Document ID: FDA-2011-F-0172-0573
Agency: fda
Document Type: Proposed Rule
Title: A Labeling Guide for Restaurants and Retail Establishments Selling Away-
From-Home Foods—Part II (Menu Labeling Requirements in Accordance
with the Patient Protection Affordable Care Act of 2010); Draft Guidance for Industry; Availability
Posted Date: 2015-09-16T04:00Z

[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Proposed Rules]
[Page 55564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23232]

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 Proposed Rules
                                                 Federal Register
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 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.
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  Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / 
Proposed Rules  

[[Page 55564]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]

A Labeling Guide for Restaurants and Retail Establishments 
Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in 
Accordance with the Patient Protection Affordable Care Act of 2010); 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``A Labeling 
Guide for Restaurants and Retail Establishments Selling Away-From-Home 
Foods--Part II (Menu Labeling Requirements in Accordance with 21 CFR 
101.11); Draft Guidance for Industry.'' The draft guidance, when 
finalized, will help certain restaurants and similar retail food 
establishments comply with the menu labeling requirements, including 
the requirements to provide calorie and other nutrition information for 
standard menu items, including food on display and self-service food.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
November 2, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements 
(HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lynn Szybist, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``A Labeling Guide for Restaurants and Retail Establishments 
Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in 
Accordance with 21 CFR 101.11); Draft 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 our current thinking on this topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    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; the rule is 
codified at Title 21 of the Code of Federal Regulations at Sec.  101.11 
(21 CFR 101.11). The final rule implements requirements of section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 343(q)(5)(H)), which in general, requires that restaurants 
and similar retail food establishments that are part of a chain with 20 
or more locations, doing business under the same name, and offering for 
sale substantially the same menu items, provide calorie information for 
standard menu items (including food on display and self-service food), 
provide, upon request, additional written nutrition information for 
standard menu items, and comply with other requirements described in 
section 403(q)(5)(H) of the FD&C Act. The draft guidance uses a 
question and answer format and is intended to help restaurants and 
similar retail food establishments covered by the final rule comply 
with the nutrition labeling requirements of the final rule.

II. Paperwork Reduction Act of 1995

    This draft 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 Sec.  101.11(d), (c)(3), and (b)(2) have 
been approved under OMB Control No. 0910-0783.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23232 Filed 9-15-15; 8:45 am]
 BILLING CODE 4164-01-P