Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Draft Guidance for Industry; Availability

Leslie Kux
Department of Health & Human Services
January 16, 2015

[Federal Register Volume 80, Number 11 (Friday, January 16, 2015)]
[Notices]
[Pages 2432-2433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2300]


Evaluating Drug Effects on the Ability To Operate a Motor 
Vehicle; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Evaluating 
Drug Effects on the Ability to Operate a Motor Vehicle.'' The purpose 
of this guidance is to assist sponsors in the evaluation of the effects 
of psychoactive drugs on the ability to operate a motor vehicle. 
Driving is a complex activity involving a wide range of cognitive, 
perceptual, and motor activities. Reducing the incidence of motor 
vehicle accidents (MVAs) that occur because of drug-impaired driving is 
a public health priority. This draft guidance recommends using a 
systematic effort to identify drugs that increase the risk of MVAs as a 
critical component of assessing drug risk and designing strategies to 
reduce this risk.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 17, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Aaron Sherman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4339, Silver Spring, MD 20993-0002, 240-
402-0493.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Evaluating Drug Effects on the Ability to Operate a Motor 
Vehicle.'' The purpose of this guidance is to assist sponsors in the 
evaluation of the effects of psychoactive drugs on the ability to 
operate a motor vehicle.
    Driving is a complex activity involving a wide range of cognitive, 
perceptual, and motor activities that can be adversely affected by 
therapeutic drugs. Reducing the incidence of MVAs that occur because of 
drug-impaired driving is a public health priority.\1\
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    \1\ See the Drugged Driving Web page on the Office of National 
Drug Control Policy Web site at http://www.whitehouse.gov/ondcp/drugged-driving.
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    Drugs that impair driving ability may also impair the ability to 
judge the extent of one's own impairment. This increases the need for 
objective evaluation of the presence and degree of driving impairment, 
with risk mitigation strategies based on that information. This 
guidance recommends a systematic effort to identify drugs for which 
evaluation of effects on driving abilities may be needed, and the types 
of studies that such an evaluation entails.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on evaluating 
drug effects on the ability to operate a motor vehicle. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

[[Page 2433]]

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively. The collection of information for prescription drug 
product labeling is approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00596 Filed 1-15-15; 8:45 am]
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