Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations 88249 

investigator shall obtain the informed 

consent of each human subject to whom 

the drug is administered, in accordance 

with part 50 of this chapter. Additional 

specific responsibilities of clinical 

investigators are set forth in this part 

and in parts 50 and 56 of this chapter. 

PART 812—INVESTIGATIONAL 

DEVICE EXEMPTIONS 

■ 6. The authority citation for part 812 

is revised to read as follows: 

Authority: 21 U.S.C. 331, 351, 352, 353, 

355, 360, 360c–360f, 360h–360j, 360hh– 

360pp, 360rr–360ss, 360bbb–8b, 371, 372, 

374, 379e, 381, 382; 42 U.S.C. 216, 241, 262. 

■ 7. Revise § 812.2 (b)(1)(iii) to read as 

follows: 

§ 812.2 Applicability. 

* * * * * 

(b) * * * 

(1) * * * 

(iii) Ensures that each investigator 

participating in an investigation of the 

device obtains from each subject under 

the investigator’s care, informed consent 

in accordance with part 50 of this 

chapter. 

* * * * * 

Dated: December 1, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2023–27935 Filed 12–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 3, 100, 165 

[Docket Number USCG–2023–0970] 

RIN 1625–AA00 

Coast Guard Sector Sault Sainte Marie; 

Sector Name Conforming Amendment 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The rule makes nonsubstantive changes to Coast Guard 

regulations in association with a change 

in the Coast Guard’s internal 

organization. The purpose of this rule is 

to reflect that U.S. Coast Guard Sector 

Sault Sainte Marie has been renamed 

U.S. Coast Guard Sector Northern Great 

Lakes. This rule will have no 

substantive effect on the regulated 

public. 

DATES: This rule is effective without 

actual notice December 21, 2023. For 

the purposes of enforcement, actual 

notice will be used from December 1, 

2023, until December 21, 2023. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2023– 

0970 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 about this rule, call 

or email Chief Warrant Officer Charles 

Palmer, U.S. Coast Guard; telephone 

906–253–2462, email Charles.b.palmer@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

AOR Area of responsibility 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

OCMI Officer in Charge of Marine 

Inspections 

OFCO Operating Facility Change Order 

SAR Search and Rescue 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

For the last several years, the Coast 

Guard has sought to better align the 

names of its assets to correspond to the 

area of responsibility which they serve. 

Review of the missions and 

engagements within the northern Great 

Lakes region highlighted that ‘‘Sector 

Sault Sainte Marie’’ alone did not 

adequately capture the breadth and 

range of Coast Guard operations and 

relationships throughout the region. The 

Coast Guard has approved the name 

change to U.S. Coast Guard Sector 

Northern Great Lakes to acknowledge 

the long-standing commitment to all 

communities of the region and to 

reaffirm the multi-mission support that 

the Coast Guard provides to ensure 

safety at sea and enhanced maritime 

governance. The geographic boundaries 

of Sector Northern Great Lakes are not 

changing, and its office is not moving 

from Sault Sainte Marie, MI. 

We did not publish a notice of 

proposed rulemaking (NPRM) before 

this final rule. The Coast Guard finds 

that this rule is exempt from notice and 

comment rulemaking requirements 

under 5 U.S.C. 553(b)(A) because the 

changes it makes are conforming 

amendments involving agency 

organization. The Coast Guard also finds 

good cause exists under 5 U.S.C. 

553(b)(B) for not publishing an NPRM 

because the changes will have no 

substantive effect on the public and 

notice and comment are therefore 

unnecessary. For the same reasons, the 

Coast Guard finds good cause exists 

under 5 U.S.C. 553(d)(3) to make the 

rule effective fewer than 30 days after 

publication in the Federal Register. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 14 U.S.C. 504(a)(2), 

as delegated at 33 CFR 1.05–1(h), to 

issue regulations necessary to 

implement technical, organizational, 

and conforming amendments and 

corrections to rules, regulations, and 

notices. 

On November 06, 2023, the Coast 

Guard issued Operating Facility Change 

Order (OFCO) No. 037–23 which 

changed the official unit name of U.S. 

Coast Guard Sector Sault Sainte Marie 

to U.S. Coast Guard Sector Northern 

Great Lakes. The previous name of 

Sector Sault Sainte Marie is described 

and reflected in regulations, which also 

contain contact details and other 

references to Sector Sault Sainte Marie. 

These conforming amendments update 

those regulations so that they contain 

current information. 

Under 14 U.S.C. 504(a)(2), the 

Commandant of the Coast Guard has the 

authority to establish and prescribe the 

purpose of Coast Guard Shore 

establishments. This authority has been 

delegated to the Chief of the Coast 

Guard’s Office of Regulations and 

Administrative Law under 33 CFR 1.05– 

1(h). 

IV. Discussion of the Rule 

OFCO No. 037–23, issued November 

06, 2023, changed the official unit name 

of U.S. Coast Guard Sector Sault Sainte 

Marie to U.S. Coast Guard Sector 

Northern Great Lakes. The November 

2023 OFCO did not change the area of 

responsibility (AOR). The AOR of U.S. 

Coast Guard Sector Northern Great 

Lakes is identical to that of what was 

U.S. Coast Guard Sector Sault Sainte 

Marie. All authorities and 

responsibilities previously assigned to 

Commander, U.S. Coast Guard Sector 

Sault Sainte Marie have been assigned 

to Commander, U.S. Coast Guard Sector 

Northern Great Lakes. Additionally, all 

authorities that were vested in the 

Commander, U.S. Coast Guard Sector 

Sault Sainte Marie as it pertains to the 

COTP, the OCMI, the Federal On Scene 

Coordinator, the Federal Maritime 

Security Coordinator, and the Search 

and Rescue Coordinator, have been 

assigned to Commander, U.S. Coast 

Guard Sector Northern Great Lakes. This 

rule does not change any sector, OCMI, 

or COTP zone boundary lines, nor does 


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88250 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations 

it have any substantive impact on 

existing regulated navigation area, safety 

zone, or security zone regulation, or any 

naval vessel protection zones. 

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. 

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 finding that the name 

change will have no substantive effect 

on the public. 

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. 

For the reasons stated in section V.A. 

above, this rule will not have a 

significant economic impact on any 

member of the public, including ‘‘small 

entities.’’ 

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 

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 consists only of 

an organizational amendment. It is 

categorically excluded from further 

review under paragraph L3 of Appendix 

A, Table 1 of DHS Instruction Manual 

023–01–001–01, Rev. 1, Implementation 

of the National Environmental Policy 

Act. 

List of Subjects 

33 CFR Part 3 

Organization and functions 

(Government agencies). 

33 CFR Part 100 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

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 parts 3, 100, and 165 as follows: 

PART 3—COAST GUARD AREAS, 

DISTRICTS, SECTORS, MARINE 

INSPECTION ZONES, AND CAPTAIN 

OF THE PORT ZONES 

■ 1. The authority citation for part 3 

continues to read as follows: 

Authority: 14 U.S.C. 501, 504; Pub. L. 107– 

296, 116 Stat. 2135; Department of Homeland 

Security Delegation No. 00170.1, Revision 

No. 01.3. 

§ 3.45–45 [Amended] 

■ 2. Amend § 3.45–45 by removing the 

words ‘‘Sector Sault Ste. Marie’’ and 

adding in their place the words ‘‘Sector 

Northern Great Lakes’’ in the section 

heading and removing the words 

‘‘Sector Sault Ste. Marie’s’’ and adding 

in their place the words ‘‘Sector 

Northern Great Lakes’ ’’ in the 

introductory text and paragraph (a). 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 3. The authority citation for part 100 

continues to read as follows: 

Authority: 46 U.S.C. 70041; 33 CFR 1.05– 

1. 

§ 100.901 [Amended] 

■ 4. Amend § 100.901 in table 1 by 

removing the words ‘‘Sector Sault Ste. 

Marie’’ and adding in their place the 

words ‘‘Sector Northern Great Lakes’’ in 

the center heading above the entry ‘‘(1) 

Bridgefest Regatta Sponsor: Bridgefest 

Committee’’. 


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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Rules and Regulations 88251 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 5. 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. 

§ 165.918 [Amended] 

■ 6. Amend § 165.918 by removing the 

words ‘‘Port Sault Sainte Marie’’ and 

adding in their place the words ‘‘Port 

Northern Great Lakes’’ in the section 

heading and wherever they appear in 

paragraphs (a)(1) through (3), (b), (d), 

and (e). 

§ 165.928 [Amended] 

■ 7. Amend § 165.928 in paragraph (g) 

by removing the words ‘‘Sault Ste. 

Marie’’ and adding in their place the 

words ‘‘Northern Great Lakes’’. 

§ 165.944 [Amended] 

■ 8. Amend § 165.944 in paragraphs 

(d)(1) and (e) by removing the words 

‘‘Sault Sainte Marie’’ and adding in 

their place the words ‘‘Northern Great 

Lakes’’. 

Dated: December 18, 2023. 

Michael T. Cunningham, 

Chief, Office of Regulations and 

Administrative Law. 

[FR Doc. 2023–28103 Filed 12–20–23; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2023–0934] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Turner Cut, Near Stockton, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary interim rule and 

request for comments 

SUMMARY: The Coast Guard is 

temporarily modifying the operating 

schedule that governs the draw of the 

Zuckerman Brothers (McDonald Island) 

bridge, mile 2.3, across Turner Cut, near 

Stockton, CA. This action is necessary 

to allow the bridge owner, Reclamation 

District 2030 (RD2030), to complete 

design plans and conduct repairs to the 

bridge to bring it back to its normal 

operating status. 

DATES: This temporary interim rule is 

effective from December 21, 2023 

through 5 p.m. on September 30, 2024. 

Comments and related material must 

reach the Coast Guard on or before 

January 22, 2024. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov. Type the docket 

number (USCG–2023–0934) in the 

‘‘SEARCH’’ box and click ‘‘SEARCH’’. In 

the Document Type column, select 

‘‘Supporting & Related Material’’. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

interim rule, call or email Carl Hausner, 

Chief, Bridge Section, Eleventh Coast 

Guard District; telephone 510–437– 

3516, email Carl.T.Hausner@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 

NOTD Notice of Temporary Deviation 

PG&E Pacific Gas and Electric 

Pub. L. Public Law 

RD2030 Reclamation District 2030 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary interim 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), 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. This bridge is secured 

closed and will be secured closed until 

design plans are finalized, coordination 

of construction schedule can be made 

with landowners and PG&E, contractor 

hired, and repairs completed. 

On June 21, 2023, RD2030 notified the 

Coast Guard that the Zuckerman 

Brothers (McDonald Island) retractable 

span bridge should not open for the 

passage of vessels. The cause was the 

gradual movement which squeezed the 

abutments towards the center movable 

steel section. The span cannot be 

opened without the risk of it being stuck 

in the open-to-navigation position. The 

Zuckerman Brothers (McDonald Island) 

bridge is the only road in and out of 

McDonald Island, which includes farms 

and a PG&E station and wells. The Coast 

Guard granted a Notice of Temporary 

Deviation (NOTD) from the operating 

schedule of the bridge, allowing the 

span to be secured in the closed 

position until repairs can be made. The 

NOTD will expire at 7 a.m. on December 

18, 2023. The design, coordination of 

work with affected parties, and repair is 

delayed. The retractable span will not 

be operational at the expiration of the 

NOTD. The Coast Guard received the 

report of these delays on November 17, 

2023. Therefore, there is insufficient 

time to provide a reasonable comment 

period and then consider those 

comments before issuing the 

modification. 

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

Guard finds that good cause exists for 

making it effective in less than 30 days 

after publication in the Federal 

Register. For reasons presented above, 

delaying the effective date of this rule 

would be impracticable and contrary to 

the public interest because the 

retractable span of the bridge is 

currently secured closed and cannot be 

operated until repairs are completed. 

We are soliciting comments on this 

rulemaking. 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 

temporary interim rule under authority 

in 33 U.S.C. 499. The Coast Guard is 

modifying the operating schedule that 

governs the Zuckerman Brothers 

(McDonald Island) bridge, mile 2.3, 

across Turner Cut, near Stockton, CA. 

The Zuckerman Brothers (McDonald 

Island) bridge has a vertical clearance, 

in the closed position, of 16 feet at mean 

high water and unlimited vertical 

clearance when opened. 

The existing drawbridge regulation, 

33 CFR 117.5, states that the draw of the 

Zuckerman Brothers (McDonald Island) 

bridge must open for vessels if a signal 

is given to do so. RD2030, the bridge 

owner, has requested this modification 

as additional time is required to 

complete bridge repairs. 

Drawtender logs from January 2022 

through June 2023 indicate the span 

opened on average, 2 times in January; 

1 time in February; 1 time in March; 3 

times in April; 11 times in May; 8 times 

in June; 18 times in July; 6 times in 

August; 7 times in September; 4 times 

in October; 2 times in November; and 3 

times in December. No complaints have 

been received from mariners since the 


khammond on DSKJM1Z7X2PROD with RULES