Proposed Rule2023-04592
Proposed Requirements for Tobacco Product Manufacturing Practice; Public Hearing; 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
Effective
April 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral hearing entitled "Proposed Requirements for Tobacco Product Manufacturing Practice." The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue of the Federal Register. The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. We are holding this public oral hearing to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 47 (Friday, March 10, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 14962-14963]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04592]
[[Page 14962]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1120
[Docket No. FDA-2013-N-0227]
Proposed Requirements for Tobacco Product Manufacturing Practice;
Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public oral hearing entitled ``Proposed Requirements for
Tobacco Product Manufacturing Practice.'' The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good
manufacturing practice (cGMP) or hazard analysis and critical control
point methodology (HACCP) regulations related to the manufacture,
preproduction design validation, packing, and storage of tobacco
products to protect public health and ensure compliance with the FD&C
Act. In accordance with this provision, FDA is proposing requirements
for tobacco product manufacturing practice (TPMP) elsewhere in this
issue of the Federal Register. The FD&C Act further requires FDA to
afford an opportunity for an oral hearing on the proposed regulation.
We are holding this public oral hearing to carry out this statutory
mandate and obtain information and views on the proposed TPMP
requirements.
DATES: The public oral hearing will be held virtually on April 12,
2023, from 9:30 a.m. to 5 p.m. Eastern Time. All written notices of
participation must be received by March 31, 2023 (email written notices
of participation to: <a href="/cdn-cgi/l/email-protection#733027231c0607011612101b331517125d1b1b005d141c05"><span class="__cf_email__" data-cfemail="17544347786263657276747f57717376397f7f6439707861">[email protected]</span></a>). Either electronic or
written comments on this public hearing must be submitted by September
6, 2023. See the SUPPLEMENTARY INFORMATION section for registration
date and information. 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.
ADDRESSES: This public oral hearing will be held via an online
teleconferencing platform. Additional details, such as the time of the
public oral hearing and registration information, will be posted at
<a href="https://www.fda.gov/tobacco-products">https://www.fda.gov/tobacco-products</a>. The online web conference meeting
link can be accessed at <a href="https://www.fda.gov/tobacco-products">https://www.fda.gov/tobacco-products</a> on the day
of the meeting.
All written notices of participation must be received by March 31,
2023 (email to: <a href="/cdn-cgi/l/email-protection#b1f2e5e1dec4c5c3d4d0d2d9f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="8bc8dfdbe4fefff9eeeae8e3cbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>). You may submit comments as
follows. Please note that late, untimely filed comments will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
September 6, 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.
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 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 for ``Proposed Requirements for Tobacco Product
Manufacturing Practices; Notice of Public Hearing; Request for
Comments.'' 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 <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., 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 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 <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 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: <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: Necola Staples or Robert Schwartz,
Center for Tobacco Products, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373,
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="aeedfafee1dbdadccbcfcdc6eec8cacf80c6c6dd80c9c1d8">[email protected]</a> or <a href="/cdn-cgi/l/email-protection#581b0c080a3d3f2d34392c3137362b183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="0a495e5a586f6d7f666b7e636564794a6c6e6b24626279246d657c">[email protected]</span></a>.
[[Page 14963]]
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA issued a
proposed regulation on TPMP requirements (TPMP proposed rule). As
described in the TPMP proposed rule, section 906(e) of the FD&C Act (21
U.S.C. 387f(e)) authorizes FDA to establish regulations requiring that
the methods used in, and the facilities and controls used for, the
manufacture, preproduction design validation (including a process to
assess the performance of a tobacco product), packing, and storage of a
tobacco product conform to cGMP or HACCP methodology. The TPMP proposed
rule (proposed 21 CFR part 1120), if finalized, would set forth the
requirements with which finished and bulk tobacco product manufacturers
must comply in the manufacture, preproduction design validation,
packing, and storage of finished and bulk tobacco products. These
requirements, if finalized, will help protect the public health by
ensuring that tobacco products are manufactured in facilities that meet
basic requirements for manufacturing, packing, and storing tobacco
products and are in compliance with chapter IX of the FD&C Act (21
U.S.C. 387 through 387u).
Section 906(e)(1)(B)(ii) of the FD&C Act requires FDA, before
issuing a final TPMP regulation, to provide the public the opportunity
for an oral hearing. To satisfy this requirement, FDA is holding this
public oral hearing pursuant to part 15 (21 CFR part 15) to provide the
opportunity for the public to present information and views on the
proposed requirements.
II. Notice of Hearing Under Part 15
To satisfy the statutory requirement under section 906(e)(1)(B)(ii)
of the FD&C Act, FDA will hold a public oral hearing consistent with
part 15. The hearing will be conducted by a presiding officer, who will
be accompanied by FDA panelists, including subject matter experts from
the Center for Tobacco Products. As provided in Sec. 15.30(f) (21 CFR
15.30(f)), the hearing is informal and the rules of evidence do not
apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR
10.205, representatives of the media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as provided in Sec.
15.30(b) (see also Transcripts). To the extent that the conditions for
the hearing, as described in this notice, conflict with any provisions
set out in part 15, this notice acts as a waiver of those provisions as
specified in Sec. 15.30(h).
III. Topics for Discussion at the Public Oral Hearing
FDA is interested in the public's views, information, and any
supporting data on the TPMP proposed rule, including the following
topics:
<bullet> The proposed scope of the regulation to cover finished and
bulk tobacco product manufacturers, including specification developers.
<bullet> Potential changes to the scope of the regulation, such as
expanding the scope to cover manufacturers of all regulated tobacco
products, including all components or parts, or limiting the scope to
cover only manufacturers of certain products.
<bullet> FDA's proposed ``umbrella'' approach with flexible
requirements to all affected entities as opposed to applying only
specific or additional requirements for certain types of tobacco
products.
<bullet> Product specifications in the Master Manufacturing Record
(MMR). The proposed approach for the MMR would include any requirement
established by the manufacturer as well as, at a minimum, certain
specifications related to product content, design, and any applicable
product standards.
<bullet> Design and development activities needed to control the
risks associated with finished and bulk tobacco product and its
production processes, packing, and storage. The proposed risk
management process would include the risk treatment requirements
intended to help prevent the manufacture and distribution of
nonconforming and/or contaminated tobacco product.
<bullet> The proposed effective date--2 years for manufacturers
(other than small tobacco product manufacturers) and a total of 6 years
for small tobacco product manufacturers--for complying with any TPMP
regulations.
IV. Participating in the Public Oral Hearing
Registration: To register to attend the free public oral hearing,
please visit the following website: <a href="https://www.fda.gov/tobacco-products">https://www.fda.gov/tobacco-products</a>. Registration information will be posted soon. Live closed
captioning will be provided during the public oral hearing. Additional
information on requests for special accommodations due to a disability
will be provided during registration.
Written Notice of Participation: During online registration you may
indicate if you wish to present information and views at the hearing
(oral statements without slides). FDA will do its best to accommodate
requests to make public presentations. Individuals and organizations
with common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin and will notify participants ahead of the hearing. All written
notices of participation must be received by March 31, 2023, 11:59 p.m.
Eastern Time (email to: <a href="/cdn-cgi/l/email-protection#cc8f989ca3b9b8bea9adafa48caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="307364605f45444255515358705654511e5858431e575f46">[email protected]</span></a>). No commercial or
promotional material will be permitted to be presented or distributed
at the public oral hearing.
Transcripts: Please be advised that as soon as a transcript of the
public oral hearing is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Once available, the transcript may be viewed at
the Dockets Management Staff (see ADDRESSES). A link to the transcript
will also be available on the internet at <a href="https://www.fda.gov/tobacco-products">https://www.fda.gov/tobacco-products</a>.
Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04592 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 10, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.