Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Draft Guidance for Industry; Availability, 2432-2433 [2015-00596]
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Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices
(Pub. L. 113–86) which reauthorized the
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ACF–801 ..........................................................................................................
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[FR Doc. 2015–00560 Filed 1–15–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[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To Operate a Motor Vehicle; Draft
Guidance for Industry; Availability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.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
SUMMARY:
VerDate Sep<11>2014
17:36 Jan 15, 2015
Jkt 235001
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 drugimpaired 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 This draft guidance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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by March 17,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.
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single copies of the draft guidance to the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access to the draft guidance document.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 https://
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,
ADDRESSES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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
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.
1 See the Drugged Driving Web page on the Office
of National Drug Control Policy Web site at
https://www.whitehouse.gov/ondcp/drugged-driving.
E:\FR\FM\16JAN1.SGM
16JAN1
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices
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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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individuals associated with the grant
applications, the disclosure of which
VerDate Sep<11>2014
17:36 Jan 15, 2015
Jkt 235001
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kotliars@mail.nih.gov.
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PO 00000
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sara.ahlgren@nih.gov.
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E:\FR\FM\16JAN1.SGM
16JAN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
---------------------------------------------------------------------------
\1\ See the Drugged Driving Web page on the Office of National
Drug Control Policy Web site at https://www.whitehouse.gov/ondcp/drugged-driving.
---------------------------------------------------------------------------
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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00596 Filed 1-15-15; 8:45 am]
BILLING CODE 4164-01-P