[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 14960-14961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 14 and 1120

[Docket No. FDA-2013-N-0227]


Proposed Requirements for Tobacco Products Manufacturing 
Practice; Tobacco Products Scientific Advisory Committee; Notice of 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Tobacco Products Scientific 
Advisory Committee (TPSAC). The general function of the committee is to 
provide advice and recommendations to FDA on regulatory issues related 
to tobacco products. This meeting will be held to discuss and provide 
an opportunity for recommendations on the Requirements for Tobacco 
Product Manufacturing Practice (TPMP) proposed rule. The meeting will 
be open to the public.

DATES: The meeting will be held on May 18, 2023, from 9 a.m. to 2 p.m. 
Eastern Time.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room, Silver Spring, MD 20993-0002. For 
those unable to attend in person, the meeting will also be webcast and 
will be available at the following link: https://fda.zoomgov.com/j/1600966352?pwd=bmRrRlp1MlUrdWVmR095KzN3eWV1UT09; Passcode: Y=Sw4a. 
Answers to commonly asked questions including information regarding 
special accommodations due to disability, visitor parking, and 
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA has established a docket for public comment (Docket No. FDA-
2013-N-0227). Please note that late, untimely filed comments will not 
be considered by the committee. Either electronic or written comments 
on this public advisory committee meeting must be submitted by May 11, 
2023, for consideration by the committee. The https://www.regulations.gov electronic filing system will accept comments on 
this public advisory committee meeting until 11:59 p.m. Eastern Time at 
the end of May 11, 2023. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if 
they are received on or before that date.
    Comments received on or before May 11, 2023, will be provided to 
the committee and become part of the docket. Comments received after 
May 11, 2023, and prior to September 6, 2023, will also become part of 
the docket, but will not be considered by the committee. In the event 
that the meeting is canceled, FDA will continue to evaluate any 
relevant information and consider any comments submitted to the docket 
for the TPSAC meeting, as appropriate. FDA also reminds the public that 
commenters may submit either electronic or written comments on the 
proposed rule published elsewhere in this issue of the Federal Register 
by September 6, 2023.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

[[Page 14961]]

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-2013-N-0227 and ``Proposed Requirements for Tobacco Products 
Manufacturing Practice; Tobacco Products Scientific Advisory Committee; 
Notice of Meeting; Request for Comments.''
    Comments on this public advisory committee meeting (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., Eastern Time, Monday through Friday, 240-402-7500.
     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 identify as confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 the 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for 
Tobacco Products, Food and Drug Administration, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 1-877-287-1373, [email protected]; or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On May 18, 2023, the committee will meet in open session to 
discuss and provide recommendations on the TPMP proposed rule (proposed 
21 CFR part 1120), published elsewhere in this issue of the Federal 
Register.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the time of the 
advisory committee meeting, and the background material will be posted 
on FDA's website after the meeting. Background material will be 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm and can be accessed by scrolling down to the appropriate 
advisory committee meeting link.
    Procedure: On May 18, 2023, from 9 a.m. to 2 p.m. Eastern Time, the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. All electronic and written submissions submitted to the 
Docket (see ADDRESSES) on or before May 11, 2023, will be provided to 
the committee. In the event that the meeting is canceled, FDA will 
continue to evaluate any relevant information and consider any comments 
submitted to the docket for the TPSAC meeting, as appropriate. FDA also 
reminds the public that commenters may submit either electronic or 
written comments on the proposed rule by September 6, 2023.
    Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. to 10:30 a.m. Eastern Time. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, along with their names, 
email addresses, and direct contact phone numbers of proposed 
participants, on or before 12 p.m. Eastern Time on May 3, 2023. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by 6 p.m., May 4, 2023.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Serina Hunter-Thomas at [email protected] (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04593 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P