[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Proposed Rules]
[Page 55564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23232]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 /
Proposed Rules
[[Page 55564]]
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);
Draft Guidance for Industry; Availability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 we) is announcing 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availability of a draft guidance for industry entitled ``A Labeling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101.11); Draft Guidance for Industry.'' The draft guidance, when
finalized, 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.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
November 2, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements
(HFS-820), Center for Food Safety and Applied Nutrition, 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 draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lynn Szybist, 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 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); Draft Guidance for Industry.'' We are
issuing the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent our current thinking on this topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule on nutrition labeling of standard menu items in
restaurants and similar retail food establishments; the rule is
codified at Title 21 of the Code of Federal Regulations at Sec. 101.11
(21 CFR 101.11). The final rule implements requirements of section
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 343(q)(5)(H)), which in general, requires that restaurants
and similar retail food establishments that are part of a chain with 20
or more locations, doing business under the same name, and offering for
sale substantially the same menu items, provide calorie information for
standard menu items (including food on display and self-service food),
provide, upon request, additional written nutrition information for
standard menu items, and comply with other requirements described in
section 403(q)(5)(H) of the FD&C Act. The draft guidance uses a
question and answer format and is intended to help restaurants and
similar retail food establishments covered by the final rule comply
with the nutrition labeling requirements of the final rule.
II. Paperwork Reduction Act of 1995
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 Sec. 101.11(d), (c)(3), and (b)(2) have
been approved under OMB Control No. 0910-0783.
III. Comments
Interested persons may submit either electronic comments regarding
the draft guidance 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 draft guidance
document at 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: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23232 Filed 9-15-15; 8:45 am]
BILLING CODE 4164-01-P