Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Rules and Regulations 24273 

1Approval and Promulgation of Implementation 

Plans; Utah; Emissions Statement Rule and 

Nonattainment New Source Review Requirements 

for the 2015 8-Hour Ozone National Ambient Air 

Quality Standards for the Uinta Basin, Northern 

Wasatch Front and Southern Wasatch Front 

Continued 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in the 

guidance document ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ have 

been approved under OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 814, 

subparts A through E, regarding 

premarket approval, have been 

approved under OMB control number 

0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for part 878 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 878.4550 to subpart E to read 

as follows: 

§ 878.4550 Autofluorescence detection 

device for general surgery and 

dermatological use. 

(a) Identification. An autofluorescence 

detection device for general surgery and 

dermatological use is an adjunct tool 

that uses autofluorescence to detect 

tissues or structures. This device is not 

intended to provide a diagnosis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) In vivo testing under anticipated 

conditions of use must characterize the 

ability of the device to detect 

autofluorescent signals from tissues or 

structures consistent with the 

indications for use. 

(2) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(3) Performance testing must 

demonstrate the electromagnetic 

compatibility and electrical, 

mechanical, and thermal safety of the 

device. 

(4) Software verification, validation, 

and hazard analysis must be performed. 

(5) Performance testing must 

demonstrate the sterility of patientcontacting components of the device. 

(6) Performance testing must support 

the shelf life of device components 

provided sterile by demonstrating 

continued sterility and package integrity 

over the labeled shelf life. 

(7) Performance testing must 

demonstrate laser and light safety for 

eye, tissue, and skin. 

(8) Labeling must include the 

following: 

(i) Instructions for use; 

(ii) The detection performance 

characteristics of the device when used 

as intended; and 

(iii) A shelf life for any sterile 

components. 

Dated: April 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08731 Filed 4–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R08–OAR–2021–0775; FRL–9330–02– 

R8] 

Approval and Promulgation of 

Implementation Plans; Utah; 

Emissions Statement Rule and 

Nonattainment New Source Review 

Requirements for the 2015 8-Hour 

Ozone National Ambient Air Quality 

Standard for the Uinta Basin, Northern 

Wasatch Front and Southern Wasatch 

Front Nonattainment Areas 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving state 

implementation plan (SIP) revisions 

submitted by the State of Utah. The 

revisions fulfill the emissions statement 

rule and nonattainment new source 

review (NNSR) requirements for the 

2015 8-hour ozone national ambient air 

quality standard (NAAQS) for the Uinta 

Basin, Northern Wasatch Front, and 

Southern Wasatch Front Marginal 

nonattainment areas. Utah submitted an 

emissions statement rule revision and a 

separate NNSR certification to meet, in 

part, the nonattainment requirements 

for Marginal ozone nonattainment areas 

under the 2015 8-hour ozone NAAQS. 

The State’s submission of the emissions 

statement rule revision also included 

revisions to emissions reporting 

requirements for stationary sources, 

which are being approved in this final 

rule as well. The EPA is taking this 

action pursuant to sections 110, 172, 

and 182 of the Clean Air Act (CAA). 

DATES: This rule is effective on May 25, 

2022. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R08–OAR–2021–0775. All 

documents in the docket are listed on 

the http://www.regulations.gov website. 

Although listed in the index, some 

information is not publicly available, 

e.g., 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 http://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Lang, Air and Radiation 

Division, EPA, Region 8, Mailcode 

8ARD–IO, 1595 Wynkoop Street, 

Denver, Colorado, 80202–1129, 

telephone number: (303) 312–6709, 

email address: lang.matthew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

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

and ‘‘our’’ means the EPA. 

I. Background 

The background for this action is 

discussed in detail in our February 1, 

2022 proposal.1 In that document we 


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24274 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Rules and Regulations 

Nonattainment Areas, 87 FR 5435 (February 1, 

2022). 2 62 FR 27968 (May 22, 1997). 

proposed to approve the SIP revision 

submitted by Utah which included 

changes to Rule R307–150 concerning 

the level of detail of inventory data 

reported by certain sources as well as 

implementation of an annual ozone 

emissions statement rule for stationary 

sources in ozone nonattainment areas. 

Additionally, we proposed to approve 

the SIP revision submitted by Utah 

certifying that the state’s previously 

approved NNSR permit program meets 

the requirement stemming from the 

Marginal ozone nonattainment 

designations of the Uinta Basin, 

Northern Wasatch Front, and Southern 

Wasatch Front areas. We proposed to 

approve the revisions because they were 

prepared in accordance with the 

requirements in sections 182(a)(3)(B), 

172(c)(5) and 172(b) of the CAA. 

EPA held a 30-day comment period 

on the proposed rulemaking beginning 

on February 1, 2022 and closing on 

March 3, 2022. We did not receive any 

comments on the proposed rulemaking 

during the comment period. 

II. Final Action 

The EPA is finalizing approval of 

revisions to Rule R307–150 submitted 

by the State of Utah on November 3, 

2020, including a revision to implement 

an emissions statement rule which was 

prepared in accordance with section 

182(a)(3)(B) of the CAA. The EPA is also 

finalizing approval of the NNSR permit 

program certification submitted by the 

State of Utah on August 2, 2021, 

because the certified NNSR Permit 

Program was prepared in accordance 

with requirements of sections 172(c)(5) 

and 173 of the CAA and fulfills the 

specific minimum SIP requirements of 

40 CFR 51.165. 

III. Incorporation by Reference 

In this document, 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 Rule 

R307–150 described in the amendments 

to 40 CFR part 52 set forth below. The 

EPA has made, and will continue to 

make, these materials generally 

available through www.regulations.gov 

and at the EPA Region 8 Office (please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section of 

this preamble for more information). 

Therefore, these materials have been 

approved by the EPA for inclusion in 

the State Implementation Plan, have 

been incorporated by reference by the 

EPA into that plan, are fully federally 

enforceable under sections 110 and 113 

of the CAA as of the effective date of the 

final rulemaking of the EPA’s approval, 

and will be incorporated by reference in 

the next update to the SIP compilation.2

IV. Statutory and Executive Order 

Reviews 

Under the CAA, 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 CAA. 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 13563 (76 FR 3821, 

January 21, 2011); 

• 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, 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 an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• 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 CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where 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). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

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 June 24, 2022. 

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, Carbon monoxide, 

Greenhouse gases, Incorporation by 

reference, Intergovernmental relations, 

Lead, Nitrogen dioxide, Ozone, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Volatile organic compounds. 

Dated: April 11, 2022. 

K.C. Becker, 

Regional Administrator, Region 8. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 


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Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Rules and Regulations 24275 

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

Subpart TT—Utah 

■ 2. Amend § 52.2320 by: 

■ a. In the table in paragraph (c): 

■ i. Revising the entries ‘‘R307–150– 

01’’, ‘‘R307–150–02’’, ‘‘R307–150–03’’, 

‘‘R307–150–04’’, ‘‘R307–150–05’’, 

‘‘R307–150–06’’, and ‘‘R307–150–07’’ 

under the heading entitled ‘‘R307–150. 

Emission Inventories’’. 

■ ii. Adding the entry ‘‘R307–150–09’’. 

■ b. In the table in paragraph (e), adding 

the entry ‘‘Ozone (8-hour, 2015) NNSR 

Certification’’ under the heading 

entitled ‘‘Summary of Criteria Pollutant 

Attainment Plans’’ at the end of the 

table. 

The revisions and additions read as 

follows: 

§ 52.2320 Identification of plan. 

* * * * * 

(c) * * * 

Rule No. Rule title 

State 

effective 

date 

Final rule citation, date Comments 

*******

R307–150. Emission Inventories 

R307–150–01 Purpose and General Requirements ............... 9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–02 Definitions ......................................................... 9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–03 Applicability ...................................................... 9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–04 Sulfur Dioxide Milestone Inventory Requirements.9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–05 Sources Identified in R307–150–3(2), Large 

Major Source Inventory Requirements.

9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–06 Sources Identified in R307–150–3(3) .............. 9/3/2020 [insert Federal Register citation], 4/25/2022.

R307–150–07 Exempted Hazardous Air Pollutants ................ 9/3/2020 [insert Federal Register citation], 4/25/2022.

* * * * * * * 

R307–150–09 Annual Ozone Emission Statement ................. 9/3/2020 [insert Federal Register citation], 4/25/2022.

* * * * * * * 

* * * * * (e) * * * 

Rule title 

State 

effective 

date 

Final rule citation, date Comments 

*******

Summary of Criteria Pollutant Attainment Plans 

*******

Ozone (8-hour, 2015) NNSR Certification .................... 7/29/2021 [insert Federal Register citation], 4/25/2022.

[FR Doc. 2022–08697 Filed 4–22–22; 8:45 am] 

BILLING CODE 6560–50–P 


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