[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Proposed Rules]
[Pages 77058-77061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21232]



[[Page 77058]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 16

[Docket No. FDA-2024-N-3654]
RIN 0910-AI97


Regulatory Hearing Before the Food and Drug Administration; 
General Provisions; Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend the Scope section of our regulation that provides 
for a regulatory hearing before the Agency to clarify when such 
hearings are available. We are proposing to revise the list of 
statutory provisions enumerated in the Scope section of the regulation 
by removing one statutory reference and adding a different statutory 
reference.

DATES: Either electronic or written comments on the proposed rule or 
its companion direct final rule must be submitted by December 4, 2024. 
If FDA receives any timely significant adverse comments on the direct 
final rule with which this proposed rule is associated, we will publish 
a document withdrawing the direct final rule within 30 days after the 
comment period ends, and we will then proceed to respond to comments 
under this proposed rule using the usual notice and comment procedures.

ADDRESSES: 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 December 4, 2024. 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-2024-N-3654 for ``Regulatory Hearing Before the Food and Drug 
Administration; General Provisions; Amendments.'' 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, the 
plain language summary of the proposed rule of not more than 100 words 
as required by the ``Providing Accountability Through Transparency 
Act,'' 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: 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].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Companion Document to Direct Final Rulemaking
III. Background
IV. Legal Authority
V. Description of the Proposed Rule
VI. Preliminary Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments

I. Executive Summary

A. Purpose of the Proposed Rule

    We are proposing to amend Sec.  16.1 (21 CFR 16.1) to revise the 
list of statutory provisions enumerated in the Scope section of the 
regulation and thus clarify the circumstances under which the Agency 
intends to use the procedures in part 16 (21 CFR part 16) for 
regulatory hearings. We are also issuing a direct

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final rule revising the list in Sec.  16.1 by removing one statutory 
reference and adding a different statutory reference under the same 
section of the same statute. Because we believe the rule contains 
noncontroversial changes and we do not expect significant adverse 
comment on the direct final rule, we are using direct final rulemaking 
procedures, as described in this document.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule, if finalized, would revise Sec.  16.1, Scope, in 
order to clarify the circumstances under which the Agency intends to 
use the procedures in part 16 for regulatory hearings. The proposed 
rule amends the list of statutory provisions enumerated in Sec.  16.1. 
Specifically, the proposed rule removes the reference to section 
906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
387f(e)(1)(B) (FD&C Act) (the statutory provision that requires FDA to 
afford an opportunity for an oral hearing prior to promulgating a 
tobacco product manufacturing practice (TPMP) requirements regulation) 
and adds a reference to section 906(e)(2)(E) of the FD&C Act (the 
statutory provision that provides a petitioner an opportunity for an 
informal hearing on an order issued on the petitioner's request for 
temporary or permanent exemption or variance from TPMP requirements).

C. Legal Authority

    FDA is issuing this rule under provisions of the FD&C Act related 
to regulations and hearings (21 U.S.C. 371), and general provisions 
respecting control of tobacco products (21 U.S.C. 387f(e)).

D. Costs and Benefits

    If finalized, this proposed rule would clarify the circumstances 
under which the Agency intends to use the procedures in part 16 for a 
regulatory hearing. Potentially affected entities would include 
manufacturers of finished and bulk tobacco products who choose to 
request an exemption or variance from TPMP requirements and are 
afforded an opportunity for a hearing on orders regarding such 
requests. Because this rule would merely clarify which of its existing 
procedures FDA intends to use when conducting certain types of hearings 
under the FD&C Act, costs and benefits of this rule are expected to be 
minimal.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published in the rule section in this issue of the Federal Register. 
This companion proposed rule provides the procedural framework to 
finalize the rule in the event the direct final rule receives any 
significant adverse comment and is withdrawn. The comment period for 
this companion proposed rule runs concurrently with the comment period 
for the direct final rule. Any comments received in response to this 
companion proposed rule will also be considered as comments regarding 
the direct final rule. FDA is publishing the direct final rule because 
we believe the rule contains noncontroversial changes and there is 
little likelihood that there will be significant adverse comments 
opposing the rule.
    A significant adverse comment is defined as a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without a change. In determining whether an adverse comment is 
significant and warrants terminating a direct final rulemaking, we will 
consider whether the comment raises an issue serious enough to warrant 
a substantive response in a notice-and comment process. Comments that 
are frivolous, insubstantial, or outside the scope of the rule will not 
be considered significant or adverse under this procedure. A comment 
recommending a regulation change in addition to those in the direct 
final rule would not be considered a significant adverse comment unless 
the comment states why the rule would be ineffective without the 
additional change. In addition, if a significant adverse comment 
applies to a part of the direct final rule and that part can be severed 
from the remainder of the rule, we may adopt as final those provisions 
of the rule that are not the subject of the significant adverse 
comment.
    If any significant adverse comments to the direct final rule are 
received during the comment period, FDA will publish, within 30 days 
after the comment period ends, a notice of significant adverse comment 
and withdraw the direct final rule. If we withdraw the direct final 
rule, any comments received will be considered comments on the proposed 
rule and will be considered in developing a final rule using the usual 
notice-and-comment procedure.
    If no significant adverse comment is received in response to the 
direct final rule during the comment period, no further action will be 
taken related to this proposed rule. Instead, we will publish a 
document confirming the effective date of the final rule within 30 days 
after the comment period ends. Additional information about direct 
final rulemaking procedures is set forth in the document entitled 
``Guidance for FDA and Industry: Direct Final Rule Procedures,'' 
announced and provided in the Federal Register of November 21, 1997 (62 
FR 62466). The guidance may be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

III. Background

    Part 16 provides procedures for regulatory hearings held before 
FDA. The procedures in part 16 apply, among other circumstances, when a 
statute or regulation provides a person an opportunity for a hearing on 
a regulatory action. In 2012, FDA amended part 16 \1\ to add several 
statutory and regulatory provisions throughout 21 CFR parts 1, 7, and 
16, to include reference to tobacco products, where appropriate, so 
that tobacco products would be subject to the same general requirements 
that apply to other FDA-regulated products. The 2012 amendments revised 
Sec.  16.1, which governs the scope of part 16, to include references 
to certain sections of the FD&C Act that provide an opportunity for a 
hearing. Among other changes, the 2012 amendments added a reference to 
section 906(e)(1)(B) of the FD&C Act to Sec.  16.1. This rule further 
amends Sec.  16.1, as described below.
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    \1\ ``Further Amendments to General Regulations of the Food and 
Drug Administration to Incorporate Tobacco Products,'' Food and Drug 
Administration, 77 FR 5171, February 2, 2012.
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    The Agency is amending the list of statutory provisions enumerated 
in Sec.  16.1(b)(1) by removing the reference to section 906(e)(1)(B) 
and adding a reference to section 906(e)(2)(E) of the FD&C Act. The 
list of statutory provisions enumerated in Sec.  16.1(b)(1) currently 
includes section 906(e)(1)(B) of the FD&C Act, which requires FDA to 
afford the public an opportunity for an oral hearing before issuing any 
TPMP requirements regulation. The purpose of an oral hearing under 
section 906(e)(1)(B) is to allow the public to provide viewpoints, 
opinions, and information on proposed TPMP rules. The procedures under 
part 16 are not aligned with the purpose and goals of the oral hearing 
required under section 906(e)(1)(B) of the FD&C Act. For example, part 
16 includes procedures to resolve a ``genuine and substantial issue

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of fact'' that is in dispute and the right to confront and cross-
examine witnesses, which are not well suited for allowing the public to 
provide viewpoints, opinions, and information to FDA regarding TPMP 
rules. Accordingly, FDA is removing the reference to section 
906(e)(1)(B) of the FD&C Act from part 16 as other available procedures 
are better suited to achieve its purposes.
    The Agency is also adding a reference to section 906(e)(2)(E) of 
the FD&C Act to Sec.  16.1(b)(1). Section 906(e)(2)(E) of the FD&C Act 
provides an opportunity for an informal hearing after the issuance of 
an order related to a petitioner's request for a temporary or permanent 
exemption or variance from TPMP requirements. The list of statutory 
provisions in Sec.  16.1(b)(1) that specifies the statutory and 
regulatory provisions under which regulatory hearings under part 16 are 
available does not currently include section 906(e)(2)(E) of the FD&C 
Act. FDA is adding this reference to clarify that it intends to use the 
procedures in part 16 when conducting such hearings.
    FDA is proposing to amend Sec.  16.1 to clarify when it intends to 
use the procedures in part 16 for regulatory hearings. If finalized, 
the amended rule would be more consistent with the statute by aligning 
the purposes of the two hearings referenced above with more appropriate 
hearing procedures under FDA's regulations. It also clarifies the 
availability of hearings under part 16 to tobacco product 
manufacturers.

IV. Legal Authority

    FDA is issuing this rule under provisions of the FD&C Act related 
to regulations and hearings (21 U.S.C. 371) and general provisions 
respecting control of tobacco products (21 U.S.C. 387f). Section 701 
(21 U.S.C. 371) vests FDA with ``the authority to promulgate 
regulations for the efficient enforcement of [the FD&C Act].'' Section 
906(e) of the FD&C Act includes provisions regarding TPMP requirements 
regulations, and temporary and permanent exemptions and variances from 
TPMP requirements.

V. Description of the Proposed Rule

    We are proposing to revise Sec.  16.1, Scope, to remove a reference 
to ``Section 906(e)(1)(B) of the FD&C Act relating to the establishment 
of good manufacturing practice requirements for tobacco products'' and 
to add a reference to ``Section 906(e)(2)(E) of the FD&C Act relating 
to exemptions or variances from tobacco product manufacturing practice 
requirements.'' The proposed rule would clarify the availability of the 
procedures in part 16 for regulatory hearings to include situations 
when a petitioner has requested a temporary or permanent exemption or 
variance from TPMP requirements.

VI. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866 
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of [the Office of Information and Regulatory 
Affairs (OIRA)] for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local territorial, or tribal governments or 
communities.'' OIRA has determined that this proposed rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule merely clarifies which of its existing 
procedures FDA intends to use when conducting certain types of hearings 
under the FD&C Act, we propose to certify that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes estimates of 
anticipated impacts, before proposing ``any rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    If finalized, this proposed rule would clarify the procedures FDA 
intends to use when conducting certain types of hearings under the FD&C 
Act. When the TPMP rule becomes final and effective, potentially 
affected entities, including manufacturers of finished and bulk tobacco 
products, who choose to request an exemption or variance from TPMP 
requirements would be afforded an opportunity for a hearing on orders 
regarding such requests.
    We do not know how many manufacturers would pursue petitioning for 
an exemption or variance from TPMP requirements, once the Agency has 
published a final TPMP rule to establish such requirements and that 
rule is in effect, nor do we know how many requirements may be included 
in each petition. We reason that a manufacturer would petition for an 
exemption or variance from a TPMP requirement only if compliance with 
said requirement is not a financially viable choice compared to the 
cost of a filing a petition. Because this rule merely clarifies which 
of its existing procedures FDA intends to use when conducting certain 
types of hearings under the FD&C Act, costs and benefits of this rule 
are expected to be minimal.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism

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implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

List of Subjects in 21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 16 be amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for part 16 continues to read as follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. Amend Sec.  16.1 by revising paragraph (b)(1) to read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) The statutory provisions are as follows:

                       Table 1 to Paragraph (b)(1)
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Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to
 the administrative detention of devices and drugs (see Sec.  Sec.
 800.55(g) and 1.980(g) of this chapter).
Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to
 the administrative detention of food for human or animal consumption
 (see part 1, subpart K of this chapter).
Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act
 relating to the modification or revocation of a variance from the
 requirements of section 419 (see part 112, subpart P of this chapter).
Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating
 to the proposed withdrawal of approval of a device premarket approval
 application.
Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating
 to the temporary suspension of approval of a premarket approval
 application.
Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating
 to a proposed order revoking a device product development protocol or
 declaring a protocol not completed.
Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating
 to revocation of a notice of completion of a product development
 protocol.
Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a
 proposed regulation to ban a medical device with a special effective
 date.
Section 518(b) of the Federal Food, Drug, and Cosmetic Act relating to a
 determination that a device is subject to a repair, replacement, or
 refund order or that a correction plan, or revised correction plan,
 submitted by a manufacturer, importer, or distributor is inadequate.
Section 518(e) of the Federal Food, Drug, and Cosmetic Act relating to a
 cease distribution and notification order or mandatory recall order
 concerning a medical device for human use.
Section 520(f)(2)(D) of the Federal Food, Drug, and Cosmetic Act
 relating to exemptions or variances from device current good
 manufacturing practice requirements (see Sec.   820.1(d)).
Section 520(g)(4) and (g)(5) of the Federal Food, Drug, and Cosmetic Act
 relating to disapproval and withdrawal of approval of an application
 from an investigational device exemption (see Sec.  Sec.   812.19(c),
 812.30(c), 813.30(d), and 813.35(c) of this chapter).
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act
 relating to the misbranding of tobacco products.
Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act
 relating to exemptions or variances from tobacco product manufacturing
 practice requirements.
Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating
 to the withdrawal of an order allowing a new tobacco product to be
 introduced or delivered for introduction into interstate commerce.
Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to
 the withdrawal of an order allowing a modified risk tobacco product to
 be introduced or delivered for introduction into interstate commerce.
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* * * * *


Sec.  16.1  [Amended]

0
3. Effective December 18, 2025, in Sec.  16.1, amend paragraph (b)(2) 
by redesignating table 1 to paragraph (b)(2) as table 2 to paragraph 
(b)(2).

    Dated: September 6, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-21232 Filed 9-19-24; 8:45 am]
BILLING CODE 4164-01-P