[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52232-52233]
[FR Doc No: 2012-21246]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0323; FRL-9720-8]

Approval and Promulgation of Implementation Plans and
Designations of Areas for Air Quality Planning Purposes; Tennessee:
Bristol; Determination of Attaining Data for the 2008 Lead Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to determine that the Bristol
nonattainment area (hereafter also referred to as the ``Bristol Area''
or ``Area'') has attained the 2008 lead NAAQS. On April 4, 2012, the
State of Tennessee, through the Tennessee Department of Environment and
Conservation, submitted a request to EPA to make a determination that
the Bristol nonattainment area for the 2008 lead national ambient air
quality standards (NAAQS or standard) has attained the 2008 lead NAAQS.
This determination of attaining data is based upon complete, quality-
assured and certified ambient air monitoring data for the 2009-2011
period showing that the Area has monitored attainment of the 2008 lead
NAAQS. Additionally, as a result of this determination, EPA is taking
final action to suspend the requirements for the Area to submit an
attainment demonstration, together with reasonably available control
measures (RACM), a reasonable further progress (RFP) plan, and
contingency measures for failure to meet RFP and attainment deadlines
for so long as the Area continues to attain the 2008 lead NAAQS.

DATES: Effective Date: This final rule is effective on September 28,
2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R04-OAR-2012-0323. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.

FOR FURTHER INFORMATION CONTACT: Steve Scofield or Zuri Farngalo,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr.
Scofield may be reached by phone at<PHONE_NUMBER> or via electronic
mail at<EMAIL_ADDRESS>Mr. Farngalo may be reached by phone at
(404) 562-9152 or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?
II. What is the effect of this action?
III. What is EPA's final action?
IV. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is taking final action to determine that the Bristol Area
(comprising the portion of Sullivan County bounded by a 1.25 kilometer
radius surrounding the Universal Transverse Mercator (UTM) coordinates
4042923 meters E, 386267 meters N, Zone 17, which surrounds the Exide
Technologies Facility) has attaining data for the 2008 lead NAAQS. This
clean data determination is based upon quality assured, quality
controlled and certified ambient air monitoring data that shows the
Area has monitored attainment of the 2008 lead NAAQS based on the 2009-
2011 data. While still preliminary, the available 2012 monitoring data
also monitored attainment for the 2008 lead NAAQS.
    Other specific requirements of the clean data determination and the
rationale for EPA's action are explained in the Notice of Proposed
Rulemaking (NPR) published on June 14, 2012 (77 FR 35652) and will not
be restated here. The comment period closed on July 16, 2012. No
comments, adverse or otherwise, were received in response to the NPR.

II. What is the effect of this action?

    This final action suspends the requirements for this Area to submit
an attainment demonstration, associated RACM, RFP plan, and contingency
measures for failure to meet RFP and attainment deadlines so long as
this Area continues to meet the 2008 lead NAAQS. Finalizing this action
does not constitute a redesignation of the Bristol Area to attainment
for the 2008 lead NAAQS under section 107(d)(3) of the Clean Air Act
(CAA). Further, finalizing this action does not involve approving a
maintenance plan for the Area as required under section 175A of the
CAA, nor does it involve a determination that the Area has met all
requirements for a redesignation.

III. What is EPA's final action?

    EPA is taking final action to determine that the Bristol Area has
attaining data for the 2008 lead NAAQS. This clean data determination
is based upon quality assured, quality controlled, and certified
ambient air monitoring data showing that this Area has monitored
attainment of the 2008 lead NAAQS during the period 2009-2011. This
final action suspends the requirements for this Area to submit an
attainment demonstration, associated RACM, RFP plans, and contingency
measures for failure to meet RFP and attainment deadlines so long as
this Area continues to meet the 2008 lead NAAQS. EPA is taking this
final action because it is in accordance with the CAA and EPA policy
and guidance.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations that Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
makes the determination based on air quality data, and suspends certain
federal requirements. Accordingly, the Administrator certifies that
this rule will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility

Act (5 U.S.C. 601, et seq.). Because this rule makes a determination
based on air quality data and suspends certain federal requirements, it
does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). This rule also does not have tribal
implications because it will not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes, as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because it only proposes to make a determination based on air quality
data and suspend certain federal requirements, and does not alter the
relationship or the distribution of power and responsibilities
established in the CAA. This rule also is not subject to Executive
Order 13045 ``Protection of Children from Environmental Health Risks
and Safety Risks'' (62 FR 19885, April 23, 1997), because it proposes
to determine that air quality in the affected area is meeting federal
standards. The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply
because it would be inconsistent with applicable law for EPA, when
determining the attainment status of an area, to use voluntary
consensus standards in place of promulgated air quality standards and
monitoring procedures that otherwise satisfy the provisions of the CAA.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et
seq.). Under Executive Order 12898, EPA finds that this rule involves a
proposed determination of attainment based on air quality data and will
not have disproportionately high and adverse human health or
environmental effects on any communities in the area, including
minority and low-income.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 29, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action, pertaining to the determination of attaining data
for the 2008 lead standard for the Bristol Area, may not be challenged
later in proceedings to enforce its requirements. See section
307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Lead, Reporting
and recordkeeping requirements.

    Dated: August 13, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart RR--Tennessee

0
2. Amend Sec.  52.2236 by designating the existing undesignated
paragraph as paragraph (a), and adding paragraph (b) to read as
follows:

Sec.  52.2236  Control strategy; lead.

    (a) * * *
    (b) Determination of attaining data. EPA has determined the
Bristol, Tennessee, nonattainment area has attaining data for the 2008
lead (Pb) NAAQS. This clean data determination suspends the
requirements for this area to submit an attainment demonstration,
associated reasonably available control measures, a reasonable further
progress plan, contingency measures, and other planning SIPs related to
attainment of the standard for as long as this area continues to meet
the 2008 Pb NAAQS.

[FR Doc. 2012-21246 Filed 8-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 10, 2010 (Volume 75, Number 27)]
[Proposed Rules]
[Page 6595-6596]
[DOCID:fr10fe10-17]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-1155; Airspace Docket No. 09-ACE-14]

Proposed Amendment of Class E Airspace; Mapleton, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Mapleton,
IA. Additional controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAPs) at James G. Whiting
Memorial Field Airport, Mapleton, IA. The FAA is taking this action to
enhance the safety and management of Instrument Flight Rules (IFR)
operations for SIAPs at the airport.

DATES: 0901 UTC. Comments must be received on or before March 29, 2010.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2009-1155/Airspace Docket No. 09-
ACE-14, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd, Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments

are specifically invited on the overall regulatory, aeronautical,
economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2009-1155/
Airspace Docket No. 09-ACE-14.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see ``ADDRESSES'' section for address and phone number) between
9 a.m and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd, Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by adding additional Class E airspace extending
upward from 700 feet above the surface for SIAPs operations at James G.
Whiting Memorial Field Airport, Mapleton, IA. Controlled airspace is
needed for the safety and management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9T, dated August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would add additional controlled airspace at James G. Whiting
Memorial Field Airport, Mapleton, IA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700 feet
or more above the surface of the earth.
* * * * *

ACE IA E5 Mapleton, IA [Amended]

Mapleton, James G. Whiting Memorial Field Airport, IA
    (Lat. 42[deg]10'42'' N., long. 95[deg]47'37'' W.)
    Mapleton NDB
    (Lat. 42[deg]10'50''N., long. 95[deg]47'41''W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of James G. Whiting Memorial Field Airport
and within 3.1 miles each side of the 030[deg] bearing from the
Mapleton NDB extending from the 6.3-mile radius to 10 miles
northeast of the airport, and within 4 miles each side of the
204[deg] bearing from the airport extending from the 6.3-mile radius
to 10.3 miles southwest of the airport.

    Issued in Fort Worth, TX on February 1, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-2930 Filed 2-9-10; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register Volume 84, Number 55 (Thursday, March 21, 2019)]
[Rules and Regulations]
[Pages 10412-10413]
[FR Doc No: 2019-05357]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0145]

Safety Zones; Annual Events Requiring Safety Zones in the Captain
of the Port Lake Michigan Zone-Tulip Time Festival Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a safety zone on Lake Macatawa in
Holland, MI for the Tulip Time Festival Fireworks on May 11, 2019 to
provide for the safety of life on navigable waterways during this
fireworks display. This action is necessary and intended to protect the
safety of life and property on navigable waters prior to, during, and
immediately after a fireworks display. During the enforcement period
listed below vessels and persons are prohibited from transiting
through, mooring, or anchoring within the safety zone unless authorized
by the Captain of the Port Lake Michigan or a designated
representative. The operator of any vessel in the regulated area must
comply with directions from the Patrol Commander or any Official Patrol
displaying a Coast Guard ensign.

DATES: The regulations in 33 CFR 165.929(c)(1) will be enforced from
9:30 p.m. through 10:30 p.m. on May 11, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email marine event coordinator MSTC
Kaleena Carpino, Prevention Department, Coast Guard Sector Lake
Michigan, Milwaukee, WI; telephone<PHONE_NUMBER>, email D09-

<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zone;
Tulip Time Festival Fireworks listed as (c)(1) in Table 165.929 of 33
CFR 165.929 on May 11, 2019 from 9:30 p.m. through 10:30 p.m. This
safety zone will encompass all of Lake Macatawa within the arc of a
circle with a 1,000-foot radius from a center point launch position at
42[deg]47.496' N, 086[deg]07.348' W (NAD 83). This action is being
taken to provide for the safety of life and property on navigable
waterways prior to, during, and immediately after this fireworks
display.
    Pursuant to 33 CFR 165.930, entry into, transiting, or anchoring
within the safety zone during an enforcement period is prohibited
unless authorized by the Captain of the Port Lake Michigan, or his
designated on-scene representative. Those seeking permission to enter
the safety zone may request permission from the Captain of Port Lake
Michigan via channel 16, VHF-FM. If you are the operator of a vessel in
the regulated area during the enforcement period you must comply with
directions from the Patrol Commander or any Official Patrol displaying
a Coast Guard ensign.
    This notice of enforcement is issued under the authority of 33 CFR
165.929 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide notification of
this enforcement period via the Local Notice to Mariners and Broadcast
Notice to Mariners. The Captain of the Port Lake Michigan or his or her
designated on-scene representative may be contacted via VHF Channel 16
or at<PHONE_NUMBER>.

    Dated: March 15, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. 2019-05357 Filed 3-20-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Notices]
[Pages 68361-68364]
[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,<PHONE_NUMBER>.

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

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

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Annual
           Type of respondent                Number of     frequency per   Total annual      Hours per      Total hours         Total capital costs
                                           recordkeepers   recordkeeper       records         record
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                         ---------------------------------------------------------------------------------------------------------------
    Total Recurring Hours...............  ..............  ..............  ..............  ..............          31,416  ..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual
                        Type of respondent                             Number of      frequency per     Total annual       Hours per       Total hours
                                                                      respondents       disclosure      disclosures       disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Restaurants.......................................................          135,705                3          407,115              2             814,230
Grocery and Convenience Store Chains..............................           41,945                1           41,945              2              83,890
--------------------------------------------------------------------------------------------------------------------------------------------------------

Other Chains......................................................           33,114                1           33,114              2              66,228
--------------------------------------------------------------------------------------------------------------------------------------------------------
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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