Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 77023 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 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. 

■ 2. Amend § 16.1 by revising paragraph 

(b)(1) to read as follows: 

§ 16.1 Scope. 

* * * * * 

(b) * * * 

(1) The statutory provisions are as 

follows: 

TABLE 1 TO PARAGRAPH (b)(1) 

Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of devices and drugs (see §§ 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 § 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 §§ 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. 

* * * * * 

§ 16.1 [Amended] 

■ 3. Effective December 18, 2025, in 

§ 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. 2024–21231 Filed 9–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2024–0032; FRL–11685– 

02–R9] 

Air Plan Revisions; California; San 

Diego County Air Pollution Control 

District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve a revision to the San Diego 

County Air Pollution Control District 

(SDCAPCD) portion of the California 

State Implementation Plan (SIP). This 

revision concerns a rule submitted to 

address section 185 of the Clean Air Act 

(CAA or ‘‘Act’’). 

DATES: This rule is effective October 21, 

2024. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R09–OAR–2024–0032. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through https://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 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: Kira 

Wiesinger, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105; phone: (415) 972–3827; email: 

wiesinger.kira@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Proposed Action 

II. Public Comments and EPA Responses 

III. EPA Action 

IV. Incorporation by Reference 

V. Statutory and Executive Order Reviews 

I. Proposed Action 

On April 2, 2024 (89 FR 22648), the 

EPA proposed to approve the following 

rule into the California SIP. 


ddrumheller on DSK120RN23PROD with RULES1
77024 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 

TABLE 1—SUBMITTED RULE

Local agency Rule Rule title Adopted Submitted 

SDCAPCD ....................................................... 45 Federally Mandated Ozone Nonattainment 

Fees.

06/09/2022 07/20/2022 

We proposed to approve this rule 

because we determined that it complies 

with the relevant CAA requirements. 

Our proposed action contains more 

information on the rule and our 

evaluation. 

II. Public Comments and EPA 

Responses 

The EPA’s proposed action provided 

a 30-day public comment period. During 

this period, we received two comments 

from members of the public. One 

comment was supportive of our 

proposed action. We thank the 

commenter for their support and input. 

The other comment was not germane to 

this action. 

III. EPA Action 

No comments were submitted that 

change our assessment of the rule as 

described in our proposed action. 

Therefore, as authorized in section 

110(k)(3) of the Act, the EPA is 

approving this rule into the California 

SIP. 

IV. Incorporation by Reference 

In this rule, the EPA is finalizing 

regulatory text that includes 

incorporation by reference. In 

accordance with requirements of 1 CFR 

51.5, the EPA is finalizing the 

incorporation by reference of SDCAPCD 

Rule 45, ‘‘Federally Mandated Ozone 

Nonattainment Fees,’’ adopted on June 

9, 2022, which addresses the CAA 

section 185 fee program requirements. 

The EPA has made, and will continue 

to make, these documents available 

through www.regulations.gov and at the 

EPA Region IX Office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

V. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, the EPA’s role is to 

approve state choices, provided that 

they meet the criteria of the Clean Air 

Act. Accordingly, this action merely 

approves state law as meeting federal 

requirements and does not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

this action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 14094 (88 FR 

21879, April 11, 2023); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) 

because it approves a state program; 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); and 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act. 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where the EPA or 

an Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations, 59 FR 7629, 

February 16, 1994) directs Federal 

agencies to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on communities with 

environmental justice (EJ) concerns to 

the greatest extent practicable and 

permitted by law. The EPA defines EJ as 

‘‘the fair treatment and meaningful 

involvement of all people regardless of 

race, color, national origin, or income 

with respect to the development, 

implementation, and enforcement of 

environmental laws, regulations, and 

policies.’’ The EPA further defines the 

term fair treatment to mean that ‘‘no 

group of people should bear a 

disproportionate burden of 

environmental harms and risks, 

including those resulting from the 

negative environmental consequences of 

industrial, governmental, and 

commercial operations or programs and 

policies.’’ 

The State did not evaluate EJ 

considerations as part of its SIP 

submittal; the CAA and applicable 

implementing regulations neither 

prohibit nor require such an evaluation. 

The EPA did not perform an EJ analysis 

and did not consider EJ in this action. 

Consideration of EJ is not required as 

part of this action, and there is no 

information in the record inconsistent 

with the stated goal of Executive Order 

12898 of achieving EJ for communities 

with EJ concerns. 

This action is subject to the 

Congressional Review Act, and the EPA 

will submit a rule report to each House 

of the Congress and to the Comptroller 

General of the United States. This action 

is not a ‘‘major rule’’ as defined by 5 

U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by November 19, 

2024. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review, nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen oxides, Ozone, Reporting and 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 77025 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: September 16, 2024. 

Martha Guzman Aceves, 

Regional Administrator, Region IX. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency amends part 52, chapter I, title 

40 of the Code of Federal Regulations as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(615) to read as 

follows: 

§ 52.220 Identification of plan—in part. 

* * * * * 

(c) * * * 

(615) The following regulation was 

submitted electronically on July 20, 

2022, by the Governor’s designee as an 

attachment to a letter of the same date. 

(i) Incorporation by reference. 

(A) San Diego County Air Pollution 

Control District. 

(1) Rule 45, ‘‘Federally Mandated 

Ozone Nonattainment Fees,’’ adopted 

on June 9, 2022. 

(2) [Reserved] 

(B) [Reserved] 

(ii) [Reserved] 

* * * * * 

[FR Doc. 2024–21494 Filed 9–19–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 1068 

General Compliance Provisions for 

Highway, Stationary, and Nonroad 

Programs 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 40 of the Code of Federal 

Regulations, Part 1060 to End, revised as 

of July 1, 2024, amend § 1068.250 by 

reinstating paragraph (i) to read as 

follows: 

§ 1068.250 Extending compliance 

deadlines for small businesses under 

hardship. 

* * * * * 

(i) We may include reasonable 

requirements on an approval granted 

under this section, including provisions 

to recover or otherwise address the lost 

environmental benefit. For example, we 

may require that you meet a less 

stringent emission standard or buy and 

use available emission credits. 

* * * * * 

[FR Doc. 2024–21640 Filed 9–19–24; 8:45 am] 

BILLING CODE 0099–10–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Parts 300–3, 301–11, 301–50, 

301–52, 301–70, 301–71, and 301–73 

[FTR Case 2023–03; Docket No. GSA–FTR– 

2023–0023, Sequence No. 2] 

RIN 3090–AK66 

Federal Travel Regulation; Updating 

Glossary of Terms and E-Gov Travel 

Service Requirements 

AGENCY: Office of Government-wide 

Policy (OGP), General Services 

Administration (GSA). 

ACTION: Final rule. 

SUMMARY: GSA is issuing a final rule 

amending the Federal Travel Regulation 

(FTR) to remove outdated information 

on deployment of the original E-Gov 

Travel Service (ETS) contract as 

agencies prepare for the next generation 

of ETS, known as ETSNext, to provide 

updated policy, and make 

miscellaneous editorial corrections. 

DATES: Effective October 21, 2024. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Cheryl D. McClain-Barnes, Office of 

Government-wide Policy at 202–208– 

4334 or email at travelpolicy@gsa.gov 

for clarification of content. For 

information pertaining to the status or 

publication schedules, contact the 

Regulatory Secretariat Division at 202– 

501–4755 or GSARegSec@gsa.gov. 

Please cite FTR case 2023–03. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In November 2003, GSA’s Federal 

Acquisition Service awarded master 

contracts for the first iteration of ETS, a 

web-based end-to-end travel 

management service. GSA published 

FTR Amendment 2003–07 (68 FR 

71026) in December 2003, to amend the 

FTR on the required use of the new 

travel service. The original ETS 

implementation policies included 

timelines with specific dates for 

agencies to deploy ETS and migrate to 

the new platform. This information 

regarding ETS implementation is no 

longer needed because all mandatory 

users have deployed ETS (either 

initially, or upon expiration of an 

exception to its use) since it became 

available to civilian agencies in the first 

quarter of 2004. 

Contracts awarded under ETS2, the 

second iteration of ETS, are set to expire 

in June 2027. GSA published a proposed 

rule (88 FR 89650) on December 28, 

2023, seeking to amend the FTR to 

remove outdated policy and provide 

updated policy as agencies prepare for 

the implementation of the next 

generation of ETS known as ‘‘E-Gov 

Travel Service, Next Generation’’ or 

‘‘ETSNext’’ for short. Accordingly, this 

rule finalizes the proposed changes to 

FTR parts 300–3, 301–11, 301–50, 301– 

52, 301–70, 301–71, and 301–73. GSA is 

also amending the FTR to make minor 

editorial changes for clarity. 

Specifically, GSA is relocating a 

definitional term at § 301–50.6, namely 

‘‘online self-service booking tool,’’ to 

part 300–3, ‘‘Glossary of Terms,’’ and 

updating the definition; renaming the 

term ‘‘Online booking tool (OBT);’’ and 

renumbering sections in part 301–50 in 

logical order. GSA is further updating 

the ‘‘Glossary of Terms’’ by capitalizing 

the initialism ‘‘ETS’’ in the body of the 

definition of ‘‘E-Gov Travel Service 

(ETS)’’ to be consistent with the 

definition heading. 

GSA is also removing and reserving 

§ 301–73.101 and relocating relevant 

language from note 1 of the section 

regarding agency funding responsibility 

for ETS to a note to § 301–73.2. Further, 

GSA is revising the note to § 301–73.106 

to remove duplicate text regarding travel 

agent services that align with present 

requirements for ETS2, but may not 

align with the terms of successor travel 

management service contract(s). Finally, 

GSA is adding a reference to the 

‘‘extenuating circumstances’’ exception 

to the use of ETS and Travel 

Management Service (TMS) to existing 

exceptions at §§ 301–50.4 and 301– 

73.102. 

II. Discussion of the Final Rule 

A. Summary of Significant Changes 

GSA has not made any significant 

changes to the regulatory language from 

the proposed to final rule. However, of 

note, the proposed rule duplicated some 

technical changes to an FTR final rule 

that took effect on April 16, 2024 (89 FR 

12250); GSA removed these duplicate 

technical changes from this final rule as 


ddrumheller on DSK120RN23PROD with RULES1