Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46449 

new safety and effectiveness 

information learned about the device 

from ongoing or completed studies that 

may reasonably affect an evaluation of 

the safety or effectiveness of the device 

or that may reasonably affect the 

statement of contraindications, 

warnings, precautions, and adverse 

reactions in the draft labeling. The 

update report shall be consistent with 

the data reporting provisions of the 

protocol. The applicant shall submit any 

update report in electronic format and 

shall include in the report the number 

assigned by FDA to the PMA. These 

updates are considered to be 

amendments to the PMA. The time 

frame for review of a PMA will not be 

extended due to the submission of an 

update report unless the update is a 

major amendment under § 814.37(c)(1). 

The applicant shall submit these 

reports— 

* * * * * 

(f) If a color additive subject to section 

721 of the Federal Food, Drug, and 

Cosmetic Act is used in or on the device 

and has not previously been listed for 

such use, then, in lieu of submitting a 

color additive petition under part 71 of 

this chapter, at the option of the 

applicant, the information required to 

be submitted under part 71 may be 

submitted as part of the PMA. When 

submitted as part of the PMA, the 

information shall be submitted in 

electronic format. A PMA for a device 

that contains a color additive that is 

subject to section 721 of the Federal 

Food, Drug, and Cosmetic Act will not 

be approved until the color additive is 

listed for use in or on the device. 

* * * * * 

(h) * * * 

(1) For devices regulated by the 

Center for Devices and Radiological 

Health, send it to the current address 

displayed on the website http://

www.fda.gov/cdrhsubmissionaddress. 

(2) For devices regulated by the 

Center for Biologics Evaluation and 

Research, send it to the current address 

displayed on the website https://

www.fda.gov/AboutFDA/CentersOffices/ 

OfficeofMedicalProductsandTobacco/ 

CBER/ucm385240.htm. 

* * * * * 

■ 9. Amend § 814.39 by revising 

paragraph (c)(1) to read as follows: 

§ 814.39 PMA supplements. 

* * * * * 

(c)(1) All procedures and actions that 

apply to an application under § 814.20 

also apply to PMA supplements except 

that the information required in a 

supplement is limited to that needed to 

support the change. A summary under 

§ 814.20(b)(3) is required for only a 

supplement submitted for new 

indications for use of the device, 

significant changes in the performance 

or design specifications, circuits, 

components, ingredients, principles of 

operation, or physical layout of the 

device, or when otherwise required by 

FDA. The applicant shall submit a PMA 

supplement in electronic format and 

shall include information relevant to the 

proposed changes in the device. A PMA 

supplement shall include a separate 

section that identifies each change for 

which approval is being requested and 

explains the reason for each such 

change. The applicant shall submit 

additional information, if requested by 

FDA, in electronic format. The time 

frames for review of, and FDA action on, 

a PMA supplement are the same as 

those provided in § 814.40 for a PMA. 

* * * * * 

■ 10. Amend § 814.104 by revising 

paragraphs (d) introductory text and 

(d)(1) and (2) to read as follows: 

§ 814.104 Original applications. 

* * * * * 

(d) Address for submissions and 

correspondence. All original HDEs, 

amendments and supplements, as well 

as any correspondence relating to an 

HDE, must be provided in electronic 

format. These materials must be sent or 

delivered to one of the following: 

(1) For devices regulated by the 

Center for Devices and Radiological 

Health, send it to the current address 

found on the website https://

www.fda.gov/cdrhsubmissionaddress. 

(2) For devices regulated by the 

Center for Biologics Evaluation and 

Research, send it to the current address 

displayed on the website https://

www.fda.gov/AboutFDA/CentersOffices/ 

OfficeofMedicalProductsandTobacco/ 

CBER/ucm385240.htm. 

* * * * * 

Dated: September 7, 2018. 

Scott Gottlieb, 

Commissioner of Food and Drugs. 

[FR Doc. 2018–19865 Filed 9–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0713] 

RIN 1625–AA00 

Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

reduce the size of the Navy Pier 

Southeast Safety Zone within the 

Chicago Harbor. This action is necessary 

to alleviate congestion near the Chicago 

Lock during regularly scheduled 

fireworks events. The current safety 

zone encompasses part of the lock 

restricting vessels during events. This 

proposed rulemaking would still 

prohibit persons and vessels from 

entering the safety zone, but would 

allow the lock to remain in full 

operation during the fireworks display. 

We invite your comments on this 

proposed rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before October 15, 2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2018–0713 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email LT John Ramos, Waterways 

Management Division, Marine Safety 

Unit Chicago, U.S. Coast Guard; 

telephone (630) 986–2155, email D09- 

DG-MSUChicago-Waterways@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, Purpose, and Legal 

Basis 

The Coast Guard regularly enforces 

the Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL listed in 33 

CFR 165.931 for weekly fireworks 

events during the boating season. The 


daltland on DSKBBV9HB2PROD with PROPOSALS
46450 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

current safety zone encompasses all 

waters of Lake Michigan within Chicago 

Harbor bounded by coordinates 

beginning at 41°53′26.5′′ N, 087°35′26.5′′ 

W; then south to 41°53′7.6′′ N, 

087°35′26.3′′ W; then west to 41°53′7.6′′ 

N, 087°36′23.2′′ W; then north to 

41°53′26.5′′ N, 087°36′24.6′′ W; then east 

back to the point of origin (NAD 83). 

The purpose of this proposed 

rulemaking is to reduce the size of the 

pre-existing safety zone to reduce 

congestion near the Chicago Lock. This 

safety zone will help ensure the safety 

of vessels and the navigable waters near 

the fireworks barge before, during, and 

after the scheduled events and alleviate 

congestion issues around the Chicago 

Lock. The proposed rule would not 

significantly change the regulatory 

language found in 33 CFR 165.931. The 

change would only reduce the size of 

the safety zone and update the 

coordinates found in 33 CFR 165.931 

(a). 

III. Discussion of Proposed Rule 

The COTP proposes to reduce the 

established safety zone outlined in 33 

CFR 165.931. The current safety zone 

encompasses all waters of Lake 

Michigan within Chicago Harbor 

bounded by coordinates beginning at 

41°53′26.5′′ N, 087°35′26.5′′ W; then 

south to 41°53′7.6′′ N, 087°35′26.3′′ W; 

then west to 41°53′7.6′′ N, 087°36′23.2′′ 

W; then north to 41°53′26.5′′ N, 

087°36′24.6′′ W; then east back to the 

point of origin (NAD 83). 

The newly proposed safety zone 

would ensure a safe distance for 

spectators. It would encompasses all 

waters of Lake Michigan within Chicago 

Harbor bounded by coordinates 

beginning at 41°53′23.74′′ N, 

087°35′35.70′′ W; then south to 

41°53′3.95′′ N, 087°35′35.11′′ W; then 

west to 41°53′3.48′′ N, 087°36′8.52′′ W; 

then north to 41°53′23.30′′ N, 

087°36′9.08′′ W; then east back to the 

point of origin (NAD 83). 

IV. Regulatory Analyses 

We developed this proposed 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 NPRM has not 

been designated a ‘‘significant 

regulatory action,’’ under Executive 

Order 12866. Accordingly, the NPRM 

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. 

We conclude that this rule is not a 

significant regulatory action because we 

anticipate that it will have minimal 

impact on the economy, will not 

interfere with other agencies, will not 

adversely alter the budget of any grant 

or loan recipients, and will not raise any 

novel legal or policy issues. The safety 

zone created by this rule will be 

relatively small and will be enforced 

intermittently only for a short period of 

time. Under certain conditions, 

moreover, vessels may still transit 

through the safety zones when 

permitted by the Captain of the Port. 

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 proposed rule would 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 

zone may be small entities, for the 

reasons stated in section IV.A above, 

this proposed rule would not have a 

significant economic impact on any 

vessel owner or operator. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this rule would have a 

significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

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 proposed 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. The Coast Guard will 

not retaliate against small entities that 

question or complain about this 

proposed rule or any policy or action of 

the Coast Guard. 

C. Collection of Information 

This proposed rule would 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 proposed 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 proposed rule does not have 

tribal implications under Executive 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would 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 proposed rule has 

implications for federalism or Indian 

tribes, please contact the person listed 

in the FOR FURTHER INFORMATION

CONTACT section. 

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 

proposed rule would not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

F. Environment 

We have analyzed this proposed 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 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46451 

U.S.C. 4321–4370f), and have made a 

preliminary determination 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 proposed rule 

involves a safety zone enforced 

intermittently. Normally such actions 

are categorically excluded from further 

review under paragraph L60(a) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 01. A 

preliminary Record of Environmental 

Consideration supporting this 

determination is available in the docket 

where indicated under ADDRESSES. We 

seek any comments or information that 

may lead to the discovery of a 

significant environmental impact from 

this proposed 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. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking, and 

will consider all comments and material 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at http://

www.regulations.gov. If your material 

cannot be submitted using http://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. 

We accept anonymous comments. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

the docket, visit http://

www.regulations.gov/privacyNotice. 

Documents mentioned in this NPRM 

as being available in the docket, and all 

public comments, will be in our online 

docket at http://www.regulations.gov 

and can be viewed by following that 

website’s instructions. Additionally, if 

you go to the online docket and sign up 

for email alerts, you will be notified 

when comments are posted or a final 

rule is published. 

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 proposes to 

amend 33 CFR part 165.931 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. Amend § 165.931 by revising 

paragraph (a) to read as follows: 

§ 165.931 Safety Zone, Chicago Harbor, 

Navy Pier Southeast, Chicago, IL. 

(a) Location. The following area is a 

safety zone: The waters of Lake 

Michigan within Chicago Harbor 

bounded by coordinates beginning at 

41°53′23.74′′ N, 087°35′35.70′′ W; then 

south to 41°53′3.95′′ N, 087°35′35.11′′ 

W; then west to 41°53′3.48′′ N, 

087°36′8.52′′ W; then north to 

41°53′23.30′′ N, 087°36′9.08′′ W; then 

east back to the point of origin (NAD 

83). 

* * * * * 

Dated: August 16, 2018. 

Thomas J. Stuhlreyer, 

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

Port, Lake Michigan. 

[FR Doc. 2018–19934 Filed 9–12–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

36 CFR Part 228 

RIN 0596–AD32 

Locatable Minerals 

AGENCY: Forest Service, USDA. 

ACTION: Advance notice of proposed 

rulemaking; request for comment. 

SUMMARY: The Forest Service is 

requesting comments from the public 

regarding the need to clarify or to 

otherwise enhance its regulations that 

minimize adverse environmental 

impacts on National Forest System 

surface resources in connection with 

operations authorized by the United 

States mining laws. These rules and 

procedures govern prospecting, 

exploration, development, mining, and 

processing operations conducted on 

National Forest System lands authorized 

by the Mining Law of 1872, as amended, 

subsequent reclamation of the land, and 

any necessary long-term post-closure 

resource management. The goals of the 

regulatory revision are to expedite 

Forest Service review of certain 

proposed mineral operations authorized 

by the United States mining laws, and, 

where applicable, Forest Service 

approval of some of these proposals by 

clarifying the regulations, to increase 

consistency with the United States 

Department of the Interior, Bureau of 

Land Management (BLM) surface 

management regulations governing 

operations authorized by the United 

States mining laws to assist those who 

conduct these operations on lands 

managed by each agency, and to 

increase the Forest Service’s nationwide 

consistency in regulating mineral 

operations authorized by the United 

States mining laws by clarifying its 

regulations . 

DATES: Comments must be received by 

October 15, 2018. 

ADDRESSES: Please submit comments via 

one of the following methods: 

• Electronically: Go to the Federal 

eRulemaking Portal: http://

www.regulations.gov. In the Search box, 

enter FS–2018–0052, which is the 

docket number for this Advanced Notice 

of Proposed Rulemaking. Then, in the 

Search panel on the left side of the 

screen, under the Document Type 

heading, click on the Notice link to 

locate this document. You may submit 

a comment by clicking on ‘‘Comment 

Now!’’ 

• By hard copy: Submit by U.S. mail 

to: USDA-Forest Service. Attn: 

Director—MGM Staff, 1617 Cole 

Boulevard, Building 17, Lakewood, CO 

80401. 

We request that you send comments 

only by the methods described above. 

We will post all comments on http://

www.regulations.gov. This generally 

means that we will post any personal 

information you provide us. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Nabahe, Minerals and Geology 

Management, 202–205–0800. 

Individuals who use telecommunication 

devices for the deaf (TDD) may call the 

Federal Information Relay Service 

(FIRS) at 1–800–877–8339 between 8:00 

a.m. and 8:00 p.m., Eastern Time, 

Monday through Friday. 

SUPPLEMENTARY INFORMATION: This 

advance notice is intended to give the 


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