Proposed Rule2023-04593
Proposed Requirements for Tobacco Products Manufacturing Practice; Tobacco Products Scientific Advisory Committee; Notice of Meeting; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 47 (Friday, March 10, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://fda.zoomgov.com/j/1600966352?pwd=bmRrRlp1MlUrdWVmR095KzN3eWV1UT09">https://fda.zoomgov.com/j/1600966352?pwd=bmRrRlp1MlUrdWVmR095KzN3eWV1UT09</a>; Passcode: Y=Sw4a.
Answers to commonly asked questions including information regarding
special accommodations due to disability, visitor parking, and
transportation may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Eastern Time, Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#306460637173705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="144044475557547270753a7c7c673a737b62">[email protected]</span></a>; 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a> 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
<a href="/cdn-cgi/l/email-protection#492f2d28262428092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="452321242a2824052321246b2d2d366b222a33">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#9bcfcbc8dad8dbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="90c4c0c3d1d3d0f6f4f1bef8f8e3bef7ffe6">[email protected]</span></a> (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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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
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