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]
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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superseded by our issuance of final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.
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17:39 Feb 06, 2015
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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
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