[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68361-68364]
From the Federal Register Online via the Government Publishing 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
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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
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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