[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13225-13226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05590]


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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]


Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments; 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 ``Nutrition Labeling 
of Standard Menu Items in Restaurants and Similar Retail Food 
Establishments--Small Entity Compliance Guide''. The small entity 
compliance guide (SECG) is intended to help small entities comply with 
the final rule entitled ``Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments.''

DATES: The SECG will be available as of March 13, 2015. Submit either 
electronic or written comments on FDA guidances at any time.

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

FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, 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

    In the Federal Register of December 1, 2014 (79 FR 71156), we 
issued a final rule requiring nutrition labeling of standard menu items 
in restaurants and similar retail food establishments (the final rule). 
The final rule, which is codified at 21 CFR 101.11, is effective 
December 1, 2015.
    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 rule 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.

[[Page 13226]]

    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115(c)(2)). The SECG represents our current 
thinking on nutrition labeling of standard menu items in restaurants 
and similar retail food establishments. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This SECG refers to collections of information described in FDA's 
final rule that published in the Federal Register of December 1, 2014 
(79 FR 71156), and that will be effective on December 1, 2015. As 
stated in the final rule, these collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). In 
compliance with the PRA (44 U.S.C. 3507(d)), the Agency has submitted 
the information collection provisions of the final rule to OMB for 
review. FDA will publish a document in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

III. Comments

    Interested persons may submit either electronic comments regarding 
the SECG 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 SECG at either 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm 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: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05590 Filed 3-12-15; 8:45 am]
 BILLING CODE 4164-01-P