[Federal Register Volume 80, Number 8 (Tuesday, January 13, 2015)]
[Notices]
[Pages 1637-1643]
[FR Doc No: 2015-00269]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0168]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Disclosure Regarding
Additional Risks in Direct-to-Consumer Prescription Drug Television
Advertisements

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: Submit either electronic or written comments on the collection
of information by February 12, 2015.

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 ``Disclosure Regarding Additional Risks in Direct-to-Consumer
(DTC) Prescription Drug Television (TV) Advertisements (Ads).'' Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Disclosure Regarding Additional Risks in Direct-to-Consumer
Prescription Drug Television

Advertisements--(OMB Control Number 0910-NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    Prescription drug advertising regulations (21 CFR 202.1) require
that broadcast (TV or radio) advertisements present the product's major
risks in either audio or audio and visual parts of the advertisement;
this is often called the ``major statement.'' There is concern that as
currently implemented in DTC ads, the major statement is often too
long, which may result in reduced consumer comprehension, minimization
of important risk information and, potentially, therapeutic non-
compliance due to fear of side effects. At the same time, there is
concern that DTC TV ads do not include adequate risk information or
leave out important information. These are conflicting viewpoints. A
possible resolution is to limit the risks in the major statement to
those that are serious and actionable, and include a disclosure to
alert consumers that there are other product risks not included in the
ad. For example, the disclosure could be, ``This is not a full list of
risks and side effects. Talk to your doctor and read the patient
labeling for more information.'' The Office of Prescription Drug
Promotion plans to investigate the effectiveness of this ``limited
risks plus disclosure'' strategy through empirical research.
    Our primary hypothesis is that, relative to inclusion of the full
major statement, providing limited risk information along with the
disclosure about additional risks will promote improved consumer
perception and understanding of serious and actionable drug risks. We
will also investigate other questions such as whether overall drug risk
and benefit perceptions are affected by these changes. To examine
differences between experimental conditions, we will conduct
inferential statistical tests such as analysis of variance. With the
sample size described further in this document, we will have sufficient
power to detect small-to-medium sized effects in the main study.
    Participants will be consumers who self-identify as having been
diagnosed with one of three possible medical conditions: Depression,
high cholesterol, or insomnia. All participants will be 18 years of age
or older. We will exclude individuals who work in healthcare or
marketing settings because their knowledge and experiences may not
reflect those of the average consumer. Recruitment and administration
of the study will take place over the Internet. Participation is
estimated to take approximately 30 minutes.
    Within medical condition, participants will be randomly assigned to
view one of four possible versions of a DTC ad, as depicted in table 1.
One version will present the full major statement without the
disclosure regarding additional risks (Conditions C, G, and K). This
version will implement existing ads in the marketplace. Stimuli
variations for the other three versions will be achieved by replacing
the audio track of the original ad with the revised risk and disclosure
statements described previously. Thus, a second version of the ad will
include the full major statement plus the disclosure about additional
risks (Conditions A, E, and I). A third version will include an
abbreviated statement of risks without the disclosure about additional
risks (Conditions D, H, and L). The fourth version will include an
abbreviated statement of risks as well as the disclosure about
additional risks (Conditions B, F, and J).
    After viewing the ad, participants will respond to questions about
information in the ad. Measures are designed to assess perception and
understanding of product risks and benefits; perception and
understanding of the disclosure about additional risks; perceptions of
product quality; intention to seek more information about the product;
and perceptions of trust/skepticism regarding product claims and the
sponsor. The questionnaire is available upon request.

                                              Table 1--Study Design
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                                                                                Major statement
              Medical condition                Disclosure regarding additional ---------------------------------
                                                            risks                  Version 1        Version 2
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Depression...................................  Present........................               A                B
                                               Absent.........................                C               D
High Cholesterol.............................  Present........................               E                F
                                               Absent.........................               G                H
Insomnia.....................................  Present........................               I                J
                                               Absent.........................               K                L
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Note. Version 1 = current major statement; Version 2 = abbreviated major statement.

    In the Federal Register of February 18, 2014 (79 FR 9217), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from 26 groups or
individuals in response to our Federal Register notice. This amounted
to 55 comments that specifically referenced the study and were PRA-
related.
    FDA's specific responses to the comments are divided into sections.
The first section addresses pharmaceutical industry comments from the
Pharmaceutical Research and Manufacturers of America (PhRMA), Abbvie,
Pfizer, and Eli Lilly and Company. The second section addresses
comments from other organizations, including the Patient, Consumer, and
Public Health Coalition, Washington Legal Foundation, Consumers Union,
and Coalition for Healthcare Communication. The third section addresses
comments from individuals (names indicated in-text when available).
Many commenters indicated support for this research. We appreciate this
support. Comments that are not PRA-relevant (e.g., ``Ban DTC'') or do
not relate to the proposed study are not included in this document or
addressed in our responses. For brevity, all public comments are
paraphrased and therefore may not reflect the exact language used by
the commenter. We assure commenters that the entirety of their comments
was considered even if not fully captured by our paraphrasing in this
document.

Responses to Comments From the Pharmaceutical Industry

PhRMA

1. Use of an existing drug ad could have confounding results due to
consumer familiarity with medicines and drug classes used to treat
their existing condition.
    Response: The decision to implement and modify existing ads was
arrived at in an effort to balance the integrity of the research with
cost considerations. It is significantly less expensive to implement
and modify existing ads than it is to create and modify fictitious ads.
Nonetheless, we appreciate this concern and in response, we have added
questions to the survey to measure ad familiarity, which we can then
control for in our analyses.
2. If FDA goes forward with the strategy to use existing ads, (a) avoid
using a drug ad that has aired within the past 12 months or that
contains any iconic images or marks, (b) alter the brand and
established names of the drugs, (c) record a new voiceover for the
major statement using fictionalized risk information, and (d) ensure
that fictionalized risks are not similar to or associated with related
drugs.
    Response: We do not intend to fictionalize the risks and side
effects or brand and established names. Our goal in using existing
information is to ensure external validity of study findings when we
draw comparisons between consumers who view existing versus modified
risk statements. We intend to control for familiarity by measuring ad
familiarity.
3. Participant sample should consist of consumers who self-identify as
having the disease the drug featured in the ad treats.
    Response: As stated in Federal Register Notice, ``participants will
be consumers who self-identify as having been diagnosed with one of
three possible medical conditions.'' The medical condition diagnosed
will be consistent with the medical condition targeted by the
advertising.

Abbvie

1. Ask participants to identify the name of the drug prior to asking
about benefits and risks.
    Response: Participants in this research will see only one drug ad
and therefore perceptions will necessarily be associated with that one
drug. It is outside the scope of this project to investigate drug name
recall and/or recognition. Therefore, to avoid unnecessarily burdening
participants, we do not intend to include these questions.
2. Include patients across a wider range of ages and with acute
conditions.
    Response: We proposed to recruit participants 18 years of age and
older who self-identify as having been diagnosed with the medical
condition being advertised. We considered many variables in choosing
the conditions to test, including acute versus chronic conditions. We
acknowledge that the type of condition (for example, acute,
symptomatic, chronic, silent) may interact with the risk profile of the
product (for example, very risky to less risky). With these variables
in mind, we chose conditions that represent chronic and symptomatic
diseases and a range of risk profiles.
3. Add a question to ascertain that participants can identify risks of
the drug.
    Response: Risk recall is currently assessed by Q6. Risk recognition
is currently assessed by Q7.
4. Regarding Q8, if a fact-based statement was presented, it would be
valuable to word the question to see if respondents comprehend the
statement.
    Response: Q8 (now Q9) reads, ``In your opinion, if [DRUG] did help
a person's [condition], how much would it help?'' The purpose of this
question is to assess anticipated efficacy magnitude of the drug based
on the advertising. This question has been subject to cognitive testing
and refinement in other FDA research, confirming that respondents
understand and are able to respond to this question.
5. Regarding Q18 and Q19 (Q23 and Q24 in revised questionnaire):
    a. These questions assume that participants are knowledgeable about
alternative treatments; if they are knowledgeable, it is unclear what
treatment participants might select as a comparator.

    Response: We agree with this concern. In response, we have added
language introducing these questions. The language reads, ``Please
think about other medicines you know of that treat [condition]. If you
are not aware of other medicines that treat [condition], please choose
the answer [Neither disagree nor agree].'' Additionally, following Q23
and Q24, we intend to inquire which drug(s) participants had in mind
with an open-ended question.
    b. The focus of the questions should be on how to interpret the
information when presented with all risks versus only major and most
likely risks.
    Response: The purpose of these questions is to assess anticipated
efficacy and risk relative to other medicines that treat the condition.
By drawing comparisons between the experimental conditions, we will be
able to assess if anticipated efficacy and risk relative to other
medicines differs due to exposure to the existing set of risks versus
an abbreviated set (Condition 1) and whether or not a disclosure is
presented (Condition 2).
    c. A question should be added to ascertain if respondents can
identify major risks of the drug.
    Response: Risk recall is currently assessed by Q6. Risk recognition
is currently assessed by Q7.
    d. To assess participant ability to balance the risks of the drug
with its benefits, respondent's knowledge of the effectiveness of the
drug should be queried using a 5 or 7 point scale anchored from Not
Effective to Very Effective.
    Response: The purpose of Q23 and Q24 is not to assess risk-benefit
tradeoff. See response to comment 5b for the purpose of these
questions. Note also that a number of questions already assess
anticipated effectiveness of the drug (e.g., Q8 and Q9). Risk-benefit
tradeoff is assessed by Q12 and Q13a-c.
6. Reword Q26 get the respondent to focus on the format of the
information presentation versus how the study was executed.
    Response: The language of this question (now Q28) has been
reformatted to include the specific disclosure language. The purpose of
this question is to assess noticeability and understanding of the
concept that not all risks were presented. Later questions (e.g., Q29a)
assess understanding of the specific statement wording.
7. Add questions to assess how informative and actionable participants
found the list of risks and side effects.
    Response: We agree with this suggestion and have now incorporated
questions into the survey to assess these reactions.

Pfizer

1. It may prove difficult for respondents to quantify risk and benefit
in Q7 and Q9 given that the ads will not explicitly quantify risk or
benefit information; FDA should use these data only to assess relative
differences across ad treatments.
    Response: The purpose of these questions (now Q8 and Q10) is to
assess perceived benefit and risk based on the advertising shown. We do
not expect participants to quantify benefits and risks as they were
empirically measured.
2. Avoid asking participants how other people will react.
    Response: We agree with this suggestion and have revised the
questionnaire accordingly.
3. Q18 and Q19 may prove difficult to interpret. Given that
participants have not seen the revised major statements before, they
may perceive drugs in the test ads to be more or less effective simply
because other drugs advertised on TV are not using these formats. If
implemented broadly, the comparative effect would likely go away.
    Response: We appreciate the possibility that findings obtained in
this study may differ from outcomes once implemented broadly. Still, it
is important to measure these constructs. Findings from this study are
one of a number of factors that would be considered prior to broad
implementation in broadcast advertisements. These questions are
reflected in Q23 and Q24 in the revised questionnaire.
4. Add questions to assess how clear, confusing, and important
participants found the list of risks and side effects; also assess
whether participants felt too much risk information and not enough risk
information was presented.
    Response: We agree with these suggestions and have incorporated
questions into the survey that assess these constructs.
5. Delete Q11; the ads likely do not provide information about how easy
or difficult it is to treat the condition with the drug.
    Response: We agree with this suggestion and have modified the
questionnaire accordingly.
6. Delete Q17; persuasiveness of the ad is subjective and difficult for
respondents to assess.
    Response: Our intention in asking this question (now Q26d) is to
determine if displaying only serious and actionable risks along with a
disclosure results in perceptions that the ad is more persuasive. We
believe this is an important construct to measure and therefore will
retain the question. Additionally, we have added Q17 (``I am interested
in trying [DRUG]'') as an indirect measure of persuasion.
7. Delete Q23; it is not clear how respondents would be able to assess
the quality of the drug.
    Response: Our intention in asking this question (now Q25) is to
determine if displaying only serious and actionable risks along with a
disclosure results in perceptions that the drug is of high quality.
This perception is based exclusively on the advertising and not on
quality as it might be measured empirically. To clarify this intention,
we have added instructions indicating that judgments should be reached
based on the information in the prescription drug ad. We believe
perceived drug quality an important construct to measure and therefore
will retain the question.
8. Delete Q29a-d; it is not clear how assessing skepticism is relevant
to the study objectives.
    Response: Due to concerns about the length of the questionnaire, we
have deleted these questions.

Eli Lilly and Company

1. Include a general population control group.
    Response: The decision not to include a general population sample
was arrived at in an effort to balance the integrity of the research
with cost considerations. Each medical condition, or general population
sample, comes at significant cost. The medical conditions we chose were
selected because they represent conditions that are both chronic,
symptomatic, and have a range of risk profiles (see response to Abbvie
Comment 2). Although we appreciate the value of collecting data on a
general population sample, we do not intend to adopt this suggestion in
the present research based on cost considerations.

2. Immediately following unaided recall (Q1b; now Q3) and category
assignments (Q2 and Q3; Q2 now deleted, Q3 now Q4), it is advised that
close-ended questions assessing respondents' perception of whether the
information in the ad is easily understood (similar to Q20 battery; now
Q13) be added.
    Response: We agree that these questions are important and central
to the research objectives, and so we have placed these questions
earlier in the revised questionnaire. However, we are unclear on the
rationale for inquiring about these topics immediately following Q4. We
plan to instead measure recall and recognition of benefits and risks
before inquiring about the clarity in presentation of benefits and
risks. We believe that involvement in answering recall and recognition
questions first will allow consumers to provide a more accurate
assessment of whether the information is easily understood.
3. Several questions (Q7, Q8, Q9, Q11, Q18, Q19, and Q23) appear to
lack relevance to the research objectives and should be modified or
deleted.
    Response: The purpose of Q7, Q8, and Q9 (now Q8 through Q11) is to
assess perceived benefit and risk of taking the drug. The purpose of
Q18 and Q19 (now Q23 and Q24) is to assess anticipated efficacy and
risk relative to other medicines that treat the condition. The purpose
of Q23 (now Q25) is to assess perceived quality of the drug. We have
modified these questions to communicate that perceptions should be
based on the impression participants received from the advertising. By
drawing comparisons between the experimental conditions, we may
determine that the risk and disclosure statements alter the previously
mentioned perceptions. We agree that Q11 lacks direct relevance to the
research objectives and therefore have deleted this item.
4. Q36 suggests that participants may be allowed to complete the study
using a mobile device; pre-testing should be conducted to determine the
appropriateness of this option.
    Response: We intend to restrict participants to using devices that
allow full functionality of study procedures. We will retain a modified
version of Q36 (now Q39) to ascertain that this requirement was
followed.
5. Provide instructions to respondents regarding ad downloading/
buffering to ensure they can see and hear the stimuli.
    Response: We agree with this suggestion and intend to implement it.
6. Maintain consistent scale parameters throughout the survey to avoid
confusion by participants and reduce bias in analysis.
    Response: We agree with this recommendation and have adopted it in
cases where the specific scale has not been validated by prior
research.
7. Terms in Q2 (e.g., over-the-counter drug) should be defined or
presented in consumer friendly language.
    Response: Due to concerns about the length of the questionnaire, we
have deleted this question.
8. In Q3, the response option ``High Blood Pressure'' may confuse
participants who are diagnosed with both high cholesterol and high
blood pressure; consider an alternative condition for high blood
pressure.
    Response: We agree with this recommendation and have replaced
``high blood pressure'' with ``seasonal allergies.'' Q3 is reflected in
Q4 in the revised questionnaire.
9. Q13, Q14, and Q15 (Q18 through Q22 battery in revised questionnaire)
should be modified so that the respondent would indicate intention or
likelihood for themselves, without asking them to project to others.
    Response: We agree with this recommendation and have modified these
questions accordingly.
10. Improve programming instructions to clarify which respondents are
asked Q27 and Q28 versus those that are skipped to Q29.
    Response: Participants in conditions in which the risk disclosure
is not shown are skipped to Q30 in revised questionnaire. We have
clarified this intention in the programming language.

Responses to Comments From Other Groups and Organizations

Patient, Consumer, and Public Health Coalition (PCPHC)

1. Define ``serious and actionable.''
    Response: We define ``actionable'' as something the patient would
know (e.g., pre-existing condition or allergy) or recognize (e.g.,
observable physical or mental symptom) and can act upon to help
mitigate (e.g., get immediate medical help to prevent a bad outcome).
For example, ``stop using the product and get immediate medical help if
you have swelling of the face, lips, tongue, or throat.'' Serious risks
would include those that appear in the warnings and precautions section
of labeling and results in any of the following outcomes: Death, a
life-threatening adverse drug experience, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect. Important
medical events that may not result in death, be life-threatening, or
require hospitalization may be considered a serious adverse drug
experience when, based upon appropriate medical judgment, they may
jeopardize the patient or subject and may require medical or surgical
intervention to prevent one of the outcomes listed previously.
2. Ensure a diverse participant sample: Internet recruitment may favor
inclusion of younger, more affluent and Internet-adept populations; the
medical conditions chosen may not adequately reflect the general U.S.
consumer audience.
    Response: The rapid expansion of Internet access across the U.S.
population has made panel participation feasible for an increasingly
broader range of respondents. Still, there are some demographic groups
that are more responsive than others; but that can be found across all
research methodologies. For example, there is a natural skew on those
that will take a research phone call and those that will attend a focus
group. The same can be said for Internet research as well. To rectify
those skews, we utilize the Research Now panel, which is recruited to
match a natural distribution of all demographic groups. Research Now
works with clients to set fixed quota expectations in the survey
instrument itself to enforce the final distribution and work with the
invitation mix to balance the outcome as needed during the field
period. Research Now's panels are recruited through a partner network
of ubiquitous brands utilizing a ``By-Invitation-Only'' approach and
through tailored online marketing with over 300 diverse online
affiliate partners and targeted Web site advertising. Specifically,
Research Now uses e-Rewards[supreg] ``By-Invitation-Only'' recruitment
methodology to invite pre-validated individuals to participate in their
Consumer and Business Panels. Their recruitment methods provide a
sample mix representative of the general population and also provide
access to hard-to-reach business professionals and low-incidence
consumers who are

typically less likely to join panels. Research Now controls and manages
the demographic make-up of their panels and enrolls individuals who
share known characteristics--ensuring access to populations of interest
to the study. Their panels also comply with, or exceed, all applicable
industry standards published by: ESOMAR, Market Research Society
(U.S.), Australian Market & Social Research Society (Australia),
Berufsverband Deutscher Markt--und Sozialforscher e.V. (Germany),
Council of American Survey Research Organizations (U.S.), and Marketing
Research and Intelligence Association (Canada).
    Regarding choice of medical conditions, we considered many
variables in choosing the conditions to test, including acute versus
chronic conditions. We acknowledge that the type of condition (for
example, acute, symptomatic, chronic, silent) may interact with the
risk profile of the product (for example, very risky to less risky).
With these variables in mind, we chose conditions that represent
chronic and symptomatic diseases and a range of risk profiles.
3. Study conditions must be as similar to real life situations as
possible.
    Response: Because this is the first test of abbreviated risk
statements with disclosures, our primary goal is to closely examine the
cognitive effects of exposure to the test ads in a controlled
experiment. As such, internal validity is a greater priority than
external validity. We considered presenting test ads within a clutter
reel to help mimic real world conditions, but worry that this approach
may introduce unwanted bias (e.g., how attention-getting the test ad is
compared to the filler ads). To increase study realism without
sacrificing internal validity, we have chosen a sample that would
potentially be interested in the drug. In addition, modified ads will
be professionally developed and appear realistic.
4. Examine presentation of major statement earlier in the
advertisement, when a greater proportion of consumers may be paying
attention.
    Response: We recognize the value of asking this question; consumers
may respond differently if the major statement was to be presented
earlier in an advertisement. However, this is a different research
question than proposed by the present study and so we do not intend to
address it in this research. We encourage other researchers to pursue
this unique empirical question.

Washington Legal Foundation

1. Supports the proposed collection and requests that it be expanded to
test an alternative hypothesis that the average consumer is very
unlikely to be ``misled into believing that the drug poses no
significant health risks for him'' if a broadcast DTC advertisement for
the drug ``alerts consumers to its potential benefits, states generally
that taking the drug poses significant potential health risks, lists
any types of individuals who are categorically contra-indicated for the
drug, and then asks the consumer to consult with his doctor for a more
detailed explanation of risks,'' and to include a First Amendment
analysis.
    Response: FDA appreciates the support for the proposed collection.
However, FDA declines to expand the scope of this proposed information
collection as suggested. The primary objective of the proposed study is
to assess whether consumer perception and understanding of serious and
actionable drug risks is improved if DTC television ads for
prescription drugs present limited information focused on those serious
and actionable risks together with a disclosure that there are
additional risks, as compared to a broader presentation of risk
information without disclosure that there are additional risks, like
that commonly used in TV ads today. The presentation of risk
information about prescription drugs to consumers implicates multiple
important public health concerns, including how the presentation of
both risk and benefit influences consumer judgments about the risk-
benefit trade-off of advertised drugs, and how it impacts consumer
decisions about whether or not to approach a healthcare provider about
advertised drugs.
    In considering how to allocate its limited resources for research,
FDA must make choices and has identified its initial hypothesis as a
useful one to help improve understanding of how different approaches in
DTC television advertisements can impact consumer perception and
understanding of drug risks. Once this proposed research is complete
and published, the results will facilitate further consideration and
analysis, including by outside entities, and may suggest additional
topics for research.
    A First Amendment analysis is likewise outside the scope of the
current proposed research and FDA therefore declines to redesign the
study along the lines suggested by the comment.\1\ Of course, when FDA
implements its regulatory program, it does so in a manner that seeks to
promote and protect the public health, consistent with its statutory
authorities and mandate, while harmonizing this goal with First
Amendment interests.
---------------------------------------------------------------------------

    \1\ We also note that we disagree with several aspects of the
comment's assertions related to First Amendment law, but we do not
believe it is necessary or appropriate to address those arguments
here.
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Consumers Union

1. Define ``serious and actionable.''
    Response: Please see our response to PCPHC Comment 1.
2. The proposed study could lead to replacing the current requirement
to reference where to get full drug/device information with a mere
mention that there are more side effects.
    Response: Adequate provision refers to elements in a broadcast ad
describing ways viewers can get the full product labeling, such as
through the manufacturer's Web site, through a print ad, by calling the
manufacturer's toll-free number, and by asking their healthcare
provider. The proposed research was not designed to inform whether
adequate provision should or should not remain in DTC advertising, and
therefore the study results should not be used for such purposes.
3. The study procedures should reflect the way an average consumer
would see or hear an ad (e.g., when the consumer's focus is not
necessarily on the ad).
    Response: Please see our response to PCPHC Comment 3.

Coalition for Healthcare Communication

1. Include a qualitative leg to the study.
    Response: Although adding a qualitative leg to the study would
likely generate interesting and insightful outcomes, cost
considerations restrict us from doing so. Note however that we do
intend to conduct cognitive interviews prior to administration of the
main study. Cognitive interviews involve a trained interviewer who will
sit with participants as they view the stimuli, complete the
questionnaire, and discuss their thought processes out loud, prompting
participants to explain why they answered certain questions as they
did. Findings from the cognitive interviews will then inform
development of the final stimuli and questionnaire.
2. Include physicians in the study.
    Response: We agree that physician perspectives about prescription
drug advertising are important and

interesting. However, as their perspective is outside the scope of the
current research, we do not intend to adopt this suggestion. Note that
we recently completed a separate study examining this topic, entitled
``Healthcare Professional Survey of Prescription Drug Promotion.''
Results from this study will be made available in the peer-reviewed
literature.
3. Recruit respondents and analyze results by age cohort.
    Response: We agree that recruiting participants across a wide range
of ages is important and our sample will reflect this shared
perspective.
4. Consider including communication media beyond television.
    Response: We understand that it is important to understand effects
of prescription drug advertising across mediums. Commonalities exist
across multiple communication mediums, but also differences that may
impact consumer perception of drug benefits and risks. Consequently,
our research program has investigated various topics across these
mediums. We intend to focus on television advertising in this study
because it is most closely related to the research objectives, and due
to cost considerations.
5. Reconsider using existing DTC ads in the proposed study.
    Response: Please refer to our response to PhRMA comments 1 and 2.
6. Clearly define what ``serious and actionable'' risks are.
    Response: Please refer to our response to PCPHC comment 1.

Responses to Comments From Individuals

Mel Sokotch

1. To ensure ad presentation is consistent with real world viewing
conditions, the test ad should be presented as part of a clutter reel.
    Response: Please refer to our response to PCPHC comment 3.
2. Immediately following the clutter reel with test ad inserted,
initial survey questions should include open-ended assessment of issues
such as recall, communication, and motivation. The ad should then be
presented again and followed by additional questions designed to assess
the impact of the ad.
    Response: Our current procedures involve two presentations of the
ad: once prior to administering the questionnaire and once during the
questionnaire immediately preceding specific questions about the risk
disclosure statement. To avoid unnecessarily burdening participants, we
do not intend to show the ad a third time, per this recommendation.

Anonymous

1. As an end consumer, the side effects listed give us information to
research further to determine the severity of the side effects.
    Response: We address this concern by asking participants, in open-
ended fashion, to list the thoughts that were going through their mind
as they viewed the ad. In doing so, we hope to learn whether this is a
broad concern among consumers. We are also assessing perceptions of
risk.
2. Prescription drug commercials seek to persuade consumers, and
healthcare providers have little time to discuss these risks and side
effects with patients; thus, providing this information in television
advertisements is important and necessary.
    Response: Current regulations (21 CFR 202.1(e)(1)) require that
prescription drug broadcast advertisements present the major risks of
the drug as well as provide adequate provision, or mention of where the
patient can obtain additional information about risks and side effects
of the drug (e.g., Web sites, magazines). We recognize that providing
risk information is an important and necessary component. As stated in
the Federal Register, however, there is also concern that the length
and content of some major statements is not adequately communicating
this important information. Thus, we are conducting empirical research
to test this question. This study does not address the question of
adequate provision.

John Bonanno; Aaron Heyman; Thomas Klugh (Similar Comment)

1. All warnings should be clearly stated.
    Response: Per 21 CFR 202.1, current regulations require that
broadcast ads disclose the product's major risks; these are typically
the most common and the most serious risks described in labeling. At
the same time the full product labeling should be made available
through other means (see Guidance for Industry: Consumer-Directed
Broadcast Advertisements \2\). With this in mind, the current study is
addressing the impact of the current major statement risk format versus
an abbreviated format, along with a disclosure indicating that not all
risk information was presented.
---------------------------------------------------------------------------

    \2\ http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125064.pdf.
---------------------------------------------------------------------------

John Sovitsky

1. Existing regulations do not go far enough; warnings should be
described in text as large as benefits, and spoken at a slower, more
intelligible speed.
    Response: Although interesting, this comment is outside the scope
of the present research.

Duane De Vries; Gary Graham (Similar Comment)

1. Consumers need all of the information that they can get to protect
them against unscrupulous drug companies.
    Response: Please see response to previous comment.

Nila Jamerson; Charles McCloud (Similar Comment)

1. Risk disclosures in drug ads are tedious and unneeded; they should
be provided by healthcare providers.
    Response: Communication between healthcare providers and patients
about drug risks is an important component of the healthcare decision
making process. Nonetheless, the regulations require that benefit
information in prescription drug ads should be balanced with
presentation of risk information so that consumers can adequately
consider both benefits and risks (i.e., the risk-benefit trade off)
before approaching a healthcare provider about the drug.

Janessa

1. Additional risks should remain in TV ads; otherwise, advertised
drugs sound like cure-all miracles.
    Response: Note that we do not propose studying whether all risk
information should be eliminated from broadcast ads. In both the
current major statement condition and the experimental condition with
abbreviated major statement plus disclosure, significant risks
associated with the drug are presented in broadcast advertisements.
Thus, we do not agree that the presentation would imply a cure-all
miracle.

Patricia Simon

1. The number of participants is far too few.
    Response: Sample size per experimental condition in the main study
is 125. This sample size is based on a statistical power analysis with
power set at .90 and alpha equal to .05 assuming a small to medium
effect size. Thus, power analyses support that our sample size is
adequate.

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
Disclosure regarding  additional risks in        Number of respondents         responses per   Total annual   Average  burden per  response  Total hours
      DTC  prescription drug TV ads                                             respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Study Screener.....................  1700 (insomnia), 539 (high                      1           6,013  0.03 (2 minutes).............          180
                                            cholesterol), 3774 (depression).
Main Study Screener......................  4252 (insomnia), 1347 (high                     1          15,032  0.03 (2 minutes).............          451
                                            cholesterol), 9433 (depression).
Pilot Study..............................  600 (200 for each medical                       1             600  0.50 (30 minutes)............          300
                                            condition).
Main Study...............................  1500 (500 for each medical                      1            1500  0.50 (30 minutes)............          750
                                            condition).
LLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL                                                   -----------------------------------------------
    Total................................  .................................  ..............  ..............  .............................        1,681
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00269 Filed 1-12-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Notices]
[Page 50271]
[DOCID:fr30se09-116]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

First Meeting, RTCA Special Committee 223: Airport Surface
Wireless Communications

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 223: Airport Surface Wireless
Communications meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 223: Airport Surface Wireless
Communications.

DATES: The meeting will be held November 3-4, 2009 from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at RTCA, 1828 L Street, NW., Suite
805, RTCA Conference Rooms, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street,
NW., Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 223: Airport Surface Wireless
Communications meeting. The agenda will include:

Tuesday, November 3, 2009

 Opening Session (Welcome, Introductions, Administrative
Remarks)
 Special Committee Leadership
 Designated Federal Official (DFO): Mr. Brent Phillips
 Co-Chair: Mr. Aloke Roy, Honeywell International
 Co-Chair: Mr. Ward Hall, ITT Corporation
 RTCA Specific Information: Mr. Rudy Ruana, RTCA Program
Director for SC-223
 Agenda Overview
 RTCA Functional Overview
 Airport Surface Wireless Communications--Background, History,
Status, Industry Related Activities
 Background on Aeronautical Information Services Datalink, RTCA
SC-206/EUROCAE WG-76
 Background on Eurocontrol Future Communication Infrastructure
Study on Airport Surface Communications
 Other presentations, discussions, and recommendations
 Review of authorizing document (Terms of Reference) as
approved by RTCA Program Management Committee on August 7, 2009
 Actions and plans for items on TOR

Wednesday, November 4, 2009

 Organization of Work, Assign Tasks and Workgroups as necessary
 Selection of Secretary for SC-223
 Presentation, Discussion, Recommendations, Assignment of
Responsibilities
 Consider Liaison with other RTCA Special Committees
 Establish Agenda, Date and Place for the next plenary meeting
 Review of Meeting summary report
 Adjourn--Expected by 2 p.m. on November 4
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 23, 2009.
James H. Williams,
RTCA Advisory Committee.
[FR Doc. E9-23532 Filed 9-29-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Page 22918]
[FR Doc No: 2013-08977]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Rule 204-3.
    OMB Control No. 3235-0047, SEC File No. 270-42.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    The title for the collection of information is ``Rule 204-3 (17 CFR
275.204-3) under the Investment Advisers Act of 1940.'' (15 U.S.C.
80b). Rule 204-3, the ``brochure rule,'' requires advisers to deliver
their brochures and brochure supplements at the start of an advisory
relationship and to deliver annually thereafter the full updated
brochure or a summary of material changes to their brochure. The rule
also requires that advisers deliver an amended brochure or brochure
supplement (or just a statement describing the amendment) to clients
only when disciplinary information in the brochure or supplement
becomes materially inaccurate. The brochure assists the client in
determining whether to retain, or continue employing, the adviser. The
information that Rule 204-3 requires to be contained in the brochure is
also used by the Commission and staff in its enforcement, regulatory,
and examination programs. This collection of information is found at 17
CFR 275.204-3 and is mandatory.
    The respondents to this information collection are investment
advisers registered with the Commission. Our latest data indicate that
there were 10,754 advisers registered with the Commission as of January
2, 2013. The Commission has estimated that compliance with rule 204-3
imposes a burden of approximately 31 hours annually based on an average
adviser having 1,200 clients. Based on this figure, the Commission
estimates a total annual burden of 331,456 hours for this collection of
information.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information collected; and (d) ways to minimize the
burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology. Consideration will be given to comments and
suggestions submitted in writing within 60 days of this publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312, or send an
email to<EMAIL_ADDRESS>
    Dated: April 11, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-08977 Filed 4-16-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Page 76939]
[FR Doc No: 2016-26710]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-227-000]

Innovative Solar 47, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Innovative Solar 47, LLC `s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 21, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 31, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-26710 Filed 11-3-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68758-68760]
[FR Doc No: 2023-21954]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98623; File No. SR-CboeBZX-2023-042]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade
Shares of the WisdomTree Bitcoin Trust Under BZX Rule 14.11(e)(4),
Commodity-Based Trust Shares

September 28, 2023.
    On June 30, 2023, Cboe BZX Exchange, Inc. (``BZX'' or ``Exchange'')
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 to
list and trade shares (``Shares'') of the WisdomTree Bitcoin Trust
(``Trust'') under BZX Rule 14.11(e)(4), Commodity-Based Trust Shares.
On July 11, 2023, the Exchange filed Amendment No. 1 to the proposed
rule change, which amended and replaced the proposed rule change in its
entirety. The proposed rule change, as modified by Amendment No. 1, was
published for comment in the Federal Register on July 19, 2023.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 97904 (July 13,
2023), 88 FR 46207 (``Notice''). Comments on the proposed rule
change, as modified by Amendment No. 1, are available at: https://www.sec.gov/comments/sr-cboebzx-2023-042/srcboebzx2023042.htm.
---------------------------------------------------------------------------

    On August 31, 2023, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change, as modified by Amendment No. 1.\5\ This order institutes
proceedings under Section 19(b)(2)(B) of the Act \6\ to determine
whether to approve or disapprove the proposed rule change, as modified
by Amendment No. 1.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 98264, 88 FR 61657
(Sept. 7, 2023). The Commission designated October 17, 2023, as the
date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

I. Summary of the Proposal, as Modified by Amendment No. 1

    As described in more detail in the Notice,\7\ the Exchange proposes
to list and trade the Shares of the Trust under BZX Rule 14.11(e)(4),
which governs the listing and trading of Commodity-Based Trust Shares
on the Exchange.
---------------------------------------------------------------------------

    \7\ See Notice, supra note 3.
---------------------------------------------------------------------------

    The investment objective of the Trust is to gain exposure to the
price of bitcoin, less expenses and liabilities of the Trust's
operations.\8\ The Trust's assets will consist of bitcoin held by the
Trust's custodian on behalf of the Trust.\9\ The Trust will value its
Shares daily based on the value of bitcoin as reflected by the CF
Bitcoin US Settlement Price (``Reference Rate'').\10\ The administrator
of the Trust will determine the net asset value (``NAV'') of the Trust
on each day that the Exchange is open for regular trading, as promptly
as practical after 4:00 p.m. ET.\11\ In determining the Trust's NAV,
the administrator will value the bitcoin held by the Trust based on the
price set by the Reference Rate as of 4:00 p.m. ET.\12\ When the Trust
sells or redeems its Shares, it will do so in ``in-kind'' transactions
with authorized participants in blocks of Shares.\13\
---------------------------------------------------------------------------

    \8\ See id. at 46215. WisdomTree Digital Commodity Services, LLC
(``Sponsor'') is the sponsor of the Trust.
    \9\ See id. The Trust generally does not intend to hold cash or
cash equivalents; however, there may be situations where the Trust
would unexpectedly hold cash on a temporary basis. See id.
    \10\ See id.
    \11\ See id. at 46216.
    \12\ See id.
    \13\ See id. at 46215.
---------------------------------------------------------------------------

II. Proceedings To Determine Whether To Approve or Disapprove SR-
CboeBZX-2023-042 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \14\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule change, as discussed below. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described below, the Commission seeks and encourages interested persons
to provide comments on the proposed rule change.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\15\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires,

among other things, that the rules of a national securities exchange be
``designed to prevent fraudulent and manipulative acts and practices''
and ``to protect investors and the public interest.'' \16\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in the Notice, in addition to any other comments they may wish to
submit about the proposed rule change. In particular, the Commission
seeks comment on the following questions and asks commenters to submit
data where appropriate to support their views:
    1. What are commenters' views on whether the proposed Trust and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
bitcoin markets and the bitcoin markets' susceptibility to
manipulation?
    2. Based on data and analysis provided and the academic research
cited by the Exchange,\17\ do commenters agree with the Exchange that
the Chicago Mercantile Exchange (``CME''), on which CME bitcoin futures
trade, represents a regulated market of significant size related to
spot bitcoin? \18\ What are commenters' views on whether there is a
reasonable likelihood that a person attempting to manipulate the Shares
would also have to trade on the CME to manipulate the Shares? \19\ Do
commenters agree with the Exchange that trading in the Shares would not
be the predominant influence on prices in the CME bitcoin futures
market? \20\
---------------------------------------------------------------------------

    \17\ See Notice, 88 FR at 46212-15.
    \18\ See id. at 46213.
    \19\ See id. at 46213-14.
    \20\ See id. at 46214.
---------------------------------------------------------------------------

    3. The Exchange states that bitcoin is resistant to price
manipulation and that other means to prevent fraudulent and
manipulative acts and practices ``exist to justify dispensing with the
requisite surveillance sharing agreement'' with a regulated market of
significant size related to spot bitcoin.\21\ In support, the Exchange
states, among other things, that the geographically diverse and
continuous nature of bitcoin trading make it difficult and
prohibitively costly to manipulate the price of bitcoin, and that the
fragmentation across bitcoin platforms, the relatively slow speed of
transactions, and the capital necessary to maintain a significant
presence on each trading platform make manipulation of bitcoin prices
through continuous trading activity challenging.\22\ The Exchange also
states that offering only in-kind creations and redemptions provides
``unique protections against potential attempts to manipulate the price
of the Shares'' and that the price the Sponsor uses to value the
Trust's bitcoin ``is not particularly important.'' \23\ Do commenters
agree with the Exchange's statements regarding the bitcoin market's
resistance to price manipulation?
---------------------------------------------------------------------------

    \21\ See id. at 46213 n.49.
    \22\ See id.
    \23\ See id. at 46219.
---------------------------------------------------------------------------

    4. The Exchange also states that it will execute a surveillance-
sharing agreement with Coinbase, Inc. (``Coinbase'') that is intended
to supplement the Exchange's market surveillance program.\24\ According
to the Exchange, the agreement is ``expected to have the hallmarks of a
surveillance-sharing agreement between two members of the [Intermarket
Surveillance Group], which would give the Exchange supplemental access
to data regarding spot [b]itcoin trades on Coinbase where the Exchange
determines it is necessary as part of its surveillance program for the
Commodity-Based Trust Shares.'' \25\ Based on the description of the
surveillance-sharing agreement as provided by the Exchange, what are
commenters' views of such an agreement if finalized and executed? Do
commenters agree with the Exchange that such an agreement with Coinbase
would be ``helpful in detecting, investigating, and deterring fraud and
market manipulation in the Commodity-Based Trust Shares''? \26\
---------------------------------------------------------------------------

    \24\ See id. at 46214.
    \25\ See id. The Exchange states that ``[t]his means that the
Exchange expects to receive market data for orders and trades from
Coinbase, which it will utilize in surveillance of the trading of
Commodity-Based Trust Shares.'' Id.
    \26\ See id. at 46214.
---------------------------------------------------------------------------

    5. Some sponsors of proposed spot bitcoin exchange-traded products
have also provided data regarding the correlation between certain
bitcoin spot markets and the CME bitcoin futures market.\27\ What are
commenters' views on the correlation between the bitcoin spot market
and the CME bitcoin futures market? What are commenters' views on the
extent to which that correlation provides evidence that the CME bitcoin
futures market is ``significant'' related to spot bitcoin?
---------------------------------------------------------------------------

    \27\ See, e.g., Notice of Filing of Amendment No. 3 to, and
Order Instituting Proceedings to Determine Whether to Approve or
Disapprove, a Proposed Rule Change to List and Trade Shares of the
ARK 21Shares Bitcoin ETF under BZX Rule 14.11(e)(4), Commodity-Based
Trust Shares, Securities Exchange Act Release No. 98112 (Aug. 11,
2023), 88 FR 55743 (Aug. 16, 2023) (including data from sponsor
21Shares US LLC that purports to show correlations of returns across
the two-year period from January 20, 2021, to February 1, 2023, of
no less than 92% among certain spot bitcoin platforms and between
the CME bitcoin futures market and such spot bitcoin platforms on an
hourly basis, and no less than 78% on a minutely basis).
---------------------------------------------------------------------------

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, and
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\28\
---------------------------------------------------------------------------

    \28\ Section 19(b)(2) of the Act, as amended by the Securities
Acts Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Acts Amendments of 1975, Senate Comm.
on Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change should be approved
or disapproved by October 25, 2023. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
November 8, 2023.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-CboeBZX-2023-042 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-CboeBZX-2023-042. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://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 website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-CboeBZX-2023-042 and should
be submitted on or before October 25, 2023. Rebuttal comments should be
submitted by November 8, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\29\
---------------------------------------------------------------------------

    \29\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21954 Filed 10-3-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Proposed Rules]
[Pages 36493-36495]
[FR Doc No: 2015-15505]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1985; Directorate Identifier 2014-NM-214-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model DHC-8-102, -103, -106, -201, -202, -301,
-311, and -315 airplanes. This proposed AD was prompted by reports of
un-annunciated failures of the direct current (DC) starter generator,
which caused caution indicators of the affected systems to illuminate
and prompted emergency descents and landings. This proposed AD would
require, for certain airplanes, replacing the DC generator control
units (GCUs) with new GCUs and replacing the GCU label. We are
proposing this AD to prevent a low voltage condition on the left main
DC bus which, during critical phases of flight, could result in the
loss of flight management, navigation, and transponder systems, and
could affect continued safe flight.

DATES: We must receive comments on this proposed AD by August 10, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1985; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Services Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-1985;
Directorate Identifier 2014-NM-214-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-31R2, dated November 11, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-
102, -103, -106, -201, -202, -301, -311, and -315 airplanes. The MCAI
states:

    Four occurrences of un-annunciated failure of the No. 1 Direct
Current (DC) Starter Generator prompted emergency descents and
landings resulting from the illumination of numerous caution
indications of the affected systems. The functionality of the
affected systems such as Flight Management System, Navigation, and
transponder systems, were reportedly reduced or lost. Investigation
determined the failure was a result of a low voltage condition of
the Left Main DC Bus. During critical phases of flight, the loss of
these systems could affect continued safe flight.
    The original issue of this [Canadian] AD mandated the
modification [replacing certain DC GCUs with new GCUs and replacing
labels] which introduces generator control unit (GCU) undervoltage
protection.
    Revision 1 of this [Canadian] AD added a GCU part number to the
applicability of Part III of this [Canadian] AD, in order to ensure
that all units are fitted with a warning label.
    Revision 2 of this [Canadian] AD corrects the GCU part number in
the applicability of Part III of this [Canadian] AD.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1985.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service bulletins.
     Service Bulletin 8-24-84, Revision D, dated April 10,
2014. This service information describes incorporating Bombardier
modification summary (ModSum) 8Q101710 by replacing the

GCU with a new GCU, and replacing the GCU label for airplanes having
certain Phoenix DC power GCU part numbers.
     Service Bulletin 8-24-89, Revision C, dated November 4,
2014. This service information describes incorporating Bombardier
ModSum 8Q101925 by replacing the GCU with a new GCU, and replacing the
GCU label for airplanes having certain Goodrich DC power GCU part
numbers.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
NPRM.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 92 airplanes of U.S.
registry.
    We also estimate that it would take about 3 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost up to
$12,098 per product. Based on these figures, we estimate the cost of
this proposed AD on U.S. operators to be up to $1,136,476, or up to
$12,353 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2015-1985; Directorate Identifier
2014-NM-214-AD.

(a) Comments Due Date

    We must receive comments by August 10, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-102, -103, -106,
-201, -202, -301, -311, and -315 airplanes, certificated in any
category, serial numbers 003 through 672 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
Power.

(e) Reason

    This AD was prompted by reports of un-annunciated failures of
direct current (DC) starter generator, which caused caution
indicators of the affected systems to illuminate and prompted
emergency descents and landings. We are issuing this AD to prevent a
low voltage condition on the left main DC bus which, during critical
phases of flight, could result in the loss of flight management,
navigation, and transponder systems, and could affect continued safe
flight.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) For Airplanes Having Certain Generation Control Units (GCUs)
Installed: Replacement of DC GCUs and GCU labels

    Within 6,000 flight hours or 36 months after the effective date
of this AD, whichever occurs first, accomplish the actions specified
in paragraphs (g)(1) and (g)(2) of this AD as applicable.
    (1) For airplanes having Goodrich DC GCU part number 51539-008B,
51539-008C, or 51539-008D installed: Incorporate Bombardier ModSum
8Q101925 by replacing the GCU with a new GCU, and replacing the GCU
label, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 8-24-89, Revision C, dated November 4,
2014.
    (2) For airplanes having Phoenix DC GCU part number GC-1010-24-
5DIII or GC-1010-24-5DII installed: Incorporate Bombardier ModSum
8Q101710 by replacing the GCU with a new GCU, and replacing the GCU
label, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 8-24-84, Revision D, dated April 10,
2014.

(h) For Airplanes Having Certain Other GCUs Installed: Replacement of
DC GCU Label

    For airplanes having Phoenix DC GCU part number GC-1010-24-5DIV
or GC-1010-24-5DV installed: Within 6,000 flight hours or 36 months
after the effective date of this AD, whichever occurs first, replace
the DC GCU label with a new GCU label, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 8-24-84,
Revision D, dated April 10, 2014.

(i) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraph (g)(1) of this AD, if those actions were performed before
the effective date of this AD using the service information
specified in paragraphs (i)(1)(i) through (i)(1)(iii) of this AD, as
applicable. This service information is not incorporated by
reference in this AD.
    (i) Bombardier Service Bulletin 8-24-89, dated November 12,
2011.
    (ii) Bombardier Service Bulletin 8-24-89, Revision A, dated
August 8, 2012.

    (iii) Bombardier Service Bulletin 8-24-89, Revision B, dated
April 9, 2014.
    (2) This paragraph provides credit for actions required by
paragraphs (g)(2) and (h) of this AD, if those actions were
performed before the effective date of this AD using the service
information specified in paragraphs (i)(2)(i) through (i)(2)(iv) of
this AD, as applicable. This service information is not incorporated
by reference in this AD.
    (i) Bombardier Service Bulletin 8-24-84, dated August 22, 2008.
    (ii) Bombardier Service Bulletin 8-24-84, Revision A, dated
August 23, 2008.
    (iii) Bombardier Service Bulletin 8-24-84, Revision B, dated
October 15, 2008.
    (iv) Bombardier Service Bulletin 8-24-84, Revision C, dated July
7, 2009.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO, ANE-170, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the ACO, send it to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2014-31R2, dated November
14, 2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-1985.
    (2) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may view this service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 17, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-15505 Filed 6-24-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Page 20314]
[FR Doc No: 2013-07824]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR13-41-001]

Enogex LLC; Notice of Filing

    Take notice that on March 28, 2013, Enogex LLC filed to revise its
Statement of Operating Conditions that was originally submitted with
Enogex's March 1, 2013 annual revised fuel percentages filing in Docket
No. PR13-41-000 to correct metadata issues, as more fully described in
the filing
    Any person desiring to participate in this rate filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on Friday, April 5, 2013.

    Dated: March 29, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-07824 Filed 4-3-13; 8:45 am]
BILLING CODE 6717-01-P