[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Rules and Regulations]
[Pages 77019-77023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21231]


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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: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a direct final rule amending the Scope section of our 
regulation that provides for a regulatory hearing before the Agency in 
order to clarify when such hearings are available. We are revising the 
list of statutory provisions enumerated in the Scope section of the 
regulation by adding one statutory reference and removing a different 
statutory reference. The Agency is issuing these amendments directly as 
a final rule because we believe they are noncontroversial and FDA 
anticipates no significant adverse comments.

DATES: This rule is effective February 3, 2025. Either electronic or 
written comments on the direct final rule or its companion proposed 
rule must be submitted by December 4, 2024. If FDA receives no 
significant adverse comments within the specified comment period, the 
Agency intends to publish a document confirming the effective date of 
the final rule in the

[[Page 77020]]

Federal Register within 30 days after the comment period on this direct 
final rule ends. If timely significant adverse comments are received, 
the Agency will publish a document in the Federal Register withdrawing 
this direct final rule within 30 days after the comment period on this 
direct final rule ends.

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 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 Direct Final Rule
    B. Summary of the Major Provisions of the Direct Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Direct Final Rulemaking Procedures
III. Background
IV. Legal Authority
V. Description of the Direct Final Rule
VI. 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 Direct Final Rule

    FDA is issuing this direct final rule 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. This rule revises 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 rulemaking, we are using 
direct final rulemaking procedures, as described in this document.

B. Summary of the Major Provisions of the Direct Final Rule

    The direct final rule revises 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 rule amends the list 
of statutory provisions enumerated in Sec.  16.1. Specifically, the 
rule removes the reference to section 906(e)(1)(B) of the Federal Food, 
Drug, & Cosmetic Act (FD&C Act) (21 U.S.C. 387f(e)(1)(B)) (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

[[Page 77021]]

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

    This direct final rule clarifies 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 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.

II. Direct Final Rulemaking Procedures

    In the document titled ``Guidance for FDA and Industry: Direct 
Final Rule Procedures,'' announced and provided in the Federal Register 
of November 21, 1997 (62 FR 62466), FDA described its procedures on 
when and how we will employ direct final rulemaking. The guidance may 
be accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. We have determined that this rule is appropriate for 
direct final rulemaking because we believe that it includes only 
noncontroversial amendments and we anticipate no significant adverse 
comments. Consistent with our procedures on direct final rulemaking, 
FDA is also publishing elsewhere in this issue of the Federal Register 
a companion proposed rule to clarify when the Agency intends to use the 
procedures under the regulation for regulatory hearings before the Food 
and Drug Administration. The companion proposed rule provides a 
procedural framework within which the rule may be finalized in the 
event that the direct final rule is withdrawn because of any 
significant adverse comments. The comment period for the direct final 
rule runs concurrently with the comment period for the companion 
proposed rule. Any comments received in response to the companion 
proposed rule will be considered as comments regarding the direct final 
rule.
    We are providing a comment period on the direct final rule of 75 
days after the date of publication in the Federal Register. If we 
receive any significant adverse comments, we intend to withdraw this 
direct final rule before its effective date by publication of a notice 
in the Federal Register. 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 this 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 part of this 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 subject to the significant 
adverse comment.
    If any significant adverse comments are received during the comment 
period, FDA will publish, before the effective date of this direct 
final rule, a notice of significant adverse comment and withdraw the 
direct final rule. If we withdraw the direct final rule, any comments 
received will be applied to the proposed rule and will be considered in 
developing a final rule using the usual notice-and-comment procedures.
    If FDA receives no significant adverse comments during the 
specified comment period, FDA intends to publish a document confirming 
the effective date within 30 days after the comment period ends.

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) included 
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) of the FD&C Act is to allow the public to provide 
viewpoints, opinions, and information on proposed TPMP rules. The 
procedures under part 16 are not in alignment 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 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 did not previously 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 amending Sec.  16.1 to clarify when it intends to use the 
procedures in part 16 for regulatory hearings. The amended rule is more 
consistent with the statute as it aligns the purposes of the two 
hearings referenced above with more appropriate hearing procedures

[[Page 77022]]

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 Direct Final Rule

    We are revising 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 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 amended rule clarifies 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. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review 
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, 
Pub. L. 104-121), 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 final rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    Because this rule is not likely to result in an annual effect on 
the economy of $100 million or more or meets other criteria specified 
in the Congressional Review Act/Small Business Regulatory Enforcement 
Fairness Act, OIRA has determined that this rule does not fall within 
the scope of 5 U.S.C. 804(2).
    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 certify that the final 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 issuing ``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 final rule will not result in an 
expenditure in any year that meets or exceeds this amount.
    This rule clarifies 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

    This direct final 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 direct final rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this direct final 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 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 direct final rule in accordance with the 
principles set forth in Executive Order 13175. We have determined that 
the rule does not contain policies that have substantial direct effects 
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. 
Accordingly, we conclude that the rule does not contain policies that 
have tribal implications as defined in the Executive Order and, 
consequently, a tribal summary impact statement is not required.

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, 21 CFR part 
16 is amended as follows:

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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. 2024-21231 Filed 9-19-24; 8:45 am]
BILLING CODE 4164-01-P