26988 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 

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 

rulemaking action of amending 

restricted area R–7001C and establishing 

four restricted areas, R–7001D, R– 

7002A, R–7002B, and R–7002C, 

qualifies for categorical exclusion under 

the National Environmental Policy Act 

(42 U.S.C. 4321 et seq.) and its 

implementing regulations at 40 CFR part 

1500, and in accordance with FAA 

Order 1050.1F, Environmental Impacts: 

Policies and Procedures, paragraph 5– 

6.5a, which categorically excludes from 

further environmental impact review 

rulemaking actions that designate or 

modify classes of airspace areas, 

airways, routes, and reporting points 

(see 14 CFR part 71, Designation of 

Class A, B, C, D, and E Airspace Areas; 

Air Traffic Service Routes; and 

Reporting Points). As such, this 

rulemaking action is not expected to 

result in any potentially significant 

environmental impacts. In accordance 

with FAA Order 1050.1F, paragraph 5– 

2 regarding Extraordinary 

Circumstances, the FAA has reviewed 

this action for factors and circumstances 

in which a normally categorically 

excluded action may have a significant 

environmental impact requiring further 

analysis. For this rulemaking action, the 

FAA has determined that no 

extraordinary circumstances exist that 

warrant preparation of an 

environmental assessment or 

environmental impact study. On 

February 2, 2022, and in accordance 

with FAA Order 1050.1F, paragraph 8– 

2—Adoption of Other Agencies’ NEPA 

Documents, the FAA adopted 

WYARNG’s Supplemental 

Environmental Assessment (SEA) and 

Finding of No Significant Impact/ 

Record of Decision (FONSI) for the 

establishment of R–7001D, at Camp 

Guernsey, Guernsey, Wyoming. 

WYARNG finalized its SEA in 

November 2021, and signed the FONSI 

on December 28, 2021. 

Lists of Subjects in 14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73 as follows: 

PART 73—SPECIAL USE AIRSPACE 

■ 1. The authority citation for part 73 

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. 

§ 73.70 Wyoming [Amended] 

■ 2. Section 73.70 is amended as 

follows: 

* * * * * 

R–7001C Guernsey, WY [Amended] 

Boundaries: Beginning at lat. 

42°27′30′′ N, long. 104°52′32′′ W; to lat. 

42°27′30′′ N, long. 104°42′32′′ W; to lat. 

42°22′30′′ N, long. 104°42′32′′ W; to lat. 

42°20′00′′ N, long. 104°52′32′′ W; to the 

point of beginning. 

Designated Altitudes: 23,501 feet MSL 

to 30,000 feet MSL. 

Time of Designation: Intermittent, 24 

hours in advance by NOTAM. 

Controlling agency: FAA, Denver 

ARTCC. 

Using agency: Adjutant General, State 

of Wyoming. 

R–7001D Guernsey, WY [New] 

Boundaries: Beginning at lat. 

42°27′30′′ N, long. 104°52′32′′ W; to lat. 

42°27′30′′ N, long. 104°42′32′′ W; to lat. 

42°22′30′′ N, long. 104°42′32′′ W; to lat. 

42°20′00′′ N, long. 104°52′32′′ W; to the 

point of beginning. 

Designated Altitudes: 30,001 feet MSL 

to 45,000 feet MSL. 

Time of Designation: By NOTAM, at 

least 24 hours in advance. 

Controlling Agency: FAA, Denver 

ARTCC. 

Using Agency: Adjutant General, State 

of Wyoming. 

R–7002A Guernsey, WY [New] 

Boundaries: Beginning at lat. 

42°27′55′′ N, long. 104°52′33′′ W; to lat. 

42°27′55′′ N, long. 104°51′46′′ W; to lat. 

42°28′21′′ N, long. 104°51′45′′ W; to lat. 

42°28′21′′ N, long. 104°48′46′′ W; to lat. 

42°27′56′′ N, long. 104°48′46′′ W; to lat. 

42°27′55′′ N, long. 104°47′28′′ W; to lat. 

42°27′30′′ N, long. 104°46′43′′ W; to lat. 

42°27′30′′ N, long. 104°52′32′′ W; to the 

point of beginning. 

Designated Altitudes: Surface to 

23,500 feet MSL. 

Time of Designation: By NOTAM, at 

least 24 hours in advance. 

Controlling Agency: FAA, Denver 

ARTCC. 

Using Agency: Adjutant General, State 

of Wyoming. 

R–7002B Guernsey, WY [New] 

Boundaries: Beginning at lat. 

42°22′25′′ N, long. 104°42′54′′ W; to lat. 

42°21′41′′ N, long. 104°42′52′′ W; to lat. 

42°21′11′′ N, long. 104°43′17′′ W; to lat. 

42°21′12′′ N, long. 104°47′16′′ W; to lat. 

42°21′19′′ N, long. 104°47′16′′ W; to the 

point of beginning. 

Designated Altitudes: Surface to 

23,500 feet MSL. 

Time of Designation: By NOTAM, at 

least 24 hours in advance. 

Controlling Agency: FAA, Denver 

ARTCC. 

Using Agency: Adjutant General, State 

of Wyoming. 

R–7002C Guernsey, WY [New] 

Boundaries: Beginning at lat. 

42°27′03′′ N, long. 104°53′54′′ W; to lat. 

42°27′03′′ N, long. 104°52′32′′ W; to lat. 

42°20′00′′ N, long. 104°52′32′′ W; to lat. 

42°20′18′′ N, long. 104°51′19′′ W; to lat. 

42°19′42′′ N, long. 104°51′17′′ W; to lat. 

42°19′43′′ N, long. 104°53′03′′ W; to lat. 

42°20′49′′ N, long. 104°54′38′′ W; to lat. 

42°22′43′′ N, long. 104°54′38′′ W; to lat. 

42°22′48′′ N, long. 104°53′22′′ W; to lat. 

42°23′39′′ N, long. 104°53′23′′ W; to lat. 

42°23′40′′ N, long. 104°53′58′′ W; to the 

point of beginning; excluding that 

airspace 500 feet AGL and below 1⁄4

mile either side of the BNSF railroad. 

Designated Altitudes: Surface to 

23,500 feet MSL. 

Time of Designation: By NOTAM, at 

least 24 hours in advance. 

Controlling Agency: FAA, Denver 

ARTCC. 

Using Agency: Adjutant General, State 

of Wyoming. 

* * * * * 

Issued in Washington, DC, May 2, 2022. 

Scott M. Rosenbloom, 

Manager, Airspace Rules and Regulations. 

[FR Doc. 2022–09692 Filed 5–5–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

20 CFR Part 641 

[Docket No. ETA–2022–0002] 

RIN 1205–AC04 

Senior Community Service 

Employment Program Conforming 

Changes to the Supporting Older 

Americans Act of 2020—Updated 

Guidance on Priority of Service, 

Durational Limits, and State Plan 

Submissions 

AGENCY: Employment and Training 

Administration, Labor Department. 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 26989 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: On February 14, 2022, the 

Department of Labor (Department) 

concurrently published both a direct 

final rule (DFR) and proposed rule 

putting forth guidance on priority 

service, durational limits, and State Plan 

submissions regarding a State’s Senior 

Community Service Employment 

Program, or SCSEP. Because the 

Department did not receive any 

significant adverse comments within the 

scope of the rulemaking, the Department 

is implementing the DFR as published. 

DATES: As of May 6, 2022, the 

Department is confirming the effective 

date of the rule published February 14, 

2022 at 87 FR 8186 as April 15, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Steven Rietzke, Chief, Division of 

National Programs, Tools and Technical 

Assistance, Office of Workforce 

Investment, at 202–693–3980 (this is not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: The DFR 

published at 87 FR 8186 on February 14, 

2022, became effective on April 15, 

2022. In the DFR, the Department stated 

that the DFR would become effective 

April 15, 2022 without further action, 

unless significant adverse comments 

were submitted by March 16, 2022 (the 

end of the public comment period), and 

the Department would publish a timely 

withdrawal of the proposed rule. In the 

same issue of the Federal Register in 

which this notice is published, the 

Department is publishing a withdrawal 

of the proposed rule, which was also 

published on February 14, 2022. 

The Department received seven 

comments on this rulemaking. Several 

of these comments were supportive of 

the provisions this rulemaking proposed 

to implement. While other comments 

could be characterized as negative or 

adverse, none of those comments were 

significant or within the scope of this 

rulemaking. One commenter was 

opposed to the time limit; however, that 

time limit is set forth in the Supporting 

Older Americans Act of 2020, and is, 

therefore, a statutory requirement 

beyond the purview of the rulemaking. 

The remaining comments were outside 

the scope of the rulemaking. The 

comments are publicly available as part 

of the rulemaking docket at https://

www.regulations.gov/docket/ETA-2022- 

0002/comments. 

The Department has determined that 

none of the adverse comments are 

significant and within the scope of the 

rulemaking. Therefore, the DFR 

published at 87 FR 8186 on February 14, 

2022, became effective on April 15, 

2022. 

Angela Hanks, 

Acting Assistant Secretary for Employment 

and Training, Labor. 

[FR Doc. 2022–09491 Filed 5–5–22; 8:45 am] 

BILLING CODE 4510–FN–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2022–N–0289] 

Medical Devices; Cardiovascular 

Devices; Classification of the Reverse 

Central Venous Recanalization System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the reverse central venous 

recanalization system 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 reverse 

central venous recanalization system’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 May 6, 

2022. The classification was applicable 

on February 10, 2020. 

FOR FURTHER INFORMATION CONTACT: Finn 

Donaldson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2568, Silver Spring, 

MD 20993–0002, 301–796–9579, 

Finn.Donaldson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

reverse central venous recanalization 

system 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, in part 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 

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 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

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) of the FD&C Act. 

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 


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