Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 46901 

whether FDA planned to exempt the 

device from premarket notification 

requirements under section 510(k) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360(k)). 

Correction 

In the Federal Register of July 28, 

2017, in FR Doc. 2017–15901, the 

following correction is made: 

On page 35066, at the bottom of the 

page below table 1, beginning in the first 

column, the third paragraph is corrected 

as follows: 

‘‘Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k), if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, FDA has determined that 

premarket notification is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, this device type is not 

exempt from premarket notification 

requirements. Persons who intend to 

market this type of device must submit 

to FDA a premarket notification, prior to 

marketing the device, which contains 

information about the adjunctive 

cardiovascular status indicator they 

intend to market.’’ 

Dated: October 2, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21659 Filed 10–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–0792] 

RIN 1625–AA00 

Safety Zone; Atlantic Intracoastal 

Waterway, Camp Lejeune, NC 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Atlantic Intracoastal Waterway in 

Camp Lejeune, North Carolina in 

support of military training exercises. 

This temporary safety zone is intended 

to restrict vessel traffic from a portion of 

the Atlantic Intracoastal Waterway 

between Mile Hammock Bay and 

Onslow Beach Swing Bridge during 

military training operations. This action 

is intended to restrict vessel traffic on 

the Atlantic Intracoastal Waterway to 

protect mariners, vessels, and training 

exercise participants from the hazards 

associated with military training 

operations. Entry of vessels or persons 

into this safety zone is prohibited unless 

specifically authorized by the Captain of 

the Port (COTP) North Carolina or a 

designated representative. 

DATES: This rule is effective from 

October 10, 2017 through October 30, 

2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

0792 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, contact 

Petty Officer Matthew Tyson, 

Waterways Management Division, U.S. 

Coast Guard Sector North Carolina, 

Wilmington, NC; telephone: 910–772– 

2221, email: Matthew.I.Tyson@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 

§ Section 

U.S.C. United States Code 

ICW IntraCoastal Waterway 

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. The Coast 

Guard was notified of the final dates 

needed for this rule on August 17, 2017. 

It is impracticable and contrary to the 

public interest to delay this action. 

Waiting for a comment period to run 

would inhibit the Coast Guards’ ability 

to protect the public and participants 

from the dangers associated with the 

military exercises scheduled from 

October 10 through October 30, 2017. 

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

Guard finds that good cause exists for 

making this temporary rule effective less 

than 30 days after publication in the 

Federal Register. Immediate 

implementation is required to protect 

the public and participants from the 

dangers associated with the military 

training exercises. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 33 U.S.C. 1231. The 

COTP North Carolina has determined 

that potential hazards associated with 

the military exercises scheduled from 

October 10 through October 30, 2017, is 

a safety concern for mariners and 

participants. The military training 

exercises involve building temporary 

bridges, crossing with amphibious 

vehicles, and other military operations 

on the ICW. These military training 

activities will block the waterway in a 

manner that restricts all vessel 

navigation and movement within this 

segment of the ICW. This rule is 

necessary to protect persons and vessels 

from the potential hazards associated 

with the military training exercises. 

IV. Discussion of the Rule 

The safety zone will be enforced on 

the following dates and times in October 

2017: 

Date Time 

10th–12th ..... 8 a.m. through 11 a.m. and 1 

p.m. through 4 p.m. 

13th .............. 9 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

18th .............. 8 a.m. through 12 p.m. 

24th .............. 8 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

25th–26th ..... 9 a.m. through 1 p.m. and 2 

p.m. through 5 p.m. 

27th–28th ..... 7 a.m. through 5 p.m. 

29th–30th ..... 7 a.m. through 11 a.m. 

The safety zone will include all 

navigable waters of the ICW from Mile 

Hammock Bay, approximate position 

34°32′46′′ N., 77°19′17′′ W., to Onslow 

Beach Swing Bridge approximate 

position 34°34′25′′ N., 77°16′14′′ W. 

(NAD 1983), an approximately four mile 

portion of the ICW. The duration of this 

zone is intended to protect mariners 

from the hazards associated with 

military training operations. No vessel 

or person will be permitted to enter the 

safety zone unless specifically 

authorized by the Captain of the Port 

North Carolina or a designated 

representative. The regulatory text 

appears at the end of this document. 


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46902 Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 

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. 

Executive Order 13771 directs agencies 

to control regulatory costs through a 

budgeting process. 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), and 

pursuant to OMB guidance it is exempt 

from the requirements of Executive 

Order 13771. 

This regulatory action determination 

is based on the size, location, and 

duration of the safety zone. Vessel 

traffic will not be allowed to enter or 

transit a portion of the ICW for up to 10 

hours on 12 separate days. The Coast 

Guard will issue a Local Notice to 

Mariners and transmit a Broadcast 

Notice to Mariners via VHF–FM marine 

channel 16 regarding the safety zone. 

This portion of the ICW has been 

determined to be a low traffic area. 

Vessels needing to transit the area 

during these times can safely transit 

offshore using New River Inlet to the 

south and Browns Inlet to the north. 

This rule does not allow vessels to 

request permission to enter the safety 

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 the precise number of small 

entities impacted is unknown, the ICW 

has a low number of vessels transiting 

the area planned for the safety zone 

during the enforcement period. 

Although 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 contact 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. If you 

believe this rule has implications for 

federalism or Indian tribes, please 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section 

above. 

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 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

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 for up to 10 hours on 12 

separate days that would prohibit entry 

into an approximately four mile portion 

of the ICW for military training 

exercises. It is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. A Record of Environmental 

Consideration supporting this 

determination is available in the docket 

where indicated under ADDRESSES. 

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

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: 


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Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 46903 

1Although states and tribes may designate as 

Class I additional areas which they consider to have 

visibility as an important value, the requirements of 

the visibility program set forth in section 169A of 

the CAA apply only to mandatory Class I Federal 

areas. When we use the term ‘‘Class I area’’ in this 

action, we mean a ‘‘mandatory Class I Federal 

area.’’ 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

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.T05–0792 to read as 

follows: 

§ 165.T05–0792 Safety Zone, Atlantic 

Intracoastal Waterway; Camp Lejeune, NC. 

(a) Location. The following area is a 

safety zone: All waters on the Atlantic 

Intracoastal Waterway, from 

approximate position 34°32′46′′ N., 

77°19′17′′ W. to 34°34′25′′ N., 77°16′14′′ 

W. (NAD 1983) at Camp Lejeune, NC. 

(b) Definitions. As used in this 

section, ‘‘designated representative’’ 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

commissioned, warrant, or petty officer 

designated by the Captain of the Port 

North Carolina (COTP) for the 

enforcement of the safety zone. 

‘‘Captain of the Port’’ means the 

Commander, Sector North Carolina. 

‘‘Participants’’ means persons and 

vessels involved in support of a military 

exercise. 

(c) Regulations. (1) The general 

regulations governing safety zones in 

§ 165.23 apply to the area described in 

paragraph (a) of this section. 

(2) With the exception of participants, 

entry into or remaining in this safety 

zone is prohibited unless authorized by 

the Captain of the Port, North Carolina 

or designated representative(s). 

(3) All vessels within this safety zone 

when this section becomes effective 

must depart the zone immediately. 

(4) The Captain of the Port, North 

Carolina can be reached through the 

Coast Guard Sector North Carolina 

Command Duty Officer, Wilmington, 

North Carolina at telephone number 

910–343–3882. 

(5) The Coast Guard and designated 

security vessels enforcing the safety 

zone can be contacted on VHF–FM 

marine band radio channel 13 (165.65 

MHz) and channel 16 (156.8 MHz). 

(d) Enforcement. The U.S. Coast 

Guard may be assisted in the patrol and 

enforcement of the safety zone by 

Federal, State, and local agencies. 

(e) Enforcement periods. This section 

will be enforced on the following dates 

and times in October 2017: 

Date Time 

10th–12th ..... 8 a.m. through 11 a.m. and 1 

p.m. through 4 p.m. 

13th .............. 9 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

Date Time 

18th .............. 8 a.m. through 12 p.m. 

24th .............. 8 a.m. through 12 p.m. and 1 

p.m. through 4 p.m. 

25th–26th ..... 9 a.m. through 1 p.m. and 2 

p.m. through 5 p.m. 

27th–28th ..... 7 a.m. through 5 p.m. 

29th–30th ..... 7 a.m. through 11 a.m. 

Dated: October 3, 2017. 

Bion B. Stewart, 

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

Port North Carolina. 

[FR Doc. 2017–21709 Filed 10–6–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2017–0092, FRL–9968–97– 

Region 9] 

Approval and Promulgation of Air 

Quality Implementation Plans; Arizona; 

Regional Haze State and Federal 

Implementation Plans 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a sourcespecific revision to the Arizona state 

implementation plan (SIP) that provides 

an alternative to Best Available Retrofit 

Technology (BART) for the Coronado 

Generating Station (‘‘Coronado’’), 

owned and operated by the Salt River 

Project Agricultural Improvement and 

Power District (SRP). The EPA has 

determined that the BART alternative 

for Coronado would provide greater 

reasonable progress toward natural 

visibility conditions than BART, based 

on the criteria established in the EPA’s 

Regional Haze Rule. In conjunction with 

this approval, we are withdrawing those 

portions of the federal implementation 

plan (FIP) that address BART for 

Coronado. We are also codifying the 

removal of those portions of the Arizona 

SIP that have either been superseded by 

this approval of the SIP revision for 

Coronado or by previously-approved 

revisions to the Arizona SIP. 

DATES: This rule is effective November 

9, 2017. 

ADDRESSES: The EPA has established 

Docket ID No. EPA–R09–OAR–2017– 

0092 for this action. All documents in 

the docket are listed on the http://

www.regulations.gov Web site. Although 

listed in the index, some information is 

not publicly available, e.g., Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available through http://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Krishna Viswanathan, EPA, Region IX, 

Air Division, Air Planning Office, (520) 

999–7880 or viswanathan.krishna@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us,’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. General Information 

II. Proposed Action 

III. Public Comments and EPA Responses 

IV. Final Action 

V. Environmental Justice Considerations 

VI. Incorporation by Reference 

VII. Statutory and Executive Order Reviews 

I. General Information 

Definitions 

For the purpose of this document, we 

are giving meaning to certain words or 

initials as follows: 

• The initials ADEQ mean or refer to 

the Arizona Department of 

Environmental Quality. 

• The words Arizona and State mean 

the State of Arizona. 

• The word Coronado refers to the 

Coronado Generating Station. 

• The initials BART mean or refer to 

Best Available Retrofit Technology. 

• The initials BOD mean or refer to 

boiler operating day. 

• The term Class I area refers to a 

mandatory Class I Federal area.1

• The initials CAA mean or refer to 

the Clean Air Act. 

• The words EPA, we, us, or our mean 

or refer to the United States 

Environmental Protection Agency. 

• The initials FIP mean or refer to 

federal implementation plan. 

• The initials lb/MMBtu mean or refer 

to pounds per million British thermal 

units. 

• The initials NAAQS mean or refer 

to National Ambient Air Quality 

Standards. 


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