[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67978-67981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0564]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Restaurant Menu Labeling: Registration for Small 
Chains Under Section 4205 of the Patient Protection and Affordable Care 
Act of 2010

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of FDA's program of voluntary registration under the Patient 
Protection and Affordable Care Act of 2010 (Affordable Care Act).

DATES: Submit either electronic or written comments on the collection 
of information by January 3, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether

[[Page 67979]]

the proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

Restaurant Menu Labeling: Registration for Small Chains Under Section 
4205 of the Patient Protection and Affordable Care Act of 2010--(OMB 
Control Number 0910-0664)--Extension

    On March 23, 2010, the President signed into law the Affordable 
Care Act (Pub. L. 111-148). Section 4205 of the legislation, which 
principally amends sections 403 (21 U.S.C. 343) and 403A (21 U.S.C. 
343-1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
requires chain restaurants and similar retail food establishments 
(SRFE) with 20 or more locations, as well as operators of 20 or more 
vending machines, to disclose certain nutrition information on certain 
food items offered for sale so that consumers can make more informed 
choices about the food they purchase. Section 4205 preempts State and 
local governments from establishing menu labeling requirements in 
restaurants and calorie declarations for food in vending machines that 
are not ``identical to'' the section 4205 requirements.
    In addition to restaurant menu and vending machine labeling, 
section 4205 of the Affordable Care Act provides that persons or firms 
not subject to the disclosure of nutrition information required by this 
legislation, such as restaurants with fewer than 20 locations or 
vending machine operators with fewer than 20 vending machines, may 
elect to be subject to the requirements provided in section 4205 by 
registering biannually with FDA. As required by section 4205, FDA 
published a notice in the Federal Register of July 23, 2010 (75 FR 
43182) (the July 23, 2010, notice) 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. The information collection requirements of FDA's program of 
voluntary registration under section 4205 of the Affordable Care Act 
were approved under the emergency processing provisions of the PRA and 
assigned OMB control number 0910-0664.
    Voluntary registration allows companies with outlets or machines 
regulated by local or State calorie labeling requirements to opt 
instead for the requirements of section 4205 of the Affordable Care 
Act. The information provided to FDA will help Federal, State or local 
officials to determine which jurisdiction's requirements apply to the 
firm.
    Description of Respondents: Respondents to this collection of 
information include retail food establishments and vending machine 
operators with fewer than 20 outlets or machines.
    FDA's July 23, 2010, notice requires that retail food 
establishments and vending machine operators register with FDA using 
the Agency's Form FDA 3757 available at 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:<a href="/cdn-cgi/l/email-protection#90bfbffdf5fee5fcf1e7e2f5f7f9e3e4e2f1e4f9fffed0f6f4f1bef8f8e3bef7ffe6">//<span class="__cf_email__" data-cfemail="9ff2faf1eaf3fee8edfaf8f6ecebedfeebf6f0f1dff9fbfeb1f7f7ecb1f8f0e9">[email protected]</span></a>. 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.
    Information FDA requires on the registration form for restaurants 
and similar retail food establishments includes the following:
    <bullet> The name, address, phone number, e-mail address, and 
contact information for the authorized official;
    <bullet> 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;
    <bullet> All trade names the restaurant or similar retail food 
establishment uses;
    <bullet> Preferred mailing address (if different from location 
address for each establishment) for purposes of receiving 
correspondence; and
    <bullet> 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.
    Information FDA requires on the registration form for vending 
machine operators includes the following:
    <bullet> The name, address, phone number, e-mail address, and 
contact information for the vending machine operator;
    <bullet> 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;
    <bullet> Preferred mailing address (if different from location 
address), for purposes of receiving correspondence; and
    <bullet> 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 of 
the Affordable Care Act.
    In addition to the initial registration, the authorized official 
must register every other year with FDA, and the registration will 
automatically expire if not renewed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual                         Hours per
       Type of respondent            Number of     frequency per   Total annual      response       Total hours
                                    respondents      response        responses       (average)
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Restaurant initial..............             103               1             103            2                206
Grocery initial.................             167               1             167            2                334
C-store initial.................              11               1              11            2                 22
Other SRFE initial..............              81               1              81            2                162
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[[Page 67980]]

 
    Total initial hours.........  ..............  ..............  ..............  ..............             724
New registrations...............               7               1               7            1                  7
Re-registrations................             355               1             355            0.25              89
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    Total recurring hours.......  ..............  ..............  ..............  ..............              96
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates the reporting burden of this information collection 
to be 724 hours in the first year and 96 hours each year thereafter. 
The registration burden will be an ongoing, semiannual reporting of 
firm contact and location information to FDA. FDA bases its per 
respondent burden on the PRA analysis for section 415 of the FD&C Act 
(21 U.S.C. 350d) as laid out for the proposed rule entitled 
``Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002'' (68 FR 5378, 
February 3, 2003) (Ref. 1). FDA estimates that the initial collection 
of the information, and presentation of it in a format that will meet 
the Agency's registration regulations, will require a burden of 
approximately 2 hours per registration for the first year because the 
registration system will not be fully automated.
    FDA estimates that renewal registrations after the first year will 
require substantially less time because firms are expected to be able 
to affirm or edit the existing information in an online account in a 
way similar to other FDA firm registration systems. Therefore, FDA 
estimates that re-registration will take 0.25 hours for each 
registrant. Because there will be entry and exit from this set of 
firms, there will also be new registrations once the system is fully 
operational. FDA estimates that initial registration under the fully 
operational system will take 1 hour.
    The pool of potential registrants will be restaurants and SRFEs 
with outlets in jurisdictions that have their own menu labeling 
regulations and that are not explicitly regulated under section 4205 of 
the Affordable Care Act. Of the existing State and local regulations, 
the minimum number of outlets for which any of them currently apply is 
15, and section 4205 applies explicitly to firms with 20 or more 
outlets. Therefore, only firms with between 15 and 19 outlets, 
inclusive, have any explicit incentive to register. However, chains 
with fewer outlets may choose to register, either because they are 
growing quickly, or because they are concerned about possible 
regulation, therefore, for the purposes of this analysis we include 
chains with between 10 and 19 outlets, inclusive. The primary source of 
potential registrants will be restaurant and specialty food chains, but 
there are significant numbers of convenience stores and grocery stores 
that prepare food onsite and have a partial function as a take-away, or 
quick-service, restaurant. In addition, small chains of similar retail 
food establishments that operate in retail, hotel, corporate, 
educational, military or entertainment settings may want to register.
    Because the statute preempts State and local regulations on vending 
machine labeling, no vending machine operators will have an incentive 
to register. Therefore, FDA estimates that zero vending machine 
operators will register with FDA under section 4205 of the Affordable 
Care Act.
    According to The NPD Group's Spring 2010 ReCount report, there were 
579,416 sole purpose eating and drinking establishments in the United 
States in the winter of 2010 (Ref. 2). Of these, 40 percent will be 
explicitly subject to FDA rulemaking for the Affordable Care Act 
because they are part of chains with 20 or more outlets (Ref. 2). Of 
the remaining 350,000 outlets, only those that would be subject to 
local or State rules concerning menu labeling would have any incentive 
to register. Approximately 7.5 percent of restaurant outlets are in 
States or localities with currently operational menu labeling 
regulation, principally New York City, Oregon, Philadelphia, and some 
New York State counties (Ref. 3). NPD's Spring 2010 ReCount report 
shows a total of 20,000 outlets are part of chains with between 10 and 
19 establishments. If outlets are evenly distributed geographically, 
then 1,500 outlets and 103 restaurant firms may have an incentive to 
register with FDA. The hourly burden for restaurant chains is 206 hours 
(= 100 chains x 1 responses/chain/year x 2 hours/response).
    From the U.S. Census County Business Patterns data, FDA estimates 
that there are approximately 62,000 grocery stores in 2010. Of these, 
approximately 6,500 are ``independents'' which means that they are part 
of chains with fewer than 11 outlets (Ref. 4), and 35,000 are known to 
belong to chains with more than 20 outlets (Ref. 5). We round the 
remaining 20,523 outlets up to 21,000 to account for those outlets in 
chains with 10 or 11 establishments. County Business Patterns show that 
11.5 percent of all grocery stores are in jurisdictions that have 
relevant menu labeling regulations. Taking 11.5 percent of 21,000 
yields approximately 2,400 stores run by 167 firms. The hourly burden 
for grocery chains is 334 hours (= 167 chains x 1 responses/chain/year 
x 2 hours/response).
    According to Stagnito Media, there are 144,000 convenience store 
outlets in the United States (Ref. 6). Of these, 64,000 are defined as 
very small ``mom and pop'' locations. Approximately 60,000 outlets are 
controlled by 1 of the top 100 chains, each having at least 65 outlets 
(Ref. 7). Of the remaining 20,000, FDA estimates that half fall in the 
10 to 19 outlet range. From County Business Patterns (Ref. 3), 1.6 
percent of all convenience store outlets are in a jurisdiction with a 
local or State menu labeling regulation that does not explicitly exempt 
convenience stores. FDA estimates that approximately 160 convenience 
store outlets from 11 firms may have an incentive to register under 
this notice. The hourly burden for convenience store chains is 22 hours 
(= 11 chains x 1 responses/chain/year x 2 hours/response).
    Additional covered establishments, such as those in operating in 
lodging, corporate, entertainment, and educational settings are often 
provided by very large firms with many hundreds or thousands of 
outlets, and will thus be explicitly covered by section 4205 of the 
Affordable Care Act rather than by the registration provisions. FDA 
estimates that an additional 81 firms, controlling approximately 1,200 
outlets may have an incentive to register. The hourly

[[Page 67981]]

burden for these additional chains is 162 hours (= 81 chains x 1 
responses/chain/year x 2 hours/response).
    If all of these restaurant and similar retail food establishment 
chains choose to register with FDA, then FDA estimates the number of 
firms registering in the first year would be approximately 362 firms. 
At two hours per registration, the total initial hourly burden will 
then be 724 hours (= 362 firms x 2 hours/firm).
    FDA estimates that the rate of growth for chains entering the 10 to 
19 outlet segment will match the rate of growth out of this segment, so 
that the number of registrants will remain constant. County Business 
Patterns data shows an average growth rate in the number of 
establishments to be 2 percent per year over the 8 years from 1999 to 
2007 for restaurants (Ref. 3). If the restaurant growth rate for 
outlets of approximately 2 percent per year applies to these chains, 
then new registrants will amount to approximately 7 per year, with the 
remaining 355 registrants only renewing their registration. The yearly 
burden for registration is estimated to be 1 hour per new registrant. 
Thus, the total hour burden will be 7 hours (7 firms x 1 hour/firm). 
The yearly burden for renewing registration is estimated to be 0.25 
hour per continuing registrant. Thus, the total hour burden will be 89 
hours (355 firms x 0.25 hour/firm = 88.75, rounded to 89). This yields 
a recurring hourly burden of 96 hours per year (7 hours + 89 hours).

II. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and 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 we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Food and Drug Administration, ``Registration of Food Facilities 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002,'' 68 FR 5378, February 3, 2003.
    2. The NPD Group, ``Chains System Size Trend Report for U.S. FDA,'' 
ReCount, Spring 2010.
    3. U.S. Census Bureau, 2007, County Business Patterns, http://www.census.gov/econ/cbp/index.html, 2007, version date September 22, 
2009.
    4. Moran, M., J. McTaggart, and D. Chanil, ``Looking Up, 
Cautiously,'' Progressive Grocer 89(3): 20-52, 2010.
    5. Food Marketing Institute, Top U.S. Supermarket & Grocery Chains 
(by 2007 grocery sales), http://www.fmi.org, 2008.
    6. Stagnito Media, ``Directory of Convenience Stores: FAQ,'' http://www.conveniencestores.com/faq.html, accessed June 1, 2010.
    7. Longo, D. ``Convenience Store News: Hot Top 100,'' Convenience 
Store News, 45(10), pp. 27-32, August 10, 2009.

    Dated: October 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-27854 Filed 11-3-10; 8:45 am]
BILLING CODE 4160-01-P


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