9244 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

(6) Physician and patient labeling 

must include: 

(i) A detailed summary of the device’s 

technical parameters; 

(ii) Instructions for use, including an 

explanation of all user-interface 

components and information regarding 

proper device placement; 

(iii) Information related to 

electromagnetic compatibility 

classification; 

(iv) Instructions on how to clean and 

maintain the device; 

(v) A summary of the clinical 

performance testing conducted with the 

device; 

(vi) Language to direct end users to 

contact the device manufacturer and 

MedWatch if they experience any 

adverse events with this device; and 

(vii) Information on how the device 

operates and the typical sensations 

experienced during treatment. 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03540 Filed 2–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0126] 

RIN 1625–AA00 

Safety Zone; Coast Guard Island, 

Alameda, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

all waters of the Alameda Estuary, from 

surface to bottom, within 250 feet of the 

pier along the southwest side of Coast 

Guard Island in support of a munitions 

transfer on February 20, 2022. The 

safety zone is necessary to protect 

personnel, vessels, and the marine 

environment from the dangers 

associated with live munitions. Entry of 

vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

San Francisco. 

DATES: This rule is effective from 8 a.m. 

through 2 p.m. on February 20, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0126 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 LT Anthony Solares, Sector San 

Francisco Waterways Safety 

Management, U.S. Coast Guard; 

telephone 415–399–3585, email 

Anthony.I.Solares@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 

CGC Coast Guard Cutter 

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 

munitions must be transferred for 

operational readiness. It is impracticable 

to publish an NPRM because we must 

establish this safety zone by February 

20, 2022. 

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 immediate action is needed to 

respond to the potential safety hazards 

associated with the munitions transfer 

near Alameda, CA beginning February 

20, 2022. 

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 (COTP) San 

Francisco has determined that potential 

hazards associated with the munitions 

transfer starting February 20, 2022 will 

be a safety concern for anyone within a 

250-foot radius of the pier along the 

southwest side of Coast Guard Island. 

This rule is needed to protect personnel, 

vessels, and the marine environment in 

the navigable waters within the safety 

zone during the munitions transfer. 

IV. Discussion of the Rule 

This rule establishes a safety zone 

from 8 a.m. until 2 p.m. on February 20, 

2022. The safety zone will cover all 

waters of the Alameda Estuary, from 

surface to bottom, within 250 feet of the 

pier along the southwest side of Coast 

Guard Island. The safety zone is 

necessary to ensure the safety of people, 

vessels, and the marine environment for 

the duration of the munitions transfer. 

No vessel or person will be permitted to 

enter the safety zone without obtaining 

permission from the COTP or a 

designated representative. 

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 the 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 of 

the Alameda Estuary for only six hours. 

The Coast Guard will issue a Broadcast 

Notice to Mariners via VHF–FM marine 

channel 16 about the zone, and the rule 

would allow 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 


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Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 9245 

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 

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 a safety 

zone lasting only six hours that will 

prohibit entry within 250 feet of the pier 

along the southwest side of Coast Guard 

Island. 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 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.T11–089 to read as 

follows: 

§ 165.T11–089 Safety Zone; Safety Zone; 

Coast Guard Island, Alameda, CA. 

(a) Location. The following area is a 

safety zone: All waters of the Alameda 

Estuary, from surface to bottom, within 

250 feet of the pier along the southwest 

side of Coast Guard Island. 

(b) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by phone at 415–399– 

3547. Those in the safety zone must 

comply with all lawful orders or 

directions given to them by the COTP or 

the COTP’s designated representative. 

(c) Enforcement period. This section 

will be enforced from 8 a.m. to 2 p.m. 

on February 20, 2022. 

Dated: February 14, 2022. 

Taylor Q. Lam, 

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

Port San Francisco. 

[FR Doc. 2022–03542 Filed 2–17–22; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0607; FRL–9454–01– 

OCSPP] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of fluopyram in 

or on cereal grain crop group 15 (except 

corn and rice), rapeseed subgroup 20A, 

and multiple animal commodities, 

which are identified and discussed later 

in this document. This regulation also 

establishes an import tolerance for 

residues of fluopyram in or on coffee. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 


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