83_FR_33442 83 FR 33305 - Drugs that Impair Safe Driving; Request for Comments

83 FR 33305 - Drugs that Impair Safe Driving; Request for Comments

DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration

Federal Register Volume 83, Issue 137 (July 17, 2018)

Page Range33305-33306
FR Document2018-15209

NHTSA is reviewing the literature on drug use and driving with the aim of updating its Drugs and Human Performance Fact Sheets that are used by the criminal justice community and others as they address drug-impaired driving. The current edition of the Fact Sheets was released in 2004 and included information on the following drugs: Carisoprodol, cocaine, dextromethorphan, diazepam, diphenhydramine, gamma-hydroxybutyrate (GHB), ketamine, lysergic acid diethylamide (LSD), marijuana, methadone, methamphetamine, methylenedioxymethamphetamine (MDMA), morphine, phencyclidine (PCP), toluene, and zolpidem. NHTSA welcomes comments and suggestions for additional drugs to be considered for inclusion in the new edition of the Fact Sheets as well as relevant research studies that have become available since 2004 that could be included in the updated fact sheets. To the extent possible, such comments and suggestions should be accompanied by information about the drug, including the extent of its use, its pharmacology and pharmodynamics, and how impairing it is for driving, along with references.

Federal Register, Volume 83 Issue 137 (Tuesday, July 17, 2018)
[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Notices]
[Pages 33305-33306]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15209]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-XXXX]


Drugs that Impair Safe Driving; Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA), 
Department of Transportation (DOT).

ACTION: Request for comment.

-----------------------------------------------------------------------

SUMMARY: NHTSA is reviewing the literature on drug use and driving with 
the aim of updating its Drugs and Human Performance Fact Sheets that 
are used by the criminal justice community and others as they address 
drug-impaired driving. The current edition of the Fact Sheets was 
released in 2004 and included information on the following drugs: 
Carisoprodol, cocaine, dextromethorphan, diazepam, diphenhydramine, 
gamma-hydroxybutyrate (GHB), ketamine, lysergic acid diethylamide 
(LSD), marijuana, methadone, methamphetamine, 
methylenedioxymethamphetamine (MDMA), morphine, phencyclidine (PCP), 
toluene, and zolpidem. NHTSA welcomes comments and suggestions for 
additional drugs to be considered for inclusion in the new edition of 
the Fact Sheets as well as relevant research studies that have become 
available since 2004 that could be included in the updated fact sheets. 
To the extent possible, such comments and suggestions should be 
accompanied by information about the drug, including the extent of its 
use, its pharmacology and pharmodynamics, and how impairing it is for 
driving, along with references.

DATES: Interested parties are invited to submit comments and 
suggestions on or before September 1, 2018.

FOR FURTHER INFORMATION CONTACT: If you have questions about this 
request for comment, please contact Richard Compton at 
[email protected] or 202-366-2699.
    Written Comments: Written statements and supporting information 
submitted during the comment period will be considered. Please submit 
all written comments no later than September 1, 2018, by any of the 
following methods:
     Federal Rulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting 
comments.
     Mail: Docket Management Facility: U.S. Department of 
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, 
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE, West 
Building Ground Floor, Room W12-140, Washington, DC 20590-0001, between 
9 a.m. and 5 p.m. ET, Monday through Friday, except Federal Holidays.
     Fax: 202-366-1767.
    Instructions: All submissions must include the agency name and 
docket number. Note that all comments received will be posted without 
change to http://www.regulations.gov, including any personal 
information provided. Please see the Privacy Act discussion below.
    Docket: For access to the docket go to http://www.regulations.gov 
at any time or to 1200 New Jersey Avenue SE, West Building, Ground 
Floor, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., 
Monday through Friday, except Federal Holidays. Telephone: 202-366-
9826.
    Privacy Act: Anyone is able to search the electronic form of all 
comments received into any of our dockets by the name of the individual 
submitting the comment (or signing the comment, if submitted on behalf 
of an association, business, labor union, etc.). You may review DOT's 
complete Privacy Act Statement in the Federal Register published on 
April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit 
http://www.regulations.gov/privacy.html.
    Confidential Business Information: If you wish to submit any 
information under a claim of confidentiality, you should submit three 
copies of your

[[Page 33306]]

complete submission, including the information you claim to be 
confidential business information, to the Chief Counsel, NHTSA, 1200 
New Jersey Ave. SE, W41-326, Washington DC 20590. In addition, you 
should submit two copies, from which you have deleted the claimed 
confidential business information, to Docket Management at the address 
given above. When you send a comment containing information claimed to 
be confidential business information, you should submit a cover letter 
setting forth the information specified in our confidential business 
information regulation (49 CFR part 512).

SUPPLEMENTARY INFORMATION: 

Background

    In the early 2000s, NHTSA convened a panel of international experts 
on drug-impaired driving to review developments in the field of drugs 
and human performance and to identify the specific effects that both 
high priority illicit and prescription drugs have on driving. The 
experts represented the fields of psychopharmacology, behavioral 
psychology, drug chemistry, forensic toxicology, medicine, and law 
enforcement. That effort resulted in the publication of a document 
entitled Drugs and Human Performance Fact Sheets (DOT HS 809 725) in 
June 2004.
    Each Fact Sheet covered one of the selected sixteen drugs that 
impair driving. The selected drugs included over-the-counter 
medications such as dextromethorphan and diphenhydramine; prescription 
medications such as carisoprodol, diazepam, and zolpidem; and abused 
and/or illegal drugs such as cocaine, GHB, ketamine, LSD, marijuana, 
methadone, methamphetamine, MDMA, morphine, PCP, and toluene. Each 
individual drug Fact Sheet covered information regarding drug 
chemistry, usage and dosage information, pharmacology, drug effects, 
effects on driving, drug evaluation and classification, and the panel's 
assessment of driving risks. More specifically, the Fact Sheets 
provided details on the physical description of the drug, synonyms, and 
pharmaceutical or illicit sources; medical and recreational uses, 
recommended and abused doses, typical routes of administration, and 
potency and purity; mechanism of drug action and major receptor sites; 
drug absorption, distribution, metabolism and elimination data; blood 
and urine concentrations; psychological and physiological effects, and 
drug interactions; drug effects on psychomotor performance effects; 
driving simulator and epidemiology studies; and drug recognition 
evaluation profiles. Each Fact Sheet concludes with general statements 
about the drugs' ability to impair driving performance. A list of key 
references and recommended reading was also provided for each drug.
    Since 2004, new research on these and other impairing drugs has 
become available. As a result, NHTSA plans to evaluate whether 
additional drugs that impair driving should be included in the Fact 
Sheets and to add them as appropriate, as well as to update information 
on the effects of the sixteen aforementioned drugs on driving. NHTSA 
will base the revised Fact Sheets on the state of current scientific 
knowledge. The agency intends to design the revised Fact Sheets to 
continue to provide practical guidance to toxicologists, 
pharmacologists, law enforcement officers, attorneys, and the general 
public to use in the evaluation of future cases.
    In order to assist on the development of the new edition of the 
Fact Sheets, NHTSA invites comments and suggestions from the general 
public on additional drugs as well as relevant research studies that 
have become available since 2004 that could be included in the updated 
fact sheets. To the extent possible, such comments and suggestions 
should be accompanied by information about the drug, including the 
extent of its use, its pharmacology and pharmodynamics, and how 
impairing it is for driving, along with references.

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on July 12, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-15209 Filed 7-16-18; 8:45 am]
 BILLING CODE 4910-59-P



                                                                               Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices                                           33305

                                               inventory of interlock programs to                          Comments are Invited: Comments are                 the extent of its use, its pharmacology
                                               support program management by                            invited on whether the proposed                       and pharmodynamics, and how
                                               documenting lessons learned and                          collection of information is (a) necessary            impairing it is for driving, along with
                                               identifying solutions to common                          for the Department’s performance; (b)                 references.
                                               problems. The collected information                      the accuracy of the estimated burden; (c)             DATES:  Interested parties are invited to
                                               would be from publicly available                         ways for the Department to enhance the                submit comments and suggestions on or
                                               sources such as program websites, and                    quality, utility and clarity of the                   before September 1, 2018.
                                               from program administrators and staff.                   information collection; and (d) ways
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT: If
                                               Administrators would be invited to take                  that the burden could be minimized
                                                                                                                                                              you have questions about this request
                                               a 15-minute online self-administered                     without reducing the quality of the
                                                                                                                                                              for comment, please contact Richard
                                               questionnaire, and administrators and                    collected information.
                                                                                                                                                              Compton at NHTSAdruginfo@dot.gov or
                                               staff would be invited to participate in                    A comment to OMB is most effective
                                                                                                                                                              202–366–2699.
                                               a semi-structured interview over the                     if OMB receives it within 30 days of
                                                                                                                                                                Written Comments: Written
                                               telephone, up to one hour (with one                      publication of this notice.
                                                                                                                                                              statements and supporting information
                                               interview per program).                                    Authority: The Paperwork Reduction Act              submitted during the comment period
                                                  Respondents: Respondents will be                      of 1995; 44 U.S.C. Section 3506(c)(2)(A).             will be considered. Please submit all
                                               administrators and staff of alcohol
                                                                                                          Issued in Washington, DC, on July 12,               written comments no later than
                                               ignition interlock programs. There are                   2018.                                                 September 1, 2018, by any of the
                                               up to 52 interlock programs; with nearly
                                                                                                        Jeff Michael,                                         following methods:
                                               one in each state, the District of                                                                               • Federal Rulemaking Portal: Go to
                                                                                                        Associate Administrator, Research and
                                               Columbia, and Puerto Rico.                                                                                     http://www.regulations.gov. Follow the
                                                                                                        Program Development.
                                                  Estimated Number of Respondents:                                                                            online instructions for submitting
                                                                                                        [FR Doc. 2018–15210 Filed 7–16–18; 8:45 am]
                                               260 (If 52 administrators and four staff                                                                       comments.
                                                                                                        BILLING CODE 4910–59–P
                                               per program were to respond).                                                                                    • Mail: Docket Management Facility:
                                                  Estimated Time per Response: The                                                                            U.S. Department of Transportation, 1200
                                               expected average completion time for                     DEPARTMENT OF TRANSPORTATION                          New Jersey Avenue SE, West Building
                                               the questionnaire is 15 minutes, and for                                                                       Ground Floor, Room W12–140,
                                               the group phone interview it is 60                       National Highway Traffic Safety                       Washington, DC 20590–0001.
                                               minutes.                                                 Administration                                          • Hand Delivery or Courier: 1200
                                                  Estimate of the Total Annual                                                                                New Jersey Avenue SE, West Building
                                               Reporting and Record Keeping Burden                      [Docket No. NHTSA–2018–XXXX]
                                                                                                                                                              Ground Floor, Room W12–140,
                                               Resulting from the Collection of                                                                               Washington, DC 20590–0001, between 9
                                               Information: Participants will incur no                  Drugs that Impair Safe Driving;
                                                                                                        Request for Comments                                  a.m. and 5 p.m. ET, Monday through
                                               burden related to annual reporting or                                                                          Friday, except Federal Holidays.
                                               record keeping due to the collection of                  AGENCY:  National Highway Traffic                       • Fax: 202–366–1767.
                                               information.                                             Safety Administration (NHTSA),                          Instructions: All submissions must
                                                  Total Estimated Annual Burden                         Department of Transportation (DOT).                   include the agency name and docket
                                               Hours: A total of 273 hours: The                         ACTION: Request for comment.                          number. Note that all comments
                                               estimated burden hours for the                                                                                 received will be posted without change
                                               questionnaire is 13 hours (52                            SUMMARY:   NHTSA is reviewing the                     to http://www.regulations.gov, including
                                               administrators × .25 hours to take the                   literature on drug use and driving with               any personal information provided.
                                               questionnaire), and the estimated                        the aim of updating its Drugs and                     Please see the Privacy Act discussion
                                               burden hours for the group interviews is                 Human Performance Fact Sheets that are                below.
                                               260 hours (260 people × 1 hour).                         used by the criminal justice community                  Docket: For access to the docket go to
                                                  Frequency of Collection: The                          and others as they address drug-                      http://www.regulations.gov at any time
                                               information collection will be                           impaired driving. The current edition of              or to 1200 New Jersey Avenue SE, West
                                               administered a single time.                              the Fact Sheets was released in 2004                  Building, Ground Floor, Room W12–
                                                  Previous Notice: A 60-day notice in                   and included information on the                       140, Washington, DC 20590, between 9
                                               the Federal Register on August 24, 2017                  following drugs: Carisoprodol, cocaine,               a.m. and 5 p.m., Monday through
                                               received three comments. The first                       dextromethorphan, diazepam,                           Friday, except Federal Holidays.
                                               comment recommended that the                             diphenhydramine, gamma-                               Telephone: 202–366–9826.
                                               questionnaire and the topics of the                      hydroxybutyrate (GHB), ketamine,                        Privacy Act: Anyone is able to search
                                               group interview be provided ahead of                     lysergic acid diethylamide (LSD),                     the electronic form of all comments
                                               time with the managers of each                           marijuana, methadone,                                 received into any of our dockets by the
                                               program’s transportation department, to                  methamphetamine,                                      name of the individual submitting the
                                               allow managers the opportunity to                        methylenedioxymethamphetamine                         comment (or signing the comment, if
                                               provide guidance to the staff. NHTSA                     (MDMA), morphine, phencyclidine                       submitted on behalf of an association,
                                               concurs with this request. The second                    (PCP), toluene, and zolpidem. NHTSA                   business, labor union, etc.). You may
                                               request was that the information                         welcomes comments and suggestions for                 review DOT’s complete Privacy Act
                                               collection should ‘‘not ask for                          additional drugs to be considered for                 Statement in the Federal Register
                                               judgments’’ about a department. NHTSA                    inclusion in the new edition of the Fact              published on April 11, 2000 (Volume
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                                               concurs with this request, as the                        Sheets as well as relevant research                   65, Number 70; Pages 19477–78), or you
                                               collected information is on features and                 studies that have become available since              may visit http://www.regulations.gov/
                                               facts of the programs. The third                         2004 that could be included in the                    privacy.html.
                                               comment was that ‘‘other approaches to                   updated fact sheets. To the extent                      Confidential Business Information: If
                                               combatting impaired driving’’ warrant                    possible, such comments and                           you wish to submit any information
                                               support. NHTSA concurs with this                         suggestions should be accompanied by                  under a claim of confidentiality, you
                                               comment.                                                 information about the drug, including                 should submit three copies of your


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                                               33306                           Federal Register / Vol. 83, No. 137 / Tuesday, July 17, 2018 / Notices

                                               complete submission, including the                       psychomotor performance effects;                       the Office of Management and Budget
                                               information you claim to be confidential                 driving simulator and epidemiology                     (OMB). Under procedures established
                                               business information, to the Chief                       studies; and drug recognition evaluation               by the Paperwork Reduction Act of
                                               Counsel, NHTSA, 1200 New Jersey Ave.                     profiles. Each Fact Sheet concludes with               1995, before seeking OMB approval,
                                               SE, W41–326, Washington DC 20590. In                     general statements about the drugs’                    Federal agencies must solicit public
                                               addition, you should submit two copies,                  ability to impair driving performance. A               comment on proposed collections of
                                               from which you have deleted the                          list of key references and recommended                 information, including extensions and
                                               claimed confidential business                            reading was also provided for each drug.               reinstatements of previously approved
                                               information, to Docket Management at                        Since 2004, new research on these                   collections. This document describes
                                               the address given above. When you send                   and other impairing drugs has become                   the collection of information for which
                                               a comment containing information                         available. As a result, NHTSA plans to                 NHTSA intends to seek OMB approval.
                                               claimed to be confidential business                      evaluate whether additional drugs that                 DATES: Comments must be received on
                                               information, you should submit a cover                   impair driving should be included in                   or before September 17, 2018.
                                               letter setting forth the information                     the Fact Sheets and to add them as                     ADDRESSES: You may submit comments
                                               specified in our confidential business                   appropriate, as well as to update                      identified by DOT Docket Number
                                               information regulation (49 CFR part                      information on the effects of the sixteen              NHTSA–2018–0060 using any of the
                                               512).                                                    aforementioned drugs on driving.                       following methods:
                                               SUPPLEMENTARY INFORMATION:                               NHTSA will base the revised Fact                         Electronic submissions: Go to http://
                                                                                                        Sheets on the state of current scientific              www.regulations.gov. Follow the online
                                               Background                                               knowledge. The agency intends to                       instructions for submitting comments.
                                                  In the early 2000s, NHTSA convened                    design the revised Fact Sheets to                        Mail: Docket Management Facility,
                                               a panel of international experts on drug-                continue to provide practical guidance                 M–30, U.S. Department of
                                               impaired driving to review                               to toxicologists, pharmacologists, law                 Transportation, 1200 New Jersey
                                               developments in the field of drugs and                   enforcement officers, attorneys, and the               Avenue SE, West Building Ground
                                               human performance and to identify the                    general public to use in the evaluation                Floor, Room W12–140, Washington, DC
                                               specific effects that both high priority                 of future cases.                                       20590.
                                               illicit and prescription drugs have on                      In order to assist on the development                 Hand Delivery: West Building Ground
                                               driving. The experts represented the                     of the new edition of the Fact Sheets,                 Floor, Room W12–140, 1200 New Jersey
                                               fields of psychopharmacology,                            NHTSA invites comments and                             Avenue SE, Washington, DC, between 9
                                               behavioral psychology, drug chemistry,                   suggestions from the general public on                 a.m. and 5 p.m., Monday through
                                               forensic toxicology, medicine, and law                   additional drugs as well as relevant                   Friday, except Federal holidays.
                                               enforcement. That effort resulted in the                 research studies that have become                        Fax: 1–202–493–2251.
                                               publication of a document entitled                       available since 2004 that could be                       Instructions: Each submission must
                                               Drugs and Human Performance Fact                         included in the updated fact sheets. To                include the agency name and the docket
                                               Sheets (DOT HS 809 725) in June 2004.                    the extent possible, such comments and                 number for this Notice. Note that all
                                                  Each Fact Sheet covered one of the                    suggestions should be accompanied by                   comments received will be posted
                                               selected sixteen drugs that impair                       information about the drug, including                  without change to http://
                                               driving. The selected drugs included                     the extent of its use, its pharmacology                www.regulations.gov, including any
                                               over-the-counter medications such as                     and pharmodynamics, and how                            personal information provided.
                                               dextromethorphan and                                     impairing it is for driving, along with                FOR FURTHER INFORMATION CONTACT:
                                               diphenhydramine; prescription                            references.                                            Mary Byrd, Contracting Officer’s
                                               medications such as carisoprodol,                             Authority: 44 U.S.C. Section 3506(c)(2)(A).       Representative, Office of Behavioral
                                               diazepam, and zolpidem; and abused                                                                              Safety Research (NPD–320), National
                                                                                                          Issued in Washington, DC, on July 12,
                                               and/or illegal drugs such as cocaine,                    2018.                                                  Highway Traffic Safety Administration,
                                               GHB, ketamine, LSD, marijuana,                                                                                  1200 New Jersey Avenue SE,
                                                                                                        Jeff Michael,
                                               methadone, methamphetamine, MDMA,                                                                               Washington, DC 20590. Ms. Byrd’s
                                                                                                        Associate Administrator, Research and
                                               morphine, PCP, and toluene. Each                                                                                phone number is 202–366–5595, and
                                                                                                        Program Development.
                                               individual drug Fact Sheet covered                                                                              her email address is mary.byrd@dot.gov.
                                                                                                        [FR Doc. 2018–15209 Filed 7–16–18; 8:45 am]
                                               information regarding drug chemistry,                                                                           SUPPLEMENTARY INFORMATION: Under the
                                                                                                        BILLING CODE 4910–59–P
                                               usage and dosage information,                                                                                   Paperwork Reduction Act of 1995,
                                               pharmacology, drug effects, effects on                                                                          before an agency submits a proposed
                                               driving, drug evaluation and                             DEPARTMENT OF TRANSPORTATION                           collection of information to OMB for
                                               classification, and the panel’s                                                                                 approval, it must publish a document in
                                               assessment of driving risks. More                        National Highway Traffic Safety                        the Federal Register providing a 60-day
                                               specifically, the Fact Sheets provided                   Administration                                         comment period and otherwise consult
                                               details on the physical description of                                                                          with members of the public and affected
                                               the drug, synonyms, and                                  [U.S. DOT Docket No. NHTSA–2018–0060]                  agencies concerning each proposed
                                               pharmaceutical or illicit sources;                                                                              collection of information. The OMB has
                                                                                                        Reports, Forms, and Record Keeping
                                               medical and recreational uses,                                                                                  promulgated regulations describing
                                                                                                        Requirements
                                               recommended and abused doses, typical                                                                           what must be included in such a
                                               routes of administration, and potency                    AGENCY:  National Highway Traffic                      document. Under OMB’s regulations (5
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                                               and purity; mechanism of drug action                     Safety Administration (NHTSA), DOT.                    CFR 1320.8(d)), an agency must ask for
                                               and major receptor sites; drug                           ACTION: Request for public comment on                  public comment on the following:
                                               absorption, distribution, metabolism                     proposed collection of information.                      (i) Whether the proposed collection of
                                               and elimination data; blood and urine                                                                           information is necessary for the proper
                                               concentrations; psychological and                        SUMMARY:   Before a Federal agency can                 performance of the functions of the
                                               physiological effects, and drug                          collect certain information from the                   agency, including whether the
                                               interactions; drug effects on                            public, it must receive approval from                  information will have practical utility;


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Document Created: 2018-07-17 01:39:45
Document Modified: 2018-07-17 01:39:45
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
ActionRequest for comment.
DatesInterested parties are invited to submit comments and suggestions on or before September 1, 2018.
ContactIf you have questions about this request for comment, please contact Richard Compton at [email protected] or 202-366-2699.
FR Citation83 FR 33305 

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