[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32037-32038]
[FR Doc No: 2017-14427]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81076; File No. SR-ICEEU-2017-005]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to Clearing House Contributions
to CDS Default Resources

July 5, 2017.

I. Introduction

    On May 4, 2017, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change (SR-
ICEEU-2017-005) to modify its Finance Procedures with respect to ICE
Clear Europe's contributions to funds available in the event of a
clearing member's default. The proposed rule change was published for
comment in the Federal Register on May 23, 2017.\3\ The Commission
received no comment letters regarding the proposed change. For the
reasons discussed below, the Commission is approving the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-80706 (May 17, 2017),
82 FR 23692 (May 23, 2017) (SR-ICEEU-2017-005) (the ``Notice'').
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II. Description of the Proposed Rule Change

    ICE Clear Europe maintains financial resources to cover potential
losses resulting from a CDS Clearing Member default by collecting
margin from CDS Clearing Members, maintaining the CDS Guaranty Fund
which is made up of CDS Member Contributions, and allocating its own
contribution. In the event that ICE Clear Europe experiences losses
from the default of a CDS Clearing Member, it first looks to the margin
and CDS Guaranty Fund contributions provided by that defaulting CDS
Clearing Member. Next, ICE Clear Europe applies part of its own
contribution--the Clearing House CDS Initial Contribution. Third, ICE
Clear Europe applies the CDS Guaranty Fund contributions of non-
defaulting CDS Clearing Members together with the remainder of its own
contribution (the Clearing House CDS GF Contribution).
    ICE Clear Europe has proposed revisions to its Finance Procedures
to permit ICE Clear Europe to redesignate all or a part of the Clearing
House CDS GF Contribution as the Clearing House CDS Initial
Contribution. If such redesignation were to occur, the Clearing House
CDS GF Contributions would no longer be used pari passu with non-
defaulting CDS Clearing Members' contributions to the CDS Guaranty
Fund. Instead, the redesignated amounts would be used before non-
defaulting CDS Clearing Members' contributions. Accordingly, ICE Clear
Europe has proposed amending paragraph 15.2(a) of the Finance
Procedures, which establishes the amount of the Clearing House CDS
Initial Contribution, to provide that ``[t]he amount of the Clearing
House CDS Initial Contribution may be further increased by [ICE Clear
Europe] redesignating all or part of any of the Clearing House CDS GF
Contributions as Clearing House CDS Initial Contributions.'' Section
15.2(a) will also provide that any redesignation will be notified by
circular. ICE Clear Europe has also proposed additional, conforming
changes to paragraphs 15.2(b) to refer to amounts so redesignated as
Clearing House CDS Initial Contribution; 15.2(c) to take into account
amounts that are redesignated when establishing the Clearing House CDS
GF Contributions; 15.2(d) to include redesignated amounts in the
Clearing House CDS GF Contribution when calculating any replenishment
to the Clearing House CDS GF

Contribution; and 15.2(g) to clarify that redesignation for purposes of
top-up as a result of exchange rate fluctuations is not required, and
that redesignation for purposes of withdrawal as a result of exchange
rate fluctuations is not permitted.
    ICE Clear Europe believes that redesignation will reduce the
likelihood that non-defaulting CDS Clearing Members' contributions will
be used in a default scenario, and has represented that it ``does not
propose to change the aggregate amount of, or basis for calculating,
the Clearing House CDS GF Contribution and Clearing House CDS Initial
Contribution.'' \4\ ICE Clear Europe has represented that its Board, in
consultation with its CDS Risk Committee, will make any redesignation
decision.\5\ With respect to flexibility on the redesignation amount,
ICE Clear Europe noted that there are ``ongoing industry discussions
concerning the appropriate level and seniority of clearing house
contributions to default resources'' and that market participants have
``evolving views'' on the subject.\6\
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    \4\ Notice, 82 FR at 23693. ICE Clear Europe noted that ``The
respective amounts [] are determined in accordance with paragraph
15.2 of the Finance Procedures, and are notified to Clearing Members
by Circular.'' Id.
    \5\ Id.
    \6\ Id.
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III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization.\7\ Section 17A(b)(3)(F) of the Act requires,\8\ among
other things, that the rules of a registered clearing agency be
designed to assure the safeguarding of securities and funds which are
in the custody or control of the clearing agency or for which it is
responsible and the protection of investors and the public interest.
Rule 17Ad-22(b)(3) requires that a clearing agency that performs
central counterparty services for security-based swaps shall establish,
implement, maintain, and enforce written policies and procedures
reasonably designed to maintain sufficient financial resources to
withstand, at a minimum, a default by the two participant families to
which it has the largest exposures in extreme but plausible market
conditions, in its capacity as a central counterparty for security-
based swaps.\9\ Rule 17Ad-22(e)(4) requires that a covered clearing
agency involved in activities with a more complex risk profile shall
establish, implement, maintain and enforce written policies and
procedures reasonably designed to effectively identify, measure,
monitor, and manage its credit exposures to participants and those
arising from its payment, clearing, and settlement processes, including
by, in relevant part, (i) maintaining sufficient financial resources to
cover its credit exposure to each participant fully with a high degree
of confidence, (ii) maintaining additional financial resources at the
minimum to enable it to cover a wide range of foreseeable stress
scenarios that include, but are not limited to, the default of the two
participant families that would potentially cause the largest aggregate
credit exposure for the covered clearing agency in extreme but
plausible market conditions, (iv) including prefunded financial
resources, exclusive of assessments for additional guaranty fund
contributions or other resources that are not prefunded, when
calculating the financial resources available, and (v) maintaining the
financial resources required under Rule 17Ad-22(e)(4)(ii) in combined
or separately maintained clearing or guaranty funds, as applicable.\10\
Rule 17Ad-22(e)(2) requires that a covered clearing agency shall
establish, implement, maintain and enforce written policies and
procedures reasonably designed to provide for governance arrangements
that are clear and transparent and support the public interest
requirements in Section 17A of the Act applicable to clearing agencies,
and the objectives of owners and participants.\11\
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    \7\ 15 U.S.C. 78s(b)(2)(C).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 17 CFR 240.17Ad-22(b)(3).
    \10\ 17 CFR 240.17Ad-22(e)(4)(i), (ii), (iv) and (v).
    \11\ 17 CFR 240.17Ad-22(e)(2)(i) and (iii).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is consistent
with Section 17A of the Act and Rule 17Ad-22 thereunder. Because ICE
Clear Europe has not proposed changing the amount of financial
resources it contributes to cover default losses, but rather, to give
itself the authority to apply some or all of those amounts in a default
scenario sooner than it otherwise would, the proposed rule change is
consistent with Section 17A(b)(3)(F) \12\ and Rules 17Ad-22(b)(3) and
(e)(4).\13\ ICE Clear Europe's flexibility in deciding whether and, if
so, how much, of the Clearing House CDS GF Contribution to designate is
consistent with the public interest in light of ongoing industry
discussions, consistent with Section 17A(b)(3)(F) of the Act.\14\
Finally, ICE Clear Europe's proposal to vest resdeisgnation authority
with its Board, in consultation with its CDS Risk Committee and
publication by circular, is consistent with the requirement in Rule
17Ad-22(e)(2) concerning governance arrangements that are clear and
transparent and support the public interest requirements of Section 17A
of the Act applicable to clearing agencies and the objectives of
participants. \15\
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    \12\ 15 U.S.C. 78q-1(b)(3)(F).
    \13\ 17 CFR 240.17Ad-22(b)(3) and (e)(4).
    \14\ 15 U.S.C. 78q-1(b)(3)(F).
    \15\ 17 CFR 240.17Ad-22(e)(2)(i) and (iii).
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IV. Conclusion

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
that the proposed rule change (SR-ICEEU-2017-005) be, and hereby is,
approved.\16\
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    \16\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Eduardo A. Aleman,
Assistant Secretary.
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    \17\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2017-14427 Filed 7-10-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35297-35298]
[FR Doc No: 2020-12456]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR20-62-001.
    Applicants: Black Hills Wyoming Gas, LLC.
    Description: Tariff filing per 284.123(b),(e)/: Black Hills Wyoming
Gas, LLC Amended SOC Filing to be effective 5/12/2020.
    Filed Date: 5/28/2020.
    Accession Number:<PHONE_NUMBER>52.
    Comments/Protests Due: 5 p.m. ET 6/18/2020.

    Docket Numbers: RP20-780-001.

    Applicants: Pine Needle LNG Company, LLC.
    Description: Compliance filing Implementation of Approved
Stipulation and Agreement in Docket No. RP20-780 to be effective 6/1/
2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5207.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-886-000.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: Sec.  4(d) Rate Filing: FLU Percentage Recomputation
to be effective 7/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5055.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-887-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: AGT May 2020 Customer Name
Change--Plymouth Rock to ENGIE Power & Gas LLC to be effective 6/27/
2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5061.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-888-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Quarterly LUF Trueup Filing to
be effective 7/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5065.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-889-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Update Filing
(Conoco June 20) to be effective 6/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5073.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-890-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: TETLP NRA Name Change
Cleanup--Plymouth Rock to ENGIE Power & Gas LLC to be effective 6/27/
2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5085.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-891-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Periodic Rate Adjustment to be
effective 7/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5086.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-892-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Chevron
911109 releases eff 6-1-2020 to be effective 6/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5088.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-893-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Negotiated Rate
Update (SoCal July 20) to be effective 7/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5089.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-894-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates Filing on 5-
28-20 to be effective 6/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5130.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-895-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Duke Energy
Indiana 712322 eff 6-1-2020 to be effective 6/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5134.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-897-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Columbia Gas
860005 6-1-2020 Releases to be effective 6/1/2020.
    Filed Date: 5/28/20.
    Accession Number: 20200528-5245.
    Comments Due: 5 p.m. ET 6/9/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 3, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-12456 Filed 6-8-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 81948-81950]
[FR Doc No: 2011-33303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0345]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Consumer Responses to Nutrition Facts Labels With Various Footnote
Formats and Declaration of Amount of Added Sugars

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.

DATES: Fax written comments on the collection of information by January
30, 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 Nutrition Facts
Labels With Various Footnote Formats and Declaration of Amount of Added
Sugars.'' 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>,
<EMAIL_ADDRESS>
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 Nutrition Facts Labels With
Various Footnote Formats and Declaration of Amount of Added Sugars--
(OMB Control Number 0910-New)

I. Background

    Under the Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535), the Nutrition Facts label is required on most packaged foods,
and this information must be provided in a specific format in
accordance with the provisions of Sec.  101.9 (21 CFR 101.9). When FDA
was determining which Nutrition Facts label format to require, the
Agency undertook consumer research to evaluate alternatives (Refs. 1 to
3). More recently, FDA conducted qualitative consumer research on the
format of the Nutrition Facts label on behalf of the Agency's Obesity
Working Group (Ref. 4), which was formed in 2003 and tasked with
outlining a plan to help confront the problem of obesity in the United
States (Ref. 5). In addition to conducting consumer research, in the
Federal Register of November 2, 2007 (72 FR 62149), FDA issued an
advance notice of proposed rulemaking (ANPRM) entitled ``Food Labeling:
Revision of Reference Values and Mandatory Nutrients'' (the 2007
ANPRM), which requested comments on a variety of topics related to a
future proposed rule to update the presentation of nutrients and
content of nutrient values on food labels. In the 2007 ANPRM, the
Agency included a request for comments on how consumers use the Percent
Daily Value in the Nutrition Facts label when evaluating the
nutritional content of food items and making purchases.
    Research has suggested that consumers use the Nutrition Facts label
in various ways, including, but not limited to, using the Nutrition
Facts label to determine if products are high or low in a specific
nutrient and to compare products (Ref. 6). One component of the
Nutrition Facts label that serves as an aid in these uses is the
Percent Daily Value. Early consumer research indicated that the Percent
Daily Value format improved consumers' abilities to make correct
dietary judgments about a food in the context of a total daily diet
(Ref. 3), which led FDA to require both quantitative and percentage
declarations of nutrient Daily Values in the Nutrition Facts label in
the 1993 Nutrition Labeling final rule (58 FR 2079, January 6, 1993).
    Research in subsequent years, however, suggested that consumers'
understanding and use of Percent Daily Value may be somewhat
inconsistent (Refs. 7 and 8). Additionally, FDA has received several
public comments suggesting that further research on Percent Daily
Values may be warranted, along with research on other modifications to
the Nutrition Facts label. Suggested research on potential
modifications includes research on: (1) The removal of the statements,
``Percent Daily Values are based on a 2,000 calorie diet. Your daily
values may be higher or lower depending on your calorie needs''; (2)
the removal of the table in the footnote that lists the Daily Values
for total fat, saturated fat, cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and 2,500 calorie diets as described
in Sec.  101.9(d)(9); and (3) changes to the presentation of and amount
of information provided in the Nutrition Facts label. Therefore, FDA,
as part of its effort to promote public health, proposes to use this
study to explore consumer responses to various food label formats for
the footnote area of the Nutrition Facts label, including those that
exhibit information such as various definitions for Percent Daily
Value, a succinct statement about daily caloric intake, and general
guidelines for high and low nutrient levels.
    This study will also explore how declaring the added sugars content
of foods might affect consumers' attention to and understanding of the
sugars and calorie contents and other information on the Nutrition
Facts label. FDA is contemplating requiring the amount of added sugars
to be declared under sugars with a double indention format because
added sugars are a component of sugars. This new requirement would be
the first time that the mandatory declaration of a nutrient is shown in
this format on the Nutrition Facts label. Because added sugars have
been linked to obesity, a significant public health problem in the
country (Ref. 9), it is important that this new requirement is
supported by evidence so that consumers can correctly use the
information. The Agency is not aware of any existing consumer research
that has examined this topic and is therefore interested in using this
study to enhance understanding of how consumers would comprehend and
use this new information.
    In the Federal Register of May 23, 2011 (76 FR 29758), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In that notice, the Agency announced its
intention to examine

consumer reactions to the declaration of vitamins and minerals on the
Nutrition Facts label. The intention was prompted by the 2003 Institute
of Medicine report that recommended declaration of weight amounts of
all nutrients, including vitamins and minerals, on the label (Ref. 10).
As the report noted, public health advice on nutrient intake is often
given in absolute amounts, but in the case of a nutrient such as
calcium, consumers may not be able to determine the amount of calcium
in a food when it is listed only as Percent Daily Values on the
Nutrition Facts label. Block and Peracchio (Ref. 11) demonstrated this
difficulty and the potential merits of providing consumers with easy-
to-use information in helping them increase their calcium intakes. The
Agency considers the recommendation of the Institute of Medicine as
well as the findings by Block and Peracchio adequate support for
requiring the weight amounts of vitamins and minerals be declared on
the Nutrition Facts label. On the other hand, consumer evidence on the
effects of declaring added sugars is lacking. Therefore, the Agency has
determined that the utility of the study would be enhanced by replacing
the examination of declaring amounts of vitamins and minerals with the
examination of declaring amount of added sugars. This change would have
minimal effects on the planned length and respondent burden of the
study and would not change the study's primary focus, which remains on
examining footnote options.
    The proposed collection of information is a controlled, randomized,
experimental study. The study will use a Web-based survey, which will
take about 15 minutes to complete, to collect information from 10,000
English-speaking adult members of an online consumer panel maintained
by a contractor. The study will aim to recruit 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 a
series of label images from a set of food labels that will be created
for the study and systematically varied in the presence or absence of:
(1) A definition for Percent Daily Value, (2) a general guideline for
``high'' and ``low'' nutrient levels, and (3) a declaration for added
sugars. A sample definition for Percent Daily Value may include, for
example, ``The Percent Daily Value is the amount of a nutrient listed
above that one serving of this product contributes to the daily diet.''
A sample guideline for high and low nutrient levels may include, for
example, ``Five percent or less is low, and 20 percent or more is
high.'' Finally, the study will also examine effects of including
reference to FDA within the Nutrition Facts footnote and a succinct
statement about daily caloric intake. All label images will be mockups
resembling food labels that may be found in the marketplace. Images
will show product identity (e.g., yogurt or frozen meal) but not any
real or fictitious brand name.
    The survey will ask its participants to view label images and
answer questions about their understanding, perceptions, and reactions
related to the viewed label. The study will focus on the following
types of consumer reactions: (1) Judgments about a food product in
terms of its nutritional attributes and overall healthfulness, (2)
ability to use the Nutrition Facts label in tasks such as identifying a
product's nutrient contents and evaluating the Percent Daily Values for
specific nutrients, and (3) label perceptions (e.g., helpfulness and
credibility). To help understand consumer reactions, the study will
also collect information on participants' background, including but not
limited to, use of the Nutrition Facts label and health status.
    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 enhance the
Agency's understanding of how various potential modifications to the
Nutrition Facts label 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 May 23, 2011, FDA published a 60-day
notice requesting public comment on the proposed collection of
information. The Agency received two comments. One of the comments was
outside of the scope of the proposed collection of information
described in the 60-day notice and is not addressed here.,
    (Comment 1) The comment suggested that, in place of the proposed
research, an educational effort be undertaken to inform consumers about
the meaning of Percent Daily Value as it is currently presented on the
Nutrition Facts label. The comment also questioned whether a study
sample obtained from the proposed online consumer panel would
sufficiently reflect the demographic diversity of the U.S. adult
population.
    (Response) FDA agrees that consumer education is important to help
consumers understand Percent Daily Value and has been conducting and
sponsoring this type of education through its Web site (Refs. 12 to 16)
and programs such as the ``Spot the Block'' campaign (Ref. 16 and 17).
FDA does not agree, however, that consumer education about how to use
the food label can substitute for consumer research, which is the
primary approach for generating empirical and scientifically valid
evidence about consumer understanding in response to any considered
modifications to the Nutrition Facts label. Consumer research allows
the Agency to evaluate objectively which considered modifications to
the Nutrition Facts label are most likely to help consumers;
additionally, such research may help enhance the design and utility of
consumer education efforts. Although the study will use an online
consumer panel, the Agency expects that, based on prior experience with
these types of panels, this approach will achieve a sample of
participants that is reflective of the Census distributions in key
demographic characteristics (gender, age, education, and race/
ethnicity). As in our previous online research, we will develop a
Census-balanced sample (Ref. 18) by setting a quota prior to the study
so that the overall sample of panelists who participate in the study
will be balanced against the U.S. Census in gender, age, education, and
race/ethnicity, i.e., inbound-balanced. The planned balancing
categories are: (1) Gender: female and male; (2) age: 18-34, 35-54, and
55+; (3) education: high-school graduate or less and 1 year or more
college education; and (4) race/ethnicity: non-Hispanic white and
other.
    To help design and refine the questionnaire, FDA plans to conduct
cognitive interviews by screening 72 panelists 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 1,000
invitations, each taking 2 minutes (0.033 hours), will need to be sent
to adult members of an online consumer panel to have 150 of them
complete a 15-minute (0.25 hours) pretest. The total for the pretest
activities is 71 hours (33 hours + 38 hours). For the survey, we
estimate that 40,000 invitations, each taking 2 minutes (0.033 hours),
will need to be sent to adult members of an online consumer panel to
have 10,000 of them complete a 15-minute (0.25 hours) questionnaire.
The total for the survey activities is 3,820 hours (1,320 hours +

2,500 hours). Thus, the total estimated burden is 3,906 hours. This
estimate is 1,352 hours lower than the 5,258 hours published in the 60-
day notice and reflects 20 fewer hours for the pretest invitation, 12
fewer hours for the pretest, and 1,320 fewer hours for the survey
invitation. Recent evidence available to the Agency suggests the study
will not need to send as many pretest or survey invitations as
originally estimated to achieve its target sample sizes in the pretest
and survey. The number of pretests was changed from 200 to 150 to
correct an error that was made in the 60-day notice.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interview Screener................              72               1              72  0.083 (5 min.)............................               6
Cognitive Interview.........................               9               1               9  1.........................................               9
Pretest Invitation..........................           1,000               1           1,000  0.033 (2 min.)............................              33
Pretest.....................................             150               1             150  0.25 (15 min.)............................              38
Survey Invitation...........................          40,000               1          40,000  0.033 (2 min.)............................           1,320
Survey......................................          10,000               1          10,000  0.25 (15 min.)............................           2,500
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          3,906
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 sites after this document is
published in the Federal Register.)

1. Levy, A.S., S.B. Fein, and R.E. Schucker, ``Nutrition Labeling
Formats: Performance and Preference,'' Food Technology, vol. 45, pp.
116-121, 1991.
2. Levy, A.S., S.B. Fein, and R.E. Schucker, ``More Effective
Nutrition Label Formats Are Not Necessarily Preferred,'' Journal of
the American Dietetic Association, vol. 92, pp. 1230-1234, 1992.
3. Levy, A.S., S.B. Fein, and R.E. Schucker, ``Performance
Characteristics of Seven Nutrition Label Formats,'' Journal of
Public Policy and Marketing, vol. 15, pp. 1-15, 1996.
4. Lando, A.M. and J. Labiner-Wolfe, ``Helping Consumers Make More
Healthful Food Choices: Consumer Views on Modifying Food Labels and
Providing Point-of-Purchase Nutrition Information at Quick-Service
Restaurants,'' Journal of Nutrition Education and Behavior, vol. 39,
pp. 157-163, 2007.
5. Food and Drug Administration, ``Calories Count: Report of the
Working Group on Obesity,'' (http://www.fda.gov/Food/LabelingNutrition/ReportsResearch/ucm081696.htm), 2004.
6. Food and Drug Administration, ``2008 Health and Diet Survey--
Topline Frequencies (Weighted),'' (http://www.fda.gov/Food/ScienceResearch/ResearchAreas/ConsumerResearch/ucm193895.htm), 2010.
7. Li, F., P.W. Miniard, and M.J. Barone, ``The Facilitating
Influence of Consumer Knowledge on the Effectiveness of Daily Value
Reference Information,'' Journal of the Academy of Marketing
Science, vol. 28, pp. 425-436, 2000.
8. Levy, L., R.E. Patterson, A.R. Kristal, et al., ``How Well Do
Consumers Understand Percentage Daily Value on Food Labels?''
American Journal of Health Promotion, vol. 14, pp. 157-160, 2000.
9. U.S. Department of Agriculture and U.S. Department of Health and
Human Services, ``Dietary Guidelines for Americans, 2010,'' 7th
Edition, Washington, DC: U.S. Government Printing Office, December
2010.
10. Institute of Medicine, ``Dietary Reference Intakes: Guiding
Principles for Nutrition Labeling and Fortification,'' (http://www.nap.edu/catalog.php?record_id=10872), 2003.
11. Block, L.G. and L.A. Peracchio, ``The Calcium Quandary: How
Consumers Use Nutrition Labels,'' Journal of Public Policy and
Marketing, vol. 25, pp. 188-196, 2006.
12. Food and Drug Administration, ``A Key to Choosing Healthful
Foods: Using the Nutrition Facts on the Food Label,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079449.htm), 2011.
13. Food and Drug Administration, ``The Food Label and You--Video,''
(http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm275409.htm), 2011.
14. Food and Drug Administration, ``How to Understand and Use the
Nutrition Facts Label,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm274593.htm), 2011.
15. U.S. Food and Drug Administration, ``Using the Nutrition Facts
Label. A How-to Guide for Older Adults,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm267499.htm), 2010.
16. Food and Drug Administration, ``Spot the Block Using the
Nutrition Facts Label to Make Healthy Food Choices--A Program for
Tweens,'' (http://www.fda.gov/Food/ResourcesForYou/Consumers/NFLPM/ucm281746.htm), 2011.
17. Food and Drug Administration, ``Spot the Block: Cartoon Network
and the FDA Encourage Kids to SPOT THE BLOCK,'' (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048815.htm), 2011.
18. American Association for Public Opinion Research (AAPOR).
``AAPOR Report on Online Panels,'' (http://www.aapor.org/AM/Template.cfm?Section=AAPOR_Committee_and_Task_Force_Reports&Template=/CM/ContentDisplay.cfm&ContentID=2223), March 2010.

    Dated: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33303 Filed 12-28-11; 8:45 am]
BILLING CODE 4160-01-P