15096 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Proposed Rules 

II. Paperwork Reduction Act of 1995

This draft guidance refers to proposed

collections of information described in 

FDA’s September 28, 2022, proposed 

rule on ‘‘Protection of Human Subjects 

and Institutional Review Boards’’ (87 FR 

58733), which this draft guidance is 

intended to interpret, and with 

previously approved collections of 

information described in the revised 

Federal Policy for the Protection of 

Human Subjects (the revised Common 

Rule). The proposed collections of 

information in the proposed rule are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3521). As 

required by the PRA, FDA has 

published an analysis of the information 

collection provisions of the proposed 

rule (87 FR 58733 at 58744) and they 

have been approved under OMB control 

number 0910–0130. The collections of 

information in 45 CFR 46 and the final 

rule entitled, ‘‘Federal Policy for the 

Protection of Human Subjects’’ 

(Common Rule) have been approved 

under OMB control number 0990–0260. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm, 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm, 

https://www.fda.gov/about-fda/officeclinical-policy-and-programs/officeclinical-policy, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, http://

www.hhs.gov/ohrp/newsroom/rfc/ 

index.html, or https://

www.regulations.gov. 

Dated: February 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04377 Filed 2–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2023–0626; FRL–11614– 

03–R9] 

Air Plan Disapproval; California; Los 

Angeles-South Coast Air Basin; 1997 

8-Hour Ozone; Extension of Comment

Period

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Environmental Protection 

Agency (EPA) is extending the comment 

period for a proposed rule published 

February 2, 2024. The current comment 

period for the proposed rule was set to 

end on March 4, 2024. In response to 

requests from several commenters, the 

EPA is extending the comment period 

for the proposed action to April 3, 2024. 

DATES: The comment period for the 

proposed rule published on February 2, 

2024, at 89 FR 7320 is extended. 

Comments must be received on or 

before April 3, 2024. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R09– 

OAR–2023–0626 at https://

www.regulations.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. The EPA may publish 

any comment received to its public 

docket. Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. If you need 

assistance in a language other than 

English or if you are a person with a 

disability who needs a reasonable 

accommodation at no cost to you, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Ginger Vagenas, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105. By phone: (415) 972–3964 or by 

email at vagenas.ginger@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

February 2, 2024, the EPA published a 

proposal to disapprove a state 

implementation plan revision submitted 

by the State of California to meet Clean 

Air Act (CAA) requirements for the 1997 

8-hour ozone national ambient air

quality standards (NAAQS) in the Los

Angeles-South Coast Air Basin,

California ozone nonattainment area.

This submission, titled ‘‘Final

Contingency Measure Plan—Planning

for Attainment of the 1997 80 ppb 8-

hour Ozone Standard in the South Coast

Air Basin,’’ addresses the CAA

requirements for the submission of

contingency measures that will be

implemented if emissions reductions

from anticipated technologies associated

with the area’s 1997 ozone NAAQS

attainment demonstration are not

achieved. For more detailed information

about this matter, please refer to the

February 2, 2024 Federal Register

document.

The notice of proposed rulemaking 

initially provided for comments to be 

submitted to the EPA on or before 

March 4, 2024 (a 30-day public 

comment period). The EPA received 

several comments requesting an 

extension of the comment period. To 

ensure the public has sufficient time to 

evaluate the proposal and develop 

comments, the EPA is extending the 

comment period until April 3, 2024. 

Dated: February 23, 2024. 

Matthew Lakin, 

Acting Director, Air and Radiation Division, 

Region IX. 

[FR Doc. 2024–04287 Filed 2–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2023–0617; FRL–11781– 

01–R3] 

Air Plan Approval; Delaware; 

Amendments to Delaware’s 

Requirements for Public Notice of 

Certain Permits 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 


ddrumheller on DSK120RN23PROD with PROPOSALS1