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, 67978-67981 [2010-27854]
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67978
Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
UCEDD: Interview with Peer Researchers and Colleagues ...........................
UCEDD: Interview with Recipients of Community Services or Members of
Organizations/Agencies that are Trained to Provide Community Services
UCEDD: Self-administered Form .....................................................................
P&A: Executive Director Interview ...................................................................
P&A: Staff Interview .........................................................................................
P&A: Board of Directors (Commissioners)-Chair and Members .....................
P&A: Group Interview with Policymakers and Collaborators ..........................
P&A: Interview with Recipient of Community Education .................................
P&A: Interview with Clients .............................................................................
P&A: Self-administered Form ..........................................................................
UCEDD: Interview with Director ......................................................................
DD Council: Group Interview with Recipients of Self-Advocacy and Leadership Education and Training ........................................................................
DD Council: Group Interview with Recipients of Education and Training to
Improve Community Capacity ......................................................................
DD Council: Self-administered Form ...............................................................
Estimated Total Annual Burden Hours: ....................................................
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
jlentini on DSKJ8SOYB1PROD with NOTICES
Dated: November 1, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–27855 Filed 11–3–10; 8:45 am]
BILLING CODE 4184–01–P
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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
ACTION:
Office of Management and Budget,
Paperwork Reduction Project, Fax:
202–395–7285, E-mail:
OIRA_SUBMISSION
@OMB.EOP.GOV., Attn: Desk Officer
for the Administration for Children
and Families.
0.75
[Docket No. FDA–2010–N–0564]
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
Food and Drug Administration,
HHS.
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:
Notice.
I. Background
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 https://
www.regulations.gov. Submit written
SUMMARY:
PO 00000
Total burden
hours
1
Food and Drug Administration
AGENCY:
Average
burden hours
per response
100
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB Comment
Number of
responses per
respondent
Frm 00034
Fmt 4703
Sfmt 4703
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
E:\FR\FM\04NON1.SGM
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Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
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 https://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
https://
menulawregistration@fda.hhs.gov. If email 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:
• 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.
Information FDA requires on the
registration form for vending machine
operators includes the following:
• 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 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:
jlentini on DSKJ8SOYB1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Restaurant initial ................................................................
Grocery initial .....................................................................
C-store initial ......................................................................
Other SRFE initial ..............................................................
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Annual
frequency
per response
Number of
respondents
Type of respondent
PO 00000
Frm 00035
103
167
11
81
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Total annual
responses
1
1
1
1
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167
11
81
04NON1
Hours per
response
(average)
2
2
2
2
Total hours
206
334
22
162
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Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
(average)
Total initial hours ........................................................
New registrations ...............................................................
Re-registrations ..................................................................
........................
7
355
........................
1
1
........................
7
355
..........................
1
0.25
724
7
89
Total recurring hours ..................................................
........................
........................
........................
..........................
96
jlentini on DSKJ8SOYB1PROD with NOTICES
1 There
Total hours
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 reregistration 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
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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 × 1
responses/chain/year × 2 hours/
response).
PO 00000
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Fmt 4703
Sfmt 4703
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 × 1 responses/
chain/year × 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 × 1 responses/chain/year
× 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
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Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
burden for these additional chains is
162 hours (= 81 chains × 1 responses/
chain/year × 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 × 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 × 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 × 0.25 hour/firm =
88.75, rounded to 89). This yields a
recurring hourly burden of 96 hours per
year (7 hours + 89 hours).
jlentini on DSKJ8SOYB1PROD with NOTICES
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, https://
www.census.gov/econ/cbp/,
2007, version date September 22, 2009.
4. Moran, M., J. McTaggart, and D.
Chanil, ‘‘Looking Up, Cautiously,’’
Progressive Grocer 89(3): 20–52, 2010.
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16:47 Nov 03, 2010
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5. Food Marketing Institute, Top U.S.
Supermarket & Grocery Chains (by 2007
grocery sales), https://www.fmi.org, 2008.
6. Stagnito Media, ‘‘Directory of
Convenience Stores: FAQ,’’ https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0543]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Importer’s Entry
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
revision 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 revision of an approved Office of
Management and Budget (OMB)
collection of information for FDA’s
Importer’s Entry Notice. This revision
reflects additional burden recognized as
a result of including tobacco products to
the list of FDA-regulated products under
the Family Smoking Prevention and
Tobacco Control Act (the Tobacco
Control 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 https://
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.
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
67981
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezutto@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from
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 revision 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.
SUPPLEMENTARY INFORMATION:
Information Request Regarding
Importer’s Entry Notice—(OMB Control
Number 0910–0046)—Revision
On June 22, 2009, the President
signed the Tobacco Control Act (Pub. L.
111–31) into law. The Tobacco Control
Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding
a new chapter granting FDA important
new authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
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]]>Agencies
[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Pages 67978-67981]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27854]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
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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 https://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.
Information FDA requires on the registration form for restaurants
and similar retail food establishments includes the following:
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.
Information FDA requires on the registration form for vending
machine operators includes the following:
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 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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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
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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, https://www.census.gov/econ/cbp/, 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), https://www.fmi.org, 2008.
6. Stagnito Media, ``Directory of Convenience Stores: FAQ,'' https://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
