
[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43182-43184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0371]


Voluntary Registration by Authorized Officials of Non-Covered 
Retail Food Establishments and Vending Machine Operators Electing To Be 
Subject to the Menu and Vending Machine Labeling Requirements 
Established by the Patient Protection and Affordable Care Act of 2010

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  Section 4205 of the Patient Protection and Affordable Care 
Act of 2010 (Affordable Care Act) established requirements for 
nutrition labeling of standard menu items for restaurants and similar 
retail food establishments with 20 or more locations doing business 
under the same name and offering for sale substantially the same menu 
items (hereinafter ``chain retail food establishments''), and for 
certain foods sold in vending machines operated by an operator that 
owns or operates 20 or more vending machines (hereinafter ``chain 
vending machine operators''). Under the Affordable Care Act, retail 
food establishments and vending machine operators not covered by 
section 4205 of the Affordable Care Act may elect to become subject to 
its requirements by registering biannually with FDA. Congress required 
that, within 120 days of enactment of the Affordable Care Act (March 
23, 2010), FDA issue a Federal Register notice specifying the terms and 
conditions for implementation of voluntary registration, pending 
promulgation of regulations. FDA is issuing this notice to assist 
restaurants and similar retail food establishments and vending machine

[[Page 43183]]

operators that are not subject to the menu labeling requirements of 
section 4205 of the Affordable Care Act, but choose to register to 
become subject to them, in voluntarily registering with FDA, pending 
promulgation of regulations.

DATES:  Submit electronic or written comments by October 21, 2010.

ADDRESSES:  Submit electronic comments on the notice to http://www.regulations.gov. Submit written comments on the notice to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kathleen Lewis, Center for Food 
Safety and Applied Nutrition (HFS-608), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2148.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 4205 of the Affordable Care Act (Public Law 111-148) 
requires restaurants and similar retail food establishments with 20 or 
more locations doing business under the same name and offering for sale 
substantially the same menu items (hereinafter ``chain retail food 
establishments'') to disclose specific nutrition information about 
certain food items offered for sale. Section 4205 also requires that 
calorie information be disclosed for certain food articles sold in 
vending machines operated by an operator that owns or operates 20 or 
more vending machines (hereinafter ``chain vending machine 
operators''). For chain retail food establishments, as that term is 
used in this notice, and for vending machines regardless of how many 
vending machines the operator owns or operates, section 4205 preempts 
State and local nutrition labeling laws unless they are ``identical`` 
to the requirements imposed by section 4205.
    This notice is to explain how retail food establishments and 
vending machine operators not otherwise subject to the provisions of 
section 4205 may voluntarily elect to become subject to them. In future 
actions, FDA will provide information to the public and the regulated 
communities about the new requirements in section 4205.

II. Terms and Conditions for Implementation of Voluntary Registration

A. Why is the section 4205 voluntary registration program being 
established?

    Congress provided in section 4205 of the Affordable Care Act that 
restaurants and similar retail food establishments and vending machine 
operators not covered by section 4205 may elect to become subject to 
its requirements by registering biannually (every other year) with FDA. 
Congress required FDA to publish a notice in the Federal Register, 
within 120 days of enactment of the Affordable Care Act (March 23, 
2010), specifying the terms and conditions for implementation of 
voluntary registration, pending promulgation of regulations.

B. What is the effect of voluntary registration under section 4205?

    Unlike chain retail food establishments (as that term is used in 
this document), restaurants and similar retail food establishments that 
are not covered by section 4205 can still be regulated under State and 
local nutrition labeling laws that are not ``identical to'' the Federal 
requirements. If these restaurants and similar retail food 
establishments voluntarily register, they will no longer be subject to 
State or local nutrition labeling requirements unless those 
requirements are identical to Federal requirements. Vending machine 
operators are in a different position; under section 4205, no State or 
locality may have a requirement concerning vending machines that is not 
``identical to'' the Federal requirements, regardless of how many 
vending machines the operator owns or operates (section 403A(a)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4))). 
Therefore, whether a vending machine operator has or has not 
registered, it cannot be subject to State or local nutrition labeling 
requirements that are not identical to the Federal requirements. 
However, Congress expressly provided in section 4205 that vending 
machine operators not subject to the requirements of the law might 
elect to be subject to them by registering with FDA.

C. Who must register?

    No restaurant or similar retail food establishment, or vending 
machine operator, is required to register under section 4205. However, 
if a restaurant or similar retail food establishment, or vending 
machine operator not otherwise subject to the provisions of section 
4205 elects to be subject to the Federal requirements of that section, 
registration must be by an authorized official.

D. Who is an authorized official of a restaurant or similar retail food 
establishment, or of a vending machine operator?

    The authorized official of a restaurant or similar retail food 
establishment or of a vending machine operator may be the owner, 
operator, agent in charge, or any other person authorized by the 
restaurant or similar retail food establishment or vending machine 
operator to register the restaurant, similar retail food establishment 
and/or vending machine operator with FDA under section 4205.

E. Should a separate registration be submitted for every location at 
which a restaurant or similar retail food establishment is operating?

    Section 4205 applies to restaurants or similar retail food 
establishments that are part of a chain with 20 or more locations, 
doing business under the same name (regardless of the type of ownership 
of the locations, e.g., individual franchisees), and offering for sale 
substantially the same menu items.
    Restaurants, similar retail food establishments, and operators of 
vending machines doing business at one or more but fewer than 20 
locations can register to be subject to section 4205. If a restaurant 
or similar retail food establishment has more than one but fewer than 
20 locations that are doing business under the same name, regardless of 
the type of ownership of the locations, which offer for sale 
substantially the same menu items, an authorized official may register 
multiple locations within the group of restaurants or retail food 
establishments on a single registration form. Alternatively, an 
authorized official of an individual restaurant or retail food 
establishment may register just that restaurant or retail food 
establishment.

F. When will the registration process begin and how often must the 
authorized official register?

    FDA will accept registrations beginning July 21, 2010, on a 
continuous basis. The authorized official must register every other 
year with FDA, and the registration will automatically expire if not 
renewed.

G. What information must be provided for the registration of 
restaurants or similar retail food establishments?

    Authorized officials for restaurants and similar retail food 
establishments must provide FDA with the following information:

[[Page 43184]]

     The name, address, phone number, e-mail address, and 
contact information for the authorized official;
     The name, address, and e-mail address of each restaurant 
or similar retail food establishment being registered, as well as the 
name and contact information for an official onsite, such as the owner 
or manager, for each specific restaurant or similar retail food 
establishment;
     All trade names the restaurant or similar retail food 
establishment uses;
     Preferred mailing address (if different from location 
address for each establishment) for purposes of receiving 
correspondence; and
     Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered restaurant or similar retail food 
establishment will be subject to the requirements of section 4205.
    As described in section II.I of this document, FDA has created and 
made available at a Web site, http://www.fda.gov/menulabeling, a form 
that contains fields requesting this information. Registrants must use 
this form to ensure that complete information is submitted.

H. What information must be provided for the registration of vending 
machine operators?

    Authorized officials for vending machine operators must provide FDA 
with the following information:
     The name, address, phone number, e-mail address, and 
contact information for the vending machine operator;
     The address of each vending machine owned or operated by 
the vending machine operator, and the name and contact information, 
including e-mail address, of the location in which each vending machine 
is located;
     Preferred mailing address (if different from location 
address), for purposes of receiving correspondence; and
     Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered restaurant or similar retail food 
establishment will be subject to the requirements of section 4205.
    As described in section II.I of this document, FDA has created and 
made available at a Web site, http://www.fda.gov/menulabeling, a form 
that contains fields requesting this information. Registrants must use 
this form to ensure that complete information is submitted.

I. How do authorized officials of restaurants, similar retail food 
establishments, and vending machine operators register?

    Authorized officials of restaurants, similar retail food 
establishments, and/or vending machine operators electing to be subject 
to the section 4205 requirements can register by visiting http://www.fda.gov/menulabeling. FDA prefers that the information be submitted 
by e-mail by typing complete information into the form (PDF), saving it 
on the registrant's computer, and sending it by e-mail to http://menulawregistration@fda.hhs.gov. If e-mail is not available, the 
registrant can either fill in the form (PDF) and print it out (or print 
out the blank PDF and fill in the information by hand or typewriter), 
and send it to FDA either by faxing the completed form to 301-436-2804 
or mailing it to the Center for Food Safety and Applied Nutrition, 
Compliance Information Branch (HFS-681), 5600 Fishers Lane, Rockville, 
MD 20857.

J. Will each registrant receive a confirmation of the registration?

    Initially, FDA will not provide automatic confirmation of 
registrations. We recommend that registrants save a copy of the 
completed form and evidence that it has been transmitted to FDA 
electronically, by fax, or by mail.

K. What does it mean to be ``registered''?

    Pending promulgation of regulations, FDA considers that an 
authorized official of any restaurant or similar retail food 
establishment, or of any vending machine operator, that completely and 
accurately provides the information described in response to sections 
II.G and II.H of this document, has registered the restaurant or 
similar retail food establishment, or vending machine operator.

L. How will future changes to the voluntary registration program be 
announced?

    FDA is required to propose regulations implementing the provisions 
of section 4205. We intend to include in those proposed regulations 
further specifications about the voluntary biannual registration of 
restaurants, similar retail food establishments, and vending machine 
operators that are not otherwise subject to the requirements of section 
4205.

III. Paperwork Reduction Act of 1995

    This notice 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 number 
0910-0664.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
notice. 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.

    Dated: July 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18123 Filed 7-21-10; 11:15 am]
BILLING CODE 4160-01-S


