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Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact Aaron Sherman at 240-402-0493. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2015 Clinical/Medical 17068dft.doc 12/17/14 Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993 Tel: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of