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, 52427-52428 [2010-21067]

Download as PDF Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 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 Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.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may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding the draft guidance.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 Electronic Access Persons with access to the Internet may obtain the draft guidance at https:// www.fda.gov/FoodGuidances. V. References emcdonald on DSK2BSOYB1PROD with NOTICES2 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 https:// 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 https://cspinet.org/new/pdf/ comparison_of_ml_policies_6-9.pdf. VerDate Mar<15>2010 17:38 Aug 24, 2010 Jkt 220001 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 52427 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 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. 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 https:// 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 SUMMARY: PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 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. E:\FR\FM\25AUN2.SGM 25AUN2 52428 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices II. Paperwork Reduction Act of 1995 emcdonald on DSK2BSOYB1PROD with NOTICES2 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 VerDate Mar<15>2010 17:38 Aug 24, 2010 Jkt 220001 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 9990 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 https:// 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 E:\FR\FM\25AUN2.SGM 25AUN2

Agencies

[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52427-52428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21067]


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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; 
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 https://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 (Sec.  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 Sec.  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.

[[Page 52428]]

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 
https://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
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