Proposed Rule2024-21232
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
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Published
September 20, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 183 (Friday, September 20, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21232]
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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 <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 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:
<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-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 <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, 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
<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: 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#12514642407775677e73667b7d7c61527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="16554246447371637a77627f79786556707277387e7e6538717960">[email protected]</span></a>.
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
[[Page 77059]]
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: <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm">https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm</a>.
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
[[Page 77060]]
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
[[Page 77061]]
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
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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
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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.