[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12619-12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06323]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1107]


Youth Tobacco Cessation: Science and Treatment Strategies; Public 
Scientific Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public scientific workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public scientific workshop entitled ``Youth 
Tobacco Cessation: Science and Treatment Strategies.'' The purpose of 
the workshop is to discuss the unique challenges associated with youth 
tobacco addiction and cessation, and the current science regarding 
youth tobacco use and addiction as well as treatment strategies to 
support youth tobacco cessation.

DATES: The public scientific workshop will be held on May 15, 2019, 
from 9 a.m. to 5 p.m. Submit either electronic or written comments on 
this workshop by May 31, 2019. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public scientific workshop will be held at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the 
Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for 
public workshop 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 May 31, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of May 31, 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.

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

[[Page 12620]]

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-2019-N-1107 for ``Youth Tobacco Cessation: Science and Treatment 
Strategies.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.gpo.gov/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.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3138, Silver 
Spring, MD 20993, 301-796-9203, [email protected] (please use 
``Youth Tobacco workshop'' as the subject line).

SUPPLEMENTARY INFORMATION: 

I. Background

    Nearly all tobacco product use begins during youth and young 
adulthood (Ref. 1). In 2017-2018, there was an alarming increase in 
tobacco product use among adolescents, primarily driven by e-cigarette 
use (Refs. 2 and 3). Youth tobacco 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. 4).
    On April 24, 2018, FDA announced its Youth Tobacco Prevention 
Plan.\1\ 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, as well as educating retailers about their key role 
in protecting youth.\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\
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605432.htm.
    \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.
---------------------------------------------------------------------------

    In addition to the prevention of initiation, which will be the 
cornerstone of any successful effort to curb youth tobacco use, FDA is 
also exploring additional approaches to address this issue. On January 
18, 2019, FDA held an open public hearing entitled ``Eliminating Youth 
Electronic Cigarette and Other Tobacco Product Use: The Role for Drug 
Therapies,'' \5\ which requested information on the potential role of 
drug therapies to support cessation and the issues impacting the 
development of such therapies for youth. FDA appreciates that youth 
have unique challenges when it comes to addiction and cessation, and 
that they may respond differently to treatments as compared to adults.
---------------------------------------------------------------------------

    \5\ https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm
---------------------------------------------------------------------------

    The challenge of developing evidence in pediatric populations 
exists in many therapeutic areas. FDA is committed to addressing this 
issue. Therefore, FDA has issued grants to the Institute for Advanced 
Clinical Trials for Children (I-ACT for Children) and the Duke Clinical 
Research Institute (DCRI) to establish a Global Pediatric Clinical 
Trials Network to facilitate clinical trials of new drugs and devices 
for children. As a part of this work, I-ACT for Children and DCRI are 
hosting this public scientific workshop, in collaboration with FDA, to 
facilitate the development of evidence to support youth tobacco 
cessation efforts, and will result in a written report. This scientific 
workshop intends to explore many of the scientific issues brought up 
during the recent public hearing on this topic.

II. Topics for Discussion at the Public Scientific Workshop

    This public scientific workshop will gather scientific information 
and stimulate discussion about the current science regarding youth 
tobacco use and addiction, and treatment strategies to support youth 
tobacco cessation with a focus on e-cigarette cessation. This is 
because e-cigarettes are the tobacco products most commonly used by 
youth (Ref. 5) and there continues to be a rampant rise in use. 
According to data from the FDA/CDC 2018 National Youth Tobacco Survey, 
more than 3.6 million middle and high school students were current e-
cigarettes users in 2018, representing a substantial increase of more 
than 1.5 million students in one year (Ref. 3). Furthermore, data 
recently published in JAMA Network Open showed that youth e-cigarette 
users are more likely to transition to conventional cigarettes, as 
compared to non-users (Ref. 6). The workshop is intended to explore the 
challenges of treating youth tobacco addiction and promoting cessation. 
In particular, the workshop will highlight differences in treatment 
strategies needed in youth as opposed to adults. The workshop will 
include presentations and panel discussions regarding substantive 
scientific information specifically relating to the unique factors 
impacting youth tobacco use and addiction and challenges associated 
with youth tobacco cessation. Topics to be addressed include (1) the 
basic science of tobacco addiction in adolescents, (2) current state of 
behavioral and pharmacotherapy cessation strategies in adolescents 
(e.g.,

[[Page 12621]]

clinical trial experience to date, use of technology and social media, 
impact of social factors), and (3) the development of strategies to 
generate robust evidence to address youth tobacco cessation (e.g., 
clinical trial design, measures of adolescent addiction, selection of 
endpoints, subpopulation and co-morbidity considerations, and patient 
recruitment and retention). Presenters may include, but are not limited 
to, staff from FDA's Center for Tobacco Products, FDA's Center for Drug 
Evaluation and Research, industry, and academia. There will be 
opportunities for the audience to ask questions during this workshop.

III. Participating in the Public Scientific Workshop

    Registration: To register for the public scientific workshop, 
please visit the following website by May 13, 2019: https://youth-tobacco-cessation.eventbrite.com. Please provide complete contact 
information for each attendee, including name, affiliation, and email 
address.
    Registration is free and based on space availability. Persons 
interested in attending this workshop must register by May 13, 2019, 5 
p.m. Eastern Time. Early registration is recommended because seating is 
limited; therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. You may choose not to register, however seating is limited, 
and space will be available on a first-come, first-served basis.
    If you need special accommodations because of a disability, please 
contact Allison Hoffman (see FOR FURTHER INFORMATION CONTACT) no later 
than May 8, 2019.
    Persons attending FDA's meetings are advised that the Agency is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Scientific Workshop: This public 
scientific workshop will also be webcast. To register for the streaming 
webcast of the workshop, please visit the following website by May 13, 
2019: https://youth-tobacco-cessation.eventbrite.com.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

IV. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. 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, 2014.'' 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. Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al. (2018). ``Notes 
from the Field: Use of Electronic Cigarettes and Any Tobacco Product 
Among Middle and High School Students--United States, 2011-2018.'' 
MMWR Morbidity and Mortality Weekly Report, 67:1276-1277. DOI: 
http://dx.doi.org/10.15585/mmwr.mm6745a5. (Available at: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm.)
3. Gentzke, A.S., M. Creamer, K.A. Cullen, et al. (2019). ``Vital 
Signs: Tobacco Product Use Among Middle and High School Students--
United States, 2011-2018.'' MMWR Morbidity and Mortality Weekly 
Report, 68:157-164. DOI: http://dx.doi.org/10.15585/mmwr.mm6806e1. 
(Available at: https://www.cdc.gov/mmwr/volumes/68/wr/mm6806e1.htm.)
4. 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.)
5. 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. DOI: https://doi.org/10.15585/mmwr.mm6722a3 (Available at 
https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm).
6. Berry, K.M., J.L. Fetterman, E.J. Benjamin, et al. (2019). 
``Association of Electronic Cigarette Use With Subsequent Initiation 
of Tobacco Cigarettes in US Youths.'' JAMA Netw Open 2(2):e187794. 
DOI: https://doi.org/10.1001/jamanetworkopen.2018.7794 (Available at 
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425.)

    Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06323 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P


