Tobacco Product Application Review; Public Meeting; Request for Comments, 48628-48630 [2018-20904]
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Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
recruited through the same internet
panel as used for the pretests.
Participants will complete the screener
questionnaire through an email
invitation. This brief screening will take
an average of 2 minutes (0.03 hours) per
respondent. If, based on this screening,
participants qualify for the study, they
will be directed to begin Session 1.
Recent national estimates of the
numbers of adolescent current cigarette
smokers, adolescents who are
susceptible to initiation of cigarette
smoking, young adult current cigarette
smokers, and older adult current
cigarette smokers informed the
estimates of 14.6 percent qualification
rate for adults and 7.8 percent
qualification rate for adolescents.
Applying these estimates and other
assumptions from previous experience
conducting similar studies to the
number of adolescents and adults to be
screened results in the desired sample
size for the main data collection of 9,760
participants, of which 7,460 will be
adults and 2,300 will be adolescents.
The three sessions of the main data
collection will take an average of 12
minutes (0.20 hours) for Session 1, 8
minutes (0.13 hours) for Session 2, and
5 minutes (0.08 hours) for Session 3, for
a total of an estimated 25 minutes (0.42
hours) per respondent. The total
estimated burden for the data collection
is 6,561 hours (4,692 hours for adults +
1,869 hours for adolescents).
daltland on DSKBBV9HB2PROD with NOTICES
II. References
The following references are on
display at 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.
1. Murphy, S.L., J. Xu, K.D. Kochanek.
‘‘Deaths: Final Data for 2010’’. National
Vital Statistics Reports, 61(4):37–41,
2013.
2. U.S. Department of Health and Human
Services. ‘‘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; 2014.
3. Jamal, A., E. Phillips, A.S. Gentzke, et al.
‘‘Current Cigarette Smoking Among
Adults—United States, 2016’’. MMWR
Morbidity and Mortality Weekly Report,
67:53–59, 2018.
4. Centers for Disease Control and
Prevention. ‘‘Cigarette SmokingAttributable Morbidity—United States,
2000’’. MMWR Morbidity and Mortality
Weekly Report, 52(35):842–844, 2003
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
5. Substance Abuse and Mental Health
Services Administration (SAMHSA). See
Table 4.10A in ’’ 2016 National Survey
on Drug Use and Health: Detailed
Tables.’’ Rockville, MD: U.S. Department
of Health and Human Services,
SAMHSA, Center for Behavioral Health
Statistics and Quality; 2017.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20913 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3504]
Tobacco Product Application Review;
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) is announcing a
public meeting entitled ‘‘Tobacco
Product Application Review.’’ This
meeting is intended to improve public
understanding and provide FDA
feedback on the policies and processes
for submitting and reviewing tobacco
product marketing applications,
including the general scientific
principles relevant to various
application pathways, to assist those
considering submitting marketing
applications for tobacco products under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
DATES: The 2-day public meeting will be
held on October 22, 2018, from 8:30
a.m. to 4:30 p.m. and on October 23,
2018, from 8:30 a.m. to 3 p.m. Submit
either electronic or written comments
on this public meeting by December 7,
2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the Hilton Washington DC/
Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD 20852, https://www3.hilton.com/en/
hotels/maryland/hilton-washington-dcrockville-hotel-and-executive-meetingctr-IADMRHF/.
You may submit comments as
follows. Please note that late, untimely
filed comments may not be considered.
The https://www.regulations.gov
electronic filing system will accept
electronic comments until 11:59 p.m.
Eastern Time on December 7, 2018.
SUMMARY:
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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 December 7, 2018.
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–3504 for ‘‘Tobacco Product
Application Review.’’ Received
comments, 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
E:\FR\FM\26SEN1.SGM
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Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Darin Achilles, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993, 877–287–1373, email:
ctpregulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
FDA is announcing a public meeting
to improve public understanding and
provide FDA feedback on the policies
and processes for submitting and
reviewing tobacco product marketing
applications, including the general
scientific principles relevant to various
application pathways, to assist those
considering submitting marketing
applications for tobacco products under
the FD&C Act. FDA will present
information about the tobacco product
application review programs, including
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
process improvements and observations
that may inform further improvements
in submissions and review processes.
The meeting will include panels of FDA
representatives, regulated industry
representatives, and other stakeholders,
and FDA will seek feedback from the
public. This meeting is not intended to
communicate any new policies or
interpretations regarding tobacco
product marketing applications and
their review.
FDA expects that parties interested in
attending this meeting include, but are
not limited to, tobacco product
manufacturers, including small business
tobacco manufacturers, importers,
distributors, wholesalers, and retailers;
scientific and medical experts; Federal,
State, and local government Agencies;
and other interested stakeholders, such
as academic researchers and public
health organizations.
In addition to the public meeting,
FDA is opening a docket as another
mechanism to receive feedback on the
tobacco product application review
process. Timely comments are
appreciated to help inform FDA’s efforts
to continue to build an efficient product
review program. FDA is open to
receiving feedback and comments on all
aspects of the product review process
and is requesting specific comment on
the following topics:
• Achieving greater efficiencies in
review while continuing to protect
public health
Æ Improving application content
Æ Streamlining review processes
Æ Refining electronic submission
systems
• Reviewing applications for products
that are rendered ‘‘new’’ due to
changes made to comply with a
product standard
• Facilitating applicant consultation
with FDA prior to submitting
applications
Æ Types of questions that would
benefit from FDA feedback
Æ Meeting request and package
content
Æ Process from meeting request
through post-meeting minutes
• Transparent review process
Æ Aspects that are highly transparent
Æ Aspects that are not highly
transparent
Æ Approaches to increase
transparency
• Clarity and utility of information
provided by FDA to applicants
Æ Means of communicating
information to applicants
Æ Information that is most useful to
applicants
Æ Timeliness of communication
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48629
II. Topics for Discussion at the Public
Meeting
Topics to be addressed in the meeting
include:
• An overview of the tobacco product
marketing application types, including
Substantial Equivalence Reports,
Substantial Equivalence Exemption
Requests, Premarket Tobacco Product
Applications, and Modified Risk
Tobacco Product Applications;
• Information required and that FDA
recommends be included in a tobacco
product marketing application;
• Administrative processes involved
in the submission and review of a
tobacco product marketing application;
and
• Other topics relevant to tobacco
product marketing applications,
including tobacco product master files,
meeting requests, grandfathered tobacco
product review, and environmental
assessments.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please submit electronic
registration requests at https://
www.surveymonkey.com/r/FDACTP
Tobacco_Product_Application_Meeting.
Requests for registration must include
the prospective attendee’s name, title,
affiliation, and contact information.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting should
register by 11:59 p.m. Eastern Time on
October 5, 2018. 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. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. If registration
reaches maximum capacity, FDA will
post a notice closing registration at
https://www.fda.gov/TobaccoProducts/
NewsEvents/default.htm.
If you need special accommodations
because of disability, please email
Workshop.CTPOS@fda.hhs.gov or call
1–877–287–1373 (Option 5) at least 7
days before the meeting.
Streaming Webcast of the Public
Meeting: There will be a webcast for this
public meeting. If you would like to
attend the meeting via webcast, please
submit electronic requests to register at
https://www.surveymonkey.com/r/
FDACTPTobacco_Product_Application_
Meeting. Requests for registration must
include the prospective attendee’s
name, title, affiliation, and contact
information.
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48630
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
Archived Webcast and Transcripts:
Please be advised that FDA will post the
webcast along with complete transcripts
on the internet at https://www.fda.gov/
TobaccoProducts/NewsEvents/
default.htm as soon as they are
available.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20904 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4317]
Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities.’’ Specifically, this guidance
sets forth FDA’s policy regarding
compounding and repackaging of
radiopharmaceuticals for human use by
entities that are registered with FDA as
outsourcing facilities. This guidance
describes how FDA generally intends to
apply section 503B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to
radiopharmaceuticals compounded by
outsourcing facilities, and it describes
the conditions under which FDA
generally does not intend to take action
for violations of certain provisions of
the FD&C Act when an outsourcing
facility repackages
radiopharmaceuticals.
DATES: The announcement of the
guidance is published in the Federal
Register on September 26, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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://
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
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–
2016–D–4317 for ‘‘Compounding and
Repackaging of Radiopharmaceuticals
by Outsourcing Facilities.’’ 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Silver Spring, MD, 301–
796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing
Facilities; Guidance for Industry.’’ In
2013, the Drug Quality and Security Act
created a new section, 503B, of the
FD&C Act (21 U.S.C. 353b), which
describes a new category of
compounders called outsourcing
facilities. Section 503B of the FD&C Act
describes the conditions that must be
satisfied for human drug products
compounded by or under the direct
supervision of a licensed pharmacist in
E:\FR\FM\26SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48628-48630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3504]
Tobacco Product Application Review; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Tobacco Product Application Review.'' This meeting
is intended to improve public understanding and provide FDA feedback on
the policies and processes for submitting and reviewing tobacco product
marketing applications, including the general scientific principles
relevant to various application pathways, to assist those considering
submitting marketing applications for tobacco products under the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: The 2-day public meeting will be held on October 22, 2018, from
8:30 a.m. to 4:30 p.m. and on October 23, 2018, from 8:30 a.m. to 3
p.m. Submit either electronic or written comments on this public
meeting by December 7, 2018. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike,
Rockville, MD 20852, https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/.
You may submit comments as follows. Please note that late, untimely
filed comments may not be considered. The https://www.regulations.gov
electronic filing system will accept electronic comments until 11:59
p.m. Eastern Time on December 7, 2018. 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 December 7, 2018.
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-3504 for ``Tobacco Product Application Review.'' Received
comments, 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
[[Page 48629]]
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: Darin Achilles, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877-
287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public meeting to improve public understanding
and provide FDA feedback on the policies and processes for submitting
and reviewing tobacco product marketing applications, including the
general scientific principles relevant to various application pathways,
to assist those considering submitting marketing applications for
tobacco products under the FD&C Act. FDA will present information about
the tobacco product application review programs, including process
improvements and observations that may inform further improvements in
submissions and review processes. The meeting will include panels of
FDA representatives, regulated industry representatives, and other
stakeholders, and FDA will seek feedback from the public. This meeting
is not intended to communicate any new policies or interpretations
regarding tobacco product marketing applications and their review.
FDA expects that parties interested in attending this meeting
include, but are not limited to, tobacco product manufacturers,
including small business tobacco manufacturers, importers,
distributors, wholesalers, and retailers; scientific and medical
experts; Federal, State, and local government Agencies; and other
interested stakeholders, such as academic researchers and public health
organizations.
In addition to the public meeting, FDA is opening a docket as
another mechanism to receive feedback on the tobacco product
application review process. Timely comments are appreciated to help
inform FDA's efforts to continue to build an efficient product review
program. FDA is open to receiving feedback and comments on all aspects
of the product review process and is requesting specific comment on the
following topics:
Achieving greater efficiencies in review while continuing to
protect public health
[cir] Improving application content
[cir] Streamlining review processes
[cir] Refining electronic submission systems
Reviewing applications for products that are rendered ``new''
due to changes made to comply with a product standard
Facilitating applicant consultation with FDA prior to
submitting applications
[cir] Types of questions that would benefit from FDA feedback
[cir] Meeting request and package content
[cir] Process from meeting request through post-meeting minutes
Transparent review process
[cir] Aspects that are highly transparent
[cir] Aspects that are not highly transparent
[cir] Approaches to increase transparency
Clarity and utility of information provided by FDA to
applicants
[cir] Means of communicating information to applicants
[cir] Information that is most useful to applicants
[cir] Timeliness of communication
II. Topics for Discussion at the Public Meeting
Topics to be addressed in the meeting include:
An overview of the tobacco product marketing application
types, including Substantial Equivalence Reports, Substantial
Equivalence Exemption Requests, Premarket Tobacco Product Applications,
and Modified Risk Tobacco Product Applications;
Information required and that FDA recommends be included
in a tobacco product marketing application;
Administrative processes involved in the submission and
review of a tobacco product marketing application; and
Other topics relevant to tobacco product marketing
applications, including tobacco product master files, meeting requests,
grandfathered tobacco product review, and environmental assessments.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please submit
electronic registration requests at https://www.surveymonkey.com/r/FDACTPTobacco_Product_Application_Meeting. Requests for registration
must include the prospective attendee's name, title, affiliation, and
contact information.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting should register by 11:59 p.m. Eastern Time on October 5, 2018.
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. If time and space permit, onsite registration on the day of
the public meeting will be provided beginning at 8 a.m. If registration
reaches maximum capacity, FDA will post a notice closing registration
at https://www.fda.gov/TobaccoProducts/NewsEvents/default.htm.
If you need special accommodations because of disability, please
email [email protected] or call 1-877-287-1373 (Option 5) at
least 7 days before the meeting.
Streaming Webcast of the Public Meeting: There will be a webcast
for this public meeting. If you would like to attend the meeting via
webcast, please submit electronic requests to register at https://www.surveymonkey.com/r/FDACTPTobacco_Product_Application_Meeting.
Requests for registration must include the prospective attendee's name,
title, affiliation, and contact information.
[[Page 48630]]
Archived Webcast and Transcripts: Please be advised that FDA will
post the webcast along with complete transcripts on the internet at
https://www.fda.gov/TobaccoProducts/NewsEvents/default.htm as soon as
they are available.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20904 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P
