Amendment of Restricted Area R-2512 Holtville, CA, 88227-88228 [2023-28032]
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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations
10. For calendar year 2022, the asset
threshold was $2,336,000,000. A
creditor that together with the assets of
its affiliates that regularly extended
first-lien covered transactions during
calendar year 2021 had total assets of
less than $2,336,000,000 on December
31, 2021, satisfied this criterion for
purposes of any loan consummated in
2022 and for purposes of any loan
consummated in 2023 for which the
application was received before April 1,
2023.
11. For calendar year 2023, the asset
threshold was $2,537,000,000. A
creditor that together with the assets of
its affiliates that regularly extended
first-lien covered transactions during
calendar year 2022 had total assets of
less than $2,537,000,000 on December
31, 2022, satisfied this criterion for
purposes of any loan consummated in
2023 and for purposes of any loan
consummated in 2024 for which the
application was received before April 1,
2024.
iv. The creditor and its affiliates do
not maintain an escrow account for any
mortgage transaction being serviced by
the creditor or its affiliate at the time the
transaction is consummated, except as
provided in § 1026.35(b)(2)(iii)(D)(1)
and (2). Thus, the exemption applies,
provided the other conditions of
§ 1026.35(b)(2)(iii) (or, if applicable, the
conditions for the exemption in
§ 1026.35(b)(2)(vi)) are satisfied, even if
the creditor previously maintained
escrow accounts for mortgage loans,
provided it no longer maintains any
such accounts except as provided in
§ 1026.35(b)(2)(iii)(D)(1) and (2). Once a
creditor or its affiliate begins escrowing
for loans currently serviced other than
those addressed in
§ 1026.35(b)(2)(iii)(D)(1) and (2),
however, the creditor and its affiliate
become ineligible for the exemption in
§ 1026.35(b)(2)(iii) and (vi) on higherpriced mortgage loans they make while
such escrowing continues. Thus, as long
as a creditor (or its affiliate) services and
maintains escrow accounts for any
mortgage loans, other than as provided
in § 1026.35(b)(2)(iii)(D)(1) and (2), the
creditor will not be eligible for the
exemption for any higher-priced
mortgage loan it may make. For
purposes of § 1026.35(b)(2)(iii) and (vi),
a creditor or its affiliate ‘‘maintains’’ an
escrow account only if it services a
mortgage loan for which an escrow
account has been established at least
through the due date of the second
periodic payment under the terms of the
legal obligation.
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Paragraph 35(b)(2)(vi)(A).
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1. The asset threshold in
§ 1026.35(b)(2)(vi)(A) will adjust
automatically each year, based on the
year-to-year change in the average of the
Consumer Price Index for Urban Wage
Earners and Clerical Workers, not
seasonally adjusted, for each 12-month
period ending in November, with
rounding to the nearest million dollars.
Unlike the asset threshold in
§ 1026.35(b)(2)(iii) and the other
thresholds in § 1026.35(b)(2)(vi),
affiliates are not considered in
calculating compliance with this
threshold. The Bureau will publish
notice of the asset threshold each year
by amending this comment. For
calendar year 2024, the asset threshold
is $11,835,000,000. A creditor that is an
insured depository institution or
insured credit union that during
calendar year 2023 had assets of
$11,835,000,000 or less on December 31,
2023, satisfies this criterion for purposes
of any loan consummated in 2024 and
for purposes of any loan secured by a
first lien on a principal dwelling of a
consumer consummated in 2025 for
which the application was received
before April 1, 2025. For historical
purposes:
1. For calendar year 2021, the asset
threshold was $10,000,000,000.
Creditors that had total assets of
10,000,000,000 or less on December 31,
2020, satisfied this criterion for
purposes of any loan consummated in
2021 and for purposes of any loan
secured by a first lien on a principal
dwelling of a consumer consummated
in 2022 for which the application was
received before April 1, 2022.
2. For calendar year 2022, the asset
threshold was $10,473,000,000.
Creditors that had total assets of
$10,473,000,000 or less on December 31,
2021, satisfied this criterion for
purposes of any loan consummated in
2022 and for purposes of any loan
secured by a first lien on a principal
dwelling of a consumer consummated
in 2023 for which the application was
received before April 1, 2023.
3. For calendar year 2023, the asset
threshold is $11,374,000,000. A creditor
that is an insured depository institution
or insured credit union that during
calendar year 2022 had assets of
$11,374,000,000 or less on December 31,
2022, satisfied this criterion for
purposes of any loan consummated in
2023 and for purposes of any loan
secured by a first lien on a principal
dwelling of a consumer consummated
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88227
in 2024 for which the application was
received before April 1, 2024.
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Brian Shearer,
Senior Advisor, Consumer Financial
Protection Bureau.
[FR Doc. 2023–28076 Filed 12–20–23; 8:45 am]
BILLING CODE 4810–AM–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 73
[Docket No. FAA–2023–2220; Airspace
Docket No. 23–AWP–59]
RIN 2120–AA66
Amendment of Restricted Area R–2512
Holtville, CA
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction;
withdrawal.
AGENCY:
This action withdraws the
final rule correction published in the
Federal Register on December 6, 2023.
That action incorrectly stated that the
action would be incorporated by
reference. The FAA has determined that
withdrawal of the final rule correction
is warranted since the action is not
incorporated by reference.
DATES: As of date 0901 UTC, December
21, 2023, the final rule correction
published December 6, 2023 (88 FR
84695), is withdrawn.
FOR FURTHER INFORMATION CONTACT:
Steven Roff, Rules and Regulations
Group, Office of Policy, Federal
Aviation Administration, 800
Independence Avenue SW, Washington,
DC 20591; telephone: (202) 267–8783.
SUPPLEMENTARY INFORMATION:
SUMMARY:
History
The FAA published a final rule in the
Federal Register for Docket No. FAA–
2023–2220 (88 FR 78636, November 16,
2023) that amended restricted area R–
2512 in the vicinity of Holtville, CA.
The section of 14 CFR part 73 to be
amended by the final rule was
inadvertently stated as § 73.22. The
correct section of 14 CFR part 73 to be
amended is § 73.25.
Subsequently, the FAA published a
final rule correction in the Federal
Register for Docket No. FAA–2023–2220
(88 FR 84695, December 6, 2023) that
amended restricted area R–2512 in the
vicinity of Holtville, CA, correcting the
section of 14 CFR part 73 to be
amended. That action incorrectly stated
E:\FR\FM\21DER1.SGM
21DER1
88228
Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations
that the action is incorporated by
reference under 1 CFR part 51. As a
result, the final rule correction is being
withdrawn.
Lists of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted
areas.
The Withdrawal
The FAA determined that the final
rule correction published in the Federal
Register on December 6, 2023 (88 FR
84695) contains incorrect references.
Therefore, the FAA withdraws that final
rule correction.
■
Issued in Washington, DC, on December
15, 2023.
Brian Konie,
Acting Manager, Rules and Regulations
Group.
[FR Doc. 2023–28032 Filed 12–20–23; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 50, 312, and 812
[Docket No. FDA–2018–N–2727]
RIN 0910–AH52
Institutional Review Board Waiver or
Alteration of Informed Consent for
Minimal Risk Clinical Investigations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule to amend its
regulations to implement a provision of
the 21st Century Cures Act (Cures Act).
This final rule allows an exception from
the requirement to obtain informed
consent when a clinical investigation
poses no more than minimal risk to the
human subject and includes appropriate
safeguards to protect the rights, safety,
and welfare of human subjects. The
final rule permits an institutional
review board (IRB) to waive or alter
certain informed consent elements or to
waive the requirement to obtain
informed consent, under limited
conditions, for certain FDA-regulated
minimal risk clinical investigations.
DATES: This rule is effective January 22,
2024.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:43 Dec 20, 2023
Jkt 262001
docket number found in brackets in the
heading of this final rule 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:
Lauren Milner, Office of Clinical Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–5514,
lauren.milner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used
Acronyms in This Document
III. Background
A. Need for the Regulation/History of This
Rulemaking
B. Summary of Comments to the Proposed
Rule
C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of General Comments and
FDA Response
C. Comments on the Proposed Waiver or
Alteration Criteria
D. Comments on Adopting the Revised
Common Rule’s Fifth Criterion for
Waiver or Alteration of Informed
Consent
E. Comments on Secondary Research
Involving Leftover Biospecimens
F. Comments on Examples of Clinical
Investigations That Would Meet the
Waiver Criteria
G. Comments on Requests for Guidance
H. Comments on the Expedited Review List
and IRB Continuing Review
I. Comments on the Cost Savings of the
Proposed Rule
J. Comments on the Proposed Effective
Date
VI. Effective Date
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs, Cost Savings, and
Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule implements the
statutory changes made to the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) by the Cures Act to allow for a
waiver or alteration of informed consent
when a clinical investigation poses no
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Fmt 4700
Sfmt 4700
more than minimal risk to the human
subject and includes appropriate
safeguards to protect the rights, safety,
and welfare of human subjects. The rule
will permit an IRB to waive or alter
certain informed consent elements or to
waive the requirement to obtain
informed consent, under limited
conditions, for certain minimal risk
clinical investigations.
B. Summary of the Major Provisions of
the Final Rule
The final rule amends FDA’s
regulations to allow IRBs responsible for
the review, approval, and continuing
review of clinical investigations to
approve an informed consent procedure
that does not include or that alters
certain informed consent elements, or to
waive the requirement to obtain
informed consent, for certain minimal
risk clinical investigations. For an IRB
to approve a waiver or alteration of
informed consent requirements for
minimal risk clinical investigations, the
rule requires an IRB to find and
document five criteria that are
consistent with the revised rule entitled
‘‘Federal Policy for the Protection of
Human Subjects’’ (the revised Common
Rule (January 19, 2017)). FDA believes
the amendment provides appropriate
safeguards to protect the rights, safety,
and welfare of the human subjects
participating in such clinical
investigations. We are also making
conforming amendments to FDA’s
regulations.
C. Legal Authority
Sections 505(i)(4) and 520(g)(3) of the
FD&C Act, as amended by the Cures
Act, in conjunction with FDA’s general
rulemaking authority in section 701(a)
of the FD&C Act, serve as FDA’s
principal legal authority for this rule. In
addition, the Cures Act directs the
Secretary of the Department of Health
and Human Services (HHS) to
‘‘harmonize differences between the
HHS Human Subject Regulations and
the FDA Human Subject Regulations,’’
to the extent practicable and consistent
with other statutory provisions.
D. Costs and Benefits
This rule will help enable the conduct
of certain minimal risk clinical
investigations for which the
requirement to obtain informed consent
is waived or for which certain elements
of informed consent are waived or
altered.
We expect costs in the form of
affected IRBs, as well as investigators
and sponsors of clinical investigations,
reading and learning the rule. We also
expect costs in the form of drafting new
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]]>Agencies
[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Rules and Regulations]
[Pages 88227-88228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28032]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 73
[Docket No. FAA-2023-2220; Airspace Docket No. 23-AWP-59]
RIN 2120-AA66
Amendment of Restricted Area R-2512 Holtville, CA
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction; withdrawal.
-----------------------------------------------------------------------
SUMMARY: This action withdraws the final rule correction published in
the Federal Register on December 6, 2023. That action incorrectly
stated that the action would be incorporated by reference. The FAA has
determined that withdrawal of the final rule correction is warranted
since the action is not incorporated by reference.
DATES: As of date 0901 UTC, December 21, 2023, the final rule
correction published December 6, 2023 (88 FR 84695), is withdrawn.
FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.
SUPPLEMENTARY INFORMATION:
History
The FAA published a final rule in the Federal Register for Docket
No. FAA-2023-2220 (88 FR 78636, November 16, 2023) that amended
restricted area R-2512 in the vicinity of Holtville, CA. The section of
14 CFR part 73 to be amended by the final rule was inadvertently stated
as Sec. 73.22. The correct section of 14 CFR part 73 to be amended is
Sec. 73.25.
Subsequently, the FAA published a final rule correction in the
Federal Register for Docket No. FAA-2023-2220 (88 FR 84695, December 6,
2023) that amended restricted area R-2512 in the vicinity of Holtville,
CA, correcting the section of 14 CFR part 73 to be amended. That action
incorrectly stated
[[Page 88228]]
that the action is incorporated by reference under 1 CFR part 51. As a
result, the final rule correction is being withdrawn.
Lists of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted areas.
The Withdrawal
0
The FAA determined that the final rule correction published in the
Federal Register on December 6, 2023 (88 FR 84695) contains incorrect
references. Therefore, the FAA withdraws that final rule correction.
Issued in Washington, DC, on December 15, 2023.
Brian Konie,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2023-28032 Filed 12-20-23; 8:45 am]
BILLING CODE 4910-13-P
