Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations 88227 

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. 

* * * * * 

Paragraph 35(b)(2)(vi)(A). 

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 

in 2024 for which the application was 

received before April 1, 2024. 

* * * * * 

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 

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 § 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 


khammond on DSKJM1Z7X2PROD with RULES
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. 

SUMMARY: 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 

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 

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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