Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 565 

3The Office of the Federal Register has published 

this document under the category ‘‘Rules and 

Regulations’’ pursuant to its interpretation of 1 CFR 

5.9(b). We note that the categorization as such for 

purposes of publication in the Federal Register 

does not affect the content or intent of the 

document. See 1 CFR 5.1(c). 

21 CFR 211.110.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations.3

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

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 

parts 210 and 211 relating to CGMP 

have been approved under OMB control 

number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics, https://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// 

www.regulations.gov. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31356 Filed 1–3–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2024–1099] 

Security Zone; Potomac River and 

Anacostia River, and Adjacent Waters, 

Washington, DC 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

a security zone along the Potomac River, 

Anacostia River, and adjacent waters at 

Washington, DC, for the State Funeral 

for former President James Carter. This 

action is necessary to protect 

government officials, mitigate potential 

terrorist acts and incidents, and enhance 

public and maritime safety and security 

immediately before, during, and after 

this activity. During the enforcement 

period, entry into or remaining within 

the zone is prohibited unless authorized 

by the Captain of the Port or their 

designated representative. 

DATES: The regulations in 33 CFR 

165.508 will be enforced from 8 a.m., 

January 7, 2025, through 4 p.m., January 

9, 2025, for the security zone location 

identified in 33 CFR 16.508(a)(6). 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email LCDR Kate Newkirk, U.S. Coast 

Guard Sector Maryland-National Capital 

Region, Waterways Management 

Division; telephone 410–576–2596, 

email Kate.M.Newkirk@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce regulations in 33 

CFR 165.508 for the locations identified 

in paragraph (a)(6) from 8 a.m., January 

7, 2025, through 4 p.m., January 9, 2025. 

This action is being taken to protect 

government officials, mitigate potential 

terrorist acts and incidents, and enhance 

public and maritime safety and security 

immediately before, during, and after 

this event. Our regulations for the 

Security Zone; Potomac River and 

Anacostia River, and adjacent waters at 

Washington, DC. The regulation at 33 

CFR 165.508(a)(6) specifies the location 

for this security zone as an area that 

includes all navigable waters described 

in paragraphs (a)(1) through (3), which 

includes Zones 1, 2, and 3. 

• Security Zone 1, paragraph (a)(1); 

all navigable waters of the Potomac 

River, from shoreline to shoreline, 

bounded to the north by the Francis 

Scott Key (US–29) Bridge, at mile 113, 

and bounded to the south by a line 

drawn from the Virginia shoreline at 

Ronald Reagan Washington National 

Airport at 38°51′21.3′′ N, 077°02′00.0′′ 

W, eastward across the Potomac River to 

the District of Columbia shoreline at 

Hains Point at position 38°51′24.3′′ N, 

077°01′19.8′′ W, including the waters of 

the Boundary Channel, Pentagon 

Lagoon, Georgetown Channel Tidal 

Basin, and Roaches Run. 

• Security Zone 2, paragraph (a)(2); 

all navigable waters of the Anacostia 

River, from shoreline to shoreline, 

bounded to the north by the John Philip 

Sousa (Pennsylvania Avenue) Bridge, at 

mile 2.9, and bounded to the south by 

a line drawn from the District of 

Columbia shoreline at Hains Point at 

position 38°51′24.3′′ N, 077°01′19.8′′ W, 

southward across the Anacostia River to 

the District of Columbia shoreline at 

Giesboro Point at position 38°50′52.4′′ 

N, 077°01′10.9′′ W, including the waters 

of the Washington Channel. 

• Security Zone 3 paragraph (a)(3); all 

navigable waters of the Potomac River, 

from shoreline to shoreline, bounded to 

the north by a line drawn from the 

Virginia shoreline at Ronald Reagan 

Washington National Airport, at 

38°51′21.3′′ N, 077°02′00.0′′ W, eastward 

across the Potomac River to the District 

of Columbia shoreline at Hains Point at 

position 38°51′24.3′′ N, 077°01′19.8′′ W, 

thence southward across the Anacostia 

River to the District of Columbia 

shoreline at Giesboro Point at position 

38°50′52.4′′ N, 077°01′10.9′′ W, and 

bounded to the south by the Woodrow 

Wilson Memorial (I–95/I–495) Bridge, at 

mile 103.8. 

During the enforcement period, as 

specified in § 165.508(b), entry into or 

remaining in these zones is prohibited 

unless authorized by the Coast Guard 

Captain of the Port Maryland-National 

Capital Region. Public vessels and 

vessels already at berth at the time of 

the security zone is implemented do not 

have to depart the security zone. All 

vessels underway within the security 

zone at the time the security zone is 

implemented are to depart the zone. To 

seek permission to transit the zone, the 

Captain of the Port Maryland-National 

Capital Region can be contacted at 

telephone number (410) 576–2525 or on 

Marine Band Radio, VHF–FM channel 

16 (156.8 MHz). Coast Guard vessels 

enforcing this zone can be contacted on 

Marine Band Radio, VHF–FM channel 

16 (156.8 MHz). The Coast Guard may 

be assisted by other Federal, state, or 

local law enforcement agencies in 

enforcing this regulation. If the Captain 

of the Port or his designated on-scene 

patrol personnel determines the security 

zone need not be enforced for the full 

duration stated in this notification, a 

Broadcast Notice to Mariners may be 

used to suspend enforcement and grant 

general permission to enter the security 

zone. 

In addition to this notification of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification to this enforcement period 

via the Local Notice to Mariners, and 

marine information broadcasts. 


khammond on DSK9W7S144PROD with RULES
566 Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Rules and Regulations 

Dated: December 30, 2024. 

Patrick C. Burkett, 

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

Port Maryland-National Capital Region. 

[FR Doc. 2024–31636 Filed 1–3–25; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF TRANSPORTATION 

Great Lakes St. Lawrence Seaway 

Development Corporation 

33 CFR Part 402 

RIN 2135–AA58 

Tariff of Tolls 

AGENCY: Great Lakes St. Lawrence 

Seaway Development Corporation, 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The Great Lakes St. Lawrence 

Seaway Development Corporation (GLS) 

and the St. Lawrence Seaway 

Management Corporation (SLSMC) of 

Canada, under international agreement, 

jointly publish and presently administer 

the St. Lawrence Seaway Tariff of Tolls 

in their respective jurisdictions. The 

Tariff sets forth the level of tolls 

assessed on all commodities and vessels 

transiting the facilities operated by the 

GLS and the SLSMC. The GLS is 

revising its regulations to reflect the fees 

and charges levied by the SLSMC in 

Canada starting in the 2025 navigation 

season, which are effective only in 

Canada. 

DATES: This rule is effective on January 

6, 2025 

ADDRESSES: Docket: For access to the 

docket to read background documents 

or comments received, go to https://

www.regulations.gov; or in person at the 

Docket Management Facility; U.S. 

Department of Transportation, 1200 

New Jersey Avenue SE, West Building 

Ground Floor, Room W12–140, 

Washington, DC 20590–001, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Carrie Mann Lavigne, Chief Counsel, 

Great Lakes St. Lawrence Seaway 

Development Corporation, 180 Andrews 

Street, Massena, New York 13662; (315) 

764–3200. 

SUPPLEMENTARY INFORMATION: The GLS 

and SLSMC of Canada, under 

international agreement, jointly publish 

and presently administer the St. 

Lawrence Seaway Tariff of Tolls 

(Schedule of Fees and Charges in 

Canada) in their respective jurisdictions. 

The Tariff sets forth the level of tolls 

assessed on all commodities and vessels 

transiting the facilities operated by the 

GLS and the SLSMC. The GLS is 

revising 33 CFR 402.12, ‘‘Schedule of 

tolls’’, to reflect the fees and charges 

levied by the SLSMC in Canada 

beginning in the 2025 navigation 

season. The GLS finds there is good 

cause to make the Tariff of Tolls 

effective on the date of publication to 

harmonize the effective dates on both 

sides of the border. 

Regulatory Notices: Privacy Act: 

Anyone is able to search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review DOT’s 

complete Privacy Act Statement in the 

Federal Register published on April 11, 

2000 (65 FR 19477–78) or you may visit 

https://www.regulations.gov. 

Regulatory Evaluation 

This regulation involves a foreign 

affairs function of the United States and 

therefore, Executive Order 12866 does 

not apply and evaluation under the 

Department of Transportation’s 

Regulatory Policies and Procedures is 

not required. 

Regulatory Flexibility Act 

Determination 

The GLS certifies that this regulation 

will not have a significant economic 

impact on a substantial number of small 

entities. The St. Lawrence Seaway 

Regulations and Rules primarily relate 

to commercial users of the Seaway, the 

vast majority of whom are foreign vessel 

operators. Therefore, any resulting costs 

will be borne mostly by foreign vessels. 

Environmental Impact 

This regulation does not require an 

environmental impact statement under 

the National Environmental Policy Act 

(49 U.S.C. 4321, et seq.) because it is not 

a major Federal action significantly 

affecting the quality of the human 

environment. 

Federalism 

The Corporation has analyzed this 

rule under the principles and criteria in 

Executive Order 13132, dated August 4, 

1999, and has determined that this rule 

does not have sufficient federalism 

implications to warrant a Federalism 

Assessment. 

Unfunded Mandates 

The Corporation has analyzed this 

rule under title II of the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4, 109 Stat. 48) and determined that 

it does not impose unfunded mandates 

on State, local, and Tribal governments 

and the private sector requiring a 

written statement of economic and 

regulatory alternatives. 

Paperwork Reduction Act 

This regulation has been analyzed 

under the Paperwork Reduction Act of 

1995 and does not contain new or 

modified information collection 

requirements subject to the Office of 

Management and Budget review. 

List of Subjects in 33 CFR Part 402 

Vessels, Waterways. 

Accordingly, the Great Lakes St. 

Lawrence Seaway Development 

Corporation is amending 33 CFR part 

402 as follows: 

PART 402—TARIFF OF TOLLS 

■ 1. The authority citation for part 402 

continues to read as follows: 

Authority: 33 U.S.C. 983(a), 984(a)(4), and 

988, as amended; 49 CFR 1.101. 

■ 2. Revise § 402.12 to read as follows: 

§ 402.12 Schedule of tolls. 

TABLE 1 TO § 402.12 

Item 

Column 1 Column 2 Column 3 

Description of charges 

Rate ($) 

Montreal to or from Lake Ontario 

(5 locks) 

Rate ($) 

Welland Canal—Lake Ontario to or 

from Lake Erie 

(8 locks) 

1. ................. Subject to item 3, for complete transit of the Seaway, a composite toll, 

comprising: 


khammond on DSK9W7S144PROD with RULES