
[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68361-68364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0567]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Restaurant Menu and Vending Machine Labeling: 
Recordkeeping and Mandatory Third Party Disclosure 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 recordkeeping and 
mandatory third party disclosure provisions of Section 4205 of the 
Patient Protection and Affordable Care Act of 2010 (ACA).

DATES: Submit either electronic or written comments on the collection 
of information by January 4, 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: 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

[[Page 68362]]

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 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 and Vending Machine Labeling: Recordkeeping and 
Mandatory Third Party Disclosure Under Section 4205 of the Patient 
Protection and Affordable Care Act of 2010--(OMB Control Number 0910-
0665)--Revision
    On March 23, 2010, the President signed into law the ACA (Pub. L. 
111-148). Section 4205 of the legislation, which principally amends 
sections 403 and 403A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343 and 343-1), requires chain restaurants and similar retail 
food establishments (SRFE) 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''), as well as 
operators of 20 or more vending machines (hereinafter ``chain vending 
machine operators''), to disclose certain nutrition information for 
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 for chain retail food establishments and vending machine 
nutrition labeling requirements that are not ``identical to'' the 
section 4205 requirements.
    Section 4205 became effective on the date the law was signed, March 
23, 2010. The provisions that went into immediate effect are as 
follows:
    For chain retail food establishments:
     Disclosing the number of calories in each standard menu 
item on menus and menu boards,
     Making additional written nutrition information available 
to consumers upon request,
     Providing a statement on menus and menu boards about the 
availability of the written nutrition information, and
     Providing calorie information (per serving or per food 
item) for self-service items and food on display, in a sign adjacent to 
each food item.
    For chain vending machine operators:
     Providing a sign in close proximity to each article of 
food (or the selection button) that discloses the number of calories 
contained in the article, unless a prospective purchaser is able to 
examine the Nutrition Facts Panel before purchasing the article, or 
visible nutrition information is otherwise provided at the point of 
purchase.
    Section 4205 of the legislation requires recordkeeping--for the 
calorie analysis--and a third party disclosure--for the menu and 
vending machine labeling.
    In the Federal Register of August 25, 2010 (75 FR 52427), FDA 
published a notice of availability of the guidance document 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 is intended 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. Persons with access to the Internet may obtain the 
guidance at the following Web site: http://www.cfsan.fda.gov/~dms/
guidance.html. In addition, the information collection requirements 
were approved under the emergency processing provisions of the PRA and 
assigned OMB control number 0910-0665.
    Menu and vending machine labeling will be used by consumers to 
assess the calorie content of their purchases. The purpose of the 
disclosure is to allow consumers to choose foods that are appropriate 
for their energy needs. Because consumers do not observe the 
preparation of food prepared by restaurants or similar retail food 
establishments, and because many of these foods were exempted from 
nutrition labeling requirements under the National Labeling Education 
Act (NLEA), consumers were not able to ascertain the calorie content of 
this food, and therefore could not make informed decisions about how 
that food fits their calorie requirements without the disclosure. The 
calorie information will be collected and recorded by the chain retail 
food establishments and chain vending machine operators that are 
required to disclose calorie information to their customers. The 
covered entities will use the records to ensure that calorie 
information that they disclose is accurate.
    Description of Respondents: Respondents to this collection of 
information include chain retail food establishments and chain vending 
machine operators.
    FDA estimates the burden of this collection of information as 
follows. The burden is described in the following paragraphs in two 
parts: A recordkeeping burden associated with discovering and recording 
the calorie count for each menu/vending item; and the third party 
disclosure burden associated with communicating that information to the 
consumer. The estimates are also separated for retail food service and 
vending operators. FDA estimates a total of 1,388,010 initial burden 
hours. This number has been divided by three in tables 1 and 2 of this 
document in order to avoid double counting in the Regulatory 
Information Service Center (RISC) and Office of Information and 
Regulatory Affairs (OIRA) Consolidated Information System to yield 
141,222 initial hours for recordkeeping and 312,448 initial hours for 
third party disclosure, for a sum of 462,670 initial hours. FDA 
estimates a total of 14,068,808 recurring hours, with nearly all of 
these for vending machine operators, including 31,408 recurring hours 
for recordkeeping and 14,037,400 recurring hours for third party 
disclosure.

Recordkeeping Burdens for Chain Retail Food Establishments

    The time burden for calorie analysis on chain retail food 
establishments is the time necessary for creating a record, managing 
the contracts for analysis, and communicating the results of the 
analysis to the outlets. FDA estimates the hourly burden of calorie 
analysis on these firms to be 4 hours per menu item.
    FDA estimates that there are approximately 1,069 restaurant chains, 
with 231,000 outlets, will be required to disclose calorie information. 
On average, we estimate that a chain has 117 items on its menu, and 
that 48 percent of chain restaurants, or 516, do

[[Page 68363]]

not already have calorie information. The hourly burden for restaurant 
chains is 241,488 hours (= 516 chains x 117 items/chain x 4 hours/
item).
    FDA estimates that there are 570 covered grocery and convenience 
store chains with an average of 40 standard menu items per chain. The 
hourly burden for grocery store chains is 91,200 hours (= 570 chains x 
40 items/chain x 4 hours/item).
    FDA estimates that there are 420 other chains that will be covered 
by the proposed rule. With 40 menu items on average, the number of 
hours required to deal with calorie analysis at these other chains is 
67,200 hours (= 420 chains x 40 items/chain x 4 hours/item).
    FDA has estimated that each of the 1,506 covered chains, on 
average, introduces new items or reformulates existing items 4 times 
per year. The recurring hourly burden of recordkeeping for new items, 
as displayed in the sixth row of table 1 of this document, is 24,096 
hours (= 1,506 chains x 4 items/chain x 4 hours/item).
    FDA estimates that 30 chains will become newly covered under the 
requirements of the proposed rule each year. With an average number of 
menu items of 60 per chain, this would result in approximately 7,200 
hours (= 30 chains x 60 items/chain x 4 hours/item). This amount is 
displayed in the seventh row of table 1 of this document.
    The final column of table 1of this document gives the estimated 
capital costs associated with calorie and nutrition analysis. These are 
the costs of acquiring nutrition analyses. FDA has estimated that the 
average cost of a full analysis is $269 per menu item. These costs are 
calculated by multiplying this per item cost by the number of items in 
column three multiplied by the number of recordkeepers in column two.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Recordkeeping Burden: Calorie Analysis and Recording \1\
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                                                              Annual
           Type of respondent                Number of     frequency per   Total annual      Hours per      Total hours         Total capital costs
                                           recordkeepers   recordkeeper       records         record
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Restaurant Chains.......................             516             117          60,372               4         241,488  $16.2 million
Grocery and Convenience Store Chains....             570              40          22,800               4          91,200  $6.1 million
Other Chains............................             420              40          16,800               4          67,200  $4.5 million
Vending Operators.......................             600              20          12,000               2          24,000  $0,000
                                         ---------------------------------------------------------------------------------------------------------------
    Total Initial Hours.................  ..............  ..............  ..............  ..............         423,888  $26.9 million
New/Reformulated Items..................           1,506               4           6,024               4          24,096  $1.6 million
New Chains..............................              30              60           1,800               4           7,200  $0.5 million
New Vendors.............................               3              20              60               2             120  $4,000
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    Total Recurring Hours...............  ..............  ..............  ..............  ..............          31,416  ..............................
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\1\ There are no operating and maintenance costs associated with this collection of information.

Third Party Disclosure Burdens for Chain Retail Food Establishments

    The third party reporting burden for chain retail food 
establishments is the time necessary to display calorie information on 
menus, menu boards, displayed food and other required locations. In 
practice, this is the time necessary to change out redesigned menu 
boards, FDA estimates 2 hours of time per menu board change.
    FDA estimates that limited service restaurant chains have an 
average of three menu boards or displays per establishment. With 
135,705 outlets having these displays, the total hourly burden 
estimated for third party disclosure at restaurants is 814,230 hours (= 
135,705 outlets x 3 displays/outlet x 2 hours/display).
    For grocery and convenience store chains, FDA estimates an average 
of 1 major menu board or display per establishment. With 41,945 
outlets, the total hourly burden is 83,890 hours (= 41,945 outlets x 1 
displays/outlet x 2 hours/display).
    For other covered chains, FDA estimates 33,114 covered outlets, 
each with an average of one major display or menu board. At 4 hours per 
disclosure, FDA estimates an hourly burden of 66,228 hours (= 33,114 
outlets x 1 displays/outlet x 2 hours/display).
    The most inexpensive technology available to vending machine 
operators for disclosing calorie content is using stickers. Because 
these do not require any initial investment and because they are not 
durable, all burden and costs will be on a recurring basis.

Recurring Disclosure Burdens for Chain Retail Food Establishments

    FDA estimates that the annual number of newly covered chains will 
be 30. At 20 establishments per chain, there will be 600 establishments 
at newly covered chains each year that will need to disclose calorie 
content. Taking an average number of displays equal to 2, the total 
hourly burden for disclosure due to newly covered chains is 2,400 hours 
(= 600 outlets x 2 displays/outlet x 2 hours/display).
    The final column of table 2 of this document gives the estimated 
capital costs associated with third party disclosure. These are the 
costs of acquiring new menu boards or displays. FDA has estimated that 
the average cost of menu board to be $550. These costs are calculated 
by multiplying this per menu board cost by the frequency of disclosures 
in column three multiplied by the number of respondents in column two.

                                      Table 2--Estimated Annual Third Party Disclosure Burden: Calorie Content \1\
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                                                                                          Annual
                        Type of respondent                             Number of      frequency per     Total annual       Hours per       Total hours
                                                                      respondents       disclosure      disclosures       disclosure
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Restaurants.......................................................          135,705                3          407,115              2             814,230
Grocery and Convenience Store Chains..............................           41,945                1           41,945              2              83,890
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Other Chains......................................................           33,114                1           33,114              2              66,228
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    Total Initial Hours................................................................................................................          964,348
New SRFE Outlets..................................................              600                2            1,200              2               2,400
Vending (Ongoing).................................................            5,000           56,000      280,000,000              0.05       14,000,000
Vending (Growth)..................................................            5,000              140          700,000              0.05           35,000
                                                                   -------------------------------------------------------------------------------------
    Total Recurring Hours..............................................................................................................       14,037,400
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\1\There are no operating and maintenance costs associated with this collection of information.

Burdens for Chain Vending Machine Operators

    Because almost all vending machines sell food that is previously 
manufactured and packaged, calorie analysis and production of calorie 
analysis displays will be most efficiently done at the manufacturer 
level instead of the operator level. Furthermore, most vended foods are 
subject to NLEA, which means that calorie content is already collected. 
A likely scenario for response to vending machine labeling is that food 
manufacturers include a set of calorie label stickers in each case of 
product. This would be efficient both because most manufacturers will 
already have the calorie information available, and because economies 
of scale exist for the manufacturer. In this case, vending machine 
operators will not need to keep a record of calorie content. Instead, 
the burden for most operators will be limited to that of administering 
records and passing the existing information on to consumers.
    FDA estimates that there are approximately 300,000 beverage 
machines that sell unpackaged products. The manufacturer of the 
ingredients to these foods (hot coffee drinks and sodas) would not 
necessarily have calorie information if the products were not subject 
to NLEA in some form. There are likely a limited number of 
manufacturers of the inputs to the beverage machines. For the purposes 
of this document, FDA estimates that there are 10 manufacturers serving 
these machines, and 20 drinks per manufacturer, so that approximately 
200 drinks would need to have calorie analysis. The cost of this 
calorie analysis will be included in the capital costs in the following 
paragraphs. FDA estimates that the recordkeeping burden for these firms 
is half that for restaurants, or two hours per item. If there are 600 
firms using beverage dispensers, then the hourly burden for 
recordkeeping is 24,000 hours (= 600 firms x 20 items/firm x 2 hours/
item).
    FDA believes that the set of items sold in these dispensary 
machines is approximately constant. If there is .5 percent growth in 
the number of firms, then approximately three new firms will become 
covered in this market in a given year. The burden associated with 
these three firms would be 120 hours (= 3 firms x 20 items/firm x 2 
hours/item). This amount is given in eighth row of table 1 of this 
document.
    The third party reporting for chain vending machine operators is 
the time necessary to install calorie displays on their vending 
machines. Because there is wide variation in the kinds of vending 
machines used--in materials, display, mechanism--there will likely be a 
variety of solutions. On the high end, a calorie display that is 
integrated with the graphics on the machine may cost several hundred 
dollars or more. On the low end, a set of calorie stickers affixed to 
the front of the machine would cost at most a few dollars per machine. 
Given the low margins in the vending machine industry, and given that 
nearly all of the regulated operators will be small businesses, FDA 
believes that almost all operators will, at least initially, choose the 
sticker option. In the long run, the manufacturers of vending machines, 
and the larger vending machine operators, such as the soft drink 
companies, may use the more integrated, and thus expensive, solution.
    FDA tentatively estimates a recurring hourly burden of 1 hour per 
machine, 2 times per year to install the displays. If there are an 
average of 20 items per machine, then the burden per response is .05 
hours (= 1 hours/machine/20 items/machine).This will be the time 
necessary to decide where to put the displays on the machine, and to 
sort, remove and affix calorie stickers. FDA expects the stickers to 
have a relatively short life, and the mix of product in a machine to 
change over time.
    FDA estimates approximately 7 million machines are serviced by 
5,000 operators, for an average number of machines per operator of 
1,400 machines. If each machine has 20 items, then the average number 
of responses per operator is 28,000. Given that stickers will likely 
need to be replaced twice per year on average, this number of responses 
doubles, to 56,000 responses per operator. The total recurring hours 
needed for third party display is then 14 million hours (= 5000 firms x 
1,400 machines/firm x 20 displays/machine x .05 hours/display x 2). 
This amount is recurring in every year, and is given in row 7 of table 
2 of this document.
    If growth in the vending machine industry is .5 percent, then each 
of the 5,000 respondents will have an average of 7 additional machines 
that would need to report calorie content each year. With an average 
number of items per machine of 20, the number of disclosures per 
respondent is 140. At .05 hours per response, the hours needed to 
disclose calorie content on new machines is 35,000 hours per year (= 
5000 firms x 7 machines/firm x 20 items/machine x .05 hours/item). This 
amount is displayed in row 8 of table 2 of this document.

    Dated: November 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28014 Filed 11-4-10; 8:45 am]
BILLING CODE 4160-01-P


