Youth Tobacco Cessation: Science and Treatment Strategies; Public Scientific Workshop; Request for Comments, 12619-12621 [2019-06323]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
12619
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Survey type
Total annual
responses
Average burden per
response
Total hours
In-depth Interviews, Cognitive Interviews Screener
In-depth Interviews, Cognitive Interviews ................
In-depth Interviews Screener ...................................
In-depth Interviews ...................................................
Survey Cognitive Interviews Screener .....................
Survey Cognitive Interviews ....................................
Pretest survey screener ...........................................
Pretest survey ..........................................................
Self-Administered Surveys—Study Screener ..........
Self-Administered Surveys .......................................
Focus Group/Small Group, Cognitive Groups
Screener.
Focus Group/Small Group, Cognitive Groups .........
Focus Group/Small Group Participant Screening ...
Focus Group/Small Group Discussion ....................
45
9
900
180
45
9
750
150
75,000
15,000
180
1
1
1
1
1
1
1
1
1
1
1
45
9
900
180
45
9
750
150
75,000
15,000
180
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
4
9
75
180
4
9
62.25
38
6,225
3,750
15
60
720
240
1
1
1
60
720
240
1.5 (90 minutes) ........
0.083 (5 minutes) ......
1.5 (90 minutes) ........
90
60
360
Total ..................................................................
........................
........................
........................
....................................
10,881.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is a new collection of
information whose total estimated
annual burden is 10,881.25 hours.
Current estimates are based on both
historical numbers of participants from
past projects as well as estimates for
projects to be conducted in the next 3
years. The number of participants to be
included in each new individual survey
will vary, depending on the nature of
the compliance efforts and the target
audience.
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
BILLING CODE 4164–01–P
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.
Notice of public scientific
workshop; request for comments.
ACTION:
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
SUMMARY:
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
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.
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.
DATES:
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
ADDRESSES:
[FR Doc. 2019–06365 Filed 4–1–19; 8:45 am]
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
E:\FR\FM\02APN1.SGM
02APN1
amozie on DSK9F9SC42PROD with NOTICES
12620
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
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/201523389.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.
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
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,
OMPTFeedback@fda.hhs.gov (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 ecigarette 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
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
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.
5 https://www.fda.gov/NewsEvents/
MeetingsConferencesWorkshops/ucm620744.htm
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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.
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.,
E:\FR\FM\02APN1.SGM
02APN1
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
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 comorbidity 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.
amozie on DSK9F9SC42PROD with NOTICES
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-tobaccocessation.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-tobaccocessation.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
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
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/.)
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: https://
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: https://
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://ecigarettes.surgeongeneral.gov/
documents/2016_sgr_full_report_non508.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.’’
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
12621
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2032]
Limited Population Pathway for
Antibacterial and Antifungal Drugs;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Limited Population
Pathway for Antibacterial and
Antifungal Drugs.’’ The purpose of the
meeting is to provide a public forum for
FDA to listen to comments on the draft
guidance for industry, ‘‘Limited
Population Pathway for Antibacterial
and Antifungal Drugs,’’ that was
published in the Federal Register on
June 13, 2018. FDA is also reopening the
comment period on this draft guidance
for comments to be submitted for
consideration before we finish work on
the final version of the guidance.
DATES: The public meeting will be held
on July 12, 2019, from 9 a.m. to 3 p.m.
Eastern Time. Submit either electronic
or written comments by August 12,
2019, to ensure that the Agency
considers your comments on the draft
guidance before it finishes work on the
final version of the guidance. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm.
1503A (the Great Room), Silver Spring,
MD 20993. Entrance for the public
meeting 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.
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[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/.)
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:
https://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: https://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
