[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52427-52428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0354]
Guidance for Industry: Questions and Answers Regarding the Effect
of Section 4205 of the Patient Protection and Affordable Care Act of
2010 on State and Local Menu and Vending Machine Labeling Laws;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding the Effect of Section 4205 of the Patient
Protection and Affordable Care Act of 2010 on State and Local Menu and
Vending Machine Labeling Laws.'' Section 4205 of the Patient Protection
and Affordable Care Act of 2010 (Affordable Care Act) establishes
requirements for nutrition labeling of standard menu items for chain
retail food establishments and chain vending machine operators. FDA is
issuing this guidance to clarify section 4205's effect on State and
local menu and vending machine labeling laws, and to ensure that
industry and State and local government understand the immediate
effects of the law.
DATES: Submit either electronic or written comments on the guidance at
any time.
ADDRESSES: Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the guidance to the Office of Nutrition, Labeling and Dietary
Supplements, Center for Food Safety and Applied Nutrition (HFS-820),
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 guidance.
FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled
``Guidance for Industry: Questions and Answers Regarding the Effect of
Section 4205 of the Patient Protection and Affordable Care Act of 2010
on State and Local Menu and Vending Machine Labeling Laws.'' FDA is
issuing this guidance in a Questions and Answers format as an
informational guide to industry and State and local governments
affected by the enactment of section 4205 of the Affordable Care Act
(Public Law 111-148), which became effective on March 23, 2010. Section
4205 of the Affordable Care Act requires restaurants or similar retail
food establishments with 20 or more locations doing business under the
same name and offering for sale substantially the same menu items
(``chain retail food establishments'') to disclose specific nutrition
information about certain food items offered for sale. Section 4205
also requires vending machines operated by persons who own or operate
20 or more vending machines (``chain vending machine operators'') to
disclose calorie information for certain food articles sold in vending
machines. FDA is issuing this guidance to clarify section 4205's effect
on State and local menu and vending machine labeling laws, and to
ensure that industry and State and local government understand the
immediate effects of the law.
FDA is issuing this guidance as level 1 guidance consistent with
FDA's good guidance practices regulation (Sec. 10.115 (21 CFR
10.115)). Consistent with FDA's good guidance practices regulation, the
agency will accept comment, but is implementing the guidance document
immediately, in accordance with Sec. 10.115(g)(2), because the agency
has determined that prior public participation is not feasible or
appropriate in light of the need to respond expeditiously to the
mandates in section 4205 of the Affordable Care Act, which was
effective on March 23, 2010. The guidance represents the agency's
current thinking on section 4205's effective date, and effect on State
and local menu and vending machine labeling laws. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
[[Page 52428]]
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in the Federal Food, Drug, and Cosmetic Act and
established by section 4205 of the Affordable Care Act. 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 section 4205
of the Affordable Care Act have been approved under OMB control no.
0910-0665.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/FoodGuidances.
Dated: August 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21067 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S