2394 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–0763 for ‘‘Food Labeling: 

Health Claims; Soy Protein and 

Coronary Heart Disease.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Crystal Rivers, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

1444. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 31, 2017, 

FDA published a proposed rule to 

revoke our regulation authorizing the 

use of health claims on the relationship 

between soy protein and coronary heart 

disease on the label or in the labeling of 

foods. We proposed this action based on 

our review of the totality of publicly 

available scientific evidence currently 

available and our tentative conclusion 

that such evidence does not support our 

previous determination that there is 

significant scientific agreement among 

qualified experts for a health claim 

regarding the relationship between soy 

protein and reduced risk of coronary 

heart disease. We provided a 75-day 

comment period for the proposed rule. 

We have received requests for a 60- 

day extension of the comment period for 

the proposed rule. Each request 

conveyed concern that the current 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the proposed 

rule. 

FDA has considered the requests and 

is extending the comment period for the 

proposed rule until March 19, 2018. We 

believe that this extension allows 

adequate time for interested persons to 

submit comments without significantly 

delaying rulemaking on these important 

issues. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00683 Filed 1–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–1058] 

RIN 1625–AA00 

Safety Zone; Lower Mississippi River, 

New Orleans, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish two temporary safety zones for 

multiple locations and dates within the 

Captain of the Port Sector New Orleans 

Zone. These safety zones are necessary 

to protect persons and vessels from 

potential safety hazards associated with 

fireworks displays on or over navigable 

waterways. Entry into these zones is 

prohibited unless specifically 

authorized by the Captain of the Port 

Sector New Orleans (COTP) or a 

designated representative. We invite 

your comments on this proposed 

rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before March 19, 2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2017–1058 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 proposed 

rulemaking, call or email Lieutenant 

Commander (LCDR) Howard Vacco, 

Sector New Orleans, US Coast Guard; 

telephone 504–365–2281, email 

Howard.K.Vacco@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port Sector New 

Orleans 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 


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U.S.C. United States Code 

II. Background, Purpose, and Legal 

Basis 

The Coast Guard proposes to establish 

temporary safety zones for the following 

fireworks displays: 

(1) On November 7, 2017, the New 

Orleans Tourism & Marketing 

Corporation notified the Coast Guard 

that it would be conducting a fireworks 

display from 7:45 p.m. through 8:45 

p.m. on May 25, 2018. The fireworks are 

to be launched from a barge on the 

Lower Mississippi River at approximate 

mile marker (MM) 95.9, above Head of 

Passes, New Orleans, LA. 

(2) On March 14, 2017, the NOLA 

2018 Foundation notified the Coast 

Guard that it would be conducting a 

fireworks display from 8 p.m. through 

8:20 p.m. on May 6, 2018. The fireworks 

are to be launched from a barge on the 

Lower Mississippi River at approximate 

MM 95.4, above Head of Passes, New 

Orleans, LA. 

The purpose of this rulemaking is to 

ensure the safety of vessels on the 

navigable waters within a one-mile 

range of the fireworks barge before, 

during, and after the scheduled event. 

The Coast Guard proposes this 

rulemaking under authority in 33 U.S.C. 

1231. 

III. Discussion of Proposed Rule 

The COTP proposes to establish two 

temporary safety zones within the 

Captain of the Port Sector New Orleans 

(COTP) Zone on two different dates and 

locations. Both safety zones will 

encompass a one-mile stretch of river 

with a duration lasting no more than 

one hour. The duration of the zones is 

intended to ensure the safety of vessels 

on these navigable waters before, 

during, and after the scheduled 

fireworks displays. No vessel or person 

would be permitted to enter the safety 

zone without obtaining permission from 

the COTP or a designated 

representative. The proposed zones are 

as follows: 

(1) Bayou Country Music Fest: a safety 

zone from 7:45 p.m. through 8:45 p.m. 

on May 25, 2018. The safety zone would 

cover all navigable waters of the Lower 

Mississippi River between MM 95.4 and 

MM 96.4, above Head of Passes. 

(2) NOLA Tricentennial 2018 Jazz and 

Heritage Fest: A safety zone from 8 p.m. 

through 9 p.m. on May 6, 2018. This 

safety zone would cover all navigable 

waters of the Lower Mississippi River 

between MM 95 and MM 96, above 

Head of Passes. 

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. 

This regulatory action determination 

is based on the size and short duration 

of the waterway closure, which would 

remain in effect for one hour on a onemile section of the waterway. In 

addition, vessel traffic seeking to transit 

the areas would be able to seek 

permission from the COTP or his 

designated representative to do so. 

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 


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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, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 (42 

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 two safety zones lasting one 

hour that would prohibit entry within a 

one-mile section of the Lower 

Mississippi River. They 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 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.T08–1058 to read as 

follows: 

§ 165.T08–1058 Safety Zones; Lower 

Mississippi River, New Orleans, LA 

(a) Safety Zones. The following areas 

are a safety zone: 

(1) Bayou Country Music Fest, New 

Orleans, LA. 

(i) Location: All navigable waters of 

the Lower Mississippi River between 

mile marker (MM) 95.4 and MM 96.4, 

above Head of Passes. 

(ii) Effective Period: This rule is 

effective from 7:45 p.m. through 8:45 

p.m. on May 25, 2018. 

(2) NOLA Tricentennial 2018 Jazz and 

Heritage Fest. 

(i) Location: All navigable waters of 

the Lower Mississippi River between 

mile marker (MM) 94 and MM 95, above 

Head of Passes. 

(ii) Effective Period: This rule is 

effective from 8 p.m. through 9 p.m. on 

May 6, 2018. 

(b) Regulations. (1) In accordance 

with the general regulations in § 165.23 

of this part, entry into these zones is 

prohibited unless specifically 

authorized by the Captain of the Port 

Sector New Orleans (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 New 

Orleans. 

(2) Vessels requiring entry into this 

safety zone must request permission 

from the COTP or a designated 

representative. They may be contacted 

on VHF–FM Channel 16 or 67. 

(3) Persons and vessels permitted to 

enter these safety zones must transit at 

their slowest safe speed and comply 

with all lawful directions issued by the 

COTP or the designated representative. 

(c) Information broadcasts. The COTP 

or a designated representative will 

inform the public through Broadcast 

Notices to Mariners of any changes in 

the planned schedule. 

Dated: January 11, 2018. 

Wayne R. Arguin, 

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

Port Sector New Orleans. 

[FR Doc. 2018–00652 Filed 1–16–18; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AP02 

Civilian Health and Medical Program of 

the Department of Veterans Affairs 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend its 

regulations governing the Civilian 

Health and Medical Program of the 

Department of Veterans Affairs 

(CHAMPVA). The proposed revisions 

would clarify and update these 

regulations to conform to changes in law 

and policy that control the 

administration of CHAMPVA and 

would include details concerning the 

administration of CHAMPVA that are 

not reflected in current regulations. The 

proposed revisions would also expand 

covered services and supplies to include 

certain preventive services and 

eliminate cost-share amounts and 

deductibles for certain covered services. 

DATES: Written comments must be 

received on or before March 19, 2018. 

ADDRESSES: Written comments may be 

submitted through http://

www.Regulations.gov; by mail or handdelivery to the Director, Regulation and 

Policy Management (00REG), 

Department of Veterans Affairs, 810 

Vermont Avenue NW, Room 1068, 

Washington, DC 20420; or by fax to 

(202) 273–9026. Comments should 

indicate that they are submitted in 


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