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; Withdrawal of Guidance, 6996 [2015-02526]

Download as PDF 6996 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices [FR Doc. 2015–02467 Filed 2–6–15; 8:45 am] BILLING CODE 4164–01–C 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; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA or we) is announcing the withdrawal 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,’’ dated August 2010. We are taking this action because the policies stated in the guidance have been superseded by our issuance of final rules on menu and vending machine labeling. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2371. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of August 25, 2010 (75 FR 52427), we announced 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.’’ The guidance stated that we were issuing the guidance to: (1) Ensure that industry and State and local governments understand the immediate effects of the law, and (2) clarify 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. We are withdrawing this guidance because we recently issued two final rules entitled ‘‘Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments’’ and ‘‘Food Labeling; Calorie Labeling of Articles of Food in Vending Machines’’ (see 79 FR 71156 (December 1, 2014) and 79 FR 71259 (December 1, 2014), respectively). The preambles for these final rules discuss issues relating to Federalism and to federal preemption of State and local laws and reflect our latest thinking on those issues. Consequently, the guidance no longer reflects our current thinking insofar as the law’s effect on State and local menu and vending machine labeling laws is concerned. FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS– 820), Food and Drug Administration, Dated: February 3, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–02526 Filed 2–6–15; 8:45 am] DATES: February 9, 2015. VerDate Sep<11>2014 17:39 Feb 06, 2015 Jkt 235001 BILLING CODE 4164–01–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0798] Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Mobile Medical Applications: Guidances for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of two guidance documents. FDA is issuing ‘‘Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices’’ to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health. FDA is also issuing an updated version of the guidance document ‘‘Mobile Medical Applications,’’ originally issued on September 25, 2013, that has been edited to be consistent with the MDDS guidance document. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: An electronic copy of the guidance document is available for SUMMARY: E:\FR\FM\09FEN1.SGM 09FEN1 EN09FE15.021</GPH> Dated: February 2, 2015. Leslie Kux, Associate Commissioner for Policy.

Agencies

[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Page 6996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02526]


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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; 
Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
withdrawal 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,'' dated August 2010. We are taking this 
action because the policies stated in the guidance have been superseded 
by our issuance of final rules on menu and vending machine labeling.

DATES: February 9, 2015.

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, 240-
402-2371.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 25, 2010 (75 FR 52427), we announced 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.'' The guidance stated that we were 
issuing the guidance to: (1) Ensure that industry and State and local 
governments understand the immediate effects of the law, and (2) 
clarify 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.
    We are withdrawing this guidance because we recently issued two 
final rules entitled ``Food Labeling; Nutrition Labeling of Standard 
Menu Items in Restaurants and Similar Retail Food Establishments'' and 
``Food Labeling; Calorie Labeling of Articles of Food in Vending 
Machines'' (see 79 FR 71156 (December 1, 2014) and 79 FR 71259 
(December 1, 2014), respectively). The preambles for these final rules 
discuss issues relating to Federalism and to federal preemption of 
State and local laws and reflect our latest thinking on those issues. 
Consequently, the guidance no longer reflects our current thinking 
insofar as the law's effect on State and local menu and vending machine 
labeling laws is concerned.

    Dated: February 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02526 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-P
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