45750 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules 

result in the airport no longer qualifying 

for controlled airspace. 

Class E airspace designations are 

published in paragraph 6005 of FAA 

Order 7400.11B, dated August 3, 2017, 

and effective September 15, 2017, which 

is incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document will be 

published subsequently in the Order. 

Regulatory Notices and Analyses 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore: (1) Is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

regulatory evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule, when 

promulgated, would not have a 

significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

Accordingly, pursuant to the 

authority delegated to me, the Federal 

Aviation Administration proposes to 

amend 14 CFR part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.11B, 

Airspace Designations and Reporting 

Points, dated August 3, 2017, and 

effective September 15, 2017, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AGL WI E5 Pulaski, WI [Removed] 

Issued in Fort Worth, Texas, on September 

25, 2017. 

Wayne Eckenrode, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. 2017–20959 Filed 9–29–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary of 

Transportation 

14 CFR Chapters I, II, and III 

23 CFR Chapters I, II, and III 

46 CFR Chapter II 

48 CFR Chapter 12 

49 CFR Chapters I, II, III, V, VI, VII, VIII, 

X, and XI 

[Docket No. DOT–OST–2017–0069] 

Notification of Regulatory Review 

AGENCY: Office of the Secretary of 

Transportation (OST); U.S. Department 

of Transportation (DOT). 

ACTION: Regulatory review. 

SUMMARY: The U.S. Department of 

Transportation (Department or DOT) is 

reviewing its existing regulations and 

other agency actions to evaluate their 

continued necessity, determine whether 

they are crafted effectively to solve 

current problems, and evaluate whether 

they potentially burden the 

development or use of domestically 

produced energy resources. As part of 

these reviews, the Department invites 

the public to provide input on existing 

rules and other agency actions that are 

good candidates for repeal, replacement, 

suspension, or modification. The 

Department may also hold a public 

meeting to discuss and consider 

comments from members of the public. 

DATES: Comments should be received on 

or before November 1, 2017. Late-filed 

comments will be considered to the 

extent practicable. 

ADDRESSES: You may file comments 

identified by the docket number DOT– 

OST–2017–0069 by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Ave. SE., Room W12–140, 

Washington, DC 20590–0001. 

• Hand Delivery or Courier: The 

Docket Management Facility is located 

on the West Building, Ground Floor, of 

the U.S. Department of Transportation, 

1200 New Jersey Ave. SE., Room W12– 

140, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

• Fax: 202–493–2251. 

Instructions: You must include the 

agency name and the Docket Number 

DOT–OST–2017–0069 at the beginning 

of your comment. All comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal information provided. 

Privacy Act: In accordance with 5 

U.S.C. 553(c), DOT solicits comments 

from the public to better inform its 

rulemaking process. DOT posts these 

comments, without edit, to 

www.regulations.gov, as described in 

the system of records notice, DOT/ALL– 

14 FDMS, accessible through 

www.dot.gov/privacy. In order to 

facilitate comment tracking and 

response, we encourage commenters to 

provide their name, or the name of their 

organization; however, submission of 

names is completely optional. Whether 

or not commenters identify themselves, 

all timely comments will be fully 

considered. If you wish to provide 

comments containing proprietary or 

confidential information, please contact 

the agency for alternate submission 

instructions. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov or to the street 

address listed above. Follow the online 

instructions for accessing the docket. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Moss, Assistant General 

Counsel for Regulation, U.S. Department 

of Transportation, 1200 New Jersey Ave. 

SE., Washington, DC 20590, 202–366– 

4723 (phone), jonathan.moss@dot.gov 

(email) or Barbara McCann, Director, 

Office of Policy Development, Strategic 

Planning and Performance, U.S. 

Department of Transportation, 1200 

New Jersey Ave. SE., Washington, DC 

20590, 202–366–8016 (phone), 

barbara.mccann@dot.gov. 

SUPPLEMENTARY INFORMATION: 

DOT Responsibilities for Regulations 

and Transportation Infrastructure 

The Department carries out its 

responsibilities through the Office of the 


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Secretary (OST) and the following 

operating administrations (OAs): 

Federal Aviation Administration (FAA); 

Federal Highway Administration 

(FHWA); Federal Motor Carrier Safety 

Administration (FMCSA); Federal 

Railroad Administration (FRA); Federal 

Transit Administration (FTA); Maritime 

Administration (MARAD); National 

Highway Traffic Safety Administration 

(NHTSA); Pipeline and Hazardous 

Materials Safety Administration; 

(PHMSA); and St. Lawrence Seaway 

Development Corporation (SLSDC). 

DOT has statutory responsibility for a 

wide range of regulations. For example, 

DOT regulates safety in the aviation, 

motor carrier, railroad, motor vehicle, 

commercial space, transit, and pipeline 

transportation areas. The Department 

also regulates aviation consumer and 

economic issues, and provides financial 

assistance and writes the necessary 

implementing rules for programs 

involving highways, airports, mass 

transit, the maritime industry, railroads, 

and motor transportation and vehicle 

safety. Finally, DOT has responsibility 

for developing policies that implement 

a wide range of regulations that govern 

programs such as acquisition and grants 

management, access for people with 

disabilities, environmental protection, 

energy conservation, information 

technology, occupational safety and 

health, property asset management, 

seismic safety, security, and the use of 

aircraft and vehicles. 

Review of Regulations and Other 

Agency Actions 

Improvement of regulations is a 

continuous focus for the Department. 

There should be no more regulations 

than necessary, and those regulations 

should be straightforward, clear, and 

designed to minimize burdens. Further, 

DOT regulations and other agency 

actions should not unnecessarily 

obstruct, delay, curtail, or otherwise 

impose significant costs on the siting, 

permitting, production, utilization, 

transmission, or delivery of energy 

resources. Once issued, regulations and 

other agency actions should be reviewed 

periodically and revised to ensure that 

they continue to meet the needs for 

which they originally were designed, 

remain cost-effective and cost-justified. 

Further, regulations and other agency 

actions should promote clean and safe 

development of our Nation’s vast energy 

resources, while avoiding regulatory 

burdens that unnecessarily encumber 

energy production, constrain economic 

growth, and prevent job creation. 

Accordingly, DOT regularly makes a 

conscientious effort to review its rules 

in accordance with the Department’s 

1979 Regulatory Policies and 

Procedures (44 FR 11034, Feb. 26, 

1979), Executive Order (E.O.) 12866, 

E.O. 13563, and section 610 of the 

Regulatory Flexibility Act. The 

Department follows a repeating 10-year 

plan for the review of existing 

regulations, which is set forth in the 

Department’s semi-annual Regulatory 

Agenda published in the Federal 

Register (see Appendix D to 

‘‘Department Regulatory Agenda; 

Semiannual Summary’’ most recently 

issued on July 20, 2017). The reviews 

conducted under this plan comply with 

section 610 of the Regulatory Flexibility 

Act. OST and OAs other than the Saint 

Lawrence Seaway Development 

Corporation (SLSDC) have also elected 

to use this repeating 10-year plan to 

comply with the review requirements of 

the Department’s Regulatory Policies 

and Procedures and E.O. 12866. SLSDC 

does not follow this practice because the 

agency is responsible for only a small 

number of regulations that were 

reviewed in 2009. Generally, the OAs 

have divided their rules into 10 

different groups and analyze one group 

each year, then start over again. The 

Department regularly invites public 

participation in those reviews and seeks 

general suggestions on rules that it 

should revise or revoke. In the fall 

Regulatory Agenda, the Department 

publishes information on the results of 

the examinations completed during the 

previous year. 

Public Participation and Request for 

Comments 

Through three new E.O.s, President 

Trump directed agencies to further 

scrutinize their regulations and other 

agency actions. On January 30, 2017, 

President Trump signed E.O. 13771, 

Reducing Regulation and Controlling 

Regulatory Costs. Under Section 2(a) of 

the E.O., unless prohibited by law, 

whenever an executive department or 

agency publicly proposes for notice and 

comment or otherwise promulgates a 

new regulation, it must identify at least 

two existing regulations to be repealed. 

On February 24, 2017, President 

Trump signed E.O. 13777, Enforcing the 

Regulatory Reform Agenda. Under this 

Executive Order, each agency must 

establish a Regulatory Reform Task 

Force (RRTF) to evaluate existing 

regulations, and make recommendations 

for their repeal, replacement, or 

modification. As part of this process, the 

Department is directed to seek input/ 

assistance from entities significantly 

affected by its regulations. 

On March 28, 2017, President Trump 

signed E.O. 13783, Promoting Energy 

Independence and Economic Growth. 

Section 2 of E.O. 13783 requires 

agencies to review all existing 

regulations, orders, guidance 

documents, policies, and other similar 

agency actions that potentially burden 

the development or use of domestically 

produced energy resources, with 

particular attention to oil, natural gas, 

coal, and nuclear energy resources. This 

review will result in a final report that 

describes the result of the required 

review and includes specific 

recommendations that, to the extent 

permitted by law, could alleviate or 

eliminate aspects of agency actions that 

burden domestic energy production. 

E.O. 13783 also requires that, for any 

specific recommendations made in the 

final report, the agency suspend, revise, 

or rescind, or publish for notice and 

comment proposed rules suspending, 

revising, or rescinding those actions, as 

appropriate and consistent with law. 

To respond to the President’s 

direction in E.O. 13771, E.O. 13777, and 

E.O. 13783, as well as other legal 

authorities, the Department seeks 

written input from the public on 

existing regulations and other agency 

actions that are good candidates for 

repeal, replacement, or modification. In 

addition to accepting written comments, 

the Department may hold a public 

meeting. In recognition of the fact that 

safety is the Department’s highest 

priority, the Department seeks 

comments on those existing regulations 

and other agency actions that may be 

repealed, replaced, or modified without 

compromising safety. The public is 

encouraged to identify regulations that 

(a) eliminate jobs or inhibit job creation; 

(b) are outdated, unnecessary, or 

ineffective; (c) impose costs that exceed 

benefits; (d) create a serious 

inconsistency or otherwise interfere 

with regulatory reform initiatives and 

policies; (e) could be revised to use 

performance standards in lieu of design 

standards, or (f) potentially burden the 

development or use of domestically 

produced energy resources. The 

Department welcomes public comment 

on any and all of its regulations and 

other agency actions, although rules that 

impose significant costs on the public 

may provide greater opportunity for 

identifying and alleviating unnecessary 

burdens. For convenience, a list of 

economically significant rulemakings 

issued over the past several years is 

included in Appendix A. 

When identifying regulations and 

other agency actions appropriate for 

suspension, repeal, replacement, or 

modification, the public is encouraged 

to consider whether there is an 

opportunity to: (1) Simplify or clarify 

language in a regulation; (2) eliminate 


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overlapping and duplicative regulations, 

including those that require repetitive 

filings for conducting business with the 

Department; (3) eliminate conflicts and 

inconsistencies in the Department’s 

regulations and those of its agencies; (4) 

eliminate conflicts and inconsistencies 

with the rules of other Federal agencies 

or state, local, or tribal governments, (5) 

determine if matters in an existing 

regulation could be better handled fully 

by the states without Federal 

regulations; (6) revise regulations in 

which technology, economic conditions 

or other factors have changed in the area 

affected by the regulation; (7) reconsider 

regulations that were based on scientific 

or other information that has been 

discredited or superseded; (8) 

reconsider the burdens imposed on 

those directly or indirectly affected by 

the regulation and, specifically, those 

that are costly when compared to the 

benefit provided; (9) reconsider burdens 

imposed on small entities; (10) foster 

innovation by revising regulations to 

include performance standards for 

regulatory compliance; and (11) reduce 

burdens by incorporating international 

or industry consensus standards into 

regulations. 

Content of Comments 

The Department will review all 

comments submitted timely to the 

docket associated with this regulatory 

review, DOT–OST–2017–0069. To 

maximize the usefulness of comments, 

the Department encourages commenters 

to provide the following information: 

1. Specific reference. A specific 

reference to the policy statement, 

guidance document, regulation, or other 

agency action that imposes the burden 

that the comment discusses. This 

should be a citation to the Code of 

Federal Regulations, a guidance 

document number, or an Internet link. 

A specific reference will assist the 

Department in identifying the 

requirement, the original source of the 

requirement, and relevant 

documentation that may describe the 

history and effects of the requirement. 

2. Description of burden. A 

description of the burden that the 

identified policy statement, guidance 

document, regulation, or other agency 

action imposes. A comment that 

describes how the policy statement, 

guidance document, regulation, or other 

agency action is burdensome is more 

useful than a comment that merely 

asserts that it is burdensome. Comments 

that reflect experience with the 

requirement and provide data 

describing that experience are more 

credible than comments that are not tied 

to direct experience. Verifiable, 

quantifiable data describing burdens are 

more useful than anecdotal 

descriptions. 

3. Description of less burdensome 

alternatives. If the commenter believes 

that the objective that motivated the 

policy statement, guidance document, 

regulation, or other agency action may 

be achieved using a less burdensome 

alternative, the commenter should 

describe that alternative in detail. 

Likewise, if the commenter believes that 

there is not a less burdensome 

alternative or there is not a legitimate 

objective motivating the requirement, 

then that should be explained in the 

comment. 

4. Examples of affected entities or 

projects. Examples of entities that are, 

have been, or will be negatively affected 

by the identified policy statement, 

guidance document, regulation, or other 

agency action and examples of entities 

that will benefit it the requirement is 

removed or revised. A comment listing 

specific entities is more useful because 

it will assist the Department in 

investigating the burden and how it may 

be most effectively addressed. 

Scope of Comments 

The Department is interested in 

comments on any DOT regulation or 

other agency action that imposes 

unjustifiable burdens on regulated 

entities or on the use or production of 

domestic energy resources. 

Issued on: September 26, 2017. 

James C. Owens, 

Acting General Counsel. 

Appendix A—DOT Economically 

Significant Rulemakings 

1. The FRA’s final rule on Electronically 

Controlled Pneumatic Brake Systems (RIN: 

2130–AC03) (published on October 16, 2008, 

at 73 FR 61511) (annualized costs of $138 

million); 

2. The PHMSA’s final rule on Pipeline 

Safety: Standards for Increasing the 

Maximum Allowable Operating Pressure for 

Gas Transmission Pipelines (RIN: 2137– 

AE25) (published on October 17, 2008, at 73 

FR 62147) (annualized costs of $95 million); 

3. The NHTSA’s final rule on Average Fuel 

Economy Standards Passenger Cars and Light 

Trucks Model Year 2011 (RIN: 2127–AK29) 

(published on March 30, 2009, at 74 FR 

14195) (annualized costs of $1.46 billion); 

4. The NHTSA’s final rule on the Federal 

Motor Vehicle Safety Standards; Roof Crush 

Resistance; Phase-In Reporting Requirements 

(RIN: 2127–AG51) (published on May 12, 

2009, at 74 FR 22347) (annualized costs of 

$0.8–1.3 billion); 

5. The PHMSA’s final rule on Pipeline 

Safety: Integrity Management Program for 

Gas Distribution Pipelines (RIN: 2137–AE15) 

(published on December 4, 2009, at 74 FR 

63905) (annualized costs of $95 million); 

6. The NHTSA’s final rule on Light-Duty 

Vehicle Greenhouse Gas Emission Standards 

and Corporate Average Fuel Economy 

Standards (RIN: 2127–AK50) (published on 

May 7, 2010, at 75 FR 25323) (annualized 

costs of approximately $10 billion); 

7. The FAA’s final rule on Automatic 

Dependent Surveillance—Broadcast 

Equipage Mandate to Support Air Traffic 

Control Service (RIN: 2120–AI92) (published 

May 28, 2010, at 75 FR 30159) (annualized 

costs of $216 million); 

8. The FHWA’s final rule on Real-Time 

System Management Information Program 

(RIN: 2125–AF19) (published on November 

9, 2010, at 75 FR 68418) (annualized costs of 

$135 million); 

9. The NHTSA’s final rule on Federal 

Motor Vehicle Safety Standards, Ejection 

Mitigation; Phase-In Reporting Requirements; 

Incorporation by Reference (RIN: 2127– 

AK23) (published on January 19, 2011, at 76 

FR 3211) (annualized costs of $2.3 billion); 

10. The FRA’s final rule on Positive Train 

Control Systems (RRR) (RIN: 2130–AC27) 

(published on May 14, 2012, at 77 FR 28285) 

(annualized costs of $2 million); 

11. The NHTSA’s final rule on 2017 and 

Later Model Year Light-Duty Vehicle 

Greenhouse Gas Emissions and Corporate 

Average Fuel Economy Standards (RIN: 

2127–AK79) (published on October 15, 2012, 

at 77 FR 62623) (annualized costs of $2.2–3.6 

billion); 

12. The FTA’s final rule on Major Capital 

Investment Projects—New/Small Starts (RIN: 

2132–AB02) (published on January 9, 2013, 

at 78 FR 1991) (annualized costs of 

$300,000); 

13. The NHTSA’s final rule on Federal 

Motor Vehicle Safety Standards; Occupant 

Crash Protection (RIN: 2127–AK56) 

(published on November 25, 2013, at 78 FR 

70415) (annualized costs of $6 million); 

14. The FMCSA’s final rule on Inspection, 

Repair, and Maintenance; Driver-Vehicle 

Inspection Report (DVIR) (RIN: 2126–AB46) 

(published on December 18, 2014, at 79 FR 

75437) (annualized cost-savings of $1.7 

billion); 

15. The NHTSA’s final rule on Federal 

Motor Vehicle Safety Standards; Electronic 

Stability Control Systems for Heavy Vehicles 

(RIN: 2127–AK97) (published on June 23, 

2015, at 80 FR 36049) (annualized costs of 

$46 million); 

16. The PHMSA’s final rule on Hazardous 

Materials: Enhanced Tank Car Standards and 

Operational Controls for High-Hazard 

Flammable Trains (RIN: 2137–AE91) 

(published on July 7, 2015, at 80 FR 26643) 

(annualized costs of $234 million); 

17. The FMCSA’s final rule on Electronic 

Logging Devices and Hours of Service 

Supporting Documents (RIN: 2126–AB20) 

(published on December 16, 2015, at 80 FR 

78291) (annualized costs of $1.8 billion); 

18. The NHTSA’s final rule on Greenhouse 

Gas Emissions and Fuel Efficiency Standards 

for Medium- and Heavy-Duty Engines and 

Vehicles—Phase 2 (RIN: 2127–AL52) 

(published on October 25, 2016, at 81 FR 

73478) (annualized costs of $4 billion); 

19. The FMCSA’s final rule on Commercial 

Driver’s License Drug and Alcohol 

Clearinghouse (RIN: 2126–AB18) (published 


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on December 5, 2016, at 81 FR 87686) 

(annualized costs of $154 million); and 

20. The FMCSA’s final rule on Minimum 

Training Requirements for Entry-Level 

Commercial Motor Vehicle Operators (RIN: 

2126–AB66) (published on December 8, 

2016, at 81 FR 88732) (annualized costs of 

$368 million). 

[FR Doc. 2017–21101 Filed 9–29–17; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket Nos. FDA–2012–N–1210 and FDA– 

2004–N–0258] 

RIN 0910–ZA49 

Food Labeling: Revision of the 

Nutrition and Supplement Facts Labels 

and Serving Sizes of Foods That Can 

Reasonably Be Consumed at One 

Eating Occasion; Dual-Column 

Labeling; Updating, Modifying, and 

Establishing Certain Reference 

Amounts Customarily Consumed; 

Serving Size for Breath Mints; and 

Technical Amendments; Proposed 

Extension of Compliance Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to extend the compliance 

dates by approximately 1.5 years for the 

final rules providing updated nutrition 

information on the label of food, 

including dietary supplements; defining 

a single-serving container; requiring 

dual-column labeling for certain 

containers; updating, modifying, and 

establishing certain reference amounts 

customarily consumed (RACCs); and 

amending the label serving size for 

breath mints. The final rules appeared 

in the Federal Register of May 27, 2016. 

We are taking this action because, after 

careful consideration, we have 

tentatively determined that additional 

time would help ensure that all 

manufacturers covered by the final rules 

have guidance from FDA to address, for 

example, certain technical questions we 

received after publication of the final 

rules, and that they are able to complete 

and print updated Nutrition Facts labels 

for their products before they are 

expected to be in compliance with the 

final rules. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by November 1, 2017. 

ADDRESSES: You may submit comments 

on the extension of the compliance 

period as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 1, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 1, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

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 Nos. FDA– 

2012–N–1210 and FDA–2004–N–0258 

for ‘‘Food Labeling: Revision of the 

Nutrition and Supplement Facts Labels 

and Serving Sizes of Foods That Can 

Reasonably Be Consumed at One Eating 

Occasion; Dual-Column Labeling; 

Updating, Modifying, and Establishing 

Certain Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments; 

Extension of Compliance Date.’’ 

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: 

Paula Trumbo, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5001 Campus 


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