[Federal Register Volume 76, Number 20 (Monday, January 31, 2011)]
[Notices]
[Pages 5384-5386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Restaurant Menu and 
Vending Machine 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
2, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0664. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

I. Background

    Restaurant Menu and Vending Machine Labeling: Registration for 
Small Chains Under Section 4205 of the Patient Protection and 
Affordable Care Act of 2010--(OMB Control Number 0910-0664)--Revision.
    On March 23, 2010, the President signed into law the Patient 
Protection and Affordable Care Act of 2010 (Affordable Care Act) (Pub. 
L. 111-148). Section 4205 of the legislation, which principally amends 
sections 403 and 403A of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 343 and 343-1, respectively), 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 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 email by 
typing complete information into the form (PDF), saving it on the 
registrant's computer, and sending it by email to http://[email protected]. 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, email address, and 
contact information for the authorized official;
     The name, address, and email 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

[[Page 5385]]

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 includes the following:
     The name, address, phone number, email 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 email 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.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of 
November 4, 2010 (75 FR 67978), FDA published a 60-day notice 
requesting public comment on the proposed collection of information. 
FDA received one letter, which contained multiple comments in response 
to the notice.
    (Comments) One comment suggested that FDA underestimated the number 
of affected businesses in the United States, particularly with regard 
to the number of affected convenience stores, and their rate of growth. 
Another comment suggested that FDA provide estimated burden hours 
individualized for each industry (i.e., convenience stores, 
restaurants, and grocery stores).
    (Response) FDA appreciates the data and suggestions provided in the 
comments and will consider them in the upcoming rulemakings. However, 
the Agency stands by its preliminary estimate of the paperwork burden 
resulting from section 4205 of the Affordable Care Act. Thus, FDA has 
not changed the burden estimates in table 1 of this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual                         Hours per
       Type of respondent            Number of     frequency per   Total annual      response       Total hours
                                    respondents      response        responses       (average)
----------------------------------------------------------------------------------------------------------------
Restaurant initial..............             103               1             103               2             206
Grocery initial.................             167               1             167               2             334
Convenience store initial.......              11               1              11               2              22
Other SRFE initial..............              81               1              81               2             162
                                 -------------------------------------------------------------------------------
    Total initial hours.........  ..............  ..............  ..............  ..............             724
                                 -------------------------------------------------------------------------------
New registrations...............               7               1               7               1               7
Re-registrations................             355               1             355            0.25              89
                                 -------------------------------------------------------------------------------
    Total recurring hours.......  ..............  ..............  ..............  ..............              96
                                 -------------------------------------------------------------------------------
    Total burden hours..........  ..............  ..............  ..............  ..............             820
----------------------------------------------------------------------------------------------------------------
\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 ``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 SRFE 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

[[Page 5386]]

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 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 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 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 2 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. 2003. ``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: January 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1994 Filed 1-28-11; 8:45 am]
BILLING CODE 4160-01-P