[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Notices]
[Pages 39257-39264]
[FR Doc No: 2023-12820]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Quantitative Research
on Front of Package Labeling on Packaged Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by July 17, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Quantitative Research on Front of Package
Labeling on Packaged Foods.'' Also include the FDA docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Quantitative Research on Front of Package Labeling on Packaged Foods

OMB Control Number 0910-NEW

I. Background

    The United States continues to face an epidemic of diet-related
chronic diseases, many of which are experienced disproportionately by
racial and ethnic minority groups, those with lower socioeconomic
status, and those living in rural areas (Ref. 1). To help address this
problem, FDA has continued to prioritize its nutrition activities (Ref.
2) to help empower consumers with nutrition information to make
healthier choices more easily and encourage industry innovation by
providing flexibility to facilitate the production of healthier foods.
FDA is focused on: (1) creating a healthier food supply for all; (2)
establishing a healthy start to set the foundation for a long, healthy
life; and (3) empowering consumers through informative labeling and
tailored education (Ref. 2; see also Ref. 3).
    FDA is exploring the development of a front of package system to
help consumers interpret the nutrient information on food products.
Front of package (FOP) labeling is intended to complement the Nutrition
Facts label by giving consumers a simple aid to provide additional
context for making healthy food selections. As part of our food-
labeling efforts, we are exploring the establishment of a standardized,
science-based FOP scheme that helps consumers, particularly those with
lower nutrition literacy, quickly and easily identify foods that are
part of a healthy dietary pattern.
    The increased attention in recent years to FOP and the experiences
of countries that have adopted FOP labeling suggest that FOP labeling
may aid nutrition comprehension and the ability to make healthier
choices, especially for those with lower nutrition literacy. FOP
schemes adopted in countries throughout the world include both
mandatory and voluntary labeling schemes and noninterpretative,
interpretative, nutrient specific, and summary schemes.
    In 2022, FDA conducted a review of the literature on FOP nutrition-
related labels and conducted a set of focus groups to test FOP concepts
and draft FOP schemes (see Docket No. FDA-2023-N-0155 for the
literature review). These focus group results provided insights into
the varying ways that consumers interpret FOP nutrition information. As
part of our efforts to promote public health, we intend to conduct an
experimental study, informed by results of the focus group testing, to
further explore consumer responses to various FOP schemes. In the
experimental study, we will test a smaller subset of FOP schemes from
the focus group testing, with additional variations informed by, among
other things, focus group results (see https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321 for information about
FDA's front of package focus groups, including graphic FOP schemes
tested). The study will be a controlled, randomized experiment that
will use a 15-minute web-based questionnaire to collect information
from 9,000 U.S. adult members of an online consumer panel maintained by
a contractor. The sample will be balanced to reflect the U.S. Census on
gender, education, age, and ethnicity/race. A measure of nutrition
literacy will also be used to balance the sample to ensure a variety of
literacy levels for each condition.
    Conditions for the study will be: (1) a set of draft FOP schemes,
including ``no-scheme'' controls; (2) three types of mock food products
(i.e., a breakfast cereal, a frozen meal, and a canned soup); and (3) a
``no-information'' condition where no explanation of the FOP scheme is
provided. The experiment will have two main parts: (1) a within-scheme
comparison and identification of healthfulness profile and (2) a
single-product (and scheme) evaluation. In part 1, participants will
see three levels of healthfulness (most healthful, middle, and least
healthful) on a single scheme and be asked to identify the most and
least healthful profile. Participants will be timed and will be
provided with a link to a Nutrition Facts label in case they want more
information to answer the question. Each participant in part 1 will
evaluate three different sets of schemes. In part 2, each participant
will be randomly assigned to a single condition (food product, scheme
type, or level of healthfulness). In this section, participants will be
asked to use the label image to respond to various measures of the
label's effectiveness. Product perceptions (e.g., healthfulness and
contribution to a healthy diet) and label perceptions (e.g.,
believability and trustworthiness) will constitute the

measures of response in the experiment. The instrument will also
collect information from participants about their history of purchasing
or consuming similar products, nutrition knowledge, dietary interests,
motivation regarding label use, health status, and demographic
characteristics.
    The studies are part of our continuing effort to help enable
consumers to make informed dietary choices and construct healthful
diets. We intend to use the results to inform our continued exploration
of an FOP labeling scheme. We will not use the results to develop
population estimates.
    Description of Respondents: Respondents to this collection of
information include members of the general public.
    In the Federal Register of January 26, 2023 (88 FR 5005), FDA
published a 60-day notice requesting public comment on the proposed
collection of information (60-day notice). We received 26 comments, 2
of which were duplicates. Of the other 24, 20 were related to the PRA.
The remaining comments were nonresponsive to the four PRA topics, so we
will not address them in this document. We have numbered each comment
to help distinguish among different topics. The number assigned is for
organizational purposes only and does not signify the comment's value,
importance, or the order in which it was received.

A. Comments Regarding the Necessity and Practical Utility of the
Information Being Collected and FDA Response

    Several comments addressed the necessity and practical utility of
collecting information on an FOP scheme that would provide information
to consumers to help them make more informed food choices.
    (Comment 1) Many comments supported FDA's proposed collection of
information through an experimental study. Many supported our consumer
research, including the study design, goals, and research on schemes.
Several other comments suggested that the study has limitations because
it only assesses purchase intention and how consumers say they will
behave, and not actual purchase or consumption behaviors.
    (Response 1) As is common with research in the scientific
literature, our study design mimics, as much as possible, how consumers
will respond to a FOP nutrition label scheme (Refs. 4 and 5). Assessing
actual purchase or consumption behavior is not possible because the
schemes to be tested are not currently available in the marketplace.
Additionally, the overall focus of this research is to assess consumer
understanding of FOP schemes that may help consumers interpret certain
nutrient information on food products; it is not meant to assess actual
purchase or consumption behaviors.

B. Comments Regarding the Accuracy of Our Burden Estimates, Including
the Validity of the Methodology and Assumptions Used, and FDA Response

    Some comments discussed the accuracy of FDA's estimate of the
burden for this information collection, including the validity of FDA's
methodology and the assumptions used.
    (Comment 2) Multiple comments encouraged FDA to increase
transparency in our FOP research, with some expressing concern that the
public has not had sufficient opportunity for input on the burdens of
the information collection or the utility of the research due to a lack
of information. Many comments urged us to provide more information on
factors such as the specific objectives of the research; research and
study design; methodologies; survey questions; visual product label
mockups; the FOP schemes to be tested; FDA's basis for choosing the FOP
schemes we have decided to test and excluding those we have excluded;
nutritional criteria being tested, including the criteria for any color
coding or ``High in'' schemes; the outcomes from our focus groups and
any other past surveys and consumer research; an analysis of foreign
FOP schemes; and the variables and conditions to be tested. One comment
asked how we developed the schemes used in the focus groups,
particularly those that contained the terms ``low,'' ``medium,'' and
``high,'' given that FDA has not defined or applied these terms in the
context used in the focus groups.
    A couple of comments suggested that FDA should collaborate with
stakeholders when conducting studies or developing an FOP scheme in the
future.
    (Response 2) Detailed information and all study materials are
available at https://www.reginfo.gov. The literature review and FOP
schemes are also available in the docket (Docket No. FDA-2023-N-0155).
The schemes to be tested include variations on schemes that are
currently available in the marketplace and others that attempt to
interpret certain nutrition information. We developed schemes based on
insights from our focus groups, analysis of the literature on FOP
labeling, and review of schemes from other countries. We recognize that
these schemes are a subset of the many possible schemes that could be
tested, and we selected them for the reasons described above.
    Regarding nutritional criteria and the ``low,'' ``medium,'' and
``high'' designations, for the purposes of the focus groups and
experimental study, we have defined the nutritional criteria and the
``low,'' ``medium,'' and ``high'' designations to be based on the
percent Daily Value (see, e.g., https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label). The study refers to these criteria.
    FDA has collaborated with stakeholders on the exploration of the
FOP schemes through our focus-group testing, 60-day notice, and this
notice, and any regulatory action we take after our testing will be
published in the Federal Register for public comment.
    (Comment 3) One comment said FDA did not provide enough information
in our 60-day notice on our testing, including the number of label
conditions, the number of food choices respondents will have, whether
there will be a separate control group, and a primary study outcome, to
allow the public to evaluate the suitability of our proposed sample
size.
    (Response 3) The 60-day notice included information about the study
to allow members of the public to provide comment. Detailed information
and all study materials are available at https://www.reginfo.gov. The
literature review and FOP schemes are also available in the docket
(Docket No. FDA-2023-N-0155). There will be 10 total label conditions,
3 food types, and a control group that will see a label with no scheme.
Primary study outcomes include the ability to correctly interpret the
nutritional profile of the product, the speed at which participants
make their decisions, and their search for more information to answer
the question (i.e., whether they want to view the Nutrition Facts
label). The proposed sample size is 9,000 participants.

C. Comments Regarding Ways To Enhance the Quality, Utility, and Clarity
of the Information To Be Collected, and FDA Response

    Many comments suggested ways to enhance the quality, utility, and
clarity of the information about the FOP schemes to be collected.
    (Comment 4) One comment said we should avoid color coding or
``low,'' ``medium,'' or ``high'' markers in our scheme because it is
unwise to base a food's healthfulness on one factor alone. Another
comment said that color-coding nutrients to limit and nutrients to
encourage in the same scheme would

confuse consumers and that we should include an option that does not
color code nutrients to encourage. A few comments said that we should
present some schemes in black and white and others with color to
identify if color should be used. Several comments said that we should
only test schemes that industry could implement without excess cost or
burden.
    (Response 4) Color-coding and interpretational aids such as
``high,'' ``medium,'' and ``low'' are being tested because prior
research has found such interpretive components helpful to consumers
when evaluating the nutritional profile of products (Refs. 6 and 7). We
disagree that testing these interpretational aids bases a food's
healthfulness on one factor alone; rather, the schemes we are testing
are intended to complement the Nutrition Facts label by giving
consumers a simple aid to provide additional context for making healthy
food selections.
    The study will test both color and black-and-white schemes (see
Docket No. FDA-2023-N-0155). We are not currently planning to test
schemes that include both nutrients to limit and nutrients to
encourage, so there will be no options in the study that cover
nutrients to encourage.
    Regarding the cost of implementation, this quantitative study
focuses on gathering information. Should we move forward with a
regulatory action, we will consider potential economic impacts of any
proposed scheme.
    (Comment 5) One comment recommended that FDA conduct indepth
interviews with diverse stakeholders because such interviews facilitate
better understanding and add nuance to findings.
    (Response 5) We have incorporated a variety of qualitative research
methods, including the use of interviews, as part of our research. The
study will employ cognitive interviews before we conduct the proposed
experiment to test whether and how participants understand the study
questions and whether the design will reach our research goals. The
study instrument will include an open-ended question, providing
participants an opportunity to express top-of-mind reactions to the
study and schemes. FDA also conducted focus groups on FOP nutrition
labels in 2022, which have informed the proposed experimental study. We
note that the quantitative nature of experimental studies allows for
statistical generalizability of effects while qualitative designs do
not.
    (Comment 6) Some comments advocated testing consumption in the home
or testing in real-world or simulated shopping environments. One
comment advocated that the FOP schemes appear alongside other commonly
found symbols on food labels.
    (Response 6) Online store settings and other naturalistic study
environments have been successfully employed in some studies on food
labeling effects. One advantage of employing such naturalistic study
environments is that they more closely reflect participants' actual
shopping experience. However, there are substantial additional costs
associated with using such research settings, and results in these
settings generally do not differ appreciably from results garnered
through the simple random-assignment-to-condition design that we
proposed. Therefore, we decline to change our study environment.
    Participants will view the schemes on mock food labels that closely
match those found in grocery stores. The study will not assess the
schemes alongside other commonly found symbols on the food label. Our
studies are designed to test general consumer responses to the schemes
presented. Testing additional variables, such as the effect of other
packaging elements on the schemes, is outside the scope of this
research. We are not testing consumption in the home because, again,
our studies are designed to test general consumer responses to the
schemes presented. We are not studying consumption behavior.
    (Comment 7) A couple of comments said that mockups of product
labels should accurately represent products in the marketplace, and
that the mockups we used in the focus-group testing included
unrealistic elements, such as fewer competing claims, small type size
for voluntary claims, and fonts not commonly used on product labels.
Several comments asserted that we should ensure label mockups are
realistic, and a few comments maintained that the mockups should not
introduce bias.
    (Response 7) FDA disagrees with the comment that its mock food
packages contain unrealistic elements, and the comment provides no
support for the claim that our chosen type size and fonts are not
commonly used on product labels. While we recognize that our mockups
contain fewer competing claims than might be on some real packages, the
mock packages represent products that might be found in the actual
marketplace and reflect a real-world food product scenario without the
introduction of bias that may come with including competing symbols or
claims.
    (Comment 8) One comment urged us to develop research objectives
that pair with our policy objectives. The comment recommended that we
add the following goal of FOP labels: ``To help people quickly and
easily identify foods that, when consumed, may lead people to exceed
daily nutritional recommendations for nutrients of concern (sodium,
added sugar, and saturated fat).'' The comment also recommended that
FDA establish more specific research objectives relating to encouraging
healthier food selections, enabling consumers to identify foods that
are part of a healthy eating pattern, and identifying foods associated
with nutrients of concern. A few comments said we need to clearly
define the quantitative consumer research's primary outcome so that we
can develop questions and research designs that will address the
intended goal. One comment said that, before conducting the
quantitative study, FDA should identify the metrics for consumer
understanding to guide the study design and interpretation of results.
    (Response 8) The goal of our research is to assess which FOP scheme
best enables consumers to identify foods that can help them build a
healthy eating pattern. We decline to add any other research objectives
because we believe that our stated research goal most closely
corresponds to our policy objectives.
    Regarding the research's primary outcome, we noted earlier that our
primary study outcomes include the ability to correctly interpret the
nutritional profile of the product, the speed at which participants
make their decisions, and their search for more information to answer
the question (i.e., want to view the Nutrition Facts label). We believe
we have developed questions and research designs that will address our
intended goal.
    We agree that we should identify the metrics for consumer
understanding to guide the study design and interpretation of results.
An element of the study design process includes identifying appropriate
metrics for measuring consumer understanding. These metrics will help
FDA interpret the study results.
    (Comment 9) Many comments urged FDA to research how FOP schemes
would impact consumer behavior, including purchase or consumption
decisions. One comment encouraged us to study consumers' selection of
calories and nutrients, foods that meet our proposed definition of
``healthy,'' and foods high in added sugars, sodium, or saturated fat.
A few comments said we should measure whether, and why, the schemes
would affect intended purchase or consumption frequency. A couple of
comments recommended

testing whether the presence of an FOP scheme makes consumers more
likely to read and understand the Nutrition Facts label. Some comments
suggested specific methods for studying and evaluating consumer
behavior.
    A few comments asserted that research on consumer behavior and how
consumers use and understand FOP labeling is necessary to avoid
consumer confusion, misleading consumers, and unintended consequences.
Another comment recommended that FDA's research assess whether
consumers interpret the label to have the same meaning that FDA
intends.
    (Response 9) We acknowledge that there are measurements we are not
including in this research effort (e.g., behavior changes). These
studies are designed to explore consumer responses to the schemes, and
inclusion of variables such as behavior changes would be outside of the
scope of our research.
    The study will measure whether participants can understand the
scheme when trying to identify certain nutrient profiles. The study
will also include an option for participants to view the Nutrition
Facts label if they so choose, but the study will not evaluate reading
and understanding of the Nutrition Facts label because this is not the
goal of the study.
    (Comment 10) One comment encouraged us to assess consumer
understanding of product healthfulness using objective measures (i.e.,
questions with factual answers). Some comments urged FDA to include
open-ended questions in our survey.
    (Response 10) One of the goals of the research is to assess
consumers' ability to use the schemes to determine product
healthfulness. In one part of the study, participants will see three
versions of a scheme and will be asked to identify the scheme with the
most healthful nutritional profile and the scheme with the least
healthful nutritional profile. The profiles are based on FDA's
characterization of levels of the percent Daily Value as either
``high'' or ``low'' (see https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label).
The questionnaire will have at least one open-ended question seeking
general feedback on the study and schemes.
    (Comment 11) One comment encouraged us to assess the
trustworthiness of the schemes. Conversely, another comment opposed
factoring in participants' ratings of believability and trustworthiness
because, according to the comment, those factors are not strong
predictors of real-world responses. Another comment said we should
evaluate the reliability of respondents' answers versus real-life
consumer behavior by considering the statistical significance of the
study.
    (Response 11) The study will include measures of trustworthiness
and believability of the schemes, and these will be considered along
with the other outcome measures. With respect to factoring in
participants' ratings of believability and trustworthiness, many
factors contribute to how people respond in the real world; thus, it is
important for the study to include a variety of outcome measures while
also limiting the scope to just the pertinent factors. We plan to
conduct tests of statistical significance to evaluate the probability
that the study findings are true patterned responses.
    (Comment 12) One comment argued that our research design should
consider the limitations of FOP schemes. Another comment encouraged FDA
to expand our research plans to include more settings and to consider
approaches that mitigate hypothetical bias.
    (Response 12) The research will take into account the many factors
that may limit consumers' ability and motivation to use FOP nutrition
labels, such as nutrition literacy, Nutrition Facts label usage, time
limitations, and health considerations. FDA disagrees with the comment
encouraging us to expand the research to include more settings. FDA is
designing the study so that the questions or tasks mirror how consumers
typically approach food label reading. Additionally, as we noted above,
results in naturalistic settings generally do not differ appreciably
from results garnered through the simple random-assignment-to-condition
design that we proposed. Therefore, we decline to change our study
environment. However, cognitive interviews and pretests will help to
improve the ``real-world'' feel of the questionnaire.
    FDA's study is designed to mitigate hypothetical bias because it
focuses on perceptions and understanding of the FOP schemes rather than
on trying to assess behaviors associated with them.
    (Comment 13) Multiple comments recommended FDA use industry
materials or schemes in our testing, such as Facts Up Front and
Consumer Brands' FOP nutrition labeling principles. Several comments
urged us to test variations of the Facts Up Front scheme, with some
reasoning that Facts Up Front has widespread adoption and that
consumers are already familiar with the program and understand how to
use it.
    (Response 13) FDA is planning to test a scheme that includes
attributes of the U.S. industry-established FOP schemes.
    (Comment 14) Some comments said we should consider flexibility and
exemptions to address space limitations regarding font size, style, and
placement in our quantitative research.
    (Response 14) The research will test placement on the food label
but will not test font size and style. Contemplating flexibility and
exemptions relating to issues such as font size and style on packages
with space limitations is not the purpose of this study, which is to
gauge consumer responses to the schemes we are testing.
    (Comment 15) One comment said FDA should test how digital
disclosure could replace an FOP scheme on the package.
    (Response 15) The goal of our current research focuses on exploring
FOP schemes that help consumers quickly and easily identify foods that
can help them build a healthy eating pattern. We are not currently
testing digital disclosures because that approach does not align with
our research goals relating to the speed and ease with which consumers
can assess foods.
    (Comment 16) A few comments cautioned against using schemes that
overlook, or mislead consumers about, a food's whole contribution to
the diet or subjectively characterize a food (for instance, as ``High
in,'' ``medium,'' or ``low in'') based on just three nutrients.
    (Response 16) FDA is interested in learning how the different
schemes to be tested help consumers put a food, as a whole, into the
context of their daily (or longer-term) diets. The schemes included in
the experimental study do not subjectively characterize a food based on
three nutrients. The ``high,'' ``medium,'' and ``low'' designations
included in the study are based on established criteria for
interpreting the percent Daily Value of a nutrient (see, e.g., https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label) and the study refers to these
criteria.
    (Comment 17) One comment said that our research should maximize
opportunities to include nutritious foods that are widely available and
within the purchase reach of most consumers.
    (Response 17) The mock food product categories to be included in
the experiment are those that are highly consumed by many consumers of
all economic levels (breakfast cereal, frozen meals, and canned soup).
There are a variety of foods in these categories,

which in turn can vary widely in terms of healthfulness.
    (Comment 18) One comment recommended that FDA test a label that
states: ``WARNING: HIGH IN [sodium/added sugars/saturated fat]''
accompanied by a warning icon.
    (Response 18) Our research goal focuses on exploring ways that FOP
labels can complement the Nutrition Facts label on packaged foods by
giving consumers additional context to quickly and easily identify
foods that can help them build a healthy dietary pattern. Our research
will test schemes that include a ``high'' designation or a ``High in''
statement as part of that goal. However, we will not test the word
``warning'' or a warning icon because doing so would not align with our
research goals of learning how to provide consumers with additional
factual context for food choices.
    (Comment 19) One comment urged FDA to include low- and no-calorie
sweeteners in the tested schemes because, according to the comment, the
public wants to know if products contain such sweeteners.
    (Response 19) Information relating to low- and no-calorie
sweeteners is available to consumers in the ingredient list of a
product. The focus of our study is to explore how to help consumers
quickly and easily identify foods that can help them build a healthy
eating pattern, with a focus on the nutrients that the Dietary
Guidelines for Americans (Dietary Guidelines) have identified as
nutrients to limit (Ref. 8).
    (Comment 20) One comment said we could improve our schemes by
limiting numerical information, emphasizing interpretive components
(e.g., a prominently placed ``High in'' designation), and adding
attention-grabbing features. The comment also recommended against
testing labels that highlight nutrients to encourage, because,
according to the comment, companies already promote the healthy aspects
of their products, and labels that combine both nutrients to limit and
nutrients to encourage would create a challenge for consumer education.
    However, other comments supported testing schemes with nutrients to
encourage, arguing that the schemes must accurately reflect the full
nutrient profile of a food; that the public should have tools to
construct a healthy diet; and that, for instance, a product with some
added sugar may be viewed as negative by the consumer if ``High in'' or
``red'' is marked on the FOP even if the product provides positive
nutrition overall. A couple of comments claimed that many of the
proposed schemes tested in the original focus groups reduced a food to
its negative nutrients rather than recognizing its overall contribution
to the diet and its positive nutrient and food group content.
    Other comments advocated testing at least one scheme with a
``positive'' approach that would, for instance, award food stars
depending on the food's nutrient content. A couple of comments said
that we should also do consumer research on summary-based systems.
    A couple of comments suggested that tested FOP schemes should align
with the Dietary Guidelines to focus on overall dietary patterns rather
than on individual nutrients.
    (Response 20) The study will test a variety of schemes reflecting
those currently found in the marketplace; some of them will contain
limited numerical information and some will contain interpretive
components. The study will assess consumers' ability to use the schemes
to make decisions to support a healthful overall dietary pattern. As we
noted earlier, the schemes we are testing are intended to complement
the Nutrition Facts label by giving consumers a simple aid to provide
additional context for making healthy food selections.
    With respect to comments that urged FDA to test a ``positive''
approach or a summary-based system, we are testing different schemes
based on our literature review and the feedback we collected through
our focus group research, which indicate that simpler schemes are
easier for consumers to understand and that consumers often already
have access to information about nutrients to encourage on the front of
food packages. As such, our current study plans do not include testing
nutrients to encourage.
    (Comment 21) One comment said it is important to understand whether
consumers viewing an FOP scheme view the foods as ones that should be
avoided, particularly for products that are healthful food choices
recommended by the Dietary Guidelines or MyPlate.
    (Response 21) The research will evaluate whether the FOP scheme
assists consumers in identifying the healthfulness of a product or
whether the scheme encourages them to avoid the product.
    (Comment 22) One comment recommended against testing Guideline
Daily Amount (GDA) labels with numeric information (e.g., amount per
serving or percent Daily Value) without an additional interpretive
component. Conversely, a couple of comments requested that we also
include GDA schemes without interpretive elements to help us understand
the benefits and limitations of the schemes, with one comment
suggesting that fact-based FOP schemes used by industry could be our
control.
    (Response 22) FDA is testing the effects of different kinds of
schemes, including GDA-type schemes. Some of the schemes being tested
have interpretational aids and some do not. Statistical analysis will
allow FDA to use each of the tested schemes as a control for other
schemes.
    (Comment 23) One comment said that FDA should consider testing the
effects of different FOP label designs both with and without additional
information to aid in label interpretation.
    (Response 23) FDA is testing the effects of different kinds of
schemes, some that have interpretational aids and some that do not.
    (Comment 24) One comment encouraged us to use survey measures with
strong psychometric properties. For example, the comment said FDA
should consider using the UNC Perceived Message Effectiveness Scale to
assess effects perceptions.
    (Response 24) FDA acknowledges the value of using measures that are
reliable, have been validated, and that have strong psychometric
properties. However, we do not believe that the UNC Perceived Message
Effectiveness Scale is appropriate for this study because this study
deals with the provision of nutritional information via food labeling.
    (Comment 25) One comment recommended that we pre-register a
protocol for the proposed experiment, including the primary outcome and
all secondary outcomes, any hypotheses or predictions, the analytic
plan, and the power calculations used to arrive at the target sample
size.
    (Response 25) FDA declines to preregister the research protocol, as
described in the comment. The comment did not explain what additional
details might be available via preregistration that would not be
available in our Federal Register notices, in the docket (Docket No.
FDA-2023-N-0155), and on https://www.reginfo.gov.
    (Comment 26) A few comments said the foods tested should reflect
more product categories, varieties, package sizes, and nutrient
profiles that would be subject to an FDA FOP scheme. For example, some
of these comments recommended that we test single-ingredient products,
individual foods, and foods that are known to be higher in sugar,
sodium, or saturated fat. Some comments said that without doing so, the
research setting would be

unrealistic, and we may not be able to apply the study findings to all
types of packaged foods, including beverages, available to consumers.
One comment said that we should compare consumer reactions to FOP
schemes across multiple food categories so that we can assess whether
reactions to standardized FOP schemes might shift perception,
purchasing, or consumption of certain products.
    (Response 26) FDA declines to add more product types to the
studies. We are proposing to test schemes on a set of mock products
that belong to large food categories, with many product types within
each category. The mock food product categories to be included in the
experiment (breakfast cereal, frozen meals, and canned soup) are those
that are highly consumed by many consumers of all economic levels.
There are a variety of foods in these categories, which can vary widely
in terms of healthfulness and the nutrients included in the schemes.
    For our research, we chose three packaged foods that are commonly
consumed and that are clearly distinct food types. The selected
products will give us sufficient information on general consumer
responses to the schemes. We also note that adding any products would
increase the scope and cost of the studies while providing limited new
information, and the comments provided no evidence that additional test
products from other food categories, varieties, package sizes, and
nutrient profiles would impact our study outcome.
    (Comment 27) One comment encouraged us to search for and consider
the design of previously conducted research on FOP schemes when
designing our own consumer research.
    (Response 27) FDA has conducted a thorough review of the scientific
literature on FOP schemes and continues to monitor the emerging
science.
    (Comment 28) One comment recommended we test additional variables,
including health status, whether respondents have nutrition-related
conditions, caregiver status, English language literacy, and method of
administration of the test, to assess how consumers understand and use
FOP schemes. The comment also said that respondents should be primary
shoppers and should span socioeconomic status. A couple of comments
said we should include demographic data, such as racial and ethnic
minority groups, those with lower socioeconomic status, those living in
rural areas, and parents of minors, to improve understanding of
behavior changes across demographic groups.
    (Response 28) The study is designed to assess how consumers
understand and use FOP schemes. Most of the variables mentioned are
included in the study, including a measure of whether the participant
is the primary grocery shopper in the household. FDA agrees that a
measure of caregiver status could be useful. Therefore, we have added
this variable to the study instrument.
    (Comment 29) A few comments said our research must include diverse
populations, including race, ethnicity, education status, nutrition
literacy, and income level. The comment continued that our research
should address the needs of the most vulnerable populations. A few
comments said we could consider over-indexing or oversampling on key
consumer constituencies, such as the populations the FOP schemes are
meant to target and caregivers. A couple of comments expressed concern
that those in underserved communities and those most at risk for diet-
related disease may not have computers and may have unreliable or no
access to the internet, making participation in the study difficult.
    (Response 29) Our study will ensure that members of underserved
communities and those most at risk for diet-related disease are
adequately represented. Participants recruited for the study will
include diverse populations, considering race, ethnicity, education
status, nutrition literacy, rural residency, and other sociodemographic
factors. The study will also oversample consumers with lower nutrition
literacy levels to ensure that we can evaluate the findings against
levels of nutrition literacy. The Pew Research Center reports that 93
percent of American adults use the internet (Ref. 9). The Institute of
Museum and Library Services reports that approximately 312 million
Americans (out of the total U.S. population of approximately 330
million, according to the 2020 U.S. Census) live in a public library
service area (Ref. 10). Virtually all public libraries provide free
internet access (Ref. 11). There is no requirement that participants
have a computer, laptop, or tablet at home to participate in this
study. In the past, participants in FDA-funded studies who did not have
a computer at home have completed studies using outside resources; for
example, a computer at the public library.
    (Comment 30) Several comments said that we may need a larger sample
size than 3,000 given the information provided and that the results of
the quantitative study will impact the entire U.S. population.
    (Response 30) FDA agrees with the comment, and we plan to increase
the sample size to 9,000.
    (Comment 31) One comment said we may need to include additional
schemes in the testing to understand category-specific, pack size-
specific considerations, such as the ``calories-only'' scheme sometimes
used on foods in small packages. Another comment urged us to include
some very small package mockups to ensure fit and readability of the
FOP scheme. Similarly, another comment urged FDA to test a beverage
option with a small or very small label to determine what nutritional
information to include and whether a beverage container with a small
label can bear an FOP scheme of readable size. Another comment stated
that FDA's research should include various beverages among the products
tested to ensure that FDA identifies differences in consumers' views
between FOP labels on food versus beverages.
    (Response 31) We are testing different schemes based on our
literature review and the feedback we collected through our focus group
research. The comments provided no evidence that including additional
schemes in our testing would help us understand category-specific,
package size-specific considerations. As such, FDA declines to add
additional schemes to our testing.
    FDA disagrees with the recommendation to add more product sizes or
types, including beverages, to the study. For our research, we chose
three packaged foods that are commonly consumed and that are clearly
distinct food types. The selected products will give us sufficient
information on general consumer responses to the schemes to inform any
future action we may take on the schemes. We also note that adding any
products would increase the scope and cost of the studies while
providing limited new information and that the comments provided no
evidence that additional test products from other food categories,
including beverages, would impact our study outcome.
    (Comment 32) One comment stated that calories should be included on
most of the tested schemes. The comment asserted that energy is the
most important component in diet planning and said that FDA must
explain why we were not including calories. Another comment recommended
that FDA include a calories-only icon in our research, while another
comment wondered if the public would consume more overall

calories if FOP does not contain information on calories.
    (Response 32) We decline to add calories to the schemes we are
testing or test a calories-only scheme. Our regulations, at 21 CFR
101.9(d)(1)(iii), require the Nutrition Facts label to display calorie
information with increased prominence, relative to other information,
in order to draw consumer attention (see 81 FR 33741 at 33939, May 27,
2016). At this point, for the purposes of the experimental study, we
believe that consumers have adequate access to calorie information,
while the purpose of our research on FOP is to determine the usefulness
of providing consumers with additional factual context for making
healthy food selections. Regarding whether the public would consume
more calories if FOP does not contain information on calories, this
comment falls outside of the scope of our current research, which
explores which schemes will provide consumers with additional
information rather than shape consumer behavior.
    (Comment 33) A couple of comments said FDA must consider how a
standardized FOP scheme would interact with the voluntary ``healthy''
symbol FDA is studying. One of these comments encouraged us to evaluate
whether having multiple FOP information systems could confuse
consumers.
    (Response 33) The purpose of this study is to evaluate how
consumers understand a FOP labeling scheme. We are not considering the
intersection of hypothetical label claims at this time, as we seek to
conduct our study in a manner that minimizes bias. It is also outside
the scope of our current quantitative research to test the effect of
multiple FOP labeling systems. Rather, we are assessing how consumers
understand the schemes that we are testing.
    (Comment 34) A few comments encouraged us to update our literature
review because, for example, schemes presented to respondents should
reflect the latest science.
    (Response 34) FDA agrees with the comment and has updated the
literature review and continues to monitor the emerging scientific
literature.
    (Comment 35) One comment said we should review the results of
studies on the long-term impacts and utility of FOP schemes, and not
rely only on very recent studies.
    (Response 35) FDA has been monitoring the scientific literature on
FOP since 2006 and continues to monitor the literature, including any
studies on long-term impacts and utility of FOP schemes.
    (Comment 36) A couple of comments said we need to identify key
metrics for success on label effectiveness, including how product
perception, label perceptions, and nutritional qualities questions will
be presented to the respondents, before conducting the study.
    (Response 36) FDA plans to use product, label, and nutrition
perception measures and will test these in cognitive interviews prior
to conducting the pretests and the experiment.
    (Comment 37) One comment recommended that we include readable
samples of category users for each of the categories being presented
(e.g., cereal, frozen meals) and evaluate results among each relevant
category user base.
    (Response 37) FDA will include questions to assess whether
participants use the product and will take this into account when
evaluating the results.

D. Comments Regarding 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, and FDA Response

    No comments discussed minimizing the information collection burden
on respondents to our proposed FOP scheme research.

E. Nonresponsive Comments to the PRA

    Some comments addressed aspects of FOP schemes that are outside the
scope of this information collection or addressed issues other than the
FOP scheme research. These discussed, for example, whether the schemes
should be voluntary or mandatory, specific ways to update the
literature review, food allergies, requirements of any proposed FOP
scheme, and constitutional and other legal issues with FOP
requirements. These are outside the scope of this information
collection, and we will not address them here. Interested parties will
have an opportunity to comment on any FOP scheme we propose in response
to its Federal Register 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    Total  hours
                                 respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Pretest 1 Screener...........             800               1             800               0.05              40
                                                                                (3 minutes)
Pretest 1....................             200               1             200               0.25              50
                                                                                (15 minutes)
Pretest 2 Screener...........             800               1             800               0.05              40
                                                                                (3 minutes)
Pretest 2....................             200               1             200               0.25              50
                                                                                (15 minutes)
Experiment Screener..........          40,000               1          40,000               0.05           2,000
                                                                                (3 minutes)
Experiment...................           9,000               1           9,000               0.25           2,250
                                                                                (15 minutes)
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................           4,430
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of participants in the study was increased from the
3,000 respondents estimated in the 60-day Federal Register notice to
41,600 with this publication. Therefore, the total burden has been
increased from 3,205 responses and 801 hours to 51,000 responses and
4,430 hours because of the increase in the sample size for the pretests
and the full experiment and screener. The reason for the increase in
burden hours is because of a decision to

target consumers with higher and lower nutrition literacy levels, rural
residence, and to ensure that the sample mirrors the demographic
distribution of the U.S. population.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500 and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they also are available
electronically at https://www.regulations.gov. References without
asterisks are not on public display at https://www.regulations.gov
because they have copyright restriction. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

* 1. Centers for Disease Control and Prevention. Overweight &
Obesity, Available at: https://www.cdc.gov/obesity/index.html.
Accessed on April 20, 2023.
* 2. FDA, FDA's Nutrition Initiatives. Available at: https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives.
Accessed on April 20, 2023.
* 3. The White House, ``Biden-Harris Administration National
Strategy on Hunger, Nutrition, and Health.'' Available at: https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf. Accessed on April
20, 2023.
4. Talati, Z., M. Egnell, S. Hercberg, et al. ``Food Choice Under
Five Front-of-Package Nutrition Label Conditions: An Experimental
Study Across 12 Countries,'' American Journal of Public Health,
109(12), 1770-1775, 2019.
5. Vargas-Meza, J., A. J[aacute]uregui, A. Contreras-Manzano, et al.
``Acceptability and Understanding of Front-of-Pack Nutritional
Labels: An Experimental Study in Mexican Consumers,'' BMC Public
Health, 19, 1751, 2019.
6. Pettigrew, S., L.M. Dana, Z. Talati, et al. ``The Role of Colour
and Summary Indicators in Influencing Front-of-Pack Food Label
Effectiveness Across Seven Countries,'' Public Health Nutrition,
24(11), 3566-3570, 2021.
7. Song, J., M.K. Brown, M. Tan, et al. ``Impact of Color-Coded and
Warning Nutrition Labelling Schemes: A Systematic Review and Network
Meta-Analysis,'' PLoS Med, 18(10), e1003765, 2021.
8. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. Dietary Guidelines for Americans, 2020-2025. 9th
Edition. December 2020. Available at https://www.dietaryguidelines.gov/resources/2020-2025-dietary-guidelines-online-materials. Accessed on May 9, 2023.
9. Pew Research Center. Internet/Broadband Fact Sheet. April 7,
2021. Available at: https://www.pewresearch.org/internet/fact-sheet/internet-broadband/. Accessed on April 19, 2023.
* 10. Institute of Museum and Library Services. ``Public Libraries
in the United States: Fiscal Year 2017,'' vol. 1, p. 2. June 2020.
Available at https://www.imls.gov/publications/public-libraries-united-states-survey-fiscal-year-2017-volume-1. Accessed on April
27, 2023.
* 11. Samantha, B., M. Crandall, K. Fisher, et al. ``Opportunity for
All: How the American Public Benefits From internet Access at U.S.
Libraries,'' Institute of Museum and Library Services, March 2010,
p. 32. Available at https://www.imls.gov/sites/default/files/publications/documents/opportunityforall_0.pdf. Accessed on April
27, 2023.

    Dated: June 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12820 Filed 6-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Notices]
[Page 46277-46278]
[DOCID:fr08se09-144]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60605; File No. SR-CHX-2009-13]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Adding Additional Trading Sessions

September 1, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on August 28, 2009, Chicago Stock Exchange, Inc. (``CHX'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the CHX. 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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CHX proposes to amend its rules to create an early trading session
beginning at 6 a.m. CT on days the Exchange is open for trading and to
create a second Late Trading Session from 3 p.m. to 3:15 p.m. CT. The
text of this proposed rule change is available on the Exchange's Web
site at (http://www.chx.com) and in 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 CHX 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 CHX 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 Exchange is proposing to create an early trading session
beginning at 6 a.m. CT on days the Exchange is open for trading and to
create a second Late Trading Session from 3 p.m. to 3:15 p.m. CT. We
believe that CHX Participants may be interested in posting bids and
offers on the CHX in an early trading session, as well as in a late
session immediately after the close of the Regular Session. In order to
facilitate additional trading activity, the Exchange proposes to create
an early trading session and a second late trading session, both of
which would operate under the same basic operational and regulatory
framework as the Regular Trading Session. CHX Participants could enter
orders to buy and sell eligible securities and those orders would
either be executed or displayed (or entered without being displayed in
the case of a reserve or undisplayed order) depending on the status of
our book and the national market system. The rules applicable to the
Regular Trading Session would govern the Early and Late Trading
Sessions, with the exception that the Regulation NMS prohibitions
regarding intermarket trade-throughs and locked and crossed markets
would not be in force. The current Late Trading Session (which would be
renamed the ``Late Crossing Session'') would be available from 3:15
p.m. to 4 p.m. CT and would be available only to Participants seeking
to execute cross orders.
    In furtherance of this initiative, the Exchange proposes to add or
amend the a [sic] number of applicable CHX rules. Definitions setting
the times of the respective trading sessions would be added to Article
1. Due to the risk of illiquidity, the Exchange does not believe that
it is appropriate to execute IOC Market Orders during any of the
Extended Hours trading sessions and we propose to restrict use of that
order type to the Regular Trading Session. We propose to add a new rule
to the Article 8 business conduct rules mandating that Participants
which allow customers to trade in extended hours trading sessions to
make certain specific risk disclosures relating to such activity. These
risk disclosures are modeled on the rules of the BATS Exchange, Inc.
regarding extended hours trading.\3\ The provisions of Article 20, Rule
1 setting the time of the various trading sessions would be amended to
make reference to the Early, Late Trading and Late Crossing sessions
and define how trading operates during those sessions. The language in
Rule 1 referring to the hours of trading for specified exchange-traded
funds would be deleted since those securities would be eligible for
trading during the Early and Late Trading session, rendering the
current text unnecessary. Finally, we would amend Article 20, Rule 8 to
reflect the manner in which the various sessions are opened and closed.
---------------------------------------------------------------------------

    \3\ BATS Exchange Rule 3.21, Customer Disclosures.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act in general,\4\ and furthers the objectives
of Section 6(b)(5) in particular,\5\ in that it is designed to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transaction in
securities, to remove impediments and perfect the mechanisms of a free
and open market, and, in general, to protect investors and the public
interest. In this case, the expansion of trading hours through the
creation of an Early Trading Session and an additional Late Trading
Session would provide participants with

additional options in seeking trade executions on our trading
facilities.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    Because the foregoing proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not 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, it has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and 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. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CHX-2009-13 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-CHX-2009-13. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such 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-CHX-
2009-13 and should be submitted on or before September 29, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-21639 Filed 9-4-09; 8:45 am]

BILLING CODE 8010-01-P