41402 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations 

on that firm’s knowledge that such 

device was being prescribed or used by 

health care providers for such use. The 

intended uses of an article may change 

after it has been introduced into 

interstate commerce by its 

manufacturer. If, for example, a packer, 

distributor, or seller intends an article 

for different uses than those intended by 

the person from whom he or she 

received the article, such packer, 

distributor, or seller is required to 

supply adequate labeling in accordance 

with the new intended uses. 

Dated: July 14, 2021. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

Dated: July 22, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–15980 Filed 7–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2021–0480] 

RIN 1625–AA00 

Safety Zone; Lake of the Ozarks, Mile 

Markers 7, 10.5, 13, 16, 22, 26, 34, and 

42, Lake of the Ozarks, MO 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing temporary safety zones in 

all navigable waters extending 420 feet 

in all directions around fireworks barges 

at eight different locations on the Lake 

of the Ozarks. These safety zones are 

needed to protect personnel, vessels, 

and the marine environment from 

potential hazards created by the 

fireworks displays. Entry of vessels or 

persons into these zones is prohibited 

unless specifically authorized by the 

Captain of the Port Sector Upper 

Mississippi River or a designated 

representative. 

DATES: This rule is effective on August 

10, 2021 at 10 p.m. to 10:30 p.m. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2021– 

0480 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 Lieutenant Commander Stephanie 

Moore, Sector Upper Mississippi River 

Waterways Management Division, U.S. 

Coast Guard; telephone 314–269–2560, 

email Stephanie.R.Moore@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 

The Coast Guard is issuing this 

temporary 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. We must establish this 

safety zone by August 10, 2021 and lack 

sufficient time to provide a reasonable 

comment period and then consider 

those comments before issuing the rule. 

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 contrary to the public 

interest because immediate action is 

needed to respond to the potential 

safety hazards associated with the 

fireworks displays on August 10, 2021. 

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 

Captain of the Port Sector Upper 

Mississippi River (COTP) has 

determined that potential hazards 

associated with the fireworks displays 

on August 10, 2021 will be a safety 

concern for anyone on the Lake of the 

Ozarks at the designated launch 

locations. This rule resulted from a 

marine event notification stating that 

there will be fireworks displays to 

celebrate a bicentinneal birthday on the 

Lake of the Ozarks. This rule is needed 

to protect personnel, vessels, and the 

marine environment in the navigable 

waters within the safety zone before, 

during, and after the fireworks display. 

IV. Discussion of the Rule 

This rule establishes safety zones on 

August 10, 2021 from 10 p.m. until 

10:30 p.m. The safety zones will be 

located on all navigable waters 

extending 420 feet in all directions 

around fireworks barges at the following 

locations on the Lake of the Ozarks at 

(1) mile marker 7 (38 12′35.20′′ N 92 

45′02.57′′ W), (2) mile marker 10.5 (38 

01′21.93′′ N 92 47′38.93′′ W), (3) mile 

marker 13 (38 11′01.86′′ N 92 41′19.32′′ 

W), (4) mile marker 16 (38 08′54.89′′ N 

92 38′29.53′′ W), (5) mile marker 22 (38 

08′54.89′′ N 92 41′18.95′′ W), (6) mile 

marker 26 (38 07′25.22′′ N 92 42′58.65′′ 

W), (7) mile marker 34 (38 07′25.22′′ N 

92 47′34.59′′ W) and (8) mile marker 42 

(38 08′55′′ N 92 52′23.30′′ W). The 

duration of these zones is intended to 

protect personnel, vessels, and the 

marine environment in these navigable 

waters before, during, and after the 

fireworks displays. No vessel or person 

will be permitted to enter the safety 

zones without obtaining permission 

from the COTP or a designated 

representative. A designated 

representative is a commissioned, 

warrant, or petty officer of the U.S. 

Coast Guard assigned to units under the 

operational control of USCG Sector 

Upper Mississippi River. The COTP or 

a designated representative will inform 

the public of the enforcement date and 

times for these safety zones, as well as 

any emergent safety concerns that may 

delay the enforcement of the 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, 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, and duration 

of the temporary safety zones. This 

action involves fireworks displays at 

multiple designated locations on the 


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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations 41403 

Lake of the Ozarks accuring 

symultaniously on August 10, 2021 and 

lasting 30 minutes. Vessels will be able 

to transit around the safety zones. 

Moreover, the Coast Guard will publish 

a Local Notice to Mariners and mariners 

may seek permission to enter the zones. 

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 

zones 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 

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 lasting thirty minutes that will 

prohibit entry on the Lake of the Ozarks 

at (1) mile marker 7 (38 12′35.20′′ N 92 

45′02.57′′ W), (2) mile marker 10.5 (38 

01′21.93′′ N 92 47′38.93′′ W), (3) mile 

marker 13 (38 11′01.86′′ N 92 41′19.32′′ 

W), (4) mile marker 16 (38 08′54.89′′ N 

92 38′29.53′′ W), (5) mile marker 22 (38 

08′54.89′′ N 92 41′18.95′′ W), (6) mile 

marker 26 (38 07′25.22′′ N 92 42′58.65′′ 

W), (7) mile marker 34 (38 07′25.22′′ N 

92 47′34.59′′ W) and (8) mile marker 42 

(38 08′55′′ N 92 52′23.30′′ W). It is 

categorically excluded from further 

review under paragraph L60 of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. It is 

categorically excluded from further 

review under paragraph L60, Table 1 of 

DHS Instruction Manual 023–01–001– 

01, Rev. 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. 0170.1. 

■ 2. Add § 165.T08–0707 to read as 

follows: 

§ 165.T08–0707 Safety Zones; Lake of the 

Ozarks, Mile Markers 7, 10.5, 13, 16, 22, 26, 

34, 42, Lake of the Ozarks, MO 

(a) Location. All navigable waters 

extending 420 feet in all directions 

around fireworks barges at the following 

locations on the Lake of the Ozarks at: 

(1) Mile marker 7 (38 12′35.20′′ N 92 

45′02.57′′ W); 

(2) Mile marker 10.5 (38 01′21.93′′ N 

92 47′38.93′′ W); 

(3) Mile marker 13 (38 11′01.86′′ N 92 

41′19.32′′ W); 

(4) Mile marker 16 (38 08′54.89′′ N 92 

38′29.53′′ W); 

(5) Mile marker 22 (38 08′54.89′′ N 92 

41′18.95′′ W); 

(6) Mile marker 26 (38 07′25.22′′ N 92 

42′58.65′′ W; 

(7) Mile marker 34 (38 07′25.22′′ N 92 

47′34.59′′ W); and 


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41404 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations 

(8) Mile marker 42 (38 08′55′′ N 92 

52′23.30′′ W). 

(b) Period of enforcement. August 10, 

2021 from 10 p.m. until 10:30 p.m. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23 of 

this part, persons and vessels are 

prohibited from entering the safety zone 

unless authorized by the Captain of the 

Port Sector Upper Mississippi River 

(COTP) or a designated representative. 

A designated representative is a 

commissioned, warrant, or petty officer 

of the U.S. Coast Guard assigned to 

units under the operational control of 

USCG Sector Upper Mississippi River. 

(2) Persons or vessels desiring to enter 

into or pass through the zone must 

request permission from the COTP or a 

designated representative. They may be 

contacted on VHF radio Channel 16 or 

by telephone at 314–269–2332. 

(3) If permission is granted, all 

persons and vessels shall comply with 

the instructions of the COTP or 

designated representative while 

navigating in the regulated area. 

(d) Informational broadcasts. The 

COTP or a designated representative 

will inform the public of the 

enforcement date and times for this 

safety zone, as well as any emergent 

safety concerns that may delay the 

enforcement of the zone through either 

A Safety Marine Information Broadcast 

(SMIB), Broadcast Notice to Mariners 

(BNM) and or Local Notices to Mariners 

(LNMs). 

R.M. Scott, 

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

Port Sector Upper Mississippi River. 

[FR Doc. 2021–16197 Filed 7–30–21; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2021–0584] 

RIN 1625–AA00 

Temporary Safety Zone; Loveless 

Wedding Fireworks, Omena, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

a fireworks display off the shore of the 

Omena Traverse Yacht Club in Omena, 

MI. The safety zone is needed to protect 

personnel, vessels, and the marine 

environment from potential hazards 

created by fireworks display. Entry of 

vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

Sault Sainte Marie or a designated 

representative. 

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

through 11:59 p.m. on August 21, 2021. 

It will be enforced from 9 p.m. through 

11 p.m. on that day. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2021– 

0584 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LT Deaven Palenzuela, U.S. Coast 

Guard Sector Sault Sainte Marie 

Waterways Management, U.S. Coast 

Guard; telephone 906–635–3223, email 

ssmprevention@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 

The Coast Guard is issuing this 

temporary 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 doing 

so would be impracticable. The event 

sponsor did not submit notice to the 

Coast Guard with sufficient time to 

publish an NPRM and receive public 

comments prior to the event. Delaying 

the effective date of this rule to wait for 

a comment period to run would be 

contrary to the public interest and 

impractical by inhibiting the Coast 

Guard’s ability to protect the public 

from the dangers associated with a 

fireworks display with a potential blast 

zone and expected fall-out area 

occurring over the water. 

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 action is needed to establish a 

safety zone in order to protect the public 

from the hazards associated with the 

fireworks display. 

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 

Captain of the Port Sault Sainte Marie 

(COTP) has determined that potential 

hazards associated with a fireworks 

display on August 21, 2021, will be a 

safety concern for anything within a 

250-foot radius of the navigable waters 

surrounding the fireworks launch site. 

This rule is needed to protect personnel, 

vessels, and the marine environment in 

the navigable waters within the safety 

zone during the fireworks display. 

IV. Discussion of the Rule 

This rule establishes a temporary 

safety zone that will be enforced from 9 

p.m. through 11 p.m. on August 21, 

2021. The safety zone will cover all 

navigable waters within 250 feet of a 

fireworks display off shore Omena 

Traverse Yacht Club in Omena, MI in 

position 45°6′6.36′′ N 85°34′48.22′′ W. 

The duration of the zone is intended to 

protect personnel, vessels, and the 

marine environment in the safety zone 

proceeding, during and immediately 

after the fireworks display. 

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 

time-of-day of the safety zone. Vessel 

traffic will be able to safely transit 

around this safety zone which would 

impact a small designated area off shore 

of Omena Traverse Yacht Club. 


khammond on DSKJM1Z7X2PROD with RULES