Contracts Management Branch, National Institute of Neurological Disorders and Stroke, NIH, Federal Building, Room 901, 7550 Wisconsin Avenue, MSC9190, Bethesda, Maryland 20892-9190

A -- CHANGES IN CLEARANCE OF ANTIEPILEPTIC DRUGS DURING PUBERTY Sol RFP No. NIH-NINDS-96-05 due 040596. Contact Point, Raina Cervantes, 301/496-1813, Contracting Officer, Kirkland Davis, 301/496-1813. The National Institute of Neurological Disorders and Stroke (NINDS), NIH will solicit proposals for performance of an observational study which will use a cross-sectional design to investigate the clearance of antiepileptic drugs (phenytoin, carbamazepine, valproate, and lamotrigine) in male and female patients during age ranges which will include pre-, peri-, and post-pubertal stages. Offerors are required to have an existing, appropriate laboratory for assay of antiepileptic drugs in blood or plasma. Performance of work under this project will require an offeror to have access to a patient population sufficient to enroll and complete a target number of 64 patients being medically treated for epilepsy at their site. Offerors shall have personnel on staff with established clinical expertise in the treatment of epilepsy and experience in evaluating and recruiting suitable patients. It is anticipated that up to ten (10) contracts will be awarded for a maximum period of 21 months each. Payment will be on a cost-reimbursement basis for the three-month preparation phase and on a fixed price per patient basis for the eighteen-month study conduct phase. This is not a Request for Proposals. Request for Proposals (RFP) No. NIH-NINDS-96-05 will be issued on or about February 5, 1996. Proposals will be due approximately sixty days after issuance of the RFP. Written requests for a copy of the RFP must cite the RFP number referenced above. Please supply this office with two (2) self-addressed mailing labels. All responsible sources may submit a proposal which shall be considered by the Government. Refer to numbered note 26. (017)

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