52036 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules 

* * * * * 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2017–24381 Filed 11–8–17; 8:45 am] 

BILLING CODE 6750–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 11 and 101 

[Docket No. FDA–2011–F–0172] 

Menu Labeling: Supplemental 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Menu 

Labeling: Supplemental Guidance for 

Industry.’’ The draft guidance, when 

finalized, will address concerns raised 

by stakeholders regarding the 

implementation of nutrition labeling 

required for foods sold in covered 

establishments. It includes expanded 

and new interpretations of policy, and 

identifies places where FDA intends to 

be more flexible in its approach. This 

draft guidance also includes many 

graphical depictions in order to convey 

our thinking on various topics and to 

provide examples of options for 

implementation. It addresses calorie 

disclosure signage for self-service foods, 

including buffets and grab-and-go foods; 

reasonable basis, and the criteria for 

considering the natural variation of 

foods; various methods for providing 

calorie disclosure information, 

including those for pizza; compliance 

and enforcement; and criteria for 

distinguishing between menus and 

other information presented to the 

consumer. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2018 to ensure that the 

Agency considers your comment on the 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 No. FDA– 

2011–F–0172 for ‘‘Menu Labeling: 

Supplemental Guidance for Industry.’’ 

Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the Office 

of Nutrition and Food Labeling, HFS– 

800, Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance. 

FOR FURTHER INFORMATION CONTACT: 

Ashley Rulffes, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

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

2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Menu Labeling Supplemental 

Guidance for Industry.’’ We are issuing 

the draft guidance consistent with our 

good guidance practices regulation (21 

CFR 10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on this topic. It does 

not establish any rights for any person, 

and is not binding on FDA or the public. 

You can use an alternate approach if it 

satisfies the requirements of the 


sradovich on DSK3GMQ082PROD with PROPOSALS
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules 52037 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

In the Federal Register of December 1, 

2014 (79 FR 71156), we published a 

final rule on nutrition labeling of 

standard menu items in restaurants and 

similar retail food establishments to 

implement the menu labeling provisions 

of section 403(q)(5)(H) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(q)(5)(H)). The menu labeling 

requirements are codified at Title 21 of 

the Code of Federal Regulations, 

§ 101.11 (21 CFR 101.11). 

In the Federal Register of May 4, 2017 

(82 FR 20825), we published an interim 

final rule (IFR) extending the 

compliance date to May 7, 2018. Our 

goals are to ensure that consumers are 

provided with consistent nutrition 

information they can use to make 

informed choices for themselves and 

their families, and to guide industry in 

clearly understanding the flexible ways 

in which the requirements can be 

implemented. 

This draft guidance addresses 

concerns raised by stakeholders 

regarding the implementation of 

nutrition labeling required for foods 

sold in covered establishments. The 

draft guidance reflects extensive further 

analysis by FDA in light of the 

comments we received to the IFR. In 

addition, given extensive further 

analysis by the Agency, we are 

withdrawing Questions and Answers 

5.17 and 5.18 in our previous guidance 

entitled ‘‘A Labeling Guide for 

Restaurants and Retail Establishments 

Selling Away-From-Home Foods—Part 

II (Menu Labeling Requirements in 

Accordance With FDA’s Food Labeling 

Regulations)’’ announced in the Federal 

Register of May 5, 2016 (81 FR 27067). 

We address the issue of distinguishing 

between menus and other information 

presented to the consumer in this draft 

guidance, and once finalized, this will 

represent our current thinking on this 

topic. The draft guidance also includes 

many graphical depictions to further 

illustrate our thinking on various topics. 

As previously stated, although you can 

comment on any guidance at any time 

(see 21 CFR 10.115(g)(5)), we do not 

intend to extend the comment period for 

the guidance, as we intend to finalize 

this guidance and provide clarity to the 

industry on these remaining questions 

ahead of the new compliance date of 

May 7, 2018. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

§ 101.11(b)(2), (c)(3), and (d) have been 

approved under OMB control number 

0910–0783. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances or 

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

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24246 Filed 11–7–17; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2017–C–6238] 

Colorcon, Inc.; Filing of Color Additive 

Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of petition. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that we have filed a 

petition, submitted by Colorcon, Inc., 

proposing that the color additive 

regulations be amended by expanding 

the permitted uses of synthetic iron 

oxide as a color additive to include use 

in dietary supplement tablets and 

capsules. 

DATES: The color additive petition was 

filed on October 3, 2017. 

ADDRESSES: For access to the docket to 

read background documents or 

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: 

Molly A. Harry, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1075. 

SUPPLEMENTARY INFORMATION: Under 

section 721(d)(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379e(d)(1)), we are giving notice that we 

have filed a color additive petition (CAP 

7C0308), submitted by Colorcon, Inc., 

275 Ruth Rd., Harleysville, PA 19438. 

The petition proposes to amend the 

color additive regulations in § 73.200 

(21 CFR 73.200) Synthetic iron oxide by 

expanding the permitted uses of 

synthetic iron oxide as a color additive 

to include use in dietary supplement 

tablets and capsules with a proposed 

limit of 5 milligrams, calculated as 

elemental iron, per day for labeled 

dosages. 

We have determined under 21 CFR 

25.32(k) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24421 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 


sradovich on DSK3GMQ082PROD with PROPOSALS