[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Proposed Rules]
[Pages 55318-55323]
[FR Doc No: 2018-24126]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2018-N-3952]

Eliminating Youth Electronic Cigarette and Other Tobacco Product
Use: The Role for Drug Therapies; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing to discuss its efforts to eliminate youth
electronic cigarette (e-cigarette) use as well as other tobacco product
use, with a focus on the potential role of drug therapies to support
youth e-cigarette cessation and the issues impacting the development of
such therapies.

DATES: The public hearing will be held on December 5, 2018, from 9 a.m.
to 5 p.m. The public hearing may be extended or may end early depending
on the level of public participation. Persons seeking to present at the
public hearing must register by Friday, November 23, 2018. Persons
seeking to attend, but not present at, the public hearing must register
by Monday, December 3, 2018. Section II provides attendance and
registration information. Electronic or written comments will be
accepted after the public hearing until Wednesday, January 2, 2019.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
A, Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before Wednesday, January 2, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of Wednesday, January 2, 2019.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date. You may
submit comments 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 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-2018-N-3952 for ``Eliminating Youth Electronic Cigarette and Other
Tobacco Product Use: The Role for Drug Therapies; Public Hearing;
Request for Comments.'' 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.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, 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.

FOR FURTHER INFORMATION CONTACT: Theresa Wells, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1202, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Nearly all tobacco product use begins during youth and young
adulthood (Ref. 1). While the current use of any tobacco product among
U.S. middle and high school students has decreased from 2011-2017,
there has been an alarming increase in e-cigarette use over this time.
In fact, since 2014, e-cigarettes \1\ have been the most commonly used
tobacco products among youth, used by 1.73 million (11.7 percent) high
school students and 390,000 (3.3 percent) middle school students in
2017 (Ref. 2). Youth e-cigarette use raises a number of health concerns
including risk of addiction to nicotine early on in life, potential
harm to the developing adolescent brain, and exposure to chemicals
including carbonyl compounds and volatile organic compounds known to
have adverse health effects; the full range of possible health effects
is not yet completely understood (Ref. 3).
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    \1\ An e-cigarette is one type of electronic nicotine delivery
system, which also includes e-cigars, e-hookah, vape pens, personal
vaporizers, and electronic pipes. See https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm
and Ref. 2.
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    On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan.
This plan focuses on three key strategies: Prevention of youth access
to tobacco products, curbing the marketing of tobacco products aimed at
youth, and educating teens about the dangers of using any tobacco
products.\2\ FDA recently launched an expansion of its ``The Real
Cost'' campaign to educate youth on the dangers of e-cigarette use \3\
and increased enforcement actions to address this critically important
public health concern.\4\
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    \2\ https://www.fda.gov/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm.
    \3\ https://www.fda.gov/tobaccoproducts/publichealtheducation/publiceducationcampaigns/therealcostcampaign/default.htm.
    \4\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm.
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    In addition to the prevention of initiation, which will be the
cornerstone of any successful effort to curb youth e-cigarette use, FDA
is also exploring additional approaches to address youth e-cigarette
use. One such approach may be the development of drug therapies, as
part of multimodal treatment strategies, including behavioral
interventions, to support tobacco product cessation. To date, research
on youth tobacco product cessation has been limited and focused on
smoking (i.e., combustible products) cessation. One recent review found
a paucity of data on either behavioral or drug therapies for smoking
cessation in young people (age less than 20 years) and concluded that
``there continues to be a need for well-designed, adequately powered,
randomized controlled trials of interventions for this population of
smokers'' (Ref. 4). FDA is not aware of any research examining either
drug or behavioral interventions for the cessation of youth or adult e-
cigarette use. In contrast, there is a large body of research on adult
smoking cessation, and multiple drugs for smoking cessation are
approved for the adult population, including a variety of prescription
and over-the-counter nicotine replacement therapy (NRT) products, as
well as the prescription drugs varenicline and bupropion hydrochloride
sustained release (see Appendix A).

II. Purpose and Scope of the Public Hearing

    FDA is holding a public hearing to obtain the public's perspectives
on the potential role drug therapies may play in the broader effort to
eliminate youth e-cigarette and other tobacco product use, as well as
the appropriate methods and study designs for evaluating youth e-
cigarette cessation therapies and the safety and efficacy of such
therapies. The Agency has determined that a public hearing is the most
appropriate way to ensure public engagement on this issue, which is of
great importance to the public health. FDA believes it is critical to
obtain input across the medical and research fields, the pharmaceutical
and tobacco industries, and among public health stakeholders (including
adolescents) regarding approaches to eliminate youth e-cigarette and
other tobacco product use, including exploring whether there is a need
for drug therapies to support youth e-cigarette cessation, and if so,
how FDA

can support the development of such therapies.

Questions for Commenters To Address

    Considering the broad range of activities focused on this public
health issue, FDA is interested in the public's view on approaches to
eliminating e-cigarette and other tobacco product use among youth.
Although FDA welcomes all feedback on any public health, scientific,
regulatory or legal considerations relating to this topic, we
particularly encourage commenters to consider the following questions
as they prepare their comments or statements. Responses to questions
should include supporting scientific justification.
    1. FDA notes that the factors driving e-cigarette use among youth
likely differ from those in the adult population. How might such
differences impact the need for, or use of, drug therapies for e-
cigarette cessation among youth?
    2. FDA is interested in whether there is a population of youth e-
cigarette users who would be likely to benefit from the use of drug
therapies for e-cigarette cessation. What age groups (older adolescent
vs. younger adolescent), patterns in tobacco use (duration and
frequency of use), and clinical features (level of addiction, presence/
absence of comorbidities including psychiatric disease) might
characterize this population? What types of products (NRT vs. non-NRT;
prescription vs. over-the-counter) might be useful?
    3. Describe the scientific, clinical, and societal factors that
could either encourage or impede the conduct of clinical trials
designed to evaluate drugs intended for youth e-cigarette cessation.
What approaches could be used to encourage research and overcome
barriers to research?
    4. What methods and study designs are appropriate for assessing
drug therapies for youth e-cigarette cessation? What are the
appropriate control groups? What are the most informative endpoints and
the best assessment tools to evaluate these endpoints?
    5. Acknowledging that to date research has been limited, are there
data available from the adult experience with smoking cessation that
could potentially be leveraged in the effort to develop drug therapies
for youth e-cigarette cessation? Have any drug therapies demonstrated
potential to help adults discontinue e-cigarette use? Are there
differences between adolescents and adults that impact the ability to
extrapolate efficacy findings from the adult population to the
adolescent population? Could existing NRT products be useful for youth
e-cigarette cessation?
    6. While this hearing is focused on the topic of e-cigarette use
among youth, as e-cigarettes are currently the most commonly used form
of tobacco in this population, FDA also welcomes comments regarding the
potential need for drug therapies to support cessation of other tobacco
products, including combustible products (i.e., cigarettes or cigars)
and smokeless tobacco products, among youth and the issues impacting
the development of such therapies.
    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. For those interested in presenting at
the meeting, either with a formal oral presentation or as a speaker in
the open public hearing session, please register by Friday, November
23, 2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. If you wish to
attend either in person or by Webcast (see Streaming Webcast of the
Public Hearing), please register for the hearing by Monday December 3,
2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. Those without internet or
email access can register and/or request to participate as an open
public hearing speaker or a formal presenter by contacting Theresa
Wells by the above dates (see FOR FURTHER INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a
presentation. Formal oral presenters may use an accompanying slide
deck, while those participating in the Open Public Hearing will have
less allotted time than formal oral presenters and will deliver oral
testimony only (no accompanying slide deck). Individuals wishing to
present should identify the number of the specific question, or
questions, they wish to address. This will help FDA organize the
presentations. Individuals and organizations with common interests
should consolidate or coordinate their presentations and request time
for a joint presentation. Individual organizations are limited to a
single presentation slot. FDA will notify registered presenters of
their scheduled presentation times. The time allotted for each
presentation will depend on the number of individuals who wish to
speak. Registered presenters making a formal oral presentation are
encouraged to submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the subject line
``Eliminating Youth Electronic Cigarette and Other Tobacco Product Use:
The Role for Drug Therapies'' on or before Wednesday, November 28,
2018. Persons registered to present are encouraged to arrive at the
hearing room early and check in at the onsite registration table to
confirm their designated presentation time. Actual presentation times,
however, may vary based on how the meeting progresses in real-time. An
agenda for the hearing and any other background materials will be made
available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm.
    If you need special accommodations because of a disability, please
contact Theresa Wells (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live Webcast of the hearing. To join the
hearing via the Webcast, please go to https://collaboration.fda.gov/ptc120518.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see Comments). A transcript
will also be available in either hard copy or on CD-ROM, after
submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's website at
https://www.fda.gov.

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, and the Center for Tobacco Products.
Under Sec.  15.30(f), the hearing is informal and the rules of evidence
do not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under Sec.
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public

administrative proceedings, including presentations by participants.
The hearing will be transcribed as stipulated in Sec.  15.30(b) (see
Transcripts). To the extent that the conditions for the hearing, as
described in this notice, conflict with any provisions set out in part
15, this notice acts as a waiver of those provisions as specified in
Sec.  15.30(h).

IV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they also are available electronically at https://www.regulations.gov.
References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may
be available at the website address, if listed. References without
asterisks are available for viewing only at the Dockets Management
Staff. FDA has verified the website addresses, as of the date this
document publishes in the Federal Register, but websites are subject to
change over time.

1.* U.S. Department of Health and Human Services (2014). ``The
Health Consequences of Smoking--50 Years of Progress: A Report of
the Surgeon General.'' Atlanta, GA: U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health available at: https://www.surgeongeneral.gov/library/reports/50-years-of-progress/index.html.
2.* Wang T.W., A. Gentzke, S. Sharapova, et al. (2018). ``Tobacco
Product Use Among Middle and High School Students--United States,
2011-2017.'' Morbidity and Mortality Weekly Report (MMWR) 67:629-
633, available at https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm).
3.* U.S. Department of Health and Human Services (2016). ``E-
Cigarette Use Among Youth and Young Adults: A Report of the Surgeon
General.'' Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health available at: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf.
4. Fanshawe T.R., W. Halliwell, N. Lindson, et al. (2017). ``Tobacco
Cessation Interventions for Young People.'' Cochrane Database of
Systematic Reviews, Rev.11:CD003289, available at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003289.pub6/epdf/full.
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     Dated: October 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24126 Filed 11-2-18; 8:45 am]
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