[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56845-56852]
[FR Doc No: 2018-24785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1779]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Disclosures of
Descriptive Presentations in Professional Oncology Prescription Drug
Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
December 14, 2018.

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 protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Disclosures of Descriptive Presentations in Professional
Oncology Prescription Drug Promotion.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, 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.

Disclosures of Descriptive Presentations in Professional Oncology
Prescription Drug Promotion

OMB Control Number--0910-NEW

I. Background

    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 (FD&C Act) (21 U.S.C. 393(d)(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.
    Under the FD&C Act and implementing regulations, promotional
labeling and advertising about prescription drugs are generally
required to be truthful, non-misleading, and to reveal facts material
to the presentations made about the product being promoted (see
sections 502(a) and (n), and 201(n) of the FD&C Act (21 U.S.C. 352(a)
and (n), and 321(n)); see also 21 CFR 202.1). As a part of the ongoing
evaluation of FDA's regulations in this area, FDA is proposing to study
the impact of disclosures as they relate to presentations of
preliminary and/or descriptive scientific and clinical data in
promotional labeling and advertising for oncology products. The use of
disclosures is one method of communicating information to healthcare
professionals about scientific and clinical data, the limitations of
that data, and practical utility of that information for use in
treatment. These disclosures may influence prescriber comprehension and
decision making and may affect how and what treatment they prescribe
for their patients.
    Pharmaceutical companies market directly to physicians through
means that include publishing advertisements in medical journals,
exhibit booths at physician meetings or events, sending unsolicited
promotional materials to doctors' offices, and presentations
(``detailing'') by pharmaceutical representatives (Ref. 1). Research
suggests that detail aids sometimes contain carefully extracted data
from clinical studies that, taken out of context, can exaggerate the
benefits of a drug (Ref. 2) or contribute to physicians prescribing the
drug for an inappropriate patient population.
    Promotional labeling and advertising for cancer drugs deserve
specific attention. Oncology drugs represented 26 percent of the 649
compounds under clinical trial investigation from 2006 to 2011 (Ref.
3). The past decade has seen a dramatic rise in the number of oncology
drugs brought to market. In the past 18 months, over 22 percent of new
drug approvals at FDA were new cancer drugs. In that time period, FDA
approved 16 cancer drugs as new molecular entities or new therapeutic
biologics out of a total of 72 (this does not include approvals of
benign hematology products or biological license application approvals
of blood reagents, or assays and anti-globulin products used in testing
kits) (Refs. 4 and 5). Although overall survival remains the gold
standard for demonstrating clinical benefit of a cancer drug, several
additional endpoints including progression free survival, disease-free
or recurrence-free survival, or durable response rate (including
hematologic response endpoints) are accepted for either regular or
accelerated approval depending on the magnitude of effect, safety
profile, and disease context (Ref. 6). In addition to the endpoints
upon which FDA approval of these products may be based, pharmaceutical
companies typically assess many other endpoints to further explore the
effects of their products. Some trials are designed to allow for formal
statistical analyses of these additional endpoints; however, in many
cases these endpoints are strictly exploratory and support only the
reporting of descriptive results. For clinicians who are not
specifically trained in clinical trial design, interpreting these
endpoints may be challenging. Pharmaceutical companies invest heavily
in the development and distribution of promotional materials to make
oncologists aware of favorable clinical trial results.
    When communicating scientific and clinical data, a specific
statement that modifies or qualifies a claim (referred to for the
purposes of this document as a disclosure) could be used to convey the
limitations of the data and practical utility of the information for
treatment. Much of the prior research on disclosures in this topic area
has been limited to the dietary supplement arena with consumers (Refs.
7 to 10). Disclosures in professional pieces could influence prescriber
comprehension as well as subsequent decision making; however, no
published data exist regarding how prescribers use and understand
scientific claims in conjunction with qualifying disclosures.
    The proposed study seeks to address the following research
questions:
    1. Do disclosures mitigate potentially misleading presentations of
preliminary and/or descriptive data in oncology drug product promotion?
    2. Does the language (technical, non-technical) of the disclosure
influence the effectiveness of the disclosure?
    3. Does the presence of a general statement about the clinical
utility of the data in addition to a specific disclosure influence
processing of claims and disclosures?
    4. Do primary care physicians (PCPs) and oncologists differ in
their processing of claims and disclosures about preliminary and/or
descriptive data?
    5. Which disclosures do physicians prefer?
    To address these questions, FDA has designed a study that will be
conducted in three independent phases, each phase examining a data
display in a promotional piece for a unique oncology or hematology
product. Independent variables will include: (1) Specific disclosure
(technical, non-technical, none), (2) general statement (present,
absent), and (3) specialty (PCPs, oncologists). Each phase will have
the following design:

----------------------------------------------------------------------------------------------------------------
                                                                         Specific disclosure
             Sample               General statement ------------------------------------------------------------
                                                         Technical       Non-technical        No disclosure
----------------------------------------------------------------------------------------------------------------
Oncologists....................  Present...........                      Control.
                                 Absent............                      .......................
PCPs...........................  Present...........                      Control.
                                 Absent............                      .......................
----------------------------------------------------------------------------------------------------------------

    Specific disclosures will include material information specifically
related to the particular data display in question. As such, each
specific disclosure may include clinical or statistical information
related to the trial design, the statistical analysis plan of the
trial, or any other material statistical or clinical information
necessary for evaluation or interpretation of the data. The team
developing the disclosures includes social science analysts,
pharmacists, oncological medical officers, statisticians, and an
oncology nurse. An example of the general statement is ``This
presentation includes exploratory information of uncertain clinical
utility and should be interpreted cautiously when used to make
treatment decisions.''

    Outcome (dependent) variables will focus on the assessment of the
data display as a whole as well as attention to the disclosure, if
present. Specifically, we will examine recognition of the clinical
endpoint in the data display, comprehension of the data display,
perceptions of the strength of the data, and the perceived credibility
of the promotional piece. We will also look at attention to the
specific disclosure and the general statement, prescriber decisions,
and prescriber preferences. Preferences will be determined by a
secondary task at the end of the questionnaire that shows each
participant all disclosure options and asks them to choose their
preferred version.
    Oncologists and PCPs will be recruited to participate via the
internet. We plan to conduct one pretest with 90 participants and one
study with 2,115 participants, both of which are expected to take
approximately 20 minutes. Voluntary participants will view
professionally developed promotional pieces that mimic currently
available promotion and answer questions.
    In the Federal Register of Monday, June 19, 2017 (82 FR 27845), FDA
published a 60-day notice requesting public comment on the proposed
collection of information (see above). Comments received along with our
responses to the comments are provided below. Comments that are not
PRA-relevant or do not relate to the proposed study are not included.
For brevity, some 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. The following acronyms are used here: FRN
= Federal Register Notice; DTC = direct-to-consumer; HCP = healthcare
professional; PCP = primary care physicians; FDA = Food and Drug
Administration; OPDP = FDA's Office of Prescription Drug Promotion.
    The first public comment responder (regulations.gov tracking number
1k1-8xz7-mwcd) included eight individual comments, to which we have
responded.
    Comment 1: ``It is unclear why FDA has chosen to conduct a study
focused on oncology therapeutics and those medical specialists who
prescribe such products.'' [verbatim] All prescription drug products
are treated the same according to regulations; therapeutic intent and
prescriber type do not invoke alternate regulatory approaches.
    Response: As we described in the 60-day Federal Register notice,
promotional activities for oncology drugs are frequent and pervasive.
Promotional labeling and advertising for cancer drugs deserve specific
attention. Oncology drugs represented 26 percent of the 649 compounds
under clinical-trial investigation from 2006 to 2011 (Ref. 3). The past
decade has seen a dramatic rise in the number of oncology drugs brought
to market. In the past 18 months, over 22 percent of new drug approvals
at FDA were new cancer drugs. In that time period, FDA approved 16
cancer drugs as new molecular entities or new therapeutic biologics out
of a total of 72 (this does not include approvals of benign hematology
products or biological license application approvals of blood reagents,
or assays and anti-globulin products used in testing kits) (Refs. 4 and
5). Although overall survival remains the gold standard for
demonstrating clinical benefit of a cancer drug, several additional
endpoints including progression free survival, disease-free or
recurrence-free survival, or response rate (including hematologic
response endpoints) are accepted for either regular or accelerated
approval depending on the magnitude of effect, safety profile, and
disease context (Ref. 6). In addition to the endpoints upon which FDA
approval may be based, pharmaceutical companies typically assess many
other endpoints to further explore the effects of their products. Some
trials are designed to allow for formal statistical analyses of these
additional endpoints; however, in many cases these endpoints are
strictly exploratory and support only the reporting of descriptive
results. For clinicians who are not specifically trained in clinical
trial design, interpreting these endpoints can be challenging.
Pharmaceutical companies invest heavily in the development and
distribution of promotional materials to educate oncologists about
favorable clinical trial results.
    As another public comment responder (regulations.gov tracking
number 1k1-8y3p-o6qb) notes, ``We agree with the FDA's assessment that
dedicated research is necessary regarding oncology drug promotion,
particularly given that a significant proportion of the drug
development pipeline is comprised of oncology products . . .''
    Comment 2: FDA should use a more targeted approach, including a
monadic design with 100 oncologists split into two experimental
conditions.
    Response: To clarify the study design, we are testing two
variations of disclosure (specific disclosure: Technical, non-
technical), two variations of general statement (general statement:
Present or absent), plus a control (control: No specific disclosure).
Participants will be healthcare professionals who are members of one of
two medical populations and will be randomly assigned to one condition.
Because we are examining the effects of multiple variables and their
interactions, the necessary sample sizes will be larger than those
suggested in this comment based on power analyses. We have, however,
changed the study design based on multiple comments and will now
examine only oncologists and primary care physicians.
    Comment 3: The length of the survey looks long--at 17 pages, it
appears that it will take approximately 30-40 minutes to complete.
    Response: We have tested the survey in-house with individuals
unfamiliar with the research project, and it appears that this survey
will take approximately 15 minutes to complete.
    Comment 4: Instead of using recall as a measure, respondents should
be allowed to have access to the materials while answering questions to
better approximate their actual experiences.
    Response: It is an open question as to whether having the materials
in front of them better approximates actual HCP experiences. In past
discussions with HCPs, some have reported that they do refer back to
materials that sales representatives leave, and others report that they
do not receive leave-behind materials or do not refer to them again. In
any case, we have a mixture of recall and comprehension questions in
our questionnaire. For the recall questions, respondents will not be
able to access the materials. They will, however, be able to review the
materials while answering the comprehension questions.
    Comment 5: Why is FDA examining non-oncologists at all? Why are you
screening out oncology for specialists in question SPECIALTY2?
    Response: HCPs of all types are exposed to prescription drug
promotion. Depending on location (e.g., rural areas) and type of
clinical setting, some non-oncologists may have a need to consider
oncologic prescription drugs to treat their patients. We agree that
oncologists are the most relevant population to study in this research.
However, we also want to know whether specific education and experience
influence the processing of claims, data, and disclosures. Upon further
review, we agree that nurse practitioners and physician assistants
without oncology experience are not a necessary group to investigate to
answer our particular research questions. We intend to use PCPs as a
control group to understand whether specific advanced training

influences the understanding of preliminary and/or descriptive oncology
data. Some PCPs may have experience with oncology prescriptions,
particularly in rural areas. We will not eliminate PCPs without
oncology experience, but we will measure oncology prescribing
experience and use this variable as a covariate in our studies.
    Comment 6: FDA should screen for the prescribing of oncologic
products.
    Response: Although we do not intend to screen out physicians
without oncology prescribing experience, we will measure this variable
and use this information to determine whether it plays a role in the
responses of PCPs.
    Comment 7: From this point (ENDPOINT) responses may be based on the
ability of respondents to recall information vs. the absence/presence
of disclosures. If FDA continues with this design, the Agency should be
prepared to control for this in the study design.
    Response: Because this is an experimental design with random
assignment to condition, any fatigue with questions that may affect the
recall of information should fall out evenly across conditions.
Therefore, any differences would be the result of our manipulations, in
this case, the presence and form of disclosures. We have given thought
to the ordering of the questions so that the most important questions
are asked in the beginning of the survey rather than toward the end.
    Comment 8: The answer to this question (CAUTIOUS) may be influenced
more by personal and subjective opinion vs. the content of the
disclosure.
    Response: Because of the experimental design with random assignment
to condition, personal and subjective opinions should be evenly and
randomly spread across experimental conditions. However, upon further
review, we have determined that this question has limited utility and
we will delete it.
    The second public comment responder (regulations.gov tracking
number 1k1-8y3p-o6qb) included one individual comment. They reported
that they support the study specifically and OPDP's overall research
efforts generally, and they agree that oncology deserves special
attention. We thank this commenter for taking the time to provide this
comment to us.
    The third public comment responder (regulations.gov tracking number
1k1-8y5u-5vp0) included eight individual comments, to which we have
responded.
    Comments 1 and 2: The commenter supports FDA social science
research and this specific project, as well as the Disclosures study
(Docket No. FDA-2017-N-0558). ``FDA's collective research indicates a
considered, objective updating of the FDA's advertising regulations,
including the use of disclosures to prevent misleading claims in
advertisements for oncology products, is timely . . . . Enabling
disclaimers would be one way to enable innovators to advertise new
oncology therapeutics for their approved uses in ways which would be
non-misleading.''
    Response: Thank you for your support.
    Comment 3: The commenter suggests making sure that primary care
physicians and advanced practitioners have experience in the oncology
field--otherwise, it seems useless to include less knowledgeable
respondents whose answers are more speculative. Overall, they question
whether advanced practitioners are appropriate for this study at all.
    Response: We have removed advanced practitioners from the design.
We will measure the oncology prescribing experience of the PCPs in our
sample, but we will not eliminate those who do not have specific
oncology training. One of our research questions is whether specific
training and experience in oncology influences the understanding of
preliminary oncology data. To do that, we need to include a group of
practitioners who may not have specific training and experience in
oncology, but who are licensed practitioners permitted by law to
prescribe oncology drugs, and who, in some cases, may do so.
    Comment 4: If the only data being presented for BENEFICIAL,
EVIDENCE1 and EVIDENCE2 are the endpoints for the disclosure without
presenting overall survival or more clinically validated data, we
suggest removing these questions.
    Response: The pieces include other clinically validated data as
would be typical in an existing piece for an oncology indication.
    Comment 5: Remove CONFUSING2 because it asks physicians to
speculate.
    Response: As this item is a perception measure, as opposed to an
accuracy measure, it is reasonable to consider some level of
speculation. Moreover, in cognitive testing, HCPs responded without
difficulty.
    Comment 6: For SCRIPT4, add an ``I don't know'' option instead of
instructing respondents to ``make your best guess.''
    Response: This item was cognitively tested and participants
expressed no difficulty answering it.
    Comment 7: Those who respond ``not at all familiar'' to FAMILIAR
should skip BTKNOW1, BTKNOW2, and ACCEL.
    Response: We agree with this comment. Those who respond ``not at
all familiar'' to FAMILIAR will skip the three items mentioned above.
    Comment 8: BTDV1 and BTDV2 present incomplete data and therefore it
is unclear how this will be a useful question. The commenter suggests
either adding an ``I need more information'' option or removing the
question.
    Response: These items present incomplete data but we have provided
enough data that HCPs should be able to make a choice. HCPs in
cognitive testing exhibited no difficulty with the question. There is
no existing data on perceptions of FDA's ``breakthrough'' designation
and this item will provide at least rudimentary information. Please
note that each respondent will see only one of the items. These items
are carefully crafted to avoid order effects and alphabetical effects.
    The fourth public commenter (regulations.gov tracking number 1k1-
8y5u-koc0) included 15 individual comments, to which we have responded.
    Comment 1 (summarized): The commenter is concerned with the
Agency's recent approaches to studies in this area. FDA has proposed to
undertake projects in a variety of disparate topics without
articulating a clear, overarching research agenda or adequate
rationales on how the proposed research related to the goal of further
protecting public health. Within the last year, the Agency has
increased such efforts at an exponential pace. At times, FDA proposes
new studies seemingly without fully appreciating its own previous
research published on the Office of Prescription Drug Promotion (OPDP)
website. Proposed studies are often unnecessary in light of existing
data. The commenter suggests that the Agency publish a comprehensive
list of its prescription drug advertising and promotion studies from
the past five years and articulate a clear vision for its research
priorities for the near future. Going forward, FDA should use such
priorities to explain the necessity and utility of its proposed
research and should provide a reasonable rationale for the proposed
research.
    Response: OPDP's mission is to protect the public health by helping
to ensure that prescription drug information is truthful, balanced, and
accurately communicated, so that patients and healthcare providers can
make informed decisions about

treatment options. OPDP's research program supports this mission by
providing scientific evidence to help ensure that our policies related
to prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that we believe are
most central to our mission, focusing in particular on three main topic
areas: Advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits; focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience; and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues. Because we recognize the
strength of data and the confidence in the robust nature of the
findings is improved through the results of multiple converging
studies, we continue to develop evidence to inform our thinking. We
evaluate the results from our studies within the broader context of
research and findings from other sources, and this larger body of
knowledge collectively informs our policies as well as our research
program. Our research is documented on our homepage, which can be found
at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey of DTC attitudes
and behaviors conducted in 1999.
    Comment 2: FDA should provide more detail about the study to
stakeholders. ``It is not clear from this description whether the study
will yield useful information to evaluate whether disclosures provide
appropriate contextual information in certain communications, whether
such disclosures can be made more effective, and where the disclosures
are necessary to ensure communications are truthful and non-
misleading.''
    Response: We have described the purpose of the study, the design,
the population of interest, and have provided the questionnaire to
numerous individuals upon request. These materials have proven
sufficient for others to comment publicly, and for academic experts to
peer-review the study successfully. Our full stimuli are under
development during the PRA process. We do not make draft stimuli public
during this time because of concerns that this may contaminate our
participant pool and compromise the research.
    Comment 3: The Agency should wait until it has completed its
broader study on disclosures more generally. This study is duplicative
of other studies.
    Response: As we discussed in the 60-day Federal Register notice,
oncological products deserve specific attention as they account for
nearly a quarter of new drug approvals and can involve the assessment
of complicated endpoints. Moreover, they have specific disclosures that
are unique to their products and deserve particular study. The other
disclosures study (Docket No. FDA-2017-N-0558) will provide important
information about a variety of disclosures in different medical
conditions. One research study cannot answer all questions or study all
aspects of an issue. These two studies will be complementary but not
redundant. Please also refer to our response to comment 1 from the
first commenter above.
    Comment 4: Given that FDA grants approval based on certain
preliminary and descriptive data, and that various limitations as to
the underlying data must already be communicated to prescribers, there
appears to be limited utility in researching disclosures regarding such
data.
    Response: We disagree that FDA grants approval on preliminary or
descriptive data. The evidentiary standard is substantial evidence.
While we recognize that no single development program can answer all
questions about a particular drug in all populations, it is not
accurate to describe the evidence supporting approval as descriptive or
preliminary. What is potentially unique about oncology products is that
many are approved under accelerated approval, in which the substantial
evidence of benefit is on a surrogate endpoint that is reasonably
likely to predict a clinical outcome. There remains some residual
uncertainty regarding whether the effect on a surrogate endpoint will
directly correlate with a clinical benefit; however, there is a
requirement that confirmatory evidence of clinical benefit be obtained
after approval. This residual uncertainty about the relationship of the
surrogate endpoint to the clinical benefit is communicated to
prescribers through the FDA-required labeling (e.g., inclusion of a
limitation of use in the Indications and Usage section of the FDA-
required labeling). In addition, reliance on a surrogate endpoint under
accelerated approval is only done for serious diseases when the
evidence indicates that the product provides a meaningful therapeutic
benefit to patients over existing treatments (21 CFR 314.500).
    However, this study does not focus on endpoints that formed the
basis for approval. This study focuses on promotional displays of
preliminary and/or descriptive data. It has not been established
whether and how current disclosure-type additions to promotion are
adequately communicating the limitations around this type of data, and
that is the purpose of the current study. Given the importance of these
limitations, it is crucial to make sure that promotional materials
directed at to prescribers convey limitations appropriately. Past
research has shown that simply including a statement somewhere in a
promotional piece does not grant it automatic usefulness (Refs. 7 to
10).
    Comment 5: FDA notes that, ``[a]lthough overall survival remains
the gold standard for demonstrating clinical benefit of a drug, several
additional endpoints are accepted as surrogates . . . [including]
disease-free survival, objective response rate, complete response rate,
progression-free survival, and time to progression.'' The Agency
further states that ``[f]or clinicians who are not specifically trained
in clinical trial design, interpreting these endpoints may be
challenging.'' FDA does not cite any sources for this claim, and there
is no basis for thinking that clinicians do not have a thorough
understanding of the data limitations described in presentations of
preliminary or descriptive scientific and clinical data. This is
especially true of oncologists.
    Response: This statement was not intended to be a claim, but rather
a statement of concern. Studies report that physicians lack sufficient
critical knowledge and skills to evaluate evidence based medicine (EBM)
and may be influenced by the way study results are presented (Refs. 11
to 13). FDA recently conducted a systematic review of research related
to prescribers' training and critical appraisal skills related to
clinical trials (Ref. 14). The study found that extant physician
knowledge and skills regarding certain statistical concepts and trial
designs were in the middle of the possible outcome score range, at
levels below those considered mastery, even after

interventions designed to increase knowledge and skills. Evidence
suggested that clinical credentials affect understanding and use of
clinical data. Physicians with formal training in biostatistics,
epidemiology, clinical research, or EBM demonstrated higher levels of
knowledge and appraisal skills than those with usual medical education
and training.
    Comment 6: The specific disclosures outlined by FDA include
``clinical or statistical information related to the trial design, the
statistical analysis plan of the trial, or any other material
statistical or clinical information necessary for evaluation or
interpretation of the data.'' The breadth of the proposed specific
disclosures appears burdensome, unnecessary, and overwhelming for the
purposes of the proposed survey.
    Response: These concepts were provided as examples of the types of
information that may be necessary for the accurate evaluation or
interpretation of the data. This statement was not meant to imply that
all of these concepts would be included in disclosures used in this
study.
    Comment 7: PCPs and non-oncology mid-level practitioners will
provide much less utility in their survey responses regarding such
disclosures.
    Response: We have changed the design. See previous comments and
responses.
    Comment 8: The Agency proposes to conduct its survey via electronic
media. FDA should consider testing non-electronic media, including
printed sales aids, as these forms are often reviewed by the proposed
study subjects.
    Response: To clarify, the stimuli presented will consist of mock
print materials in .pdf format, administered via the internet.
Conducting the study in person would require a greater expenditure of
resources without appreciable benefits.
    Comment 9: The Agency should consider using a consistent sliding
scale format for all survey responses. Just within pages 7-9 of the
survey, FDA proposes numerous different schemes for survey responses:
(1) ``Not at all beneficial--Extremely beneficial;'' (2) ``Completely
agree--Completely disagree;'' (3) ``No evidence--Strong (or conclusive)
evidence;'' (4) ``Not at all complex--Extremely complex;'' (5) ``Not at
all confusing--Extremely confusing;'' and (6) additional responses in
which subjects are asked to agree with certain statements. The variety
in response options is confusing in format and could potentially
introduce error. To the extent possible, FDA should make the response
format consistent throughout the survey. Further, the Agency should
ensure the sliding scale format consistently provides an odd number of
responses to permit a ``neutral'' response. Certain questions (e.g.,
the IMPROVE question on page 7) provide six choices, not permitting a
neutral response.
    Response: Although one scale throughout would be easier for
respondents, it will not necessarily provide better data. When a series
of adjacent questions have the same response options, respondents may
use a response mechanism known as anchoring and adjusting when
reporting (Ref. 15). Respondents use their response to the initial
survey question on a topic as the ``cognitive anchor,'' and then adjust
up or down based on subsequent questions (Ref. 16). Anchoring and
adjusting is more likely to occur for questions when respondents have
some level of uncertainty in their answer (Ref. 17), which would be
expected in this study. Epley and Gilovich (Ref. 17) found that when
respondents use an anchoring and adjusting strategy, they often adjust
insufficiently. Respondents start with the response they used for the
first item and then search for the next value that is ``close enough.''
This can result in responses to adjacent items being more similar than
responses to the same items if they used an item-specific scale (Not at
all beneficial to Extremely beneficial; Not at all complex to Extremely
complex). Using the same scale across all survey questions would
artificially increase the correlations between all questions making it
more difficult to identify differences based on the stimuli or
respondent characteristics. Furthermore, use of item-specific scales
compared with agree-disagree scales reduces primacy effects (tendency
of respondents to select options at the beginning of the list) (Ref.
18), and increases reliability and validity (Ref. 19). Careful
consideration was made to use agree-disagree scales only when item-
specific scales would not be appropriate (e.g., presenting patient
vignettes) or unnecessarily complex (e.g., asking about ``complex
terminology, statistical terms, or jargon,'' inquiring about ``strong''
evidence).
    In terms of neutral points, given the focus of the questions, we
believe that offering a neutral response option is not necessary to
measure opinions and attitudes accurately. Consequently, our objective
is to force a selection and have participants make at least a weak
commitment in either a positive or negative direction. Of concern is
that offering a neutral midpoint could potentially encourage
``satisficing''--cuing participants to choose a neutral response
because it is offered (Ref. 20). Additionally, providing a midpoint
leads to the loss of information regarding the direction in which
people lean (Ref. 21). Research has found that neither format (either
with or without a neutral point) is necessarily better or produces more
valid or reliable results (Ref. 22). Instead, it should be left to the
researcher to determine the goals of the study. During cognitive
testing, a majority of participants were satisfied with the response
options and all participants felt comfortable choosing a response in
the absence of a midpoint.
    Use of a midpoint is an issue we have examined in previous studies
and we determined that we achieve valid and reliable responses without
a midpoint. To increase consistency with measures used in previous
studies, and in support of the arguments presented above, we are opting
to exclude a midpoint. Finally, if a participant does not feel that
they can choose a response because of a lack of a neutral option, they
will be able to skip the question.
    Comment 10: In the BENEFICIAL question on page 7 of the survey, it
is unclear what relevance the subject's perception of clinical benefit
of a drug has in studying FDA's proposed research purpose.
    Response: For prescription drug products, advertisers must ensure
that both the benefits and limitations are appropriately conveyed. If
limitations are not appropriately conveyed, viewers may have an
inflated view of the benefits of the product, relative to its risks.
This question investigates this issue.
    Comment 11: In a study setting, subjects may be prone to read and
pay attention to more or all of the information presented. Subjects
also are more aware of the importance of their responses. The Agency
should address what efforts it will take to avoid response bias by
study subjects.
    Response: We initially had this concern many years ago when OPDP
began conducting research. However, since that time, we have seen no
evidence of this bias. In fact, we often deal with the opposite
problem--ensuring that respondents spend a minimum amount of time
looking at mock materials. Moreover, cognitive testing participants
have told us that they would not spend extra time on materials if they
were answering questions without an interviewer in the room.
Individuals, especially HCPs, are busy, and we believe our experiments
do not overestimate the amount of time participants spend on actual
materials.

    Comment 12: Although the draft survey did not contain Informed
Consent text, the Agency should ensure that this text does not state or
imply that the survey is being conducted on behalf of the U.S. Food and
Drug Administration. Such a statement could potentially influence
subjects' responses to study questions. Instead, this information might
be provided at the conclusion of the study.
    Response: We will ensure that all materials reference the U.S.
Department of Health and Human Services rather than FDA.
    Comment 13: The CAUTIOUS question on page 8 should be rephrased or
omitted. Subjects may be biased to respond that they interpret all data
with caution, regardless of the underlying scientific evidence
presented in study stimuli.
    Response: We agree with this comment and will delete this item.
    Comment 14: The DECISIONS question on page 8 should be omitted. How
survey participants ``feel about the data presented'' will be highly
dependent on their external experience in making prescribing decisions.
This question thus may lead to highly variable results.
    Response: Because this is an experimental design with random
assignment to conditions, external experiences in making prescribing
decisions should be randomly scattered across experimental conditions.
Thus, we will be able to infer causation to our manipulations of
disclosures if we find any differences across experimental conditions.
We believe the presence and form of the disclosure may influence this
dependent variable and believe it will reveal important information
about how HCPs process the data.
    Comment 15: The PREFERENCE and PREFERWHY questions on page 16
should be moved to the beginning of the survey or omitted altogether.
Subjects' responses regarding their preference in sales aid disclosure
statements will be heavily influenced by earlier portions of the
survey.
    Response: We have given careful thought to the ordering of the
questions in the questionnaire. Because preference is of secondary
interest to us, we have included it after our primary outcome
variables, so that it does not influence them. We recognize that prior
questions may influence these measures and will interpret them with
that caveat in mind.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of    responses  per   Total annual         Average burden per response \2\         Total hours
                                                respondents      respondent      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Study Screener Completes............             150               1             150  0.03 (2 minutes)..........................               5
Main Study Screener Completes...............           3,525               1           3,525  0.03 (2 minutes)..........................             106
Pretest Study...............................              90               1              90  0.33 (20 minutes).........................              30
Main Study..................................           2,115               1           2,115  0.33 (20 minutes).........................             698
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             839
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ No capital costs or operating and maintenance costs are associated with collection of this information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

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, 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. Johar, K., ``An Insider's Perspective: Defense of the
Pharmaceutical Industry's Marketing Practices,'' Albany Law Review,
76:299-334, 2012-2013.
*2. Wick, C., M. Egger, S. Trelle, et al., ``The Characteristics of
Unsolicited Clinical Oncology Literature Provided by Pharmaceutical
Industry,'' Annals of Oncology, 18(9):1580-1582, 2007.
* 3. Fisher, J.A., M.D. Cottingham, and C.A. Kalbaugh, ``Peering
Into the Pharmaceutical `Pipeline': Investigational Drugs, Clinical
Trials, and Industry Priorities,'' Social Science & Medicine,
131:322-330, 2015.
4. Centerwatch, ``FDA Approved Drugs for Oncology,'' https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology (accessed on October 5, 2018).
5. https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm596371.htm.
* 6. Beaver, J.A., L.J. Howie, L. Pelosof, et al., ``A 25-Year
Experience of U.S. Food and Drug Administration Accelerated Approval
of Malignant Hematology and Oncology Drugs and Biologics: A
Review,'' JAMA Oncology, 4:849-856, 2018.
* 7. Dodge, T. and A. Kaufman, ``What Makes Consumers Think Dietary
Supplements Are Safe and Effective? The Role of Disclaimers and FDA
Approval,'' Health Psychology, 26:513-517, 2007.
* 8. Dodge, T., D. Litt, and A. Kaufman, ``Influence of the Dietary
Supplement Health and Education Act on Consumer Beliefs About the
Safety and Effectiveness of Dietary Supplements,'' Journal of Health
Communication, 16(3):230-244, 2011.
* 9. Mason, M.J., D.L. Scammon, and X. Fang, ``The Impact of
Warnings, Disclaimers, and Product Experience on Consumers'
Perceptions of Dietary Supplements,'' The Journal of Consumer
Affairs, 41(1):74-99, 2007.
* 10. France, K.R. and P.F. Bone, ``Policy Makers' Paradigms and
Evidence From Consumer Interpretations of Dietary Supplement
Labels,'' The Journal of Consumer Affairs, 39(1):27-51, 2005.
* 11. Ghosh, A.K. and K. Ghosh, ``Translating Evidence-Based
Information into Effective Risk Communication: Current Challenges
and Opportunities,'' The Journal of Laboratory and Clinical
Medicine, 145(4):171-180, 2005.
* 12. Harewood, G.C. and L.M. Hendrick, ``Prospective, Controlled
Assessment of the Impact of Formal Evidence-Based Medicine Teaching
Workshop on Ability to Appraise the Medical Literature,'' Irish
Journal of Medical Science, 179(1):91-94, 2010.
* 13. Fritsche, L., T. Greenhalgh, Y. Falck-Ytter, et al., ``Do
Short Courses in Evidence Based Medicine Improve Knowledge and
Skills? Validation of Berlin Questionnaire and Before and After
Study of Courses in Evidence Based Medicine,'' British Medical
Journal, 325(7376):1338-1341, 2002.
* 14. Kahwati, L., D. Carmondy, N. Berkman,

et al., ``Prescribers' Knowledge and Skills for Interpreting
Research Results: A Systematic Review,'' Journal of Continuing
Education in the Health Professions, 37(2):129-136, 2017.
* 15. Tversky, A. and D. Kahneman,'' Judgment Under Uncertainty:
Heuristics and Biases,'' Science, 185(4157):1124-1131, 1974.
* 16. Gehlbach, H. and S. Barge, ``Anchoring and Adjusting in
Questionnaire Responses,'' Basic and Applied Social Psychology,
34(5):417-433, 2012.
* 17. Epley, N. and T. Gilovich, ``The Anchoring-and-Adjustment
Heuristic: Why the Adjustments are Insufficient,'' Psychological
Science, 17(4):311-318, 2006.
* 18. H[ouml]hne, J.K. and D. Krebs, ``Scale Direction Effects in
Agree/Disagree and Item-Specific Questions: A Comparison of Question
Formats,'' International Journal of Social Research Methodology,
21(1):91-103, 2017.
* 19. Saris, W.E., M. Revilla, J.A. Krosnick, et al., ``Comparing
Questions with Agree/Disagree Response Options to Questions with
Item-Specific Response Options'' Survey Research Methods, 4:61-79,
2010.
* 20. Krosnick, J.A. and S. Presser, ``Question and Questionnaire
Design,'' In: Handbook of Survey Research (pp. 263-314). Bingley,
United Kingdom: Emerald Group Publishing Limited, 2010.
21. Converse, J.M. and S. Presser, Survey Questions: Handcrafting
the Standardized Questionnaire, (No. 63). Thousand Oaks, CA: SAGE
Publications, 1986.
22. DeVellis, R.F., Scale Development: Theory and Applications,
(Vol. 26). Thousand Oaks, CA: SAGE Publications, 2016.

    Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24785 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P


Mr. George Fenwick, President

American Bird Conservancy

P. O. Box 249

4249 Loudoun Ave

The Plains, VA 20198-0249

Dear Mr. Fenwick:

I am writing to respond to your August 28, 2006 letter regarding
aldicarb and its risk to birds.  Your letter indicates that the Agency
has already required the registrant to submit additional avian
reproductive data.  In addition, your letter suggests that the Agency
should wait for this data before issuing a reregistration decision on
aldicarb.  Let me first clarify the status of the two studies that you
have inquired about and then address your second point.

The Agency has identified the need for two avian reproduction studies in
previously released ecological risk assessments for the N-methyl
carbamate pesticide, aldicarb.  These studies are 71-4(a) Avian
Reproduction – Quail, and 71-4(b) Avian Reproduction – Duck.  In
response to the identified data gaps, Bayer CropScience has commented
that these studies are unnecessary.  It is important to note that the
Agency has not issued a data call in (DCI) notice to Bayer CropScience
requesting these studies.  In other words, the Agency has not formally
requested or required these studies.  When the RED is issued, we may
indeed require these studies as part of the DCI; however, that decision
is yet to come, pending public comment.  Likewise, Bayer CropScience has
not refused to do these studies, but simply presented their argument on
why they feel they are not necessary.  As part of the reregistration
process, the registrant is allowed to comment, as well as other
interested parties, on why they think that additional studies are needed
or not needed, and in turn, the Agency must review these arguments and
will determine if they are valid.  In the case of aldicarb, these
studies have been identified as data gaps and the Agency has responded
to Bayer CropScience’s comments informing them we may  require these
studies, pending public comment.

In general, when the Agency issues a reregistration decision, the
registrants are sent a DCI after publication of the decision and then
are required to respond accordingly.  The Agency completes
reregistration decisions with the results from studies previously
required of the registrant(s) and will require additional data as
necessary to confirm its decision.  When the Agency receives and reviews
the confirmatory data, changes to the regulatory decision will be made,
if appropriate.

	In responding to your second point that the Agency should wait for the
avain reproduction studies before making a reregistration decision;
it’s important to note that, as mentioned above, these studies have
not previously been required of the registrants.  Given this, the
potential for mortality to birds is an area of initial focus.  Once the
risks and benefits are addressed for acute effects, the potential
chronic reproductive concerns, which are important, can be evaluated
based on the extent of remaining exposure potential that would be
associated with any label changes.

The Agency is currently in Phase 4 of the reregistration process for
aldicarb and will soon be seeking public comment on how to address risks
that aldicarb poses to birds, as well as the benefits of aldicarb use.
We look forward to receiving your input on risk mitigation options and
continuing to work with you in the future.

Sincerely,

/s/

Debra Edwards, Ph.D.

Director

Special Review and Reregistration Division

Dated November 13, 2006

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Page 33032]
[FR Doc No: 2014-13478]

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

SECURITIES AND EXCHANGE COMMISSION

In the Matter of WebXU, Inc., File No. 500-1; Order of Suspension
of Trading

June 5, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
WebXU, Inc. because of questions regarding the accuracy of publicly
available information about the company's finances.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT on
June 5, 2014, through 11:59 p.m. EDT on June 18, 2014.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-13478 Filed 6-5-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Page 27984]
[FR Doc No: 2018-12912]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2011-0928; FRL-9979-47-OAR]

Proposed Information Collection Request; Comment Request; Fuel
Use Requirements for Great Lake Steamships (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Fuel Use Requirements for Great
Lakes Steamships'' (EPA ICR No. 2458.03, OMB Control No. 2060-0679) to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through August 31, 2018. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before August 14, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2011-0928, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Alan Stout, Office of Transportation
and Air Quality, Environmental Protection Agency, 2565 Plymouth Road,
Ann Arbor, MI 48105;<PHONE_NUMBER>; [email protected].

SUPPLEMENTARY INFORMATION:
    Supporting documents explaining in detail the information that the
EPA will be collecting are available in the public docket for this ICR.
The docket can be viewed online at www.regulations.gov or in person at
the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The U.S. Environmental Protection Agency (EPA) adopted
requirements for marine vessels operating in and around U.S.
territorial waters to use reduced-sulfur diesel fuel. This requirement
does not apply for steamships, but it would apply for steamships that
are converted to run on diesel engines. A regulatory provision allows
vessel owners to qualify for a waiver from the fuel-use requirements
for a defined period for such converted vessels.
    One condition of the exemption from the fuel standard is that
engines meet current emission standards. EPA uses the data to oversee
compliance with regulatory requirements, including communicating with
affected companies and answering questions from the public or other
industry participants regarding the waiver in question. Since the IMO
Tier III NOX standards apply for Category 3 engines
installed on U.S. vessels, we don't expect anyone to use the steamship
exemption.
    Form Numbers: None.
    Respondents/affected entities: 0.
    Respondent's obligation to respond: Required to obtain a benefit
(40 CFR 1043.95).
    Estimated number of respondents: 0.
    Frequency of response: One time for a new notification.
    Total estimated burden: 0 hours (per year). Burden is defined at 5
CFR 1320.03(b).
    Total estimated cost: $0.
    Changes in Estimates: The burden estimate decreases from the
current estimate of 14 hours per year in the total estimated respondent
burden currently approved by OMB. Since the IMO Tier III NOX
standards apply for Category 3 engines installed on U.S. vessels, we
don't expect anyone to use the steamship exemption.

    Dated: June 4, 2018.
William J. Charmley,
Director, Assessment and Standards Division.
[FR Doc. 2018-12912 Filed 6-14-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 18, 2008 (Volume 73, Number 118)]
[Notices]
[Page 34809-34811]
[DOCID:fr18jn08-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57952; File No. SR-Amex-2008-44]

 Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Modifying the Provisions
Governing Contacts Between Specialists and Issuers

June 11, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 20, 2008, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Amex Rule 27 to (i) modify the
provisions governing contacts between specialists and issuers or, in
the case of exchange traded funds (``ETFs'') and structured products,
sponsors, and (ii) clarify other procedures applicable to the
allocation of securities to specialists.
    The text of the proposed rule change is available on the Amex's Web
site at http://www.amex.com, the Amex's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to revise Amex Rule 27
in order to better reflect the different treatment that is afforded
ETFs and structured products in connection with the allocation of
securities to specialists. This is reflected in the fact that ETFs and
structured products are typically allocated to a specialist within a
few days after approval of the issuer's application for listing on the
Exchange. However, in the case of other equity securities, the
allocation process may take a longer period of time so that allocation
to a specialist may not occur within a few days of approval of the
issuer's listing application.
    Amex Rule 27 sets forth the procedures and policies pursuant to
which the Allocations Committee allocates securities listing on the
Exchange to specialists. In particular, paragraph (e) describes the
Exchange's ``issuer choice'' program under which issuers or, in the
case of an ETF or structured product, sponsors, select their
specialists from a list of the most qualified specialists prepared by
the Allocations Committee and is designed to be read in conjunction
with Commentaries .02 and .03 thereto.
    Commentaries .02 and .03 contain guidelines for communications
between specialists and issuers or, in the case of ETFs and structured
products, sponsors that have not yet listed a security on the Exchange,
have applied to list a security on the Exchange and/or have a security
that has been approved for listing on the Exchange.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release Nos. 44972 (October 23,
2001), 66 FR 55031 (October 31, 2001) (SR-Amex-2001-19); and 45260
(January 9, 2002), 67 FR 2255 (January 16, 2002) (SR-Amex-2001-19).
---------------------------------------------------------------------------

(i) Commentary .02
    Commentary .02 prohibits equity specialists and other members from
making direct or indirect contact with an issuer that has requested a
listing qualification review \4\ for the purpose of influencing the
issuer's choice of a specialist. In addition, any communication between
equity specialists and issuers is prohibited once an issuer has been
approved for listing and the Allocations Committee has prepared the
list of qualified specialists. The exception to such prohibition is
Exchange-arranged interviews between an issuer approved for listing and
any specialist(s) the issuer requests to interview.
---------------------------------------------------------------------------

    \4\ The listing qualification review is the process whereby an
issuer undergoes review by the Exchange's Listing Qualifications
Department. The listing qualification review will commence once the
listing application is submitted to the Exchange.
---------------------------------------------------------------------------

    The interviews are closely monitored by the Exchange and the
Exchange will take appropriate action in the event an inappropriate
communication is deemed by the Exchange to have occurred during the
interview. The Exchange proposes to clarify that such appropriate
action may include the disqualification of a specialist for the
allocation. The proposed rule change will also make Commentary .02 more
consistent with Commentary .03, which currently permits the Exchange to
disqualify ETF and structured product specialists deemed to have made
inappropriate representations.
    The Exchange also proposes adding a provision to Commentary .02
addressing post-interview communications between specialists and
issuers approved for listing on the Exchange. The proposed rule change
would prohibit post-interview contacts between specialists and issuers
and provide a means for issuers to obtain further information from the
specialists

through the Exchange's Equity Sales Group.
    Finally, the Exchange proposes to simplify the description of the
procedures set forth in Commentary .02 by adding defined terms and
moving the provision concerning an issuer's ability to request
specialists to be placed on the list of qualified specialists to
paragraph (e)(i) of Rule 27. The Exchange believes that such changes
will simplify Commentary .02 and avoid potential confusion for
specialists and/or issuers engaged in the Amex listing process.
(ii) Commentary .03
    Current Commentary .03, unlike Commentary .02, applies to ETFs and
structured products and contains provisions governing contacts between
specialists and other members and sponsors and issuers prior to such
sponsor or issuer deciding to list a security on the Exchange. Pursuant
to the current Commentary .03, specialists and other members must
notify the Exchange in writing before any planned contact with a
potential sponsor or issuer for the purpose of listing the ETFs or
structured products of such sponsor or issuer on the Exchange, or
within five (5) business days of unanticipated contact where
discussions regarding the listing occur. Exchange approval of planned
contact is required and the Exchange will grant such approval where it
appears that the contact will assist rather than impede the Exchange's
effort to list the new ETF or structured product.\5\
---------------------------------------------------------------------------

    \5\ See supra note 3.
---------------------------------------------------------------------------

    The Exchange does not believe that the communication restrictions
set forth in Commentary .03 are necessary, in that it is unlikely that
such contact would impede the Exchange's effort to list an issuer. As a
result, the Exchange proposes to delete such restrictions. The
Commission previously approved a rule change to Commentary .02 removing
similar restrictions on equity specialists.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 47914 (May 23,
2003), 68 FR 32782 (June 2, 2003) (SR-Amex-2002-112); and 48132
(July 7, 2003), 68 FR 41665 (July 14, 2003) (SR-Amex-2002-112).
---------------------------------------------------------------------------

    ETF and structured product specialists are also currently required
to promptly report to the Exchange any representations or commitments
that they, or an individual acting on their behalf, have made to an
employee of, or any individual acting on behalf of, an issuer or
sponsor. The Exchange proposes to amend Commentary .03 to require
specialists to only disclose in their applications to be allocated an
ETF or structured product representations or commitments that relate to
the prospective listing of the ETF or structured product and that are
made within the six (6) months preceding the date allocation
applications are solicited with respect to that ETF or structured
product. The Exchange further proposes, in the event an ETF or
structured product is not allocated within five (5) days of the
allocation application, to require specialists and other members to
update their applications accordingly to report all representations or
commitments since last reported to the Exchange.
    While the disclosure requirement is intended to ensure the
integrity of the allocation process, the Exchange believes that if it
is interpreted too broadly, it could impair such process by requiring
specialists to disclose every representation or commitment that they,
or an individual acting on their behalf, have ever made to an employee
of, or any individual acting on behalf of, an issuer or sponsor. By
narrowing the time frame of the disclosure requirement to six (6)
months prior to listing, the Exchange believes that specialists will be
able to provide more detailed disclosures of any representations and/or
commitments they have made with regard to a particular listing, thereby
enabling the Exchange to better monitor the appropriateness of such
representations and/or commitments.
    Commentary .03 also includes procedures related to the interview
process. The Exchange proposes to clarify that such procedures apply to
issuers and sponsors whose securities have been approved for listing on
the Exchange in accordance with Rule 27(e)(i).
(iii) Other Changes
    Finally, the Exchange proposes to make technical revisions to
paragraphs (c) and (e)(i) of Rule 27 in order to consistently use the
term ``issuer'' as opposed to ``company'', clarify the applicability of
the provisions to equity, ETF and structured product listings \7\ and,
in general, to simplify the reading of the text.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change will enhance
the clarity of and provide additional transparency to the Amex's
allocation policy and procedures. Such additional clarity and
transparency to the provisions governing specialist-issuer
communications will facilitate uniform application and ease
administration of Rule 27.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\8\ in general, and furthers the objectives of Section 6(b)(5) of
the Act,\9\ in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File

Number SR-Amex-2008-44 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-Amex-2008-44. 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 Amex. 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-
Amex-2008-44 and should be submitted on or before July 9, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-13708 Filed 6-17-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Notices]
[Pages 28772-28774]
[FR Doc No: E9-14168]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2006-25755]

Operating Limitations At Laguardia Airport

ACTION: Notice of order to show cause and request for information.

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SUMMARY: The FAA is issuing an order to show cause, which solicits the
views of interested persons on the FAA's tentative determination to
extend through October 30, 2010, the December 13, 2006, order limiting
the number of scheduled and unscheduled operations at LaGuardia Airport
during peak operating hours. The text of the order to show cause is set
forth in this notice.

DATES: Any written information that responds to the FAA's order to show
cause must be submitted by July 1, 2009.

ADDRESSES: You may submit written information, identified by docket
number FAA-2006-25755, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments by mail to Docket Operations, U.S.
Department of Transportation, M-30, Room W12-140, 1200 New Jersey
Avenue, SE., Washington, DC 20590-0001. Persons wishing to receive
confirmation of receipt of their written submission

should include a self-addressed stamped postcard.
     Hand Delivery: Deliver comments to Docket Operations in
Room W12-140 on the ground floor of the West Building at 1200 New
Jersey Avenue, SE., Washington DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Facsimile: Fax comments to the docket operations personnel
at<PHONE_NUMBER>.
    Privacy: We will post all comments that we receive, without change,
at http://www.regulations.gov, including any personal information that
you provide. Using the search function of the docket Web site, anyone
can find and read the electronic form of all comments in any of our
dockets, including the name of the individual sending the comment or
signing the comment on behalf of an association, business, labor union,
or other entity or organization. You may review the DOT's complete
Privacy Act Statement in the Federal Register at 65 FR 19477-78 (April
11, 2000), or you may find it at http://docketsinfo.dot.gov.
    Reviewing the docket: To read background documents or comments
received, go to http://www.regulations.gov at any time and follow the
online instructions for accessing the docket; or go to Docket
Operations in Room W12-140 on the ground floor of the West Building at
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: James W. Tegtmeier, Associate Chief
Counsel for the Air Traffic Organization; telephone--(202) 267-8323; e-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Order To Show Cause

    The Federal Aviation Administration (FAA) has tentatively
determined that it will extend through October 30, 2010, the FAA's
December 13, 2006, order limiting scheduled and unscheduled operations
at LaGuardia Airport, as subsequently amended (December 2006 order).\1\
This order to show cause invites air carriers and other interested
persons to submit comments in Docket FAA-2006-25755 on this proposal to
extend the duration of the December 2006 order.\2\
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    \1\ Operating Limitations at New York LaGuardia Airport, 71 FR
77,854 (Dec. 27, 2006); 72 FR 63,224 (Nov. 8, 2007) (transfer,
minimum usage, and withdrawal amendments); 72 FR 48,428 (Aug. 19,
2008) (reducing the reservations available for unscheduled
operations); 74 FR 845 (Jan. 8, 2009) (extending the expiration date
of the December 2006 order until October 24, 2009); 74 FR 2,646
(Jan. 15, 2009) (reducing the peak-hour cap on scheduled operations
to 71).
    \2\ The FAA separately solicited comments on proposals to extend
the January 15, 2008, order limiting scheduled operations at John F.
Kennedy International Airport (JFK) and the May 15, 2008, order
limiting scheduled operations at Newark Liberty International
Airport (Newark). The public may file or review documents related to
these proposals in Dockets FAA-2007-29320 (JFK) and FAA-2008-0221
(Newark).
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    As a result of the limited capacity of LaGuardia's two-runway
configuration, the airport cannot accommodate the number of scheduled
and unscheduled flights that operators would like to conduct there
without causing significant congestion-related delays. LaGuardia was
one of the original U.S. airports at which the FAA capped the number of
peak-hour operations under the High Density Rule.\3\ The High Density
Rule limited the number of scheduled operations at the airport to 62
per hour.
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    \3\ 33 FR 17,896, 17,898 (Dec. 3, 1968); 34 FR 2,603 (Feb. 26,
1969).
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    In a statute enacted in April 2000, Congress began to phase out the
High Density Rule at LaGuardia and other airports.\4\ Before fully
extinguishing the High Density Rule at LaGuardia on January 1, 2007,
the statute directed the Secretary of Transportation immediately to
grant a number of exemptions from the High Density Rule for specific
types of scheduled operations.\5\ Demand for exemptions to operate
scheduled service at LaGuardia soared. By November 2000, the
debilitating delays that resulted from the surging demand required the
FAA to roll back and limit the number of operations at LaGuardia.\6\
The FAA limited the peak-hour scheduled operations at a total of 75
hourly departures and arrivals.
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    \4\ 49 U.S.C. 41715(a)(2).
    \5\ 49 U.S.C. 41716.
    \6\ 65 FR 69,126, 69,127-28 (Nov. 15, 2000).
---------------------------------------------------------------------------

    In the ensuing years, the FAA examined and proposed various
alternatives to the High Density Rule in an effort to control
congestion at LaGuardia.\7\ When it became apparent that the FAA would
not have a replacement rule in place before the High Density Rule
expired at LaGuardia, and recognizing that LaGuardia is prone to
overscheduling, the FAA issued the December 2006 order to limit the
number of scheduled and unscheduled operations at the airport until the
FAA could issue a final rule. During much of the time that the December
2006 order has remained in effect, the airport has continued to
experience significant congestion-related delays. As a result, the FAA
reduced the peak-hour limit on unscheduled operations from six to
three.\8\ More recently, the FAA reduced the peak-hour limit on
scheduled operations from 75 to 71.\9\
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    \7\ 71 FR 51,360 (Aug. 29, 2006) (Notice of Proposed
Rulemaking); 73 FR 20,846 (April 17, 2008) (Supplemental Notice of
Proposed Rulemaking).
    \8\ 72 FR at 48,428.
    \9\ 74 FR at 2,646.
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    The FAA established the order's October 2009 expiration date to
permit time for a recently issued final rule to take effect to control
congestion at LaGuardia.\10\ However, the rule was stayed by the U.S.
Court of Appeals for the District of Columbia Circuit prior to the
rule's effective date, and the FAA is currently soliciting comments on
a proposal to rescind the final rule.\11\ As a result of the FAA's
reconsideration of the rule, the court is holding in abeyance the
briefing schedule in the rule's associated litigation.
---------------------------------------------------------------------------

    \10\ 74 FR at 845.
    \11\ 74 FR 22,717 (May 14, 2009).
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    In light of the events that have transpired since the December 2006
order took effect, it is now unlikely that the FAA will have an
effective final rule on the order's current expiration date. In the
absence of the FAA's extension of the order, the FAA anticipates a
return of the congestion-related delays that required the FAA to limit
the number of operations at the airport. The hourly capacity at
LaGuardia has not increased since the order took effect. Because the
demand for operations at New York-area airports remains high, the FAA
has determined that an extension of the December 2006 order appears to
be appropriate while the FAA identifies the appropriate long-term
solution to congestion at LaGuardia.
    Order to Show Cause:
    To prevent a recurrence of overscheduling at LaGuardia during the
interim between the expiration of the December 2006 order on October
24, 2009, and the effective date of a replacement rule, the FAA
tentatively intends to extend the December 2006 order. The order will
continue to apply to both scheduled and unscheduled operations at the
airport. Maintaining the existing order for an additional, finite
period constitutes a reasonable approach to preventing unacceptable
congestion and delays at LaGuardia until a long-term measure is
implemented. The December 2006 order, as extended, would expire on
October 30, 2010.
    Accordingly, the FAA directs all interested persons to show cause
why the FAA should not make final its tentative findings and tentative
decision to extend the December 2006 order through October 30, 2010, by
filing their

written views in Docket FAA-2006-25755. The FAA does not intend this
request for the views of interested persons to address any issues
related to the existing final rule or any future congestion management
rule. Therefore, any submission to the current docket should be limited
to the proposed extension of the December 2006 order.

    Issued in Washington, DC, on June 11, 2009.
Rebecca MacPherson,
Assistant Chief Counsel for Regulations.
[FR Doc. E9-14168 Filed 6-16-09; 8:45 am]
BILLING CODE 4910-13-P