Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 52427 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

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 

(menu labeling third party disclosures 

and recordkeeping) and OMB Control 

No. 0910–0664 (voluntary registration 

program). 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the draft guidance. 

It is only necessary to send one set of 

comments. It is no longer necessary to 

send two sets 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may obtain the draft guidance at http:// 

www.fda.gov/FoodGuidances. 

V. References 

FDA has placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES), 

and they may be seen by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday. (FDA has 

verified the Web site addresses, but FDA 

is not responsible for any subsequesnt 

changes to the Web sites after this 

document publishes in the Federal 

Register.) 

1. Howlett, E.A., S. Burton, K. Bates, and 

K. Huggins, ‘‘Coming to a Restaurant Near 

You? Potential Consumer Responses to 

Nutrition Information Disclosure on Menus,’’ 

Journal of Consumer Research 36(3): 494– 

503, 2009. Available at http:// 

www.journals.uchicago.edu/doi/pdf/10.1086/ 

598799. 

2. Tandon, P.S., J.Wright, C. Zhou, C.B. 

Rogers, D.A. Christakis, ‘‘Nutrition Menu 

Labeling May Lead to Lower-Calorie 

Restaurant Meal Choices for Children,’’ 

Pediatrics 125(2): 244–248, 2010. 

3. Center for Science in the Public Interest, 

‘‘Comparison of Menu Labeling Policies,’’ 

Available at http://cspinet.org/new/pdf/ 

comparison_of_ml_policies_6-9.pdf. 

Dated: August 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21065 Filed 8–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

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 (§ 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 

§ 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. 


emcdonald on DSK2BSOYB1PROD with NOTICES2
52428 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES2