This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

86613 

Vol. 88, No. 239 

Thursday, December 14, 2023 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2011–F–0172] 

Menu Labeling: Supplemental 

Guidance for Industry (Edition 2); Draft 

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 (Edition 2).’’ The draft 

guidance, when finalized, will update 

the existing guidance to add new 

questions and answers to address 

voluntary declaration of added sugars 

and voluntary declaration of nutrition 

information for menus on third-party 

platforms. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 12, 2024 to ensure that we 

consider your comment on the draft 

guidance before we begin 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed 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: 

Sonia Hudson, Office of Nutrition and 

Food Labeling (HFS–820), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2731; or Holli Kubicki, Office 

of Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 


lotter on DSK11XQN23PROD with PROPOSALS1
86614 Federal Register / Vol. 88, No. 239 / Thursday, December 14, 2023 / Proposed Rules 

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

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

343(q)(5)(H)) (‘‘Food Labeling; Nutrition 

Labeling of Standard Menu Items in 

Restaurants and Similar Retail Food 

Establishments’’). The menu labeling 

requirements are codified at § 101.11 (21 

CFR 101.11). Before these requirements, 

consumers could find nutrition 

information on most packaged foods; 

however, this labeling was not generally 

and consistently available in restaurants 

and similar retail food establishments 

that serve ready-to-eat, prepared food. 

Providing calorie and other nutrition 

information for ready-to-eat prepared 

foods in restaurants and similar retail 

food establishments enables consumers 

to make informed and healthful dietary 

choices. 

In the Federal Register of May 5, 2018 

(83 FR 20731), we announced the 

availability of a final guidance entitled 

‘‘Menu Labeling: Supplemental 

Guidance for Industry’’ that addresses 

stakeholder questions regarding the 

implementation of nutrition labeling 

requirements for foods sold in covered 

establishments and includes examples 

of alternatives to aid in compliance. A 

‘‘covered establishment’’ is a restaurant 

or similar retail food establishment that 

is a part of a chain with 20 or more 

locations doing business under the same 

name (regardless of the type of 

ownership, e.g., individual franchises) 

and offering for sale substantially the 

same menu items, as well as a restaurant 

or similar retail food establishment that 

voluntarily registers with FDA to be 

covered by the Federal menu labeling 

requirements (§ 101.11(a); see 21 U.S.C. 

343(q)(5)(H)(i)). 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Menu Labeling: Supplemental 

Guidance for Industry (Edition 2).’’ The 

draft guidance is a revision to the 

guidance issued in May 2018. We are 

including two new questions and 

answers regarding voluntarily declaring 

added sugars as part of additional 

written nutrition information and 

voluntarily providing nutrition 

information consistent with the menu 

labeling requirements through thirdparty platforms. The guidance, if 

finalized, will support further alignment 

of menu labeling with our Nutrition 

Facts label regulation at 21 CFR 101.9, 

because we recommend that covered 

establishments voluntarily include the 

declaration of ‘‘added sugars’’ as part of 

the additional written nutrition 

information under § 101.11(b)(2)(ii)(A). 

Additionally, with the popularity of 

using third-party platforms, such as 

third-party online ordering websites and 

delivery applications to order food for 

pickup and delivery from chain 

restaurants and similar retail food 

establishments, we recommend the 

voluntary disclosure of calorie 

information for standard menu items to 

help consumers make informed and 

healthful decisions when ordering their 

meals online using a third-party 

platform. 

On November 6–8, 2023, FDA hosted 

a virtual public meeting and listening 

session to explore what Federal 

Agencies, communities, and private 

industry are doing to encourage the 

reduced consumption of added sugars. 

Issuing this draft guidance is one 

important step that FDA can take to 

make progress towards this goal. 

FDA is issuing the draft guidance to 

receive comments on the new questions 

and answers, and, as appropriate, will 

move the questions and answers to the 

final guidance document, after 

reviewing comments and incorporating 

any changes to the questions and 

answers. For ease of reference, a 

question retains the same number when 

it moves from the draft guidance to the 

final guidance. 

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 applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995

This draft guidance contains proposed

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3521). 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to publish a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, we will publish a 60-day 

notice of the proposed collection of 

information in a future issue of the 

Federal Register. 

This draft guidance also refers to 

previously approved FDA collections of 

information. The collections of 

information in § 101.11 have been 

approved under OMB control number 

0910–0782. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/FoodGuidances,h https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

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

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27450 Filed 12–13–23; 8:45 am] 

BILLING CODE 4164–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket No. 21–341; FCC 23–95, FR 

ID 186836] 

Protecting Consumers From SIM-Swap 

and Port-Out Fraud 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document, the Federal 

Communications Commission adopted a 

Further Notice of Proposed Rulemaking 

(FNPRM) that seeks comment on 

whether to harmonize the existing 

requirements governing customer access 

to Customer Proprietary Network 

Information (CPNI) with the new 

Subscriber Identity Module (SIM) 

change authentication and protection 

measures that the Commission adopted; 

whether limitations on employee access 

to CPNI prior to customer 

authentication should be extended to all 

telecommunications carriers; what steps 

the Commission can take to harmonize 

government efforts to address SIM swap 

and port-out fraud; and how providers 

should notify customers of failed 

authentication attempts. 

DATES: Comments are due on or before 

January 16, 2024, and reply comments 

are due on or before February 12, 2024. 

Written comments on the Paperwork 

Reduction Act proposed information 

collection requirements must be 

submitted by the public and other 

interested parties on or before February 

12, 2024. 

ADDRESSES: You may submit comments, 

identified by WC Docket No. 21–341, by 

any of the following methods: 

D Federal Communications 

Commission’s website: https://


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