Document ID: FDA-2010-D-0354-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2010-08-25T04:00Z

[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]               
[Page 52427-52428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au10-130]                         

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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