[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Rules and Regulations]
[Page 14805]
[FR Doc No: 2011-6227]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2010-0882; FRL-9281-4]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Adoption of the Revised Lead Standards and Related Reference
Conditions and Update of Appendices; Withdrawal of Direct Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: Due to an adverse comment, EPA is withdrawing the direct final
rule to approve revisions to Virginia's State Implementation Plan
(SIP). These SIP revisions add the primary and secondary lead standards
of 0.15 micrograms per cubic meter ([mu]g/m3), related reference
conditions, and update the list of appendices under ``Documents
Incorporated by Reference.'' In the direct final rule published on
January 26, 2011 (76 FR 4537), we stated that if we received any
adverse comments by February 25, 2011, the rule would be withdrawn and
would not take effect. EPA received an adverse comment within the
comment period. EPA will address the comment received in a subsequent
final action based upon the proposed action also published on January
26, 2011 (76 FR 4579). EPA will not institute a second comment period
on this action.

DATES: The direct final rule published at 76 FR 4537, January 26, 2011,
is withdrawn as of March 18, 2010.

ADDRESSES: EPA has established docket number EPA-R03-OAR-2010-0882 for
this action. The index to the docket is available electronically at
http://www.regulations.gov and in hard copy at Air Protection Division,
U.S. Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 8, 2011.
Shawn M. Garvin,
Regional Administrator, Region III.

    Accordingly, the amendments to the table in 40 CFR 52.2420,
published on January 26, 2011 (76 FR 4537) on page 4539 is withdrawn as
of March 18, 2011.

[FR Doc. 2011-6227 Filed 3-17-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18595-18597]
[FR Doc No: 2014-07285]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71820; File No. SR-NYSEMKT-2014-28]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Extending a Pilot
Program Related to Rule 128--Equities, Entitled ``Clearly Erroneous
Executions For Equities''

March 27, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 26, 2014, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in

Items I and II below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend a pilot program related to Rule
128--Equities, entitled ``Clearly Erroneous Executions For Equities.''
The text of the proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to extend the effectiveness of the
Exchange's current rule applicable to Clearly Erroneous Executions.
Portions of Rule 128--Equities, explained in further detail below, are
currently operating as a pilot program set to expire on April 8,
2014.\4\ The Exchange proposes to extend the pilot program to coincide
with the pilot period for the Plan to Address Extraordinary Market
Volatility Pursuant to Rule 608 of Regulation NMS under the Act (the
``Limit Up-Limit Down Plan'' or the ``Plan''), including any extensions
to the pilot period for the Plan.\5\
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    \4\ See Securities Exchange Act Release No. 70517 (September 26,
2013), 78 FR 60943 (October 2, 2013) (SR-NYSEMKT-2013-78).
    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
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    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Rule 128--Equities to provide for uniform treatment: (1) Of
clearly erroneous execution reviews in multi-stock events involving
twenty or more securities; and (2) in the event transactions occur that
result in the issuance of an individual stock trading pause by the
primary listing market and subsequent transactions that occur before
the trading pause is in effect on the Exchange.\6\ The Exchange also
adopted additional changes to Rule 128--Equities that reduced the
ability of the Exchange to deviate from the objective standards set
forth in Rule 128--Equities,\7\ and in 2013, adopted a provision
designed to address the operation of the Plan.\8\
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    \6\ See Securities Exchange Act Release No. 62886 (Sept. 10,
2010), 75 FR 56613 (Sept. 16, 2010) (SR-NYSEAmex-2010-60).
    \7\ Id.
    \8\ See Securities Exchange Act Release No. 68801 (Feb. 1,
2013), 78 FR 8630 (Feb. 6, 2013) (SR-NYSEMKT-2013-11); Securities
Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6,
2012) (the ``Limit Up-Limit Down Release''); see also Exchange Rule
128--Equities (i).
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    The Exchange believes the benefits to market participants from the
more objective clearly erroneous executions rule should continue on a
pilot basis to coincide with the operation of the Limit Up-Limit Down
Plan. The Exchange believes that continuing the pilot will protect
against any unanticipated consequences. Thus, the Exchange believes
that the protections of the Clearly Erroneous Rule should continue
while the industry gains further experience operating the Plan.
 2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\9\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\10\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system. Although the Limit Up-Limit Down Plan is
operational, the Exchange believes that maintaining the pilot will help
to protect against unanticipated consequences. Thus, the Exchange
believes that the protections of the Clearly Erroneous Rule should
continue while the industry gains further experience operating the
Plan. The Exchange also believes that the pilot program promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning review of transactions as clearly
erroneous. Thus, the Exchange believes that the extension of the pilot
would help assure that the determination of whether a clearly erroneous
trade has occurred will be based on clear and objective criteria, and
that the resolution of the incident will occur promptly through a
transparent process. The proposed rule change would also help assure
consistent results in handling erroneous trades across the U.S.
markets, thus furthering fair and orderly markets, the protection of
investors and the public interest. Based on the foregoing, the Exchange
believes the benefits to market participants from the more objective
clearly erroneous executions rule should continue on a pilot basis to
coincide with the operation of the Limit Up-Limit Down Plan.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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 B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change
implicates any competitive issues. To the contrary, as noted above, the
Exchange believes FINRA and other national securities exchanges are
also filing similar proposals, and thus, that the proposal will help to
ensure consistency across market centers.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.

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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest,
as it will allow the clearly erroneous pilot program to continue
uninterrupted while the industry gains further experience operating
under the Limit Up-Limit Down Plan, and avoid any investor confusion
that could result from a temporary interruption in the pilot program.
For this reason, the Commission designates the proposed rule change to
be operative upon filing.\13\
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    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2014-28 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2014-28. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2014-28 and should
be submitted on or before April 23, 2014.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07285 Filed 4-1-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16287-16288]
[FR Doc No: 2012-6615]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66590; File No. SR-ISE-2012-12]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to API Fees

March 14, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on February 29, 2012, the International Securities
Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its API or login fees. The text of
the proposed rule change is available on the Exchange's Web site
(http://www.ise.com), at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The ISE is proposing to amend its Schedule of Fees regarding the
Exchange's API or login fees. ISE currently charges its Members a fee
for each login that a Member uses for quoting or order entry, with a
lesser charge for logins used for the limited purpose of ``listening''
to broadcast messages.\3\ The Exchange currently has the following
categories of authorized logins: (1) Quoting, order entry and listening
(allowing the user to enter quotes, orders, and perform all other
miscellaneous functions, such as setting parameters and pulling
quotes); (2) order entry and listening (allowing the user to enter
orders and perform all other miscellaneous functions, such as setting
parameters and pulling quotes (but not quoting)); and (3) listening
(allowing the user only to query the system and to respond to broadcast
messages).\4\ The Exchange notes that quoting, order entry and
listening are functionalities available only to Exchange Market Makers,
i.e., Primary Market Makers and Competitive Market Makers, while only
order entry and listening are functionalities available to non-Market
Makers, i.e., Electronic Access Members.
---------------------------------------------------------------------------

    \3\ See Exchange Act Release No. 53522 (March 20, 2006), 71 FR
14975 (March 24, 2006) (SR-ISE-2006-09).
    \4\ Id.
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    ISE Market Makers currently receive an allocation of 1.8 million
quotes per day per user.\5\ If a Market Maker submits more quotes than
those allocated, i.e., 1.8 million quotes per day per user as measured
on average in a single month, the Market Maker is charged for
additional users depending upon the number of quotes submitted. Each
month, the total number of quotes submitted by a Market Maker is
divided by the number of trading days, resulting in the average quotes
per day entered by that Market Maker. This number is then divided by
1.8 million and rounded up to the nearest whole number, resulting in an
implied number of users based on quotes. Market Makers are charged on a
monthly basis for the greater of a) the greatest number of users that
logged into the system, or b) the number of implied users based on
quotes.
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    \5\ See Exchange Act Release No. 64269 (April 8, 2011), 76 FR
20752 (April 13, 2011) (SR-ISE-2011-21).
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    ISE currently charges Market Makers a standardized fee of $1,000
per month for each quoting session of up to 1.8 million quotes per day,
on average for a month, including for any incremental usage. For
example, a Market Maker with 10 logins currently pays $10,000 in fees
as long as it quotes on average 18 million quotes or less per day. If
that Market Maker instead sends an average of 20 million quotes per day
during a month, its fees would total $12,000 for a total of 12
sessions, with the extra 2 million quotes per day counting towards two
additional sessions.
    The Exchange now proposes to lower the quote allowance for each
login session from 1.8 million quotes per day to 1.5 million quotes per
day, including the quote allowance for each incremental login. The
Exchange is not proposing any changes to the fee charged for each login
session. The fee for each login session will remain at $1,000 per
month. With this proposed rule change, ISE expects to raise revenue to
offset the lower quoting volume at the Exchange.
    The Exchange has designated this proposal to be operative on March
1, 2012.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the

Act \6\ in general, and furthers the objectives of Section 6(b)(4) of
the Act \7\ in particular, in that it is an equitable allocation of
reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The Exchange believes that the
proposal does not constitute an inequitable allocation of fees, as all
similarly situated Members will be subject to the same fee structure,
and access to the Exchange's market is offered on fair and non-
discriminatory terms. In other words, the proposed rule change will
treat similarly situated Members in the same manner by allocating the
same quoting allowance to all Members. The Exchange further believes
that its proposal to lower the quote allowance per each login is both
equitable and reasonable as it will help the Exchange manage quote
message traffic. The Exchange believes that Market Makers are generally
quoting more efficiently on the Optimise trading platform and does not
believe that lowering the quoting allowance will impact Market Makers
adversely from conducting their activity on the Exchange. Further, the
Exchange's proposal does not preclude Members from obtaining additional
logins if they have a need beyond the quoting allowance allocated per
each login.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Exchange Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act.\8\ At any time within 60 days of
the filing of such proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Exchange Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Exchange Act. Comments may be submitted
by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-12 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2012-12. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2012-12 and should be
submitted on or before April 10, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-6615 Filed 3-19-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 70 (Wednesday, April 11, 2012)]
[Notices]
[Pages 21779-21782]
[FR Doc No: 2012-8699]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0221]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Consumer Responses to Labeling Statements on Food Packages

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the PRA).

DATES: Fax written comments on the collection of information by May 11,
2012.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Experimental Study on Consumer Responses to Labeling Statements
on Food Packages.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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.

Experimental Study on Consumer Responses to Labeling Statements on Food
Packages--(OMB Control Number 0910-NEW)

I. Background

    The Nutrition Labeling and Education Act requires almost all
packaged foods to bear nutrition labeling in the form of the Nutrition
Facts label. The law also allows manufacturers to provide other
nutrition information on labels in the form of various types of
statements, including claims, as long as such statements comply with
the regulatory limits that govern the use of each type of statement.
There are three types of claims that the food industry can voluntarily
use on food labels: (1) Health claims, (2) nutrient content claims
(e.g., ``Low fat''), and (3) structure/function claims (e.g., ``Calcium
builds strong bones.''). Although the different types of claims are
regulated differently, they all must be truthful and not misleading
(Ref. 1).
    With the increased public interest in identifying healthier foods,
U.S. food processors have been adding nutritional information in the
form of nutrition symbols to food labels in addition to claims.
Examples of nutrition symbols that have been used or suggested include
nutrient-specific disclosures (e.g., ``Guideline Daily Amounts'') (Ref.
2), calorie declarations (Ref. 3), summary product rating (e.g.,
``Smart Spot'') (Ref. 4), a hybrid summary indicator with nutrient-
specific disclosure (e.g., ``Sensible Solution: Good Source of Calcium,
Good Sources of 8 Vitamins and Minerals'') (Ref. 5), the Facts-Up-Front
icon, with and without positive nutrients (Ref. 6), and the symbol
recommended by the Institute of Medicine (Ref. 7). Claims related to
non-nutritional product characteristics are also used in food labeling.
The claims may feature, among other things, statements about how foods
are grown or made (e.g., ``Organic'' and ``All Natural'') or absence of
a substance (e.g., ``Gluten-free'').
    Many consumers use claims and the Nutrition Facts label in food
choice decisions (Refs. 8 through 10). While some products carry only a
single labeling statement (e.g., either one claim or one symbol) on
their packages, many products carry two or more labeling statements. In
addition, on the same package the attributes of one statement may
differ from those of other statements in terms of featured nutrient,
type of claim, framing of statement, nature of statement, and
presentation of statement. For example, a package may display one or
more statements such as symbols relating to nutrition content,
statements in words relating to the presence of certain nutrients,
statements in words relating to the absence of other nutrients,
statements in words describing the health benefits of consuming foods
containing or not containing certain nutrients, and statements in words
describing how the product was produced. Moreover, all of those symbols
and statements are distributed in various places on the package in
different font sizes and colors.
    There exists a large body of literature on the impacts of different
types of labeling statements on consumer perceptions and choices of
products (Refs. 11 and 12). The majority of the research, including the
consumer research that the Agency has previously conducted (Refs. 13
and 14), has focused on single labeling statements by eliciting study
participants' reactions to variants of a given statement. An advantage
of this research approach is that it helps isolate the effects of
individual statements and avoid potential confounding effects caused by
the presence of other statements. A disadvantage of this research
approach, however, is that it does not necessarily reflect the labels
consumers see in the marketplace. In particular, the existing

literature provides little information about how the coexistence of two
or more different labeling statements affects product perceptions and
choices. This information, however, is critical for understanding the
roles played by labeling statements in dietary decisions.
    Research suggests consumer product perceptions and purchase
decisions can be influenced by labeling statements and different
labeling statements may have different influences (Refs. 11 through
14). Therefore, FDA, as part of its effort to promote public health,
proposes to use this study to explore consumer responses to food labels
that bear multiple labeling statements. Specifically, the study plans
to examine: (1) Consumer responses to food labels that exhibit various
combinations of the number and type of statements, (2) whether and how
consumer responses to one label characteristic may be affected by the
other characteristic (i.e., the interactions between different
characteristics of labeling statements), and (3) whether and how
labeling statements affect consumers' use of the Nutrition Facts label.
    The proposed collection of information is a controlled randomized
experimental study. The study will use a 15-minute Web-based survey to
collect information from 4,000 English-speaking adult members of an
online consumer panel maintained by a contractor. The study will aim to
produce a sample that reflects the U.S. Census on gender, education,
age, and ethnicity/race.
    The study will randomly assign each of its participants to view two
label images from a set of food labels that will be created for the
study. These images will be systematically varied in the following
aspects: (1) Number of statements (ranging from none to three); (2)
featured nutrient and food product (fat--snack bar, sodium--chips, or
fiber--breakfast cereal); (3) type of statement (text such as
``Supports Cardiovascular Functioning'' or graphic, specifically the
Facts-Up-Front icons and one of the icon concepts proposed by the
Institute of Medicine) (Refs. 13 and 14); and (4) nature of featured
product attribute (such as ``Supports the Immune System'' or ``All
Natural''). With regard to claims, the study will focus on examples of
nutrient content claims and structure/function claims that can be found
on many food packages (Ref. 15). All label images will be mockups
resembling food labels that may be found in the marketplace. Images
will show product identity (e.g., tortilla chips) but not any real or
fictitious brand name. The study will provide interested participants
access to the Nutrition Facts label but not together with a product
image.
    The survey will ask its participants to view label images and
answer questions about their perceptions and reactions related to the
viewed product and label. Product perceptions (e.g., healthfulness,
potential health benefits, levels of nutrients, and taste) and label
perceptions (e.g., helpfulness and credibility) will constitute the
measures of responses in the experiment. To help understand the data,
the survey will also collect information about participants'
background, such as familiarity with and consumption, purchase, and
perception of the categories of food included in the study; awareness
and knowledge of nutrients; dietary interests; motivation regarding
label use and health literacy; and health status and demographic
characteristics.
    The study is part of the Agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets. Results of the study will be used primarily to enrich the
Agency's understanding of how multiple claims and other labeling
statements on food packages may affect how consumers perceive a product
or a label, which may in turn affect their dietary choices. Results of
the study will not be used to develop population estimates.
    In the Federal Register of April 13, 2011 (76 FR 20675), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. The Agency received four responses to the
notice. One of the responses was outside of the scope of the proposed
collection of information described in the 60-day notice and is not
addressed here. The remaining three responses contained multiple
comments. These comments, and the Agency's responses, are discussed in
the following paragraphs.
    (Comment 1) Two comments suggested that FDA provide mock stimuli
for public comment prior to initiating the study.
    (Response) We appreciate the suggestion for the Agency to provide
the experimental stimuli for public comment prior to initiating the
study. Per the PRA, a copy of the proposed experimental stimuli is
provided in the Appendix of the supporting document.
    (Comment 2) One comment suggested that the study include questions
to probe how non-misleading nutrient content, health, and structure/
function claims may improve consumers' understanding of a product's
nutritional attributes.
    (Response) We agree and have included measures to assess how
participants' understanding of a product's nutritional attributes may
be affected by non-misleading claims.
    (Comment 3) Two comments expressed concerns about four questions
proposed in the draft questionnaire. Two of the questions of concern
asked if participants had ever heard or read that certain foods
(unnamed) may help lower the risk of seven different types of health
problems, such as cancer, diabetes, and others. The third and fourth
questions of concern asked whether specific nutrients (e.g., calcium,
potassium, etc.) or a particular food product, respectively, might help
reduce the risk of the same health problems asked about in the other
two questions. Both comments suggested that such questions would
demonstrate that ``consumers misinterpret structure function claims as
health claims'' and argued that such a demonstration would be
inconsistent with the stated purpose of the information collection.
    (Response) FDA does not agree that the proposed questions on
participants' prior knowledge of foods' health benefits and inferences
from reading a label would bias the study toward health claims rather
than structure/function claims. Since label inferences can be affected
by what consumers already know or believe about a food, the prior
knowledge questions are included to help understand study participants'
reactions to labeling statements. The question about perceived health
benefits of a product is one of the most important measures of label
inferences. The Agency's previous research has shown that consumer
inferences of the health benefits of a product do not necessarily vary
between types of labeling statements (i.e., health claims, structure/
function claims, and nutrient content claims). Hence, this question is
not expected to produce erroneous data with respect to inferences about
structure/function claims.
    (Comment 4) One comment suggested that FDA consider including an
experimental condition in which participants would view a label bearing
up to three different labeling statements because consumers are
routinely exposed to this amount of information on food packages. In
the originally proposed design, FDA included label manipulations
involving only up to two different labeling statements.
    (Response) We agree with the comment and have revised the study to
include experimental conditions containing up to three labeling
statements on a label.
    (Comment 5) One comment suggested including an assessment of how
the

various labeling statements affect whether participants intend to
purchase the product or not.
    (Response) As we proposed in the draft questionnaire, we will
include a question about purchase intention.
    (Comment 6) One commenter noted that prior research has shown that
the appearance of packaging and statements on the front of the package
can increase the likelihood of consumers using the Nutrition Facts
label.
    (Response) FDA agrees that information about consumers' use of the
Nutrition Facts label is important and plans to record and analyze how
likely the study's participants are to consult the Nutrition Facts
label when viewing claims and other statements on the front label of a
product.
    (Comment 7) One comment questioned the relevance of asking
participants to rate the safety or trustworthiness of a product based
on the label information they view.
    (Response) Although the label content of a product may not be
intended to influence consumer assumptions regarding the safety of a
product, prior research has demonstrated that such influence may occur
(Ref. 16). Therefore, it would be useful to understand whether similar
reactions happen in a multiclaim context. Nevertheless, the products
that the proposed study plans to include (breakfast cereal, chips, and
snack bars) are generally not associated with safety issues that may
lead to foodborne illness or other safety hazards. Therefore, the study
will omit the proposed question on perceived product safety. On the
other hand, the Agency has determined that it is still important and
relevant to elicit study participants' perceptions of the
trustworthiness of various labeling statements (not foods, as stated in
the comment), especially when these statements feature different
nutrients or product benefits. Thus, the study will keep the proposed
question on perceived trustworthiness of the label.
    (Comment 8) One comment suggested that the study ask about
participants' interest in nutrients for which there is concern of
inadequate intake among Americans. The comment recommended replacing
Vitamin D and omega-3 fatty acids for Vitamins A and C, as proposed in
the previous draft questionnaire.
    (Response) We agree with the comment and have incorporated the
suggestion in the revised questionnaire.
    (Comment 9) One comment suggested that a plausible distractor or
wrong choice be included in the question about the nutrients
participants try to limit or increase in their diet to test the
validity of the responses.
    (Response) We disagree with the comment. Our previous surveys
indicate respondents can provide valid responses to these questions
(for example, Ref. 17). Furthermore, we are concerned that the validity
of the responses would suffer if a distractor or wrong choice is
included because participants may be confused by the presence of such
options in the question.
    To help design and refine the questionnaire, FDA plans to conduct
cognitive interviews by screening 72 panelists in order to obtain 9
participants in the interviews. Each screening is expected to take 5
minutes (0.083 hour), and each cognitive interview is expected to take
1 hour. The total for cognitive interview activities is 15 hours (6
hours + 9 hours). Subsequently, we plan to conduct pretests of the
questionnaire before it is administered in the study. We expect that
1,600 invitations, each taking 2 minutes (0.033 hour), will need to be
sent to panelists to have 200 of them complete a 15-minute (0.25 hour)
pretest. The total for the pretest activities is 103 hours (53 hours +
50 hours). For the survey, we estimate that 32,000 invitations, each
taking 2 minutes (0.033 hour) to complete, will need to be sent to the
consumer panel to have 4,000 of its members complete a 15-minute (0.25
hour) questionnaire. The total for the survey activities is 2,056 hours
(1,056 hours + 1,000 hours). Thus, the total estimated burden is 2,174
hours. FDA's burden estimate is based on prior experience with research
that is similar to this proposed study.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of
                         Activity                               No. of       responses per   Total annual        Average  burden per        Total hours
                                                              respondents     respondent       responses              response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener..............................              72               1              72             0.083 (5 minutes)               6
Cognitive interview.......................................               9               1               9                        1 hour               9
Pretest invitation........................................           1,600               1           1,600             0.033 (2 minutes)              53
Pretest...................................................             200               1             200             0.25 (15 minutes)              50
Survey invitation.........................................          32,000               1          32,000             0.033 (2 minutes)           1,056
Survey....................................................           4,000               1           4,000             0.25 (15 minutes)           1,000
                                                           ---------------------------------------------------------------------------------------------
    Total.................................................  ..............  ..............  ..............  ............................           2,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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 site after this document
publishes in the Federal Register.)
    1. U.S. Food and Drug Administration, ``Claims That Can Be Made
for Conventional Foods and Dietary Supplements,'' September 2003.
Available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.

    2. Kellogg's, ``How to Read a Nutrition Label,'' 2010. Available
at http://www.kelloggs.com/en_US/the-benefits-of-cereal/how-to-read-a-nutrition-label.html.
    3. PepsiCo, ``Nutrition Labeling,'' 2010. Available at http://www.pepsico.com/Purpose/Human-Sustainability/Nutrition-Labeling.html.
    4. Schmit, J., ``PepsiCo Labels Some of Its Snacks `Smart,' ''
USA Today, September 2, 2004. Available at http://www.usatoday.com/money/industries/food/2004-09-02-smart-spot_x.htm.
    5. Kraft Foods, ``Sensible Solution,'' 2010. Available at http://www.kraftrecipes.com/kf/HealthyLiving/SensibleSolution/SensibleSolution_Landing.aspx.
    6. FactsUpFront.org, ``Facts Up Front,'' 2011. Available at
http://factsupfront.com/.
    7. Institute of Medicine, ``Front-of-Package Nutrition Rating
Systems and Symbols: Promoting Healthier Choices,'' 2011. Available
at http://www.iom.edu/Reports/

2011/Front-of-Package-Nutrition-Rating-Systems-and-Symbols-
Promoting-Healthier-Choices.aspx.
    8. Centers for Disease Control and Prevention, ``2005-2006
National Health and Examination Survey Questionnaire, Diet Behavior
and Nutrition section,'' Unpublished results of questions DBQ.750
and DBQ.780. Questionnaire available at http://www.cdc.gov/nchs/data/nhanes/nhanes_05_06/sp_dbq_d.pdf.
    9. U.S. Food and Drug Administration, ``2008 Health and Diet
Survey,'' March 20, 2010. Available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm.
    10. Food Marketing Institute, ``2009 U.S. Grocery Shopper Trends
Survey,'' Washington, DC 2009.
    11. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers'
Use of Nutritional Labels: A Review of Research Studies and
Issues,'' Academy of Marketing Science Review, 2006(9), 2006.
Available at http://www.amsreview.org/articles/drichoutis09-2006.pdf.
    12. L[auml]hteenm[auml]ki, L., P. Lampila, K. Grunert, et. al,
``Impact of Health-Related Claims on the Perception of Other Product
Attributes,'' Food Policy, 23: 230-239, 2010.
    13. Labiner-Wolfe, J., C.-T. J. Lin, and L. Verrill, ``Effect of
Low Carbohydrate Claims on Consumer Perceptions About Food Products'
Healthfulness and Helpfulness for Weight Management,'' Journal of
Nutrition Education and Behavior, 42(5): 315-320, 2010.
    14. Roe, B., A.S. Levy, and B.M. Derby, ``The Impact of Health
Claims on Consumer Search and Product Evaluation Outcomes: Evidence
From FDA Experimental Data,'' Journal of Public Policy and
Marketing, 18(1): 89-105, 1999.
    15. LeGault, L., M.B. Brandt, N. McCabe, et. al, ``2000-2001
Food Label and Package Survey: An Update on Prevalence of Nutrition
Labeling and Claims on Processed, Packaged Foods,'' Journal of the
American Dietetic Association, 104(6): 952-958, 2004.
    16. Kapsak, W.R., D. Schmidt, N.M. Childs, et. al, ``Consumer
Perceptions of Graded, Graphic and Text Label Presentations for
Qualified Health Claims,'' Critical Reviews in Food Science and
Nutrition, 48: 248-256, 2008.
    17. U.S. Food and Drug Administration, ``Health and Diet Survey:
Dietary Guidelines Supplement--Report of Findings (2004 and 2005),
2008. Available at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm080331.htm.

    Dated: April 5, 2012.
David Dorsey,
Acting Association Commissioner for Policy and Planning.
[FR Doc. 2012-8699 Filed 4-10-12; 8:45 am]
BILLING CODE 4160-01-P