[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Proposed Rules]
[Pages 27067-27068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10462]


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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); 
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 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 FDA's Food 
Labeling Regulations).'' The guidance 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. In addition, we note that enforcement of 
the Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments final rule will commence 1 year 
after the date on which this document publishes in the Federal 
Register.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 27068]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``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).'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office 
of Nutrition and Food Labeling, Center for Food Safety and Applied 
Nutrition (HFS-820), 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 guidance.

FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, 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 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).'' We are issuing this guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The guidance represents 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 alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of September 16, 2015 (80 FR 55564), we 
announced 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).'' We invited comment on the draft guidance by 
November 2, 2015.
    We received many comments on the draft guidance and have modified 
the guidance as appropriate by revising several questions and answers 
and adding new questions and answers. (The new questions and answers 
are at 5.5, 5.7, 5.11, 5.17, 5.35, 7.11, and 7.12.) Changes to the 
guidance include additional examples and explanations to clarify how 
the provisions of the rule would apply to various situations. The 
guidance announced in this document finalizes the draft guidance dated 
September 2015.

II. Enforcement

    On December 18, 2015, the President signed the Consolidated 
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the 
Consolidated Appropriations Act states that none of the funds made 
available under the Consolidated Appropriations Act may be used to 
implement, administer, or enforce the final rule entitled ``Food 
Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments'' until 1 year after the date we 
publish a Level 1 guidance with respect to nutrition labeling of 
standard menu items in restaurants and similar retail food 
establishments. As a result, enforcement of the final rule published 
December 1, 2014 (79 FR 71156), will commence May 5, 2017.

III. 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 Sec.  101.11(d), (c)(3), and (b)(2) have 
been approved under OMB control no. 0910-0783.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either 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: April 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10462 Filed 5-4-16; 8:45 am]
 BILLING CODE 4164-01-P