Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 77451 

(C) The method comparison study 

must include predefined maximum 

acceptable differences between the test 

and comparator method across all 

primary outcome measures in the 

clinical study protocol. 

(D) The final release test results for 

each lot used in the clinical study. 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21616 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0820] 

RIN 1625–AA00 

Safety Zone; Kernwood Avenue Bridge 

Repairs—Danvers River, Salem, MA, 

and Beverly, MA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary Interim Rule and 

request for comments. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the navigable waters at mile 1.0 Danvers 

River, within a 100-yard radius of the 

center point of the Kernwood Avenue 

Bridge between Salem, MA and Beverly, 

MA. The temporary safety zone is 

necessary to protect personnel, vessels 

and the marine environment from 

potential hazards created during bridge 

repairs. When enforced, entry of vessels 

or persons into this zone is prohibited 

unless specifically authorized by the 

Captain of the Port Boston or a 

designated representative. 

DATES: 

Effective date: This rule is effective 

without actual notice from September 

23, 2024 through 11:59 p.m. on 

December 31, 2024. For the purposes of 

enforcement, actual notice will be used 

from September 15, 2024, until 

September 23, 2024. 

Comments due date: Comments and 

related material must be received by the 

Coast Guard on or before October 23, 

2024. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2024–0820 using the Federal eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

rulemaking, call or email Mr. Timothy 

Chase, Waterways Management 

Division, U.S. Coast Guard Sector 

Boston, telephone 617–447–1620, or 

email Timothy.w.chase@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

NAD 83 North American Datum 1983 

§ Section 

U.S.C. United States Code 

MASSDOT Massachusetts Department of 

Transportation 

II. Background Information and 

Regulatory History 

On August 28, 2024, the 

Massachusetts Department of 

Transportation (MassDOT) bridge 

division notified the Waterways 

Management Division of U. S. Coast 

Guard Sector Boston that operations to 

make repairs to the Kernwood Avenue 

Bridge, spanning the Danvers River 

between Salem, MA, and Beverly, MA, 

will begin September 15, 2024. 

The Coast Guard is issuing this 

temporary rule under the authority in 5 

U.S.C. 553(b)(B). This statutory 

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.’’ The Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

construction schedule for Kernwood 

Avenue Bridge was only recently 

finalized and prompt action is needed to 

respond to the potential safety hazards 

associated with this project. It is 

impracticable and contrary to the public 

interest to publish an NPRM because 

prompt action is needed to establish this 

safety zone by September 15, 2024, to 

allow for the timely repairs to the 

Kernwood Avenue Bridge and ensure 

the safety of mariners transiting the area 

from the dangers associated with the 

operations associated with these repairs. 

Also, 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 

because prompt action is needed to 

ensure public safety during repair 

operations to the Kernwood Avenue 

Bridge. 

Although this regulation is published 

as an interim rule without prior notice, 

public comment is nevertheless 

desirable to ensure that the regulation is 

both workable and reasonable. 

Accordingly, persons wishing to 

comment may do so by submitting 

written comments as set out under 

ADDRESSES in this preamble. 

Commenters should include their names 

and addresses, identify the docket 

number for the regulation, and give 

reasons for their comments. If the Coast 

Guard determines that changes to the 

temporary interim rule are necessary, 

we will publish a temporary final rule 

or other appropriate document. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034. The 

Captain of the Port Boston (COTP) has 

determined that potential hazards 

associated with bridge repair operations 

starting September 15, 2024, will be a 

safety concern for anyone within a 100- 

yard radius of the center point of the 

Kernwood Avenue Bridge. This rule is 

needed to protect personnel, vessels, 

and the marine environment in the 

navigable waters within the safety zone 

while bridge repair operations are taking 

place. 

IV. Discussion of Rule 

This rule establishes a safety zone 

from September 15, 2024, through 11:59 

p.m. on December 31, 2024. While the 

safety zone will be effective through this 

period, it will only be enforced during 

active repair operations, when work 

barges and cranes will be placed in the 

narrow navigable channel, or other 

instances which may create a hazard to 

navigation. The active repair operations 

will take place during the overnight 

hours, from 9 p.m. through 5 a.m., 

Sunday through Thursday, when 

boating traffic is minimal. 

The safety zone will cover all 

navigable waters within a 100-yard 

radius of the center point of the 

MassDOT Kernwood Avenue Bridge, at 

mile 1.0, spanning the Danvers River, 

between Salem, MA, and Beverly, MA, 

in approximate position 42°32′34.8′′ N 

70°53′54.2′′ W (NAD 83). During times 

of enforcement, all persons or vessels 

will be prohibited from entering the 

safety zone without permission from the 

COTP or a designated representative. 

The Coast Guard will make notice of 

the safety zone via the Local Notice to 

Mariners and issue a Broadcast Notice 

to Mariners via marine channel 16 

(VHF–FM) as soon as practicable in 


khammond on DSKJM1Z7X2PROD with RULES
77452 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 

response to an emergency or hazardous 

condition. In addition, if the project is 

completed before 11:59 p.m. on 

December 31, 2024, enforcement of the 

safety zone will be suspended, and 

notice given via Local Notice to 

Mariners. The First Coast Guard District 

Local Notice to Mariners can be found 

at: http://www.navcen.uscg.gov. 

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 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). 

Accordingly, this rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This regulatory action determination 

is based on the size, location, duration, 

and time of year of the safety zone. 

Vessel traffic will not be able to safely 

transit around this safety zone when 

enforced. As a result, enforcement of the 

safety zone will be limited in duration 

during active repair operations, in the 

overnight hours, Sunday through 

Thursday, during the winter months 

when vessel traffic is minimal. 

Additionally, the Salem, Beverly, and 

Danvers Harbor Masters will be on 

scene during work hours to inform any 

potential vessels of the safety zone. The 

Coast Guard will make notice of this 

safety zone via the Local Notice to 

Mariners and issue a Broadcast Notice 

to Mariners via marine channel 16 

(VHF–FM) as soon as practicable in 

response to an emergency or hazardous 

condition. This rule also allows vessels 

to seek permission to enter the zone. 

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 because they are able to 

transit with permission from COTP or 

the COTP’s designated representative. 

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 will 

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 does 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 

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 the 

establishment of a temporary safety 

zone for the navigable waters within 

100-yard radius of the center point of 

the MassDOT Kernwood Avenue Bridge, 

at mile 1.0, spanning the Danvers River 

between Salem, MA, and Beverly, MA, 

from September 15, 2024, through 

December 31, 2024, during active repair 

operation on the bridge. The safety zone 

will only be enforced from 9 p.m. to 5 

a.m. Sunday through Thursday, when 

work barges and cranes will be placed 

in the narrow navigable channel, or in 

response to an emergency or hazardous 

condition. It is categorically excluded 

from further review under paragraph 

L60(a) 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 contact the 

person listed in the FOR FURTHER


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 77453 

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. 

VI. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking and 

will consider all comments and material 

received during the comment period. If 

we determine that changes to the 

temporary interim rule are necessary, 

the Coast Guard will publish a 

temporary final rule or other 

appropriate document. If you submit a 

comment, please include the docket 

number for this rulemaking, indicate the 

specific section of this document to 

which each comment applies, and 

provide a reason for each suggestion or 

recommendation. 

Submitting comments. We encourage 

you to submit comments through the 

Federal Decision-Making Portal at 

https://www.regulations.gov. To do so, 

go to https://www.regulations.gov, type 

USCG–2024–0303 in the search box and 

click ‘‘Search.’’ Next, look for this 

document in the Search Results column, 

and click on it. Then click on the 

Comment option. If you cannot submit 

your material by using https://

www.regulations.gov, call or email the 

person in the FOR FURTHER INFORMATION

CONTACT section of this rule for alternate 

instructions. 

Viewing material in docket. To view 

documents mentioned in this temporary 

interim rule as being available in the 

docket, find the docket as described in 

the previous paragraph, and then select 

‘‘Supporting & Related Material’’ in the 

Document Type column. Public 

comments will also be placed in our 

online docket and can be viewed by 

following instructions on the https://

www.regulations.gov Frequently Asked 

Questions web page. Also, if you click 

on the Dockets tab and then the 

temporary interim rule, you should see 

a ‘‘Subscribe’’ option for email alerts. 

The option will notify you when 

comments are posted, or a subsequent 

document is published. 

We review all comments received, but 

we will only post comments that 

address the topic of the rule. We may 

choose not to post off-topic, 

inappropriate, or duplicate comments 

that we receive. 

Personal information. We accept 

anonymous comments. Comments we 

post to https://www.regulations.gov will 

include any personal information you 

have provided. For more about privacy 

and submissions to the docket in 

response to this document, see DHS’s 

eRulemaking System of Records notice 

(85 FR 14226, March 11, 2020). 

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, 70124; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.3. 

■ 2. Add § 165.T01–0820 to read as 

follows: 

§ 165.T01–0820 Safety Zone; Kernwood 

Avenue Bridge Repairs—Danvers River, 

Salem, MA, and Beverly, MA. 

(a) Location. The following area is a 

safety zone: all navigable waters within 

a 100-yard radius of the center point of 

the Massachusetts Department of 

Transportation (MassDOT) Kernwood 

Avenue Bridge, at mile 1.0 spanning the 

Danvers River between Salem, MA, and 

Beverly, MA, in approximate position 

42°32′34.8′′ N 70°53′54.2′′ W. 

(b) Enforcement period. The safety 

zone in paragraph (a) of this section is 

effective from September 15, 2024, 

through 11:59 p.m. on December 31, 

2024. The section is subject to 

enforcement from 9 p.m. to 5 a.m. 

Sunday through Thursday, or in 

response to an emergency or hazardous 

condition during this period. The Coast 

Guard will make notice of this safety 

zone via the Local Notice to Mariners 

and issue a Broadcast Notice to 

Mariners via marine channel 16 (VHF– 

FM) as soon as practicable in response 

to an emergency or hazardous 

condition. In addition, if the project is 

completed before 11:59 p.m. on 

December 31, 2024, enforcement of the 

safety zone will be suspended, and 

notice given via Local Notice to 

Mariners. The First Coast Guard District 

Local Notice to Mariners can be found 

at: http://www.navcen.uscg.gov. 

(c) Definitions. As used in this 

section: 

(1) Designated representative means 

any Coast Guard commissioned, 

warrant, petty officer, or any federal, 

state, or local law enforcement officer 

who has been designated by the Captain 

of the Port Boston (COTP) to act on his 

or her behalf. The designated 

representative may be on an official 

patrol vessel or may be on shore and 

will communicate with vessels via 

VHF–FM radio or loudhailer. In 

addition, members of the Coast Guard 

Auxiliary may be present to inform 

vessel operators of this regulation. 

(2) Official patrol vessels mean any 

Coast Guard, Coast Guard Auxiliary, 

state, or local law enforcement vessels 

assigned or approved by the COTP to 

enforce this section. 

(d) Regulations. When this safety zone 

is enforced, the following regulations, 

along with those contained in 33 CFR 

165.23 apply: 

(1) No person or vessel may enter or 

remain in the safety zone described in 

paragraph (a) of this section without the 

permission of the COTP or the COTP’s 

designated representatives. Any person 

or vessel permitted to enter the safety 

zone must comply with the lawful 

directions and orders of the COTP or the 

COTP’s designated representatives. 

(2) To seek permission to enter the 

safety zone, individuals may reach the 

COTP or a COTP-designated 

representative via Channel 16 (VHF– 

FM) or (857) 416–3015 (Sector Boston 

Command Center). 

J.J. Schock, 

Commander, U.S. Coast Guard, Acting 

Captain of the Port Boston. 

[FR Doc. 2024–21688 Filed 9–20–24; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0755] 

RIN 1625–AA00 

Safety Zone; Lake Erie, Hamburg, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone 

within 656 yards of the Andrew D. 

Byers Water Circular DZ, adjacent to 

Hamburg Beach on Lake Erie. The safety 

zone is needed to protect personnel, 

vessels, and the marine environment 

from potential hazards created by a 

military exercise. Entry of vessels or 

persons into this zone is prohibited 

unless specifically authorized by the 

Captain of the Port Eastern Great Lakes 

or a designated representative. 

DATES: This rule is effective from 6 a.m. 

through 11:30 p.m. from September 26, 

2024, through September 27, 2024. 


khammond on DSKJM1Z7X2PROD with RULES