[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9003-9004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0258]


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--
Small Entity Compliance Guide; 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 ``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--Small Entity Compliance Guide.'' The 
small entity compliance guide (SECG) is intended to help small entities 
comply with a final rule we issued in the Federal Register of May 27, 
2016, 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.'' The final rule is designed to ensure that serving sizes 
are based on more recent consumption data and that consumers have 
serving size information on the Nutrition Facts label that will assist 
them in maintaining healthy dietary practices.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 9004]]

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-2004-N-0258 for ``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--Small Entity Compliance Guide.'' 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 SECG to the Office 
of Nutrition and Food Labeling, Center for Food Safety and Applied 
Nutrition (HFS-800), 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 SECG.

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

    In the Federal Register of May 27, 2016 (81 FR 34000), we issued a 
final rule pertaining to serving sizes for food. The final rule amends 
the definition of a single-serving container; requires dual-column 
labeling for certain containers; updates, modifies, and establishes 
certain Reference Amounts Customarily Consumed (RACCs); amends the 
serving size for breath mints; and makes certain technical amendments 
to various aspects of preexisting serving size regulations. The final 
rule, which is codified at Sec. Sec.  101.9 and 101.12 (21 CFR 101.9 
and 101.12), became effective July 26, 2016, and has a compliance date 
of July 26, 2018, for manufacturers with $10 million or more in annual 
food sales, and July 26, 2019, for manufacturers with less than $10 
million in annual food sales. On October 2, 2017, FDA published a 
proposed rule to extend the compliance dates by approximately 1.5 
years--to January 1, 2020, for manufacturers with $10 million or more 
in annual food sales and to January 1, 2021, for manufacturers with 
less than $10 million in annual food sales--and explained that, pending 
completion of the rulemaking with respect to the compliance dates, we 
intend to exercise enforcement discretion with respect to the 
compliance dates announced in the final rule (82 FR 45753). A final 
determination regarding the compliance dates is pending.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rules on nutrition labeling, taken as a whole, will have 
a significant economic impact on a substantial number of small 
entities. In compliance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by 
Pub. L. 110-28), we are making available the SECG to explain the 
actions that a small entity must take to comply with the rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG 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. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
Sec. Sec.  101.9 and 101.12 have been approved under OMB control number 
0910-0381.

III. Electronic Access

    Persons with access to the internet may obtain the SECG 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: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04284 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P


