[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Proposed Rules]
[Pages 55318-55323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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, 703-380-3900, [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

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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

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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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