[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 [www.gpo.gov]
[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: [email protected]). 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 
https://www.fda.gov/tobacco-products. The online web conference meeting 
link can be accessed at https://www.fda.gov/tobacco-products on the day 
of the meeting.
    All written notices of participation must be received by March 31, 
2023 (email to: [email protected]). You may submit comments as 
follows. Please note that late, untimely filed comments will not be 
considered. The https://www.regulations.gov 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., 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 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.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: 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, 
[email protected] or [email protected].

[[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:
     The proposed scope of the regulation to cover finished and 
bulk tobacco product manufacturers, including specification developers.
     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.
     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.
     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.
     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.
     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: https://www.fda.gov/tobacco-products. 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: [email protected]). 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 https://www.regulations.gov. 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 https://www.fda.gov/tobacco-products.

    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