[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Proposed Rules]
[Pages 55323-55324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2018-D-1459]


Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed at One Eating Occasion, Reference Amounts Customarily 
Consumed, Serving Size-Related Issues, Dual-Column Labeling, and 
Miscellaneous Topics; Draft Guidance for Industry; Availability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 Agency) is announcing 
the availability of a draft guidance for industry entitled ``Food 
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One 
Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-
Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The 
draft guidance, when finalized, will provide questions and answers on 
topics related primarily to implementing two final rules, one entitled 
``Food Labeling: 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,'' and the other 
entitled ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels.'' This draft guidance also discusses formatting issues 
for dual-column labeling, products that have limited space for 
nutrition labeling, and additional issues dealing with compliance.

DATES: Submit either electronic or written comments on the draft 
guidance by January 4, 2019 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 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-2018-D-1459 for ``Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed At One Eating Occasion, Reference Amounts 
Customarily Consumed, Serving Size-Related Issues, Dual-Column 
Labeling, and Miscellaneous Topics; Draft 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, 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: Jillonne Kevala, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed At One Eating Occasion, Reference Amounts Customarily 
Consumed, Serving Size-Related Issues, Dual-

[[Page 55324]]

Column Labeling, and Miscellaneous Topics.'' 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. This guidance is not subject to Executive 
Order 12866.
    The draft guidance, when finalized, will provide questions and 
answers on topics related primarily to implementing two final rules: 
(1) ``Food Labeling: 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'' (81 
FR 34000 (May 27, 2016)) and (2) ``Food Labeling: Revision of the 
Nutrition and Supplement Facts Labels'' (81 FR 33742 (May 27, 2016)). 
This draft guidance also discusses formatting issues for dual-column 
labeling, products that have limited space for nutrition labeling, and 
additional issues dealing with compliance.

II. The Paperwork Reduction Act

    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 21 CFR part 101 have been approved under 
OMB control number 0910-0381.

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 website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: October 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24124 Filed 11-2-18; 8:45 am]
 BILLING CODE 4164-01-P