[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]


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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.

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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/index.html.
    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


