Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 39535 

SUPPLEMENTARY INFORMATION: FDA is 

amending our regulations in 21 CFR 

part 860 that set forth procedures for 

mailing reclassification petitions 

(§ 860.123 (21 CFR 860.123)) to revise 

the mailing address for CDRH. The 

current mailing address in the 

regulation for CDRH is as follows: 

Center for Devices and Radiological 

Health, Regulations Staff, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4438, 

Silver Spring, MD 20993–0002. The 

room number, 4438, has been changed; 

the new room number is G609. The 

mailing address is revised as follows: 

Center for Devices and Radiological 

Health, Regulations Staff, Document 

Mail Center–WO66–G609, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. 

Sections 513(e) and (f), 514(b), 515(b), 

and 520(l) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360c(e) and (f); 360d(b); 360e(b), 

and 360j(l)), provide for the 

reclassification of a device and prescribe 

procedures to petition for 

reclassification. FDA provides 

procedures for the content and form of 

reclassification petitions submitted 

pursuant to § 860.123(b)(1) for devices 

regulated by CDRH. The address for 

submitting a reclassification petition for 

devices regulated by CDRH in 

§ 860.123(b)(1) is amended to reflect the 

new room number. The addresses 

remain the same for the Center for 

Biologics Evaluation and Research and 

the Center for Drug Evaluation and 

Research. 

List of Subjects in 21 CFR Part 860 

Administrative practice and 

procedure, Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 860 is 

amended as follows: 

PART 860—MEDICAL DEVICE 

CLASSIFICATION PROCEDURES 

■ 1. The authority citation for part 860 

continues to read as follows: 

Authority: 21 U.S.C. 360c, 360d, 360e, 

360i, 360j, 371, 374. 

■ 2. Revise § 860.123(b)(1) to read as 

follows: 

§ 860.123 Reclassification petition: 

Content and form. 

* * * * * 

(b) * * * 

(1) For devices regulated by the 

Center for Devices and Radiological 

Health, addressed to the Food and Drug 

Administration, Center for Devices and 

Radiological Health, Regulations Staff, 

Document Mail Center–WO66–G609, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002; for devices 

regulated by the Center for Biologics 

Evaluation and Research, addressed to 

the Food and Drug Administration, 

Center for Biologics Evaluation and 

Research, Document Control Center, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. G112, Silver Spring, MD 20993– 

0002; for devices regulated by the 

Center for Drug Evaluation and 

Research, addressed to the Food and 

Drug Administration, Center for Drug 

Evaluation and Research, Central 

Document Control Room, 5901–B 

Ammendale Rd., Beltsville, MD 20705– 

1266, as applicable. 

* * * * * 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17564 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2017–0699] 

RIN 1625–AA00 

Safety Zone: PG&E Evolution, King 

Salmon, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone in 

the navigable waters of Humboldt Bay 

in King Salmon, CA in support of the 

Pacific Gas and Electric Evolution that 

will be effective on August 2, 2017 and 

on August 30, 2017. This safety zone is 

established to ensure the safety of 

workers, mariners, and other vessels 

transiting the area from the dangers 

associated with this evolution. 

Unauthorized persons or vessels are 

prohibited from entering into, transiting 

through, or remaining in the safety zone 

without permission of the Captain of the 

Port or their designated representative. 

DATES: This rule is effective without 

actual notice from August 21, 2017 until 

August 30, 2017. For the purposes of 

enforcement, actual notice will be used 

from August 2, 2017, until August 21, 

2017. 

This rule is being enforced from 8 

a.m. to 4 p.m. on August 2, 2017 and 

from 8 a.m. to 4 p.m. on August 30, 

2017. 

ADDRESSES: Documents mentioned in 

this preamble are part of docket USCG– 

2017–0699. To view these documents go 

to http://www.regulations.gov, type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this rulemaking. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Marcia Medina, U.S. 

Coast Guard Sector San Francisco; 

telephone (415) 399–7443 or email at 

D11-PF-MarineEvents@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

APA Administrative Procedures Act 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NAD North American Datum of 1983 

NPRM Notice of Proposed Rulemaking 

PG&E Pacific Gas & Electric 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary final 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.’’ Due to the date 

of the event, notice and comment 

procedures would be impracticable in 

this instance. 

For similar reasons as those stated 

above, 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. 

III. Legal Authority and Need for Rule 

The legal basis for the proposed rule 

is 33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 

1.05–1, 6.04–1, 6.04–6, 160.5; 

Department of Homeland Security 

Delegation No. 0170.1, which 

collectively authorize the Coast Guard 

to establish safety zones. 

The Pacific Gas and Electric Company 

will sponsor the Pacific Gas and Electric 

Evolution on August 2, 2017 and on 

August 30, 2017, in the navigable waters 

of Humboldt Bay in King Salmon, CA. 

The evolution is necessary to complete 

an inspection and for re-licensing 

purposes. The evolution is scheduled to 

take place on August 2, 2017 and on 


sradovich on DSK3GMQ082PROD with RULES
39536 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 

August 30, 2017. The Coast Guard 

believes that a safety zone is necessary 

to provide for the safety of workers, 

mariners, and other vessels transiting 

the area due to the danger posed by the 

inspection of the dynamic fuel storage 

installation. This restricted area will 

apply to all vessels transiting the 

specified area. 

IV. Discussion of the Rule 

For the reasons stated above, the 

Coast Guard is establishing a safety zone 

for the duration of the event. Upon 

commencement of the evolution, the 

safety zone will encompass the 

navigable waters of Humboldt Bay 

within a 300 meter radius of position: 

40°44′31′′ N., 124°12′39′′ W. (NAD83). 

The safety zone is issued to establish a 

temporary restricted area on the waters 

surrounding the evolution. The Coast 

Guard or a designated representative 

will enforce a safety zone in navigable 

waters of Humboldt Bay within a 300 

meter radius of position: 40°44′31′′ N., 

124°12′39′′ W. (NAD83) during the 

evolution. The evolution is necessary to 

complete an inspection and for relicensing purposes is scheduled to take 

place on August 2, 2017 and on August 

30, 2017. At the conclusion of the 

evolution the safety zone shall 

terminate. 

The effect of the temporary safety 

zone will be to restrict navigation in the 

vicinity of the evolution. Except for 

persons or vessels authorized by the 

Coast Guard Patrol Commander, no 

person or vessel may enter or remain in 

the restricted area. These regulations are 

needed to keep mariners and vessels 

away from the immediate vicinity of the 

evolution to ensure the safety of 

workers, mariners, and other vessels 

transiting the area. 

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, it 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 limited duration and 

narrowly tailored geographic area of the 

safety zone. Although this rule restricts 

access to the waters encompassed by the 

safety zone, the effect of this rule will 

not be significant because it is outside 

of the Fields Landing Channel and the 

public will be notified via a Broadcast 

Notice to Mariners to ensure the safety 

zone will result in minimum impact. 

The entities most likely to be affected 

are waterfront facilities, commercial 

vessels, and pleasure craft engaged in 

recreational activities. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 1980 

(RFA), 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. 

This rule may affect the following 

entities, some of which may be small 

entities: Owners and operators of 

waterfront facilities, commercial 

vessels, and pleasure craft engaged in 

recreational activities and sightseeing, if 

these facilities or vessels are in the 

vicinity of the safety zone at times when 

this zone is being enforced. This rule 

will not have a significant economic 

impact on a substantial number of small 

entities for the following reasons: (i) 

This rule will encompass only a small 

portion of the waterway for a limited 

period of time, (ii) vessel traffic can 

transit safely around the safety zone, 

and (iii) the maritime public will be 

advised in advance of this safety zone 

via Broadcast Notice to Mariners. 

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, 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 39537 

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 

(NEPA) (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 of limited size and duration. This 

rule is categorically excluded from 

further review under paragraph 34(g) of 

Figure 2–1 of the Commandant 

Instruction. A Record of Environmental 

Consideration is available in the docket 

for this rulemaking. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this rule. 

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, and 

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: 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.T11–867 to read as 

follows: 

§ 165.T11–867 Safety Zone; PG&E 

Evolution, King Salmon, CA. 

(a) Location. This temporary safety 

zone is established for the navigable 

waters of Humboldt Bay in King 

Salmon, California as depicted in 

National Oceanic and Atmospheric 

Administration (NOAA) Chart 18622. 

The safety zone will encompass the 

navigable waters of Humboldt Bay 

within a 300 meter radius of position: 

40°44′31′′ N., 124°12′39′′ W. (NAD83). 

(b) Enforcement period. The zone 

described in paragraph (a) of this 

section will be enforced from 8 a.m. 

until 4 p.m. on August 2, 2017 and from 

8 a.m. until 4 p.m. on August 30, 2017. 

The Captain of the Port San Francisco 

(COTP) will notify the maritime 

community of periods during which this 

zone will be enforced via Broadcast 

Notice to Mariners in accordance with 

33 CFR 165.7. 

(c) Definitions. As used in this 

section, ‘‘designated representative’’ 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

on a Coast Guard vessel or a Federal, 

State, or local officer designated by or 

assisting the COTP in the enforcement 

of the safety zone. 

(d) Regulations. (1) Under the general 

regulations in 33 CFR part 165, subpart 

C, entry into, transiting or anchoring 

within this safety zone is prohibited 

unless authorized by the COTP or a 

designated representative. 

(2) The safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or a designated 

representative. 

(3) Vessel operators desiring to enter 

or operate within the safety zone must 

contact the COTP or a designated 

representative to obtain permission to 

do so. Vessel operators given permission 

to enter or operate in the safety zone 

must comply with all directions given to 

them by the COTP or a designated 

representative. Persons and vessels may 

request permission to enter the safety 

zone through the 24-hour Command 

Center at telephone (415) 399–3547 or 

on VHF channel 16. 

Dated: August 1, 2017. 

Anthony J. Ceraolo, 

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

Port San Francisco. 

[FR Doc. 2017–17655 Filed 8–18–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2017–0387; FRL–9966–34– 

Region 4] 

Air Plan Approval; SC: Miscellaneous 

Revisions to Multiple Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking direct final 

action to approve changes to the South 

Carolina State Implementation Plan 

(SIP) to revise several miscellaneous 

rules, covering definitions, source tests, 

credible evidence, open burning, air 

pollution episodes, and fugitive 

particulate matter. EPA is approving 

portions of SIP revisions submitted by 

the State of South Carolina, through the 

South Carolina Department of Health 

and Environmental Control (SC DHEC) 

on the following dates: July 18, 2011, 

June 17, 2013, April 10, 2014, August 8, 

2014, January 20, 2016, and July 27, 

2016. These actions are being taken 

pursuant to the Clean Air Act. 

DATES: This direct final rule is effective 

October 20, 2017 without further notice, 

unless EPA receives adverse comment 

by September 20, 2017. If EPA receives 

such comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2017–0387 at http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

EPA may publish any comment received 

to its public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Multimedia submissions (audio, video, 

etc.) must be accompanied by a written 

comment. The written comment is 

considered the official comment and 

should include discussion of all points 

you wish to make. EPA will generally 

not consider comments or comment 

contents located outside of the primary 

submission (i.e., on the Web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

D. Brad Akers, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air, Pesticides 

and Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. Mr. Akers 

can be reached via telephone at (404) 

562–9089 or via electronic mail at 

akers.brad@epa.gov. 

SUPPLEMENTARY INFORMATION: 


sradovich on DSK3GMQ082PROD with RULES