cardiovascular and safety evaluations of potential medications to reduce drug use. The project will require performance of experiments in laboratory animals to systematically evaluate the cardiovascular and toxicological effects of potential treatment drugs, both new and marketed, for treatment of drug abuse. Specifically, the goals of the project are to determine the compound's effects on the cardiovascular system and to use the results of these studies for safety assessment purposes. The tasks include determination of: (1) the effects of potential medications on the action potential duration (APD) recorded in Purkinje fibers isolated from sheep, (2) the maximum tolerated acute dose of a test article and its effect on the QT interval in the conscious dog, (3) the compound's effect on cardiovascular system in a 14-day study in the dog, (4) the compound's potential effect on the cardiovascular system in an acute drug interaction in the dog, (5) the effects in a repeat dose drug interaction study in unrestrained dogs. In the last type of study listed, the objective of this study shall be to determine the onset, peak effects, and return to baseline of selected cardiovascular hemodynamic and conductivity parameters following the administration (usually oral) of the test compound daily for 28 days. In addition, the response shall be compared to the effects observed when a challenge dose of cocaine is administered to the same animals. Typically, the challenge dose shall be administered intravenously once per week. In all studies, a veterinary cardiologist shall evaluate the ECG recording. The findings shall be presented in a comprehensive report that shall include tabulations and graphical presentations of the collected individual and averaged data. Appropriate statistical methods shall be used to determine treatment-related effects for all data collected. A complete report is required for each study and the requirements for report content and format shall follow the Good Laboratory Practice (GLP) guidelines. The organization should provide documentation of possession of a DEA Registration for Schedules II-V controlled substances, evidence compliance with the NIH guidelines on the care and use of laboratory animals and indicate that the laboratory is operated according to the FDA's Good Laboratory Practices Guideline. In addition, the organization should indicate that a veterinary pathologist and a surgical team that can prepare the animals with devices for recording the cardiovascular parameters are on staff. The cardiovascular parameters include, but are not limited to, the following: heart rate, blood pressure, contractility, and flow. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. 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 February 24, 2000 to NIDA, Contracts Management Branch. See Note 25. Posted 02/07/00 (W-SN422765). (0038)

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