Revisions of the Section 232 Steel and Aluminum Tariff Exclusions Process, 43740-43743 [2024-10725]
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Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Rules and Regulations
Impacts: Policies and Procedures,’’
paragraph 5–6.5a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant the preparation of an
environmental assessment.
Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Correction to the Final Rule
Accordingly, pursuant to the
authority delegated to me, the
amendment of Class D airspace for
Greenbrier Valley Airport, Lewisburg,
WV, in Docket No. FAA–2023–2275, as
published in the Federal Register of
April 8, 2024 (89 FR 24367), FR Doc.
2024–07245, in 14 CFR part 71, is
corrected as follows:
§ 71.1
[Corrected]
1. On page 24368, in the third column,
correct the description for AEA WV D
Lewisburg, WV [Amended] to read:
*
*
*
*
*
■
AEA WV D Lewisburg, WV [Amended]
Greenbrier Valley Airport, WV
(Lat. 37°51′30″ N, long. 80°23′58″ W)
That airspace extending upward from the
surface to and including 4,800 feet MSL
within a 4-mile radius of Greenbrier Valley
Airport. This Class D airspace area is
effective during the specific dates and times
established in advance by a Notice to Air
Missions. The effective date and time will
thereafter be published continuously in the
Chart Supplement.
Issued in College Park, Georgia, on May 15,
2024.
Patrick Young,
Manager, Airspace & Procedures Team North,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2024–10967 Filed 5–17–24; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 705
[Docket No. 240306–0071]
RIN 0694–AJ27
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Revisions of the Section 232 Steel and
Aluminum Tariff Exclusions Process
Bureau of Industry and
Security, U.S. Department of Commerce.
ACTION: Final rule.
AGENCY:
This final rule revises aspects
of the process for requesting exclusions
from the duties and quantitative
SUMMARY:
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limitations on imports of aluminum and
steel discussed in five previous Bureau
of Industry and Security (‘‘BIS’’) interim
final rules implementing the exclusion
process authorized by the President
under section 232 of the Trade
Expansion Act of 1962, as amended
(‘‘Section 232’’). The changes in this
final rule are also informed by public
comments on a proposed rule on the
Section 232 exclusions process that was
published by BIS on August 28, 2023
(August 2023 Proposed Rule), detailed
below. This final rule thus removes 12
General Approved Exclusions (GAEs)
that were added in the December 2020
rule and maintained through the
December 2021 rule, consisting of six
GAEs for steel and six GAEs for
aluminum.
DATES: This final rule is effective July 1,
2024.
FOR FURTHER INFORMATION CONTACT: For
questions regarding this interim final
rule, contact Kevin Coyne at 202–482–
2313 or via email Kevin.Coyne@
bis.doc.gov, or email Steel232@
bis.doc.gov regarding provisions in this
rule specific to steel exclusion requests
and Aluminum232@bis.doc.gov
regarding provisions in this rule specific
to aluminum exclusion requests.
SUPPLEMENTARY INFORMATION:
Background
On March 8, 2018, Proclamations
9704 and 9705 were issued imposing
duties on imports of aluminum and
steel, respectively. The Proclamations
also authorized the Secretary of
Commerce (‘‘the Secretary’’) to grant
exclusions from the duties if the
Secretary determines the steel or
aluminum article for which the
exclusion is requested is not ‘‘produced
in the United States in a sufficient and
reasonably available amount or of a
satisfactory quality’’ or should be
excluded ‘‘based upon specific national
security considerations,’’ and provided
authority for the Secretary to issue
procedures for exclusion requests. On
April 30, 2018, Proclamations 9739 and
9740, and on May 31, 2018,
Proclamations 9758 and 9759, set
quantitative limitations on the import of
steel and aluminum from certain
countries in lieu of the duties. On
August 29, 2018, in Proclamations 9776
and 9777, the Secretary was authorized
to grant exclusions from quantitative
limitations based on the same standards
applicable to exclusions from the tariffs.
Implementing and Improving the 232
Exclusions Process
Since March 19, 2018, Commerce has
published five interim final rules (IFRs)
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that established and made various
improvements to the Section 232
exclusions process, as well as a Notice
of Inquiry and a Proposed Rule seeking
public comment on certain aspects of
the Section 232 exclusions process.
On March 19, 2018, BIS issued an
IFR, Requirements for Submissions
Requesting Exclusions from the
Remedies Instituted in Presidential
Proclamations Adjusting Imports of
Steel into the United States and
Adjusting Imports of Aluminum into the
United States; and the Filing of
Objections to Submitted Exclusion
Requests for Steel and Aluminum (83
FR 12106), establishing the Section 232
exclusions process in supplements no. 1
and 2 to 15 CFR part 705.
On September 11, 2018, BIS issued a
second IFR, Submissions of Exclusion
Requests and Objections to Submitted
Requests for Steel and Aluminum (83
FR 46026), which revised the exclusions
process to increase transparency,
fairness, and efficiency.
On June 10, 2019, BIS issued a third
IFR, Implementation of New Commerce
Section 232 Exclusions Portal (84 FR
26751), that revised the two
supplements to part 705 to grant the
public the ability to submit new
exclusion requests through the Section
232 Exclusions Portal while still
allowing the opportunity for public
comment on the portal.
On May 26, 2020, BIS issued a notice
of inquiry with request for comment,
Notice of Inquiry Regarding the
Exclusions Process for Section 232 Steel
and Aluminum Import Tariffs and
Quotas (85 FR 31441), that sought
public comment on the appropriateness
of the information requested and
considered in applying the exclusion
criteria and the efficiency and
transparency of the process employed.
On December 14, 2020, BIS issued a
fourth IFR, Section 232 Steel and
Aluminum Tariff Exclusions Process (85
FR 81060) (4th IFR), which established
General Approved Exclusions (GAEs) to
reduce the number of exclusion requests
for products consistently found not to
be produced in the United States,
reducing the submission burden on both
industry and the Section 232 exclusions
process. The 4th IFR identified 123
GAEs that had generally never received
an objection or very few objections via
the Section 232 exclusions process.
GAEs are available to all would-be
requesters for steel and aluminum
products imported under 10-Digit
Harmonized Tariff Schedule of the
United States (HTSUS) classifications
without quantity limit or expiration
date. For information regarding the
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adoption of the GAE policy, please
review the 4th IFR.
On December 9, 2021, BIS
subsequently suspended 30 GAEs in its
fifth IFR, Removal of Certain General
Approved Exclusions Under the Section
232 Steel and Aluminum Tariff
Exclusion Process (86 FR 70003), on the
Section 232 Exclusions process because
they were determined by BIS to no
longer fit the criteria of a GAE.
On January 3, 2022, Presidential
Proclamations 10327 (87 FR 1) and
10328 (87 FR 11) were published. These
Proclamations implemented an
understanding reached between the
United States and the European Union
including the establishment of tariff rate
quotas for steel and aluminum articles
imported from the European Union
member countries. Proclamation 10328
also directed the Secretary of Commerce
to seek public comment on the Section
232 exclusions process, including the
responsiveness of the exclusions
process to market demand and
enhanced consultation with U.S. firms
and labor organizations.
On February 10, 2022, BIS published
Request for Public Comments on the
Section 232 Exclusions Process (87 FR
7777) (February 2022 Notice), as
directed by Presidential Proclamation
10328. The notice sought public
comment on a variety of topics
regarding the responsiveness of the
exclusions process to market demand
and enhanced consultation with U.S.
firms and labor organizations. The
notice comment period closed in March
2022, having received nearly 100
comments.
On August 28, 2023, BIS published its
proposed rule entitled Revisions of the
Section 232 Steel and Aluminum
Exclusions Process (88 FR 58525)
(August 2023 Proposed Rule). The rule
proposed several revisions to the
Section 232 exclusions process,
including adjustments to the current
criteria for identifying GAEs, the
introduction of new General Denied
Exclusions (GDEs), and the introduction
of new certification requirements for
both Requestors and Objectors.
Public Comments and BIS Responses
The public comment period on the
August 2023 Proposed Rule closed on
October 12, 2023. BIS received roughly
100 public comments on the proposed
rule. This is the first of at least two final
actions stemming from the August 2023
Proposed Rule. While BIS will further
analyze the comments received on the
August 2023 Proposed Rule, the public
comments described below provide a
sufficient basis for the action taken in
this final rule. This rule is a response to
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that issue alone. BIS will respond to
comments received on the August 2023
Proposed Rule in a forthcoming final
rule that details broader changes to the
Section 232 exclusions process.
Comment 1: BIS received multiple
comments regarding the efficacy of
specific GAEs. The majority of
commenters opposed the continuing use
of certain GAEs as thwarting the
objective of the Section 232 action,
including the ability to submit
objections to exclusion requests. One
commenter specifically said:
As a result of these GAEs, the vast volume
of aluminum extrusion imports exempt from
Section 232 tariffs . . . are once again able
to directly and unfairly compete with U.S.produced extrusions. This includes imports
. . . covered by the GAEs (HTSUS
7609.00.0000; 7604.21.0010; 7604.29.1010;
and 7604.29.5090) . . . By offering blanket
duty-free treatment to importers of these
products, the GAEs have effectively gutted
any relief the Section 232 could provide for
the extrusions industry.
BIS Response: GAEs addressed a longstanding request from exclusion
requesters to create a more efficient
process to approve certain exclusions
where Commerce has determined that:
(1) No objections will be received; and
(2) it is warranted to approve an
exclusion for all importers to use. As
always, BIS evaluates all changes to the
Section 232 exclusions process to
determine if they improve the efficiency
and effectiveness of the process, and
thus U.S. national security. It was clear
to BIS that an evaluation of the GAEs
was warranted. The initial review has
highlighted the need to remove
additional GAEs. Removing these GAEs
supports the effectiveness of the Section
232 tariffs and therefore U.S. national
security.
Regulatory Changes
With this final rule, BIS is removing
12 of the 93 GAEs from supplements no.
2 and no. 3 to part 705 (six from each
supplement). These GAEs were
introduced in the December 2020 rule
and maintained through the December
2021 rule. This final rule removes the
following 12 GAEs:
• 6 GAEs for steel: GAE.24.S:
7211296080; GAE.43.S: 7209900000;
GAE.46.S: 7216330090; GAE.84.S:
7209270000; GAE.90.S: 7216100010;
and GAE.93.S: 7208380015 and
• 6 GAEs for aluminum: GAE.1.A:
7609000000; GAE.4.A: 7604210010;
GAE.5.A: 7604291010; GAE.9.A:
7601209080; GAE.10.A: 7607116010;
and GAE.13.A: 7604295090.
The steel and aluminum articles
specified by these 12 GAEs will revert
to the duties and treatment previously
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established under Presidential
Proclamations 9704 and 9705 as well as
subsequent Proclamations.
BIS does not anticipate that
suspension of these 12 GAEs will
substantially increase the total volume
of submitted exclusion requests in the
Section 232 Exclusions Portal. BIS has
received 1,645 exclusion requests from
31 requestors for articles covered by
these 12 GAEs in the Section 232
Exclusions Portal over an approximate
eighteen-month period prior to the
December 2020 rule. BIS estimates that
the removal of these 12 GAEs will affect
roughly 30 requestors who submit
exclusion requests and will lead to the
submission of an additional 1,000
exclusion requests per year in the
Section 232 Exclusions Portal.
This final rule makes no additional
changes to the other 81 GAEs that will
continue to remain in supplements no.
2 and no. 3. As noted above, BIS made
the determination to remove these 12
GAEs based on public comments
received to the August 2023 Proposed
Rule that was bolstered by internal
analysis of exclusions data. It must be
noted that should analysis of these
GAEs change in the future, BIS may
reissue these GAEs in whole or in part
in subsequent rules.
Rulemaking Requirements
1. Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been determined to be a ‘‘significant
regulatory action,’’, under Executive
Order 12866. Pursuant to Proclamations
9704 and 9705 of March 8, 2018, and
Proclamations 9776 and 9777 of August
29, 2018, the establishment of
procedures for an exclusions process
under each Proclamation shall be
published in the Federal Register.
2. The Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.) (PRA)
provides that an agency generally
cannot conduct or sponsor a collection
of information, and no person is
required to respond to nor be subject to
a penalty for failure to comply with a
collection of information, unless that
collection has obtained Office of
Management and Budget (OMB)
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Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Rules and Regulations
approval and displays a currently valid
OMB Control Number.
This final regulation involves three
collections currently approved by OMB
with the following control numbers:
• Exclusions from the Section 232
National Security Adjustments of
Imports of Steel and Aluminum (control
number 0694–0139).
• Objections from the Section 232
National Security Adjustments of
Imports of Steel and Aluminum (control
number 0694–0138).
• Procedures for Submitting Rebuttals
and Surrebuttals Requests for
Exclusions from and Objections to the
Section 232 Adjustments for Steel and
Aluminum (OMB control number 0694–
0141).
This rule is expected to increase the
burden hours for one of the collections
associated with this rule, OMB control
number 0694–0139. This increase is
expected because of the removal of 6
GAEs for steel and 6 GAEs for
aluminum, which is expected to result
in an increase of 1,000 exclusion request
submissions per year. These GAE
removals are expected to increase the
burden hours for this collection by
4000, for a total cost increase of
$148,000 to the public. BIS submitted,
and OMB approved a non-substantive
change for an increase in 4000 burden
hours to the current 237,846. As BIS
asserted in the 4th IFR that the steel and
aluminum articles identified as being
eligible for GAEs, including those being
removed in today’s rule, had not
received any objections, the addition of
those new GAEs was not estimated to
result in a decrease in the number of
objections, rebuttals, or surrebuttals
received by BIS.
3. This rule does not contain policies
with Federalism implications as that
term is defined in Executive Order
13132.
4. The provisions of the
Administrative Procedure Act (5 U.S.C.
553) (APA) requiring notice of proposed
rulemaking, the opportunity for public
comment, and a delay in effective date
are inapplicable because this regulation
involves a military or foreign affairs
function of the United States. (See 5
U.S.C. 553(a)(1)). As explained in the
reports submitted by the Secretary to the
President, steel and aluminum are being
imported into the United States in such
quantities or under such circumstances
as to threaten to impair the national
security of the United States, and
therefore the President is implementing
these remedial actions (as described
Proclamations 9704 and 9705 of March
8, 2018) to protect U.S. national security
interests. That implementation includes
the creation of an effective process by
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which affected domestic parties can
obtain exclusion requests ‘‘based upon
specific national security
considerations.’’ BIS started this process
with the publication of the March 19
rule and refined the process with the
publication of the September 11, June
10, December 2020, and December 2021
rules and is continuing the process with
the publication of this final rule.
Commenters on the past rules (March
19, September 11, and June 10 rule,
December 2020, and December 2021)
were generally supportive and
welcomed the idea of creating an
exclusion process, but most of the
commenters believe the exclusion
process, although improving over time,
still could be significantly improved for
it to achieve the intended purpose. The
commenters identified several areas
where transparency, effectiveness, and
fairness of the process could be
improved. BIS understands the
importance of having a transparent, fair,
and efficient product exclusion request
process, consistent with the directive
provided by the President to create this
type of process to mitigate any
unintended consequences of imposing
the tariffs on steel and aluminum to
protect critical U.S. national security
interests. The revisions to the 232
exclusions process are informed by the
comments received in response to the
August 2023 Proposed Rule and BIS’s
experience with managing the 232
exclusions process.
Additionally, BIS finds that there is
good cause under 5 U.S.C. 553(d)(3) to
waive the delay in effective date; given
the delays would be either
impracticable or contrary to the public
interest because the actions are tied to
the effectiveness of the Section 232
tariffs and therefore U.S. national
security. The public comments on this
matter indicated that there was an
urgency to ensuring the changes are
implemented for the effectiveness of the
Section 232 process. Therefore, this
final rule will be effective upon
publication in the Federal Register.
Consistent with the Regulatory
Flexibility Act, as amended by the
Small Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA) (5 U.S.C.
601 et seq.), BIS has prepared the
following final regulatory flexibility
analysis (FRFA) of the impact that this
final rule will have on small businesses.
Description of the Reasons Why Action
Is Being Considered
The policy reasons for issuing this
final rule are discussed in the
background section of the preamble of
this document and, consequently, are
not repeated here.
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Statement of the Objectives of, and
Legal Basis for, the Proposed Rule;
Identification of All Relevant Federal
Rules Which May Duplicate, Overlap or
Conflict With the Proposed Rule
The objective of this final rule, and all
other Section 232-related rules
published by BIS, is discussed in the
background section of the preamble of
this document and, consequently, are
not repeated here. The legal basis for
this final rule is as follows: Section 232
of the Trade Expansion Act of 1962, as
amended (19 U.S.C. 1862) and Reorg.
Plan No. 3 of 1979 (44 FR 69273,
December 3, 1979).
No other Federal rules duplicate,
overlap, or conflict with this final rule.
Number and Description of Small
Entities Regulated by the Proposed
Action
This final rule would apply to all
persons engaged in the Section 232
exclusions process. BIS does not collect
or maintain the data necessary to
determine exactly how many of the
affected persons are small entities as
that term is used by the Small Business
Administration. However, BIS does ask
requestors of the Section 232 exclusions
process to self-identify if they are a
small business as defined by the Small
Business Administration. From this
data, BIS has estimated the total number
of requestors and objectors who are
likely to be small businesses that would
be impacted by changes identified in
this rule.
Roughly 380 requestors self-identified
as small businesses, filing roughly
27,000 exclusion requests in the Section
232 exclusions portal since March 2022,
when BIS began including the option for
requestors to self-identify as a small
business. BIS does not have the same
self-identification option for objectors.
However, over the same period of time,
roughly 100 objectors filed objections in
the Section 232 exclusions portal; many
of these are easily identifiable as being
large corporations, not small businesses.
Therefore, somewhere between 380 and
500 small businesses could be impacted
by these changes. Specific burden
estimates for OMB under control
numbers 0694–0139 (Exclusions from
the Section 232 National Security
Adjustments of Imports of Steel and
Aluminum), 0694–0138 (Objections
from the Section 232 National Security
Adjustments of Imports of Steel and
Aluminum), and 0694–0141 (Procedures
for Submitting Rebuttals and
Surrebuttals Requests for Exclusions
from and Objections to the Section 232
Adjustments for Steel and Aluminum)
are detailed in paragraph 2 of the
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Rulemaking Requirements section
above.
Based on the analysis provided above,
the revisions in this rule would not
impose a significant economic impact
on a substantial number of small
businesses.
Description of the Projected Reporting,
Recordkeeping, and Other Compliance
Requirements of the Proposed Rule
The changes in this rule and the
corresponding reporting, recordkeeping,
and other compliance requirements are
discussed in the background section of
the preamble of this document and,
consequently, are not repeated here. To
the extent that compliance with the
changes in this rule would impose a
burden on persons, including small
businesses, BIS believes the burden will
be minimal.
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Significant Alternatives and Underlying
Analysis
As noted above, BIS does not believe
that the revisions in this rule will have
a significant economic impact on small
businesses. Nevertheless, consistent
with 5 U.S.C. 603(c), BIS considered
significant alternatives to these
revisions to assess whether the
alternatives would: (1) accomplish the
stated objectives of this final rule
(consistent with the objectives of the
Section 232 exclusions process); and (2)
minimize any significant economic
impact of this final rule on small
entities. BIS has determined that
revisions detailed above are the least
disruptive alternative for implementing
changes to the Section 232 exclusions
process.
Lastly, consistent with 5 U.S.C.
603(c), BIS assessed the use of
performance standards rather than
design standards and also considered
whether an exemption for small
businesses was practical under the
circumstances (i.e., within the context
of the changes in this rule).
This final rule does not contain an
exemption for small businesses from the
Section 232 exclusions process changes
because these controls are essential to
U.S. national security and BIS’
regulations apply to all parties. An
exemption for small businesses would
undermine the effectiveness of these
revisions.
Conclusion
BIS has identified changes to the
Section 232 exclusions process.
Consequently, consistent with the
Regulatory Flexibility Act, BIS has
prepared this FRFA addressing the
impact that this final rule will have on
small entities. BIS’s assessment
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indicates that the amendments in this
rule will not have a significant
economic impact on a substantial
number of small entities.
Please submit any comments
concerning this FRFA in accordance
with the instructions provided in the
ADDRESSES section of this final rule.
List of Subjects in 15 CFR Part 705
Administrative practice and
procedure, Business and industry,
Classified information, Confidential
business information, Imports,
Investigations, National defense.
For the reasons set forth in the
preamble, part 705 of subchapter A of
15 CFR chapter VII is amended as
follows:
PART 705—EFFECT OF IMPORTED
ARTICLES ON THE NATIONAL
SECURITY
1. The authority citation for part 705
continues to read as follows:
■
Authority: Section 232 of the Trade
Expansion Act of 1962, as amended (19
U.S.C. 1862) and Reorg. Plan No. 3 of 1979
(44 FR 69273, December 3, 1979).
2. Supplement no. 2 to part 705 is
amended by removing the entries for
‘‘GAE.24.S: 7211296080;’’ ‘‘GAE.43.S:
7209900000;’’ ‘‘GAE.46.S: 7216330090;’’
‘‘GAE.84.S: 7209270000;’’ ‘‘GAE.90.S:
7216100010;’’ and ‘‘GAE.93.S:
7208380015’’.
■ 3. Supplement no. 3 to part 705 is
amended by removing the entries for
‘‘GAE.1.A: 7609000000;’’ ‘‘GAE.4.A:
7604210010;’’ ‘‘GAE.5.A: 7604291010;’’
‘‘GAE.9.A: 7601209080;’’ ‘‘GAE.10.A:
7607116010;’’ and ‘‘GAE.13.A:
7604295090’’.
■
Matthew S. Borman,
Principal Deputy Assistant Secretary for
Export Administration.
[FR Doc. 2024–10725 Filed 5–17–24; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA–2018–N–3074]
Ophthalmic Devices; Reclassification
of Ultrasound Cyclodestructive Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
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43743
we) is issuing a final order reclassifying
the ultrasound cyclodestructive device,
a postamendments class III device
(product code LZR), into class II (special
controls), subject to premarket
notification. FDA is also establishing
special controls that are necessary to
provide a reasonable assurance of safety
and effectiveness of the device. FDA is
finalizing this reclassification on its
own initiative based on valid scientific
evidence. For this class II device,
instead of a premarket approval
application, manufacturers may submit
a premarket notification, i.e., a 510(k)
submission, and obtain FDA clearance
of the device before marketing it.
DATES: This order is effective June 20,
2024.
FOR FURTHER INFORMATION CONTACT:
Claudine Krawczyk, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1238, Silver Spring,
MD 20993, 301–796–6860,
claudine.krawczyk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended, establishes
a comprehensive system for the
regulation of medical devices intended
for human use. Section 513 of the FD&C
Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting
the regulatory controls needed to
provide reasonable assurance of their
safety and effectiveness. The three
categories of devices are class I (general
controls), class II (special controls and
general controls), and class III
(premarket approval and general
controls).
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices) are
automatically classified by section
513(f)(1) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval, unless and
until (1) FDA reclassifies the device into
class I or class II; or (2) FDA issues an
order finding the device to be
substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to
a predicate device that does not require
premarket approval. The Agency
determines whether new devices are
substantially equivalent to previously
marketed devices by means of the
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and our
implementing regulations (part 807,
subpart E (21 CFR part 807, subpart E)).
E:\FR\FM\20MYR1.SGM
20MYR1
Agencies
[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Rules and Regulations]
[Pages 43740-43743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10725]
=======================================================================
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 705
[Docket No. 240306-0071]
RIN 0694-AJ27
Revisions of the Section 232 Steel and Aluminum Tariff Exclusions
Process
AGENCY: Bureau of Industry and Security, U.S. Department of Commerce.
ACTION: Final rule.
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SUMMARY: This final rule revises aspects of the process for requesting
exclusions from the duties and quantitative limitations on imports of
aluminum and steel discussed in five previous Bureau of Industry and
Security (``BIS'') interim final rules implementing the exclusion
process authorized by the President under section 232 of the Trade
Expansion Act of 1962, as amended (``Section 232''). The changes in
this final rule are also informed by public comments on a proposed rule
on the Section 232 exclusions process that was published by BIS on
August 28, 2023 (August 2023 Proposed Rule), detailed below. This final
rule thus removes 12 General Approved Exclusions (GAEs) that were added
in the December 2020 rule and maintained through the December 2021
rule, consisting of six GAEs for steel and six GAEs for aluminum.
DATES: This final rule is effective July 1, 2024.
FOR FURTHER INFORMATION CONTACT: For questions regarding this interim
final rule, contact Kevin Coyne at 202-482-2313 or via email
[email protected], or email [email protected] regarding
provisions in this rule specific to steel exclusion requests and
[email protected] regarding provisions in this rule specific to
aluminum exclusion requests.
SUPPLEMENTARY INFORMATION:
Background
On March 8, 2018, Proclamations 9704 and 9705 were issued imposing
duties on imports of aluminum and steel, respectively. The
Proclamations also authorized the Secretary of Commerce (``the
Secretary'') to grant exclusions from the duties if the Secretary
determines the steel or aluminum article for which the exclusion is
requested is not ``produced in the United States in a sufficient and
reasonably available amount or of a satisfactory quality'' or should be
excluded ``based upon specific national security considerations,'' and
provided authority for the Secretary to issue procedures for exclusion
requests. On April 30, 2018, Proclamations 9739 and 9740, and on May
31, 2018, Proclamations 9758 and 9759, set quantitative limitations on
the import of steel and aluminum from certain countries in lieu of the
duties. On August 29, 2018, in Proclamations 9776 and 9777, the
Secretary was authorized to grant exclusions from quantitative
limitations based on the same standards applicable to exclusions from
the tariffs.
Implementing and Improving the 232 Exclusions Process
Since March 19, 2018, Commerce has published five interim final
rules (IFRs) that established and made various improvements to the
Section 232 exclusions process, as well as a Notice of Inquiry and a
Proposed Rule seeking public comment on certain aspects of the Section
232 exclusions process.
On March 19, 2018, BIS issued an IFR, Requirements for Submissions
Requesting Exclusions from the Remedies Instituted in Presidential
Proclamations Adjusting Imports of Steel into the United States and
Adjusting Imports of Aluminum into the United States; and the Filing of
Objections to Submitted Exclusion Requests for Steel and Aluminum (83
FR 12106), establishing the Section 232 exclusions process in
supplements no. 1 and 2 to 15 CFR part 705.
On September 11, 2018, BIS issued a second IFR, Submissions of
Exclusion Requests and Objections to Submitted Requests for Steel and
Aluminum (83 FR 46026), which revised the exclusions process to
increase transparency, fairness, and efficiency.
On June 10, 2019, BIS issued a third IFR, Implementation of New
Commerce Section 232 Exclusions Portal (84 FR 26751), that revised the
two supplements to part 705 to grant the public the ability to submit
new exclusion requests through the Section 232 Exclusions Portal while
still allowing the opportunity for public comment on the portal.
On May 26, 2020, BIS issued a notice of inquiry with request for
comment, Notice of Inquiry Regarding the Exclusions Process for Section
232 Steel and Aluminum Import Tariffs and Quotas (85 FR 31441), that
sought public comment on the appropriateness of the information
requested and considered in applying the exclusion criteria and the
efficiency and transparency of the process employed.
On December 14, 2020, BIS issued a fourth IFR, Section 232 Steel
and Aluminum Tariff Exclusions Process (85 FR 81060) (4th IFR), which
established General Approved Exclusions (GAEs) to reduce the number of
exclusion requests for products consistently found not to be produced
in the United States, reducing the submission burden on both industry
and the Section 232 exclusions process. The 4th IFR identified 123 GAEs
that had generally never received an objection or very few objections
via the Section 232 exclusions process. GAEs are available to all
would-be requesters for steel and aluminum products imported under 10-
Digit Harmonized Tariff Schedule of the United States (HTSUS)
classifications without quantity limit or expiration date. For
information regarding the
[[Page 43741]]
adoption of the GAE policy, please review the 4th IFR.
On December 9, 2021, BIS subsequently suspended 30 GAEs in its
fifth IFR, Removal of Certain General Approved Exclusions Under the
Section 232 Steel and Aluminum Tariff Exclusion Process (86 FR 70003),
on the Section 232 Exclusions process because they were determined by
BIS to no longer fit the criteria of a GAE.
On January 3, 2022, Presidential Proclamations 10327 (87 FR 1) and
10328 (87 FR 11) were published. These Proclamations implemented an
understanding reached between the United States and the European Union
including the establishment of tariff rate quotas for steel and
aluminum articles imported from the European Union member countries.
Proclamation 10328 also directed the Secretary of Commerce to seek
public comment on the Section 232 exclusions process, including the
responsiveness of the exclusions process to market demand and enhanced
consultation with U.S. firms and labor organizations.
On February 10, 2022, BIS published Request for Public Comments on
the Section 232 Exclusions Process (87 FR 7777) (February 2022 Notice),
as directed by Presidential Proclamation 10328. The notice sought
public comment on a variety of topics regarding the responsiveness of
the exclusions process to market demand and enhanced consultation with
U.S. firms and labor organizations. The notice comment period closed in
March 2022, having received nearly 100 comments.
On August 28, 2023, BIS published its proposed rule entitled
Revisions of the Section 232 Steel and Aluminum Exclusions Process (88
FR 58525) (August 2023 Proposed Rule). The rule proposed several
revisions to the Section 232 exclusions process, including adjustments
to the current criteria for identifying GAEs, the introduction of new
General Denied Exclusions (GDEs), and the introduction of new
certification requirements for both Requestors and Objectors.
Public Comments and BIS Responses
The public comment period on the August 2023 Proposed Rule closed
on October 12, 2023. BIS received roughly 100 public comments on the
proposed rule. This is the first of at least two final actions stemming
from the August 2023 Proposed Rule. While BIS will further analyze the
comments received on the August 2023 Proposed Rule, the public comments
described below provide a sufficient basis for the action taken in this
final rule. This rule is a response to that issue alone. BIS will
respond to comments received on the August 2023 Proposed Rule in a
forthcoming final rule that details broader changes to the Section 232
exclusions process.
Comment 1: BIS received multiple comments regarding the efficacy of
specific GAEs. The majority of commenters opposed the continuing use of
certain GAEs as thwarting the objective of the Section 232 action,
including the ability to submit objections to exclusion requests. One
commenter specifically said:
As a result of these GAEs, the vast volume of aluminum extrusion
imports exempt from Section 232 tariffs . . . are once again able to
directly and unfairly compete with U.S.-produced extrusions. This
includes imports . . . covered by the GAEs (HTSUS 7609.00.0000;
7604.21.0010; 7604.29.1010; and 7604.29.5090) . . . By offering
blanket duty-free treatment to importers of these products, the GAEs
have effectively gutted any relief the Section 232 could provide for
the extrusions industry.
BIS Response: GAEs addressed a long-standing request from exclusion
requesters to create a more efficient process to approve certain
exclusions where Commerce has determined that: (1) No objections will
be received; and (2) it is warranted to approve an exclusion for all
importers to use. As always, BIS evaluates all changes to the Section
232 exclusions process to determine if they improve the efficiency and
effectiveness of the process, and thus U.S. national security. It was
clear to BIS that an evaluation of the GAEs was warranted. The initial
review has highlighted the need to remove additional GAEs. Removing
these GAEs supports the effectiveness of the Section 232 tariffs and
therefore U.S. national security.
Regulatory Changes
With this final rule, BIS is removing 12 of the 93 GAEs from
supplements no. 2 and no. 3 to part 705 (six from each supplement).
These GAEs were introduced in the December 2020 rule and maintained
through the December 2021 rule. This final rule removes the following
12 GAEs:
6 GAEs for steel: GAE.24.S: 7211296080; GAE.43.S:
7209900000; GAE.46.S: 7216330090; GAE.84.S: 7209270000; GAE.90.S:
7216100010; and GAE.93.S: 7208380015 and
6 GAEs for aluminum: GAE.1.A: 7609000000; GAE.4.A:
7604210010; GAE.5.A: 7604291010; GAE.9.A: 7601209080; GAE.10.A:
7607116010; and GAE.13.A: 7604295090.
The steel and aluminum articles specified by these 12 GAEs will
revert to the duties and treatment previously established under
Presidential Proclamations 9704 and 9705 as well as subsequent
Proclamations.
BIS does not anticipate that suspension of these 12 GAEs will
substantially increase the total volume of submitted exclusion requests
in the Section 232 Exclusions Portal. BIS has received 1,645 exclusion
requests from 31 requestors for articles covered by these 12 GAEs in
the Section 232 Exclusions Portal over an approximate eighteen-month
period prior to the December 2020 rule. BIS estimates that the removal
of these 12 GAEs will affect roughly 30 requestors who submit exclusion
requests and will lead to the submission of an additional 1,000
exclusion requests per year in the Section 232 Exclusions Portal.
This final rule makes no additional changes to the other 81 GAEs
that will continue to remain in supplements no. 2 and no. 3. As noted
above, BIS made the determination to remove these 12 GAEs based on
public comments received to the August 2023 Proposed Rule that was
bolstered by internal analysis of exclusions data. It must be noted
that should analysis of these GAEs change in the future, BIS may
reissue these GAEs in whole or in part in subsequent rules.
Rulemaking Requirements
1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be a ``significant
regulatory action,'', under Executive Order 12866. Pursuant to
Proclamations 9704 and 9705 of March 8, 2018, and Proclamations 9776
and 9777 of August 29, 2018, the establishment of procedures for an
exclusions process under each Proclamation shall be published in the
Federal Register.
2. The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
(PRA) provides that an agency generally cannot conduct or sponsor a
collection of information, and no person is required to respond to nor
be subject to a penalty for failure to comply with a collection of
information, unless that collection has obtained Office of Management
and Budget (OMB)
[[Page 43742]]
approval and displays a currently valid OMB Control Number.
This final regulation involves three collections currently approved
by OMB with the following control numbers:
Exclusions from the Section 232 National Security
Adjustments of Imports of Steel and Aluminum (control number 0694-
0139).
Objections from the Section 232 National Security
Adjustments of Imports of Steel and Aluminum (control number 0694-
0138).
Procedures for Submitting Rebuttals and Surrebuttals
Requests for Exclusions from and Objections to the Section 232
Adjustments for Steel and Aluminum (OMB control number 0694-0141).
This rule is expected to increase the burden hours for one of the
collections associated with this rule, OMB control number 0694-0139.
This increase is expected because of the removal of 6 GAEs for steel
and 6 GAEs for aluminum, which is expected to result in an increase of
1,000 exclusion request submissions per year. These GAE removals are
expected to increase the burden hours for this collection by 4000, for
a total cost increase of $148,000 to the public. BIS submitted, and OMB
approved a non-substantive change for an increase in 4000 burden hours
to the current 237,846. As BIS asserted in the 4th IFR that the steel
and aluminum articles identified as being eligible for GAEs, including
those being removed in today's rule, had not received any objections,
the addition of those new GAEs was not estimated to result in a
decrease in the number of objections, rebuttals, or surrebuttals
received by BIS.
3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) (APA) requiring notice of proposed rulemaking, the opportunity for
public comment, and a delay in effective date are inapplicable because
this regulation involves a military or foreign affairs function of the
United States. (See 5 U.S.C. 553(a)(1)). As explained in the reports
submitted by the Secretary to the President, steel and aluminum are
being imported into the United States in such quantities or under such
circumstances as to threaten to impair the national security of the
United States, and therefore the President is implementing these
remedial actions (as described Proclamations 9704 and 9705 of March 8,
2018) to protect U.S. national security interests. That implementation
includes the creation of an effective process by which affected
domestic parties can obtain exclusion requests ``based upon specific
national security considerations.'' BIS started this process with the
publication of the March 19 rule and refined the process with the
publication of the September 11, June 10, December 2020, and December
2021 rules and is continuing the process with the publication of this
final rule. Commenters on the past rules (March 19, September 11, and
June 10 rule, December 2020, and December 2021) were generally
supportive and welcomed the idea of creating an exclusion process, but
most of the commenters believe the exclusion process, although
improving over time, still could be significantly improved for it to
achieve the intended purpose. The commenters identified several areas
where transparency, effectiveness, and fairness of the process could be
improved. BIS understands the importance of having a transparent, fair,
and efficient product exclusion request process, consistent with the
directive provided by the President to create this type of process to
mitigate any unintended consequences of imposing the tariffs on steel
and aluminum to protect critical U.S. national security interests. The
revisions to the 232 exclusions process are informed by the comments
received in response to the August 2023 Proposed Rule and BIS's
experience with managing the 232 exclusions process.
Additionally, BIS finds that there is good cause under 5 U.S.C.
553(d)(3) to waive the delay in effective date; given the delays would
be either impracticable or contrary to the public interest because the
actions are tied to the effectiveness of the Section 232 tariffs and
therefore U.S. national security. The public comments on this matter
indicated that there was an urgency to ensuring the changes are
implemented for the effectiveness of the Section 232 process.
Therefore, this final rule will be effective upon publication in the
Federal Register.
Consistent with the Regulatory Flexibility Act, as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5
U.S.C. 601 et seq.), BIS has prepared the following final regulatory
flexibility analysis (FRFA) of the impact that this final rule will
have on small businesses.
Description of the Reasons Why Action Is Being Considered
The policy reasons for issuing this final rule are discussed in the
background section of the preamble of this document and, consequently,
are not repeated here.
Statement of the Objectives of, and Legal Basis for, the Proposed Rule;
Identification of All Relevant Federal Rules Which May Duplicate,
Overlap or Conflict With the Proposed Rule
The objective of this final rule, and all other Section 232-related
rules published by BIS, is discussed in the background section of the
preamble of this document and, consequently, are not repeated here. The
legal basis for this final rule is as follows: Section 232 of the Trade
Expansion Act of 1962, as amended (19 U.S.C. 1862) and Reorg. Plan No.
3 of 1979 (44 FR 69273, December 3, 1979).
No other Federal rules duplicate, overlap, or conflict with this
final rule.
Number and Description of Small Entities Regulated by the Proposed
Action
This final rule would apply to all persons engaged in the Section
232 exclusions process. BIS does not collect or maintain the data
necessary to determine exactly how many of the affected persons are
small entities as that term is used by the Small Business
Administration. However, BIS does ask requestors of the Section 232
exclusions process to self-identify if they are a small business as
defined by the Small Business Administration. From this data, BIS has
estimated the total number of requestors and objectors who are likely
to be small businesses that would be impacted by changes identified in
this rule.
Roughly 380 requestors self-identified as small businesses, filing
roughly 27,000 exclusion requests in the Section 232 exclusions portal
since March 2022, when BIS began including the option for requestors to
self-identify as a small business. BIS does not have the same self-
identification option for objectors. However, over the same period of
time, roughly 100 objectors filed objections in the Section 232
exclusions portal; many of these are easily identifiable as being large
corporations, not small businesses. Therefore, somewhere between 380
and 500 small businesses could be impacted by these changes. Specific
burden estimates for OMB under control numbers 0694-0139 (Exclusions
from the Section 232 National Security Adjustments of Imports of Steel
and Aluminum), 0694-0138 (Objections from the Section 232 National
Security Adjustments of Imports of Steel and Aluminum), and 0694-0141
(Procedures for Submitting Rebuttals and Surrebuttals Requests for
Exclusions from and Objections to the Section 232 Adjustments for Steel
and Aluminum) are detailed in paragraph 2 of the
[[Page 43743]]
Rulemaking Requirements section above.
Based on the analysis provided above, the revisions in this rule
would not impose a significant economic impact on a substantial number
of small businesses.
Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Proposed Rule
The changes in this rule and the corresponding reporting,
recordkeeping, and other compliance requirements are discussed in the
background section of the preamble of this document and, consequently,
are not repeated here. To the extent that compliance with the changes
in this rule would impose a burden on persons, including small
businesses, BIS believes the burden will be minimal.
Significant Alternatives and Underlying Analysis
As noted above, BIS does not believe that the revisions in this
rule will have a significant economic impact on small businesses.
Nevertheless, consistent with 5 U.S.C. 603(c), BIS considered
significant alternatives to these revisions to assess whether the
alternatives would: (1) accomplish the stated objectives of this final
rule (consistent with the objectives of the Section 232 exclusions
process); and (2) minimize any significant economic impact of this
final rule on small entities. BIS has determined that revisions
detailed above are the least disruptive alternative for implementing
changes to the Section 232 exclusions process.
Lastly, consistent with 5 U.S.C. 603(c), BIS assessed the use of
performance standards rather than design standards and also considered
whether an exemption for small businesses was practical under the
circumstances (i.e., within the context of the changes in this rule).
This final rule does not contain an exemption for small businesses
from the Section 232 exclusions process changes because these controls
are essential to U.S. national security and BIS' regulations apply to
all parties. An exemption for small businesses would undermine the
effectiveness of these revisions.
Conclusion
BIS has identified changes to the Section 232 exclusions process.
Consequently, consistent with the Regulatory Flexibility Act, BIS has
prepared this FRFA addressing the impact that this final rule will have
on small entities. BIS's assessment indicates that the amendments in
this rule will not have a significant economic impact on a substantial
number of small entities.
Please submit any comments concerning this FRFA in accordance with
the instructions provided in the ADDRESSES section of this final rule.
List of Subjects in 15 CFR Part 705
Administrative practice and procedure, Business and industry,
Classified information, Confidential business information, Imports,
Investigations, National defense.
For the reasons set forth in the preamble, part 705 of subchapter A
of 15 CFR chapter VII is amended as follows:
PART 705--EFFECT OF IMPORTED ARTICLES ON THE NATIONAL SECURITY
0
1. The authority citation for part 705 continues to read as follows:
Authority: Section 232 of the Trade Expansion Act of 1962, as
amended (19 U.S.C. 1862) and Reorg. Plan No. 3 of 1979 (44 FR 69273,
December 3, 1979).
0
2. Supplement no. 2 to part 705 is amended by removing the entries for
``GAE.24.S: 7211296080;'' ``GAE.43.S: 7209900000;'' ``GAE.46.S:
7216330090;'' ``GAE.84.S: 7209270000;'' ``GAE.90.S: 7216100010;'' and
``GAE.93.S: 7208380015''.
0
3. Supplement no. 3 to part 705 is amended by removing the entries for
``GAE.1.A: 7609000000;'' ``GAE.4.A: 7604210010;'' ``GAE.5.A:
7604291010;'' ``GAE.9.A: 7601209080;'' ``GAE.10.A: 7607116010;'' and
``GAE.13.A: 7604295090''.
Matthew S. Borman,
Principal Deputy Assistant Secretary for Export Administration.
[FR Doc. 2024-10725 Filed 5-17-24; 8:45 am]
BILLING CODE 3510-33-P