[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