6996 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

Dated: February 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[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. 

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superseded by our issuance of final 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 

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. 

SUMMARY: 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 


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