82_FR_52268 82 FR 52052 - Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Guidance for Industry; Availability

82 FR 52052 - Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 216 (November 9, 2017)

Page Range52052-52053
FR Document2017-24367

The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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 This guidance finalizes the draft guidance issued on January 16, 2015, of the same name.

Federal Register, Volume 82 Issue 216 (Thursday, November 9, 2017) 
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52052-52053]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24367]


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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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a 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 This guidance finalizes the draft guidance issued on January 
16, 2015, of the same name.

DATES: The announcement of the guidance is published in the Federal 
Register on November 9, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a

[[Page 52053]]

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-2300 for ``Evaluating Drug Effects on the Ability to Operate 
a Motor Vehicle.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 4204, Silver Spring, MD 20993-0002, 301-796-0692.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a 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.
    Drugs that impair driving ability may also impair an individual's 
ability to judge the extent of his or her 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 guidance finalizes the draft guidance issued on January 16, 
2015, (80 FR 2432) of the same name. Changes made to the guidance took 
into consideration comments received. In addition to editorial changes 
made primarily for clarification, the guidance provides multiple areas 
of clarification throughout the document.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on evaluating drug effects on the ability to 
operate a motor vehicle. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

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.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24367 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P

52052 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices ACTION: Notice. location of the advisory committee DEPARTMENT OF HEALTH AND meeting, and the background material HUMAN SERVICES SUMMARY: The Food and Drug will be posted on FDA’s Web site after Administration (FDA) announces a the meeting. Background material is Food and Drug Administration forthcoming public advisory committee available at https://www.fda.gov/ meeting of the Tobacco Products [Docket No. FDA–2014–D–2300] AdvisoryCommittees/Calendar/ Scientific Advisory Committee. The default.htm. Scroll down to the Evaluating Drug Effects on the Ability general function of the committee is to appropriate advisory committee meeting To Operate a Motor Vehicle; Guidance provide advice and recommendations to link. for Industry; Availability the Agency on FDA’s regulatory issues. Procedure: Interested persons may The meeting will be open to the public. AGENCY: Food and Drug Administration, present data, information, or views, DATES: The meeting will be held on HHS. orally or in writing, on issues pending January 24, 2018, from 8:30 a.m. to 5 before the committee. Written ACTION: Notice of availability. p.m. and January 25, 2018, from 8 a.m. submissions may be made to the contact to 3 p.m. SUMMARY: The Food and Drug person on or before January 4, 2018. Administration (FDA or Agency) is ADDRESSES: FDA White Oak Conference Oral presentations from the public will announcing the availability of a Center, Building 31, the Great Room be scheduled between approximately 8 guidance for industry entitled (Rm. 1503), 10903 New Hampshire a.m. and 9 a.m. on January 25, 2018. ‘‘Evaluating Drug Effects on the Ability Ave., Silver Spring, MD 20993–0002. Those individuals interested in making to Operate a Motor Vehicle.’’ The Answers to commonly asked questions formal oral presentations should notify purpose of this guidance is to assist including information regarding special the contact person and submit a brief sponsors in the evaluation of the effects accommodations due to a disability, statement of the general nature of the of psychoactive drugs on the ability to visitor parking, and transportation may evidence or arguments they wish to operate a motor vehicle. Driving is a be accessed at: https://www.fda.gov/ present, the names and addresses of complex activity involving a wide range AdvisoryCommittees/AboutAdvisory proposed participants, and an of cognitive, perceptual, and motor Committees/ucm408555.htm. indication of the approximate time activities. Reducing the incidence of FOR FURTHER INFORMATION CONTACT: requested to make their presentation on motor vehicle accidents (MVAs) that Caryn Cohen, Office of Science, Center or before December 27, 2017. Time occur because of drug-impaired driving for Tobacco Products, Food and Drug allotted for each presentation may be is a public health priority. This Administration, Document Control limited. If the number of registrants guidance finalizes the draft guidance Center, Bldg. 71, Rm. G335, 10903 New requesting to speak is greater than can issued on January 16, 2015, of the same Hampshire Ave., Silver Spring, MD be reasonably accommodated during the name. 20993–0002, 1–877–287–1373, email: scheduled open public hearing session, DATES: The announcement of the TPSAC@fda.hhs.gov, or FDA Advisory FDA may conduct a lottery to determine guidance is published in the Federal Committee Information Line, 1–800– the speakers for the scheduled open Register on November 9, 2017. 741–8138 (301–443–0572 in the public hearing session. The contact ADDRESSES: You may submit either Washington, DC area). A notice in the person will notify interested persons Federal Register about last minute electronic or written comments on regarding their request to speak by modifications that impact a previously Agency guidances at any time as December 28, 2017. announced advisory committee meeting follows: Persons attending FDA’s advisory cannot always be published quickly committee meetings are advised that the Electronic Submissions enough to provide timely notice. Agency is not responsible for providing Submit electronic comments in the Therefore, you should always check the access to electrical outlets. following way: Agency’s Web site at https:// FDA welcomes the attendance of the • Federal eRulemaking Portal: https:// www.fda.gov/AdvisoryCommittees/ public at its advisory committee www.regulations.gov. Follow the default.htm and scroll down to the meetings and will make every effort to instructions for submitting comments. appropriate advisory committee meeting accommodate persons with disabilities. Comments submitted electronically, link, or call the advisory committee If you require accommodations due to a including attachments, to https:// information line to learn about possible disability, please contact Caryn Cohen www.regulations.gov will be posted to modifications before coming to the at least 7 days in advance of the the docket unchanged. Because your meeting. meeting. comment will be made public, you are SUPPLEMENTARY INFORMATION: FDA is committed to the orderly solely responsible for ensuring that your Agenda: On January 24 and 25, 2018, conduct of its advisory committee comment does not include any the committee will discuss modified meetings. Please visit our Web site at confidential information that you or a risk tobacco product applications, https://www.fda.gov/Advisory third party may not wish to be posted, submitted by Philip Morris Products Committees/AboutAdvisoryCommittees/ such as medical information, your or S.A. for IQOS system with Marlboro ucm111462.htm for procedures on anyone else’s Social Security number, or Heatsticks, IQOS system with Marlboro public conduct during advisory confidential business information, such Smooth Menthol Heatsticks, and IQOS committee meetings. as a manufacturing process. Please note system with Marlboro Fresh Menthol Notice of this meeting is given under that if you include your name, contact sradovich on DSK3GMQ082PROD with NOTICES Heatsticks. the Federal Advisory Committee Act (5 information, or other information that FDA intends to make background U.S.C. app. 2). identifies you in the body of your material available to the public no later comments, that information will be than 2 business days before the meeting. Dated: October 31, 2017. posted on https://www.regulations.gov. If FDA is unable to post the background Lauren Silvis, • If you want to submit a comment material on its Web site prior to the Chief of Staff. with confidential information that you meeting, the background material will [FR Doc. 2017–24379 Filed 11–8–17; 8:45 am] do not wish to be made available to the be made publicly available at the BILLING CODE 4164–01–P public, submit the comment as a VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\09NON1.SGM 09NON1

Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52053 written/paper submission and in the electronic and written/paper comments provides multiple areas of clarification manner detailed (see ‘‘Written/Paper received, go to https:// throughout the document. Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the This guidance is being issued docket number, found in brackets in the consistent with FDA’s good guidance Written/Paper Submissions heading of this document, into the practices regulation (21 CFR 10.115). Submit written/paper submissions as ‘‘Search’’ box and follow the prompts The guidance represents the current follows: and/or go to the Dockets Management thinking of FDA on evaluating drug • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, effects on the ability to operate a motor written/paper submissions): Dockets Rockville, MD 20852. vehicle. It does not establish any rights Management Staff (HFA–305), Food and You may submit comments on any for any person and is not binding on Drug Administration, 5630 Fishers guidance at any time (see 21 CFR FDA or the public. You can use an Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). alternative approach if it satisfies the • For written/paper comments Submit written requests for single requirements of the applicable statutes submitted to the Dockets Management copies of this guidance to the Division and regulations. This guidance is not Staff, FDA will post your comment, as of Drug Information, Center for Drug subject to Executive Order 12866. well as any attachments, except for Evaluation and Research, Food and information submitted, marked and II. The Paperwork Reduction Act of Drug Administration, 10001 New identified, as confidential, if submitted 1995 Hampshire Ave., Hillandale Building, as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– This guidance refers to previously Instructions: All submissions received 0002. Send one self-addressed adhesive approved collections of information that must include the Docket No. FDA– label to assist that office in processing are subject to review by the Office of 2014–D–2300 for ‘‘Evaluating Drug your requests. See the SUPPLEMENTARY Management and Budget (OMB) under Effects on the Ability to Operate a Motor INFORMATION section for electronic the Paperwork Reduction Act of 1995 Vehicle.’’ Received comments will be access to the guidance document. (44 U.S.C. 3501–3520). The collections placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: of information in 21 CFR parts 312 and those submitted as ‘‘Confidential Naomi Lowy, Center for Drug 314 have been approved under OMB Submissions,’’ publicly viewable at Evaluation and Research, Food and control numbers 0910–0014 and 0910– https://www.regulations.gov or at the Drug Administration, 10903 New 0001, respectively. Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 4204, III. Electronic Access Friday. Silver Spring, MD 20993–0002, 301– Persons with access to the internet • Confidential Submissions—To 796–0692. may obtain the guidance at either submit a comment with confidential SUPPLEMENTARY INFORMATION: https://www.fda.gov/Drugs/Guidance information that you do not wish to be I. Background ComplianceRegulatoryInformation/ made publicly available, submit your FDA is announcing the availability of Guidances/default.htm or https:// comments only as a written/paper a guidance for industry entitled www.regulations.gov. submission. You should submit two copies total. One copy will include the ‘‘Evaluating Drug Effects on the Ability Dated: November 3, 2017. information you claim to be confidential to Operate a Motor Vehicle.’’ The Anna K. Abram, with a heading or cover note that states purpose of this guidance is to assist Deputy Commissioner for Policy, Planning, ‘‘THIS DOCUMENT CONTAINS sponsors in the evaluation of the effects Legislation, and Analysis. CONFIDENTIAL INFORMATION.’’ The of psychoactive drugs on the ability to [FR Doc. 2017–24367 Filed 11–8–17; 8:45 am] Agency will review this copy, including operate a motor vehicle. BILLING CODE 4164–01–P the claimed confidential information, in Driving is a complex activity its consideration of comments. The involving a wide range of cognitive, second copy, which will have the perceptual, and motor activities that can DEPARTMENT OF HEALTH AND claimed confidential information be adversely affected by therapeutic HUMAN SERVICES redacted/blacked out, will be available drugs. Reducing the incidence of MVAs for public viewing and posted on that occur because of drug-impaired Food and Drug Administration https://www.regulations.gov. Submit driving is a public health priority. Drugs that impair driving ability may [Docket No. FDA–2014–N–0920] both copies to the Dockets Management Staff. If you do not wish your name and also impair an individual’s ability to Agency Information Collection contact information to be made publicly judge the extent of his or her own Activities; Submission for Office of available, you can provide this impairment. This increases the need for Management and Budget Review; information on the cover sheet and not objective evaluation of the presence and Comment Request; Health and Diet in the body of your comments and you degree of driving impairment, with risk Survey, as Used by the Food and Drug must identify this information as mitigation strategies based on that Administration ‘‘confidential.’’ Any information marked information. This guidance recommends as ‘‘confidential’’ will not be disclosed a systematic effort to identify drugs for AGENCY: Food and Drug Administration, except in accordance with 21 CFR 10.20 which evaluation of effects on driving HHS. and other applicable disclosure law. For abilities may be needed and the types of ACTION: Notice. studies that such an evaluation entails. sradovich on DSK3GMQ082PROD with NOTICES more information about FDA’s posting of comments to public dockets, see 80 This guidance finalizes the draft SUMMARY: The Food and Drug FR 56469, September 18, 2015, or access guidance issued on January 16, 2015, Administration (FDA or we) is the information at: https://www.gpo.gov/ (80 FR 2432) of the same name. Changes announcing that a proposed collection fdsys/pkg/FR-2015-09-18/pdf/2015- made to the guidance took into of information has been submitted to the 23389.pdf. consideration comments received. In Office of Management and Budget Docket: For access to the docket to addition to editorial changes made (OMB) for review and clearance under read background documents or the primarily for clarification, the guidance the Paperwork Reduction Act of 1995. VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\FR\FM\09NON1.SGM 09NON1


Document Created: 2018-10-25 10:30:11
Document Modified: 2018-10-25 10:30:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on November 9, 2017.
ContactNaomi Lowy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4204, Silver Spring, MD 20993-0002, 301-796-0692.
FR Citation82 FR 52052 
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