Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2049 

and Drugs, 21 CFR parts 882 and 1270 

are amended as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for part 882 

continues to read as follows: 

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

360j, 360l, 371. 

§ 882.5975 [Removed] 

■ 2. Remove § 882.5975. 

PART 1270—[REMOVED] 

■ 3. Under the authority of 42 U.S.C. 

216, 243, 264, 271, part 1270 is 

removed. 

Dated: January 6, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–00492 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0022] 

RIN 1625–AA00 

Safety Zones; Delaware River 

Dredging, Marcus Hook, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is reestablishing temporary safety zones on 

the waters of the Delaware River in 

portions of Marcus Hook Range and 

Anchorage 7 off Marcus Hook Range. 

The safety zones temporarily restrict 

vessel traffic from transiting or 

anchoring in portions of the Delaware 

River while maintenance dredging is 

being conducted within the Delaware 

River. The safety zones are needed to 

protect personnel, vessels, and the 

marine environment from hazards 

created by dredging operations. Entry of 

vessels or persons into these zones is 

prohibited unless specifically 

authorized by the COTP or his 

designated representatives. 

DATES: This rule is effective without 

actual notice from January 13, 2022 

through January 31, 2022. For the 

purposes of enforcement, actual notice 

will be used from January 6, 2022, until 

January 13, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0022 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Petty Officer Jennifer Padilla, 

Waterways Management Branch, U.S. 

Coast Guard Sector Delaware Bay; 

telephone (215) 271–4889, email 

Jennifer.l.padilla@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

On September 2, 2021, the Coast 

Guard established temporary safety 

zones on the waters of the Delaware 

River in portions of Marcus Hook Range 

and Anchorage 7 off Marcus Hook 

Range to temporarily restrict vessel 

traffic from transiting or anchoring in 

portions of the Delaware River in 

association with maintenance dredging 

within the Delaware River (86 FR 49241, 

Sept. 2, 2021). That rule expired 

November 2, 2021. On January 6, 2022, 

the dredging company informed the 

Coast Guard about additions to the 

original contract and the need to extend 

the project. The new estimated 

completion date is January 31, 2022. 

The Coast Guard is issuing this rule 

without prior notice and opportunity to 

comment pursuant to authority under 

section 4(a) of the Administrative 

Procedure Act (APA) (5 U.S.C. 553(b)). 

This provision authorizes an agency to 

issue a rule without prior notice and 

opportunity to comment when the 

agency for good cause finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing a notice of proposed 

rulemaking (NPRM) with respect to this 

rule because it is impracticable and 

contrary to the public interest. There is 

insufficient time to allow for a 

reasonable comment period prior to the 

start date for dredging operations. The 

rule must be in force by January 6, 2022, 

to serve its purpose of ensuring the 

safety of the public from hazards 

associated with dredging operations 

such as submerged and floating 

pipeline, booster pumps, head sections 

and vessels with a restricted ability to 

maneuver. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

immediate action is needed to mitigate 

the potential safety hazards associated 

with dredging operations in these 

locations. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

(previously 33 U.S.C. 1231). The COTP 

has determined that there are potential 

hazards associated with dredging 

operations. The purpose of this 

rulemaking is to ensure the safety of 

personnel, vessels, and the marine 

environment within a 250-yard radius of 

dredging operations and all associated 

pipeline and equipment. 

IV. Discussion of the Rule 

This rule re-establishes the safety 

zones established on September 2, 2021, 

(86 FR 49241, Sept. 2, 2021). The reestablished zones will be in effect from 

January 6, 2022, through January 31, 

2022. This change is reflected in a 

revised enforcement paragraph, 

paragraph (e). This rule makes no other 

changes to the previoius rule. The 

locations and restrictions of the safety 

zones established by the September rule 

remain the same. 

The safety zones are necessary to 

facilitate annual maintenance dredging 

of the Delaware River in the vicinity of 

Marcus Hook Range and Anchorage 7 

off Marcus Hook Range (as described in 

33 CFR 110.157(a)(8)). Dredging will 

most likely be conducted with the 

dredge ESSEX, though other dredges 

may be used, along with associated 

dredge pipeline and boosters. The 

pipeline consists of a combination of 

floating hoses immediately behind the 

dredge and submerged pipeline leading 

to upland disposal areas. Due to the 

hazards related to dredging operations, 

the associated pipeline, and the location 

of submerged pipeline, safety zones are 

being established in the following areas: 

(1) Safety zone one includes all 

navigable waters within 250 yards of the 

dredge displaying lights and shapes for 

vessels restricted in ability to maneuver 

as described in 33 CFR 83.27, and all 

related dredge equipment when the 

dredge is operating in Marcus Hook 

Range, and Anchorage 7. This safety 

zone is being established for the 

duration of the maintenance project. 

Vessels requesting to transit the safety 

zone must contact the dredge on VHF 

channel 13 or 16 at least 1 hour prior 


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2050 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

to arrival to arrange safe passage. At 

least one side of the main navigational 

channel will be kept clear for safe 

passage of vessels in the vicinity of the 

safety zone. At no time will the entire 

main navigational channel be closed to 

vessel traffic. Vessels should avoid 

meeting in these areas where one side 

of the main navigational channel is 

open and proceed per this rule and the 

Rules of the Road (33 CFR subchapter 

E). 

(2) Safety zone two includes all the 

waters of Anchorage 7 off Marcus Hook 

Range, as described in 33 CFR 

110.157(a)(8). Vessels wishing to anchor 

in Anchorage 7 off Marcus Hook Range 

while this rule is in effect must obtain 

permission from the COTP at least 24 

hours in advance by calling (215) 271– 

4807. Vessels requesting permission to 

anchor within Anchorage 7 off Marcus 

Hook must be at least 650 feet in overall 

length. The COTP will permit, at 

minimum, only one vessel to anchor at 

a time on a ‘‘first-come, first-served’’ 

basis. Vessels will only be allowed to 

anchor for a 12 hour period. Vessels that 

require an examination by the Public 

Health Service, Customs, or Immigration 

authorities will be directed to an 

anchorage by the COTP for the required 

inspection. Vessels are encouraged to 

use Anchorage 9 near the entrance to 

Mantua Creek, Anchorage 10 at Naval 

Base, Philadelphia, and Anchorage 6 off 

Deepwater Point Range as alternative 

anchorages. 

Preference is being given to vessels at 

least 650 feet in length in the Anchorage 

7 while this rule is in effect, because 

vessels of this size are limited in their 

ability to utilize other anchorages due to 

draft. The depth of Anchorage 7 

provides an acceptable depth for large 

vessels to bunker and stage for facility 

arrival. Smaller vessels maintain a host 

of other options to include, but are not 

limited to Anchorage 9 and 10 as 

recommended above. 

Entry into, transiting, or anchoring 

within safety zone one is prohibited 

unless vessels obtain permission from 

the COTP or make satisfactory passing 

arrangements with the operating dredge 

per this rule and the Rules of the Road 

(33 CFR subchapter E). The COTP may 

issue updates regarding the vessel and 

equipment being utilized for these 

dredging operations via Marine Safety 

Information Bulletin and Broadcast 

Notice to Mariners. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action’’ under 

Executive Order 12866. Accordingly, 

this rule has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on size, location, duration, and 

traffic management of the safety zones. 

The safety zones will be enforced in an 

area and in a manner that does not 

conflict with transiting commercial and 

recreational traffic. At least one side of 

the main navigational channel will be 

open for vessels to transit at all times. 

Moreover, the Coast Guard will work in 

coordination with the pilots to ensure 

vessel traffic can transit the area safely. 

Although this regulation will restrict 

access to regulated areas, the effect of 

this rule will not be significant because 

there are a number of alternate 

anchorages available for vessels to 

anchor. Furthermore, vessels may 

transit through the safety zones with the 

permission of the COTP or make 

satisfactory passing arrangements with 

the dredge ESSEX, or other dredge(s) 

that may be used in accordance with 

this rule and the Rules of the Road (33 

CFR subchapter E). The Coast Guard 

will notify the maritime public about 

the safety zones through maritime 

advisories, allowing mariners to alter 

their plans accordingly. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2051 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves safety 

zones to protect waterway users that 

would prohibit entry within 250 yards 

of dredging operations, within Marcus 

Hook Anchorage and will close only one 

side of the main navigation channel. It 

is categorically excluded from further 

review under paragraph L[60a] of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T05–0022, to read as 

follows: 

§ 165.T05–0022 Safety Zones, Delaware 

River Dredging; Marcus Hook, PA. 

(a) Location. The following areas are 

safety zones: 

(1) Safety zone one includes all waters 

within 250 yards of the dredge 

displaying lights and shapes for vessels 

restricted in ability to maneuver as 

described in 33 CFR 83.27, as well as all 

related dredge equipment, while the 

dredge is operating in Marcus Hook 

Range. For enforcement purposes 

Marcus Hook Range includes all 

navigable waters of the Delaware River 

shoreline to shoreline, bound by a line 

drawn perpendicular to the center line 

of the channel at the farthest upriver 

point of the range to a line drawn 

perpendicular to the center line of the 

channel at the farthest downriver point 

of the range. 

(2) Safety zone two includes all the 

waters of Anchorage 7 off Marcus Hook 

Range, as described in 33 CFR 

110.157(a)(8) and depicted on U. S. 

Nautical Chart 12312. 

(b) Definitions. As used in this 

section, designated representative 

means any Coast Guard commissioned, 

warrant, or petty officer who has been 

authorized by the Captain of the Port to 

assist with enforcement of the safety 

zone described in paragraph (a) of this 

section. 

(c) Regulations. (1) Entry into or 

transiting within the safety zone one is 

prohibited unless vessels obtain 

permission from the Captain of the Port 

via VHF–FM channel 16 or 215–271– 

4807, or make satisfactory passing 

arrangements via VHF–FM channel 13 

or 16 with the operating dredge per this 

section and the rules of the Road (33 

CFR subchapter E). Vessels requesting to 

transit shall contact the operating 

dredge via VHF–FM channel 13 or 16 at 

least 1 hour prior to arrival. 

(2) Vessels desiring to anchor in safety 

zone two, Anchorage 7 off Marcus Hook 

Range, must obtain permission from the 

COTP at least 24 hours in advance by 

calling (215) 271–4807. The COTP will 

permit, at minimum, one vessel at a 

time to anchor on a ‘‘first-come, firstserved’’ basis. Vessels will only be 

allowed to anchor for a 12 hour period. 

Vessels that require an examination by 

the Public Health Service, Customs, or 

Immigration authorities will be directed 

to an anchorage for the required 

inspection by the COTP. 

(3) Vessels desiring to anchor in safety 

zone two, Anchorage 7 off Marcus Hook 

Range, must be at least 650 feet in 

length overall. 

(4) This section applies to all vessels 

except those engaged in the following 

operations: Enforcement of laws, service 

of aids to navigation, and emergency 

response. 

(d) Enforcement. The U.S. Coast 

Guard may be assisted by federal, state 

and local agencies in the patrol and 

enforcement of the zone. 

(e) Enforcement period. This rule will 

be enforced from January 6, 2022, 

through January 31, 2022, unless 

cancelled earlier by the Captain of the 

Port. 

Dated: January 6, 2022. 

Jonathan D. Theel, 

Captain, U. S. Coast Guard, Captain of the 

Port, Delaware Bay. 

[FR Doc. 2022–00560 Filed 1–12–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 410 and 414 

[CMS–6081–N] 

Medicare Program; Updates to Lists 

Related to Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) Conditions of Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Updates to and selection of 

certain codes. 

SUMMARY: This document announces the 

updated Healthcare Common Procedure 

Coding System (HCPCS) codes on the 

Master List of DMEPOS Items 

Potentially Subject to Face-to-Face 

Encounter and Written Order Prior to 

Delivery and/or Prior Authorization 

Requirements. It also announces the 

initial selection of HCPCS codes on the 

Required Face-to-Face Encounter and 

Written Order Prior to Delivery List and 

the updates the HCPCS codes on the 

Required Prior Authorization List. 

DATES: The implementation is effective 

on April 13, 2022. Prior authorization 

will be implemented in 3 incremental 

phases, with the final phase being 

national implementation. Phase 1 

includes 1 state per jurisdiction and is 

effective April 13, 2022, Phase 2 

includes 4 States per jurisdiction and is 

effective July 12, 2022, and Phase 3 is 

nationwide and is effective October 10, 

2022. 

FOR FURTHER INFORMATION CONTACT:

Susan Billet, (410) 786–1062. 


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