Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Rules and Regulations 24271 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document amends FAA Order JO 

7400.11F, Airspace Designations and 

Reporting Points, dated August 10, 

2021, and effective September 15, 2021. 

FAA Order JO 7400.11F is publicly 

available as listed in the ADDRESSES

section of this document. FAA Order JO 

7400.11F lists Class A, B, C, D, and E 

airspace areas, air traffic service routes, 

and reporting points. 

The Rule 

This amendment to 14 CFR 71 

amends the Class E airspace extending 

upward from 700 feet above the surface 

at Greenville Municipal Airport, 

Greenville, PA, by removing the 

Youngstown VORTAC and the 

associated extension from the airspace 

legal description. 

This action is the result of an airspace 

review caused by the decommissioning 

of the Youngstown VOR, which 

provided navigation information for the 

instrument procedures at this airport, as 

part of the VOR MON Program. 

FAA Order JO 7400.11, Airspace 

Designations and Reporting Points, is 

published yearly and effective on 

September 15. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore: (1) Is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that only affects air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, does not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1F, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 5–6.5.a. This airspace action 

is not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AEA PA E5 Greenville, PA [Amended] 

Greenville Municipal Airport, PA 

(Lat. 41°26′48′′ N, long. 80°23′28′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.3-mile 

radius of Greenville Municipal Airport. 

Issued in Fort Worth, Texas, on April 20, 

2022. 

Martin A. Skinner, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2022–08710 Filed 4–22–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2021–N–1011] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Autofluorescence Detection Device for 

General Surgery and Dermatological 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the autofluorescence 

detection device for general surgery and 

dermatological use into class II (special 

controls). The special controls that 

apply to the device type are identified 

in this order and will be part of the 

codified language for the 

autofluorescence detection device for 

general surgery and dermatological use’s 

classification. We are taking this action 

because we have determined that 

classifying the device into class II 

(special controls) will provide a 

reasonable assurance of safety and 

effectiveness of the device. We believe 

this action will also enhance patients’ 

access to beneficial innovative devices. 

DATES: This order is effective April 25, 

2022. The classification was applicable 

on November 2, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Mavadia-Shukla, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4643, 

Silver Spring, MD 20993–0002, 301– 

348–1596, Jessica.Mavadia-Shukla@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

autofluorescence detection device for 

general surgery and dermatological use 

as class II (special controls), which we 

have determined will provide a 

reasonable assurance of safety and 

effectiveness. In addition, we believe 

this action will enhance patients’ access 

to beneficial innovation, by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 


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24272 Federal Register / Vol. 87, No. 79 / Monday, April 25, 2022 / Rules and Regulations 

1FDA notes that the ACTION caption for this final 

order is styled as ‘‘Final amendment; final order,’’ 

rather than ‘‘Final order.’’ Beginning in December 

2019, this editorial change was made to indicate 

that the document ‘‘amends’’ the Code of Federal 

Regulations. The change was made in accordance 

with the Office of Federal Registers (OFR) 

interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 

section 513(f)(2)(B)(i) of the FD&C Act). 

As a result, other device sponsors do not 

have to submit a De Novo request or 

premarket approval application to 

market a substantially equivalent device 

(see section 513(i) of the FD&C Act, 

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On September 27, 2017, FDA received 

AiBiomed, Corp.’s request for De Novo 

classification of the Parathyroid 

Detection (Model PTeye) System. 

Subsequently, on December 22, 2017, 

FDA received Fluoptics’s similar 

request for De Novo classification of the 

Fluobeam 800 Clinic Imaging Device 

used with Fluocase 800 Control System. 

FDA reviewed both requests in order to 

classify the devices under the criteria 

for classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the requests, 

we determined that the devices can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the devices. 

Therefore, on November 2, 2018, FDA 

issued orders to both requesters 

classifying the devices into class II. In 

this final order, FDA is codifying the 

classification of these devices by adding 

21 CFR 878.4550.1 We have named the 

generic type of device autofluorescence 

detection device for general surgery and 

dermatological use, and it is identified 

as an adjunct tool that uses 

autofluorescence to detect tissues or 

structures. This device is not intended 

to provide a diagnosis. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—AUTOFLUORESCENCE DETECTION DEVICE FOR GENERAL SURGERY AND DERMATOLOGICAL USE RISKS AND

MITIGATION MEASURES

Identified risks Mitigation measures 

Electrical, mechanical, or thermal hazards leading to user 

injury or discomfort.

Electromagnetic compatibility testing; Electrical, mechanical and thermal safety testing; Software verification, validation, and hazard analysis; and Labeling. 

Tissue, skin burn, or eye injury due to light and laser exposure.Light and laser exposure safety testing and Labeling. 

Infection and cross contamination ..................................... Sterilization validation, Shelf life testing, and Labeling. 

Adverse tissue reaction ...................................................... Biocompatibility evaluation. 

False identification of target tissues or structures leading 

to errors in patient management (e.g., removal of 

healthy tissue or not removing diseased tissue).

In vivo performance testing; Software verification, validation, and hazard analysis; 

and Labeling. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. In order for 

a device to fall within this classification, 

and thus avoid automatic classification 

in class III, it would have to comply 

with the special controls named in this 

final order. The necessary special 

controls appear in the regulation 

codified by this order. We encourage 

sponsors to consult with us if they wish 

to use a non-animal testing method they 

believe is suitable, adequate, validated, 

and feasible. We will consider if such an 

alternative method could be assessed for 

equivalency to an animal test method. 

This device is subject to premarket 

notification requirements under section 

510(k) of the FD&C Act. 


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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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