Document ID: FDA-2010-D-0370-0072
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Withdrawals: Questions and Answers on Implementation of Menu Labeling Provisions, Section 4205, Patient Protection and Affordable Care Act, 2010
Posted Date: 2011-01-25T05:00Z

[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Page 4360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1530]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0370]

Draft Guidance for Industry: Questions and Answers Regarding 
Implementation of the Menu Labeling Provisions of Section 4205 of the 
Patient Protection and Affordable Care Act of 2010; Withdrawal of Draft 
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance entitled ``Draft Guidance for Industry: 
Questions and Answers Regarding Implementation of the Menu Labeling 
Provisions of Section 4205 of the Patient Protection and Affordable 
Care Act of 2010'' dated August 2010, that was announced in the Federal 
Register of August 25, 2010. FDA now intends to complete the notice and 
comment rulemaking process for the Patient Protection and Affordable 
Care Act of 2010 (hereinafter ``section 4205'') before initiating 
enforcement activities based, in part, on extensive comments on the 
draft guidance submitted to the Agency. FDA believes that this approach 
to implementing section 4205 will minimize uncertainty and confusion 
among all interested persons.

DATES: The withdrawal is effective January 25, 2011.

FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Foods 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 25, 2010 (75 FR 52426), FDA announced the 
availability of a draft guidance entitled ``Draft Guidance for 
Industry: Questions and Answers Regarding Implementation of the Menu 
Labeling Provisions of Section 4205 of the Patient Protection and 
Affordable Care Act of 2010.'' As stated in the draft guidance, certain 
provisions of section 4205 became requirements immediately upon 
enactment of the law. FDA recognized that industry may need additional 
guidance from the Agency and time to comply with these provisions. As a 
result, FDA stated that it expected to refrain from initiating 
enforcement action against establishments that are subject to, but not 
in compliance with, the provisions of section 4205 that became 
requirements immediately upon enactment of the law until a time period 
established in the draft guidance. FDA also stated that it anticipated 
issuing the guidance in December 2010.
    Based, in part, on extensive comments on the draft guidance 
submitted to the Agency, FDA now intends to complete the notice-and-
comment rulemaking process for section 4205 before initiating 
enforcement activities. As noted in the draft guidance, FDA is required 
to issue proposed regulations to carry out provisions of section 4205 
no later than March 23, 2011. FDA intends to meet this statutory 
deadline. In the course of developing the proposed rule, the Agency has 
considered the comments received on the draft guidance. FDA will then 
review the comments it receives on the proposed rule and issue a final 
rule expeditiously.
    FDA believes that this approach to implementing section 4205 will 
minimize uncertainty and confusion among all interested persons. The 
Agency also believes that expeditious completion of the rulemaking 
process will most rapidly lead to full and consistent availability of 
the newly required nutrition information for consumers.
    For these reasons, FDA is at this time withdrawing the draft 
guidance entitled ``Draft Guidance for Industry: Questions and Answers 
Regarding Implementation of the Menu Labeling Provisions of Section 
4205 of the Patient Protection and Affordable Care Act of 2010.''

    Dated: January 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1530 Filed 1-21-11; 12:00 pm]
BILLING CODE 4160-01-P