[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58110-58116]
[FR Doc No: 2022-20623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1050]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Targeted Mechanism of
Action Presentations in Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments (including recommendations) on the
collection of information by October 24, 2022.

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

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].
    For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, [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.

Targeted Mechanism of Action Presentations in 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.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides 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 are most central to our mission. Our research focuses 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. This study will inform
the first two topic areas, advertising features and target populations.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings are 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 home page,
which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
    In 2014, OPDP conducted focus groups designed to provide insights
on how consumers and healthcare providers (HCPs), including physicians,
nurse practitioners, and physician assistants, interpret the term
``targeted'' in prescription drug promotional materials. Although
diverse views were voiced, there appeared to be some tendency toward
the impression that products with promotional materials using this term
would be safer and more effective than other similar treatments. OPDP
is also now conducting a nationally representative survey regarding the
ways in which consumers and primary care physicians (PCPs) interpret
terms and phrases commonly used in prescription drug promotional
materials, including assessment of impressions of the terms
``targeted'' and ``targeted mechanism of action'' (targeted MoA) (86 FR
24867, May 10, 2021). Building upon this line of research, the proposed
study will investigate the influence of targeted MoA claims, graphics,
and disclosures that provide context about a drug's targeted MoA,
utilizing an experimental design with both consumer and HCP samples.
The experimental approach described here is intended to complement and
augment the prior research by facilitating assessment of causality.
Specifically, the proposed study will explore how varied targeted MoA
presentations affect consumer and HCP understanding of the MoA of a
drug, perception of drug benefits and risks, attention to risk
information, and interest in the drug.
    Table 1 depicts the study design. Participants will be randomly
assigned to one of 12 experimental conditions in which the presence
versus absence of: (1) a targeted MoA claim, (2) a graphic depicting a
targeted MoA, and (3) a disclosure that provides context about the
targeted MoA of the drug are varied in a branded website for a
fictitious prescription drug indicated to treat bladder cancer and
cancers of the urinary tract (renal pelvis, ureter, or urethra) that
have spread or cannot be removed by surgery. We selected cancer as the
medical condition for study given the prevalence of targeted MoA
presentations in promotional materials for prescription drugs indicated
to treat various forms of cancer. Notably, there will be three
variations related to the targeted MoA graphic: (1) no graphic, (2) an
inaccurate graphic (graphic 1) showing only the effect of the drug on
cancerous cells but not on healthy cells, and (3) an accurate graphic
(graphic 2) that will show the effect of the drug on both cancerous and
healthy cells. The design will be replicated in both the consumer and
HCP samples with stimuli specifically created for each audience. Draft
stimuli were informed by, but not identical to, actual targeted MoA
presentations from a marketplace evaluation conducted under FDA
guidance. Draft stimuli were also informed by an FDA subject matter
expert's review. Following exposure to the stimuli, the participants
will complete a questionnaire designed to assess relevant outcome
measures. A copy of the questionnaire is available upon request. All
aspects of this study will be completed online. Participation is
estimated to take approximately 20 minutes, excluding the screener's
time.

                                                                  Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Targeted MoA graphic
                                                                                --------------------------------------------------
                  Sample                            Disclosure                Targeted MoA claim           Present          Present
                                                                                (graphic 1--     (graphic 2--        Absent
                                                                                inaccurate)       accurate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCP......................................  Present.....................  Present.....................     \1\ [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
                                           Absent......................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
Consumer.................................  Present.....................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
                                           Absent......................  Present.....................         [ssquf]          [ssquf]          [ssquf]
                                                                         Absent......................         [ssquf]          [ssquf]          [ssquf]
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Each [ssquf] symbol represents an experimental condition.

    For the HCP sample, we will recruit oncologists, PCPs with oncology
experience, and nurse practitioners and physician assistants who
specialize in oncology. We will also recruit a general population
sample of adult volunteers 18 years or older for the consumer sample. A
general population, rather than a diagnosed consumer sample, was
selected because of concerns about being able to recruit enough
participants for this particular study if we selected a cancer-specific
sample.
    We will ask consumers to consider a hypothetical scenario in which
they have recently been diagnosed with cancer and are actively looking
for available treatments. HCPs will be asked to consider a scenario in
which they are actively looking for available treatments for a patient
who has been diagnosed with cancer. We will also ask consumers if they
have ever been diagnosed with cancer. HCP participants will be drawn

from online HCP panels, and general population consumer participants
will be drawn from online consumer panels. Informed by power analyses,
we will recruit a sample of 540 HCPs and 540 consumers for the main
study.
    In the Federal Register of October 28, 2021 (86 FR 59736), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received five comments that were
Paperwork Reduction Act (PRA) related. Within the submissions, FDA
received multiple comments that the Agency has addressed in this
notice. For brevity, some public comments are paraphrased and,
therefore, may not state the exact language used by the commenter. All
comments were considered even if they were not fully captured by our
paraphrasing in this document. One submission (ID number FDA-2021-N-
1050-0002) was read and considered but was outside the scope of the
research and is not addressed further. Comments and responses are
numbered here for organizational purposes only.
    (Comment 1) One comment stated that FDA has already investigated
how HCPs and consumers interpret the terms ``targeted'' and ``targeted
mechanism of action.''
    (Response 1) Prior qualitative research \1\ looked at how consumers
and HCPs interpret the term ``targeted'' in prescription drug
promotional materials. This initial qualitative research suggested that
products using the term ``targeted'' may appear safer or more effective
than other similar treatments but did not fully explore the
implications of those interpretations. Robust empirical evidence is
needed to understand how complex concepts, such as ``targeted'' and
``targeted MoA,'' are interpreted or whether they lead to inaccurate
inferences about a drug's efficacy and side effects when presented to
consumers and HCPs in prescription drug promotion. The present research
seeks to extend previous studies by investigating the effects of
including a graphic and by exploring whether the inclusion of a
disclosure statement can help to clarify the information. It is
possible that the presence of targeted MoA graphics affects the
impressions of the product, which we are assessing in this study. It is
also possible that any inflated perceptions consumers or HCPs may have
based on the MoA claim or graphics can be adjusted by adding a
disclosure. These are the questions this research is aiming to address
through an experimental design. We conducted a literature review, which
found that only two published articles (Refs. 1 and 2) have focused on
assessing the impact of exposure to MoA presentations in prescription
drug promotion. We also conducted a marketplace evaluation, which found
that these types of presentations are widespread in the prescription
drug promotion marketplace. Together, this preliminary work highlights
the importance of this study and the need for experimental research
that examines the effect of targeted MoA presentations in prescription
drug promotion on both consumers and HCPs.
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    \1\ See ``Focus Groups to Investigate Specific Terminology in
Prescription Drug Promotion (completed in 2014),'' available at
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm.
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    (Comment 2) Two comments proposed recruiting cancer patients rather
than general population consumers because, according to one comment,
cancer patients are more likely to be exposed to promotional materials
regarding cancer products and may be more familiar with cancer-related
terms than the general population. The comments also suggested that
being diagnosed with a life-threatening illness may influence
perception of risk/benefit and interest in a drug. One comment
encouraged the Agency to look for ways to mitigate such bias, and the
other specifically proposed that the Agency focus the research on a
target consumer respondent sample of those who have had a cancer
diagnosis and allow the screening criteria to straddle across multiple
cancer diagnoses.
    (Response 2) We chose a general population sample because of
concerns about being able to recruit enough participants if we selected
a cancer-specific sample. However, we agree that in a future study, a
small, carefully designed replication study with cancer patients could
be valuable. We will also ask participants if they have been diagnosed
with cancer and control for any impact that a diagnosis of prior cancer
may have.
    (Comment 3) One comment objected that access to the specific study
stimuli and questionnaire was not provided.
    (Response 3) We have described the purpose of the study, the
design, and the population of interest and have provided the
questionnaire to numerous individuals upon request. We provided the
disclosure language in the questionnaire. 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 our research.
    (Comment 4) Two comments suggested that the research assumes that
all targeted MoA claims that do not include a discussion of off-target
effects are misleading and that it is misleading to suggest that
targeted therapies are safer or more effective. The comments noted that
this assumption would be overly broad and simplified and may result in
biased results.
    (Response 4) This research does not assume that any specific
presentation is or is not misleading. Rather, this research aims to
understand whether variations in MoA presentations of a targeted drug
(e.g., presenting an inaccurate graphic depicting a drug's MoA without
a disclosure relative to an accurate graphic depicting the MoA) may
affect consumer and HCP perceptions of the drug. In this way, the
research will provide more information to help determine whether these
audiences are misled by the tested presentations.
    (Comment 5) Two comments focused on the proposed graphics. One
expressed concern about the ability of a graphic to depict a targeted
MoA accurately (particularly as it refers to the impact on off-target
healthy cells) and to convey a truthful and non-misleading
representation. The other comment proposed changes to the inaccurate
graphic in terms of how it depicted healthy and cancer cells.
    (Response 5) We tested candidate graphics in cognitive interviews
to confirm that the audience interpreted the graphics as intended. The
graphics were also reviewed by medical professionals, and we consulted
with a doctoral-trained researcher who publishes extensively on the
effects of graphic presentations in health communication and
advertising.
    (Comment 6) One comment noted that it is unclear what proportion of
the sample will be oncologists versus PCPs with oncology experience.
The comment also stated that while PCPs may have a role in the cancer
patient's journey and may provide input along the way to diagnosis, as
well as during the management phase of treatment, they are not routine
decision makers for new treatments or treatment changes.
    (Response 6) 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 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, graphics, and disclosures. We

intend to use PCPs as a control group to understand whether specific
advanced training influences the understanding of MoA claims, graphics,
and associated disclosures. Further, including PCPs with oncology
experience alongside oncologists has yielded useful data in prior
studies (Ref. 3). The sample will be equally distributed across
oncologists, PCPs with oncology experience, and nurse practitioners and
physician assistants with oncology experience.
    (Comment 7) One comment stated that the study should only recruit
nurse practitioners and physician assistants who specialize in
oncology.
    (Response 7) We agree. Only nurse practitioners and physician
assistants who specialize in oncology are eligible for the study.
    (Comment 8) One comment noted that the instructions at the top of
the questionnaire ask participants to ``make your best guess'' based on
the web page they just viewed. The comment stated that respondents
should not be asked to guess as their response and argued that these
instructions undermine the importance of the participants' answers.
    (Response 8) The instructions are displayed before perceived
efficacy and risk questions where consumer participants are told,
``Most people don't know how a prescription drug will affect them until
they've taken the drug. But we'd like you to make your best guess based
on the web page you just saw. Please answer the following questions
based on what you saw on the web page.'' HCPs are told, ``Please answer
the following questions based on what you saw on the web page rather
than prior knowledge of this class of medications.''
    These instructions have been cognitively tested in prior studies,
as well as in the present study, and we found no evidence that these
instructions undermined the perceived importance of participants'
answers. Instead, the instructions helped to indicate that we wanted
participants to form an opinion and that they did not need to base
their opinion on prior knowledge to do so.
    (Comment 9) One comment suggested that the recall questions
(questions 6 through 11) and especially the ``foil'' responses could
bias the responses to the questions that follow them and recommended
locating the recall questions after other questions.
    (Response 9) We always approach question ordering carefully,
attempting to balance several considerations, including the reduction
of bias from one question to another, the flow, and the importance of
each item. In this case, we are prioritizing measures of specific claim
comprehension over other more general questions in our questionnaire,
which is why questions 6 through 11 are placed earlier in the
questionnaire. Answering recall and comprehension questions first will
allow consumers and HCPs to provide a more accurate response and will
allow us to better understand whether the information was comprehended.
We did not encounter any issues with recall questions influencing
responses to questions found later in the survey during cognitive
interviews.
    (Comment 10) One comment recommended using a consistent scale
throughout the survey. Another suggested changing questions 12, 13, 14,
16, 17, 18, 19, 20, 22, and 23 to 7-point scales to add a midpoint.
    (Response 10) We use true/false/don't know or yes/no/don't know
response options for the comprehension questions and Likert-type scales
for perceptions and opinion questions. Using one scale throughout the
survey would not necessarily provide better data. For nearly all
Likert-type questions, we use 6-point scales with the endpoints
labeled. Some of these questions with Likert-type scales are validated
questions; for these, we have maintained the response options from the
validated measures. Other questions were altered from validated
measures, and similarly, we preferred to maintain the Likert-type
scales that the original measure had. We will change question 5 from a
7-point to a 6-point scale to increase consistency. We will retain the
5-point scales with all response options labeled for the two validated
scales for beliefs about medications and trust in prescription drug
materials.
    Regarding the inclusion of a midpoint, this is a matter of debate
in the literature and has never been resolved. Based on input from
cognitive interviews and in response to public comments, we will be
adding a neutral point to the comparative efficacy and risk questions
(i.e., questions 17 through 23), which will change these questions to
be 7-point response options with endpoints and midpoint labeled.
    (Comment 11) Two comments stated that the 6-point scales do not
allow the respondent to pick neither agree/disagree/unknown. One
comment noted that this is a concern for most 6-point scale questions
but particularly for questions 17 through 23, which compare the study
drug to other medications. The comments recommended either an anchored
neutral middle point on the scale or a box for uncertain/do not know
responses.
    (Response 11) There are benefits and drawbacks to including a
neutral or ``no reaction'' response in survey research, and the
decision to use a neutral midpoint depends on the goal of the measures
(Refs. 4 and 5). For questions assessing comprehension of the MoA
claim, we included a ``do not know'' option as this response would
indicate some level of uncertainty about the MoA, and that uncertainty
itself would be meaningful and actionable information. However, when
assessing perceptions and attitudes about the claim, graphic, or
disclosure, our objective is to force a selection. Inclusion of a
neutral response option in these instances could potentially encourage
satisficing--cuing participants to select a neutral response when there
is uncertainty (Ref. 7). For the comparative risk and efficacy
questions (questions 17 through 23), we will include a midpoint based
on results from cognitive interviews; however, these interviews did not
point to the need to include a midpoint for the other questions.
    (Comment 12) Questions 17 through 23 ask about the efficacy and
risks of the study drug compared to other prescription drugs for the
same indication. One comment contended that, without prior knowledge of
the efficacy and risks of the prescription drugs on the market, it
would be difficult for respondents to make a fully informed conclusion.
Another comment asserted that the comparative risk and efficacy
questions should be revised to establish a clear comparator, such as
chemotherapy. Finally, a comment recommended removing these questions
as consumers should not be assessing a drug's safety or efficacy
compared to other drugs.
    (Response 12) There are instances in the clinical setting when
consumers will discuss the safety and risk information of a drug
compared to others (e.g., if a patient switches from one drug to
another or if a family member asks the consumer to talk to their doctor
about another drug). We acknowledge that in a clinical setting,
patients and HCPs may use additional information to make decisions
about how a drug compares to another. However, the intent of questions
17 through 23 is to understand whether exposure to different
presentations of the MoA claim, graphics, and disclosure results in
different comprehension or perceptions, such as perception of
comparative risks and efficacy. Except for the varied presentations,
all participants will have the same level of information regarding the
MoA of the drug. So, we would expect that all

participants would be equally informed of the drug, and differences
among study conditions could be attributed to the experimental
manipulations. Additionally, any subjective experiences outside the
experiment setting should be evenly distributed across study conditions
as a function of random assignment; therefore, they should not have any
impact on the outcomes of the study. Still, cognitive interviews
indicated that HCPs and consumers preferred that a midpoint be added to
the response scale for these questions, which we added in the revised
questionnaire. Based on cognitive interviews, we also revised the
questions to include the phrase ``compared to other similar
prescription drugs that are for/treat bladder cancer.'' We will also
review these questions and make any necessary adjustments based on pre-
testing results.
    (Comment 13) One comment stated that the questionnaire does not
consider the HCP respondents' baseline understanding or expectations of
targeted treatments.
    (Response 13) We expect that any knowledge or expectations of
targeted treatments that consumers and HCPs already have outside of the
experiment setting should be evenly distributed across study conditions
as a function of random assignment; therefore, observed differences
between conditions are unlikely to be caused by these individual
differences. However, we added an item that assesses HCPs' knowledge of
targeted therapies for cancer treatments.
    (Comment 14) One comment encouraged FDA to disseminate all final
results of completed research related to this topic.
    (Response 14) FDA's research is documented on our homepage, which
can be found at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The
website includes links to the latest Federal Register notices and peer-
reviewed publications produced by our office. The Agency also
anticipates disseminating the results of this study after the final
analyses of the data are completed. The exact timing and nature of any
such dissemination has not been determined, but dissemination of
research results often occurs through presentations at trade and
academic conferences, publications, articles, and postings on FDA's
website.
    (Comment 15) One comment recommended that certain populations, such
as those who work in pharmaceutical marketing or for the U.S.
Department of Health and Human Services (HHS), be excluded from the
study.
    (Response 15) We agree. Participants will be excluded from
participation if they work for a pharmaceutical, advertising, or market
research company or are employed by HHS.
    (Comment 16) One comment recommended that participants who are
unable to recall key elements of the stimuli, such as indication, risk
elements, presence of claim, and presence of disclaimers, be excluded
from the study because they are not able to appropriately assess the
MoA presentations.
    (Response 16) The fact that a consumer or HCP is not able to recall
certain information does not mean they did not see that information or
subconsciously process it (Ref. 6). Therefore, we do not plan to
exclude anyone based on their self-reported recall of elements in the
stimuli.
    (Comment 17) One comment suggested that participants should be
asked questions 30 through 34 as part of a pre-test and be stratified
based on their responses.
    (Response 17) Typically, stratified randomization is used if there
are prognostic variables that correlate with outcome measures and
researchers are concerned about such factors not being evenly
distributed across groups (Ref. 8). We have no reason to expect that
the aforementioned factors would have a strong association with the
outcome measures, nor do we have reason to believe that we will not
achieve adequate balance of prognostic variables given the large sample
size proposed for this study (Ref. 8). Random assignment will help to
produce groups that are, on average, probabilistically similar to each
other. Because randomization eliminates most other sources of
systematic variation, we can be reasonably confident that any effect
that is found is the result of the intervention and not some
preexisting differences between the groups (Ref. 9). However, we have
included questions 30 through 34 to assess the association of factors
such as health literacy, prior cancer diagnosis, or familiarity with
cancer treatment options with our outcomes and statistically control
for those variables if necessary.
    (Comment 18) One comment suggested that in order to ensure that
differences in risk assessment across stimuli are due to the
manipulation of MoA information, the prominence of the risk
presentation should be standardized across the 12 versions of the
stimuli and displayed in accordance with FDA's guidance document
entitled ``Presenting Risk Information in Prescription Drug and Medical
Device Promotion.'' \2\ The comment also encouraged the use of
qualifiers to delineate which side effects are considered serious.
---------------------------------------------------------------------------

    \2\ The draft guidance for industry ``Presenting Risk
Information in Prescription Drug and Medical Device Promotion'' (May
2009) is available on the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
When finalized this guidance will represent FDA's thinking on this
issue.
---------------------------------------------------------------------------

    (Response 18) In creating the stimuli, we created one web page that
was the basis for all the stimuli. The risk presentation was
standardized across the experimental conditions, and we kept FDA's
guidance in mind when displaying stimuli. Regarding the suggested use
of qualifiers to delineate which side effects are considered
``serious,'' we again note that we kept FDA's guidance in mind with
respect to the risk presentation.
    (Comment 19) One comment noted that the disclosure for patients
should be reworded as follows to prevent implied bias: ``[Drug X]
delivers medicine directly to cancer cells and can also harm healthy
cells.''
    (Response 19) We revised the statement to read ``[Drug X] could
also affect healthy cells.'' With this change, the consumer disclosure
is consistent with the content of the disclosure shown to HCPs.
    (Comment 20) One comment asserted that most promotional materials
in the real world qualify MoA statements with language mirroring the
labeling (e.g., ``Pre-clinical studies demonstrate . . .'') and
recommended that the research materials be updated to include similar
qualifying language.
    (Response 20) The addition of such language may create an imbalance
of information across the various experimental conditions and could
confound interpretation of the results. As such, we did not include the
qualifying language mentioned above.
    (Comment 21) One comment suggested that study participants should
be allowed to refer back to the product website as often as needed
rather than only being permitted to view it once.
    (Response 21) As a practice, we often purposely do not permit study
participants to refer back to the product website as often as needed
for these types of studies. Rather, for this study, we will instruct
participants to read the website carefully and alert them that they
will be answering several questions about the content that they just
saw and that they cannot return to the website. The goal of this study
is not to assess participants' comprehension of verbatim information in
the stimuli, for which

repeated exposures to stimuli may be more appropriate in another study.
Rather, the present study is interested in gist understanding of the
information. Allowing for multiple exposures to the stimuli could
potentially influence study outcomes and confound interpretation of the
study results. A large literature supports presence of a ``mere
exposure effect'' in social science research, where more exposure
enhances processing and increases positive affect toward stimuli (Refs.
10 and 11).
    (Comment 22) One comment recommended removing question 16 (i.e.,
risk-benefit tradeoff) for consumers because consumers may not have the
experience or background to assess a drug's benefit-risk profile. The
comment also suggested that this question ignores the role of
prescribers in informing patients of the relevant risks and benefits of
prescription medications.
    (Response 22) We disagree that consumers do not form their own
perceptions about risk-benefit tradeoffs after seeing direct-to-
consumer (DTC) promotional materials and before any discussion with an
HCP. Consumers often wish to participate in shared decision making with
HCPs when selecting prescription drugs and may request specific
prescription drugs from their HCPs based on promotions they have seen
in the marketplace. Because the information consumers receive through
DTC prescription drug promotion can impact these requests, it is
important to investigate how the information in prescription drug
promotional pieces impacts consumer attention, understanding, and
perceptions. In addition, the purpose of these questions is to assess
perceived benefit and risk based on the promotional material shown. The
question includes instructions indicating that judgments should be
reached based on the information on the prescription drug website. As
such, we plan to ask participants about their perceptions of the risk-
benefit tradeoff using question 16, which is a common and validated
item in DTC research.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                 Number of       Number of
          Activity             respondents 2   responses per   Total annual     Average burden per   Total hours
                                                respondent       responses          response 3
----------------------------------------------------------------------------------------------------------------
Pretest:
    General population:                  528               1             528  0.08 (5 min.)........         42.2
     pretest screener
     completes (assumes 75%
     eligible).
    General population:                  396               1             396  0.33 (20 min.).......        130.7
     number of completes,
     pretest.
    HCP: pretest screener                660               1             660  0.08 (5 min.)........         52.8
     completes (assumes 60%
     eligible).
    HCP: number of                       396               1             396  0.33 (20 min.).......        130.7
     completes, pretest.
Main Study:
    General population:                  792               1             792  0.08 (5 min.)........         63.4
     number of main study
     screener completes
     (assumes 75% eligible).
    General population:                  594               1             594  0.33 (20 min.).......        196.0
     number of completes,
     main study.
    HCP: number of main                  990               1             990  0.08 (5 min.)........         79.2
     study screener
     completes (assumes 60%
     eligible).
    HCP: number of                       594               1             594  0.33 (20 min.).......        196.0
     completes, main study.
                             -----------------------------------------------------------------------------------
        Total...............  ..............  ..............  ..............  .....................          891
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 As with most online and mail surveys, it is always possible that some participants are in the process of
  completing the survey when the target number is reached and that those surveys will be completed and received
  before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for
  both samples in the study.
3 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 (see ADDRESSES) 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. O'Donoghue, A.C., Williams, P.A., Sullivan, H.W., et al.
``Effects of Comparative Claims in Prescription Drug Direct-to-
Consumer Advertising on Consumer Perceptions and Recall.'' Social
Science & Medicine, 120:1-11, 2014.
*2. Sullivan, H.W., O'Donoghue, A.C., Gard Read, J., et al.
``Testimonials and Informational Videos on Branded Prescription Drug
websites: Experimental Study to Assess Influence on Consumer
Knowledge and Perceptions.'' Journal of Medical internet Research,
20(1):e13, 2018.
3. Boudewyns, V., O'Donoghue, A.C., Paquin, R.S., et al. ``Physician
Interpretation of Data of Uncertain Clinical Utility in Oncology
Prescription Drug Promotion.'' The Oncologist, 26(12):1071-1078,
2021.
4. Moors, G. ``Exploring the Effect of a Middle Response Category on
Response Style in Attitude Measurement.'' Quality & Quantity,
42(6):779-794, 2008.
5. Sturgis, P., Roberts, C., and Smith, P. ``Middle Alternatives
Revisited: How the Neither/nor Response Acts as a Way of Saying `I
Don't Know?''' Sociological Methods & Research, 43(1):15-38, 2014.
6. Shapiro, S. and Krishnan, H.S. ``Memory-Based Measures for
Assessing Advertising Effects: A Comparison of Explicit and Implicit
Memory Effects.'' Journal of Advertising, 30(3):1-13, 2001.
7. Krosnick, J.A. ``Questionnaire Design.'' In: Vannette, D.,
Krosnick, J. (eds). The Palgrave Handbook of Survey Research (pp.
439-455). Palgrave Macmillan, Cham, 2018.
8. Friedman, L.M., Furberg, C.D., DeMets, D.L., et al. Fundamentals
of Clinical Trials. 5th ed. New York, NY: Spring Science-Business
Media, 1998.
9. Fisher, R.A. The Design of Experiments. Edinburgh, United
Kingdom: Oliver & Boyd, 1935.
10. Bornstein, R.F. ``Exposure and Affect: Overview and Meta-
analysis of Research, 1968-1987.'' Psychological Bulletin,
106(2):265-289, 1989.

11. Bornstein, R.F. and D'Agostino, P.R. ``The Attribution and
Discounting of Perceptual Fluency: Preliminary Tests of a Perceptual
Fluency/Attributional Model of the Mere Exposure Effect.'' Social
Cognition, 12(2):103-128, 1994.

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20623 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 11, 2008 (Volume 73, Number 239)]
[Notices]
[Page 75419-75420]
[DOCID:fr11de08-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

December 3, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-383-089.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc submits Seventh Revised
Sheet 1404 et al. to FERC Gas Tariff 1R3.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0168.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP98-18-038.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, LP submits Second
Revised Sheet 6L to its FERC Gas Tariff 1R1.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0167.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP00-445-022.
    Applicants: Alliance Pipeline L.P.
    Description: Alliance Pipeline LP submits Fifteenth Revised Sheet
11 et al to its FERC Gas Tariff, Original Volume 1.
    Filed Date: 11/28/2008.
    Accession Number: 20081202-0166.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: RP08-97-004.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits 2nd Sub Eighteenth
Revised Sheet 570 to its FERC Gas Tariff, Original Volume 2.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0165.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-16-003.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Cimarron River Pipeline, LLC submits Substitute First
Revised Sheet 20 et al to FERC Gas Tariff, Original Volume 1.
    Filed Date: 12/2/2008.
    Accession Number: 20081202-0159.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-124-000.
    Applicants: Questar Pipeline Company.
    Description: Questar Pipeline Company submits Forty-Sixth Revised
Sheet 5 to FERC Gas Tariff, First Revised Volume 1, to be effective 1/
1/09.
    Filed Date: 11/28/2008.
    Accession Number: 20081202-0041.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: RP09-125-000.
    Applicants: National Fuel Gas Supply Corporation
    Description: National Fuel Gas Supply Corporation submits 122nd
Revised Sheet 9 to its FERC Gas Tariff 1R4.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0164.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-126-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: National Fuel Gas Supply Corporation submits Thirty
Third Revised Sheet 8 to its FERC Gas Tariff 1R4.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0163.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-127-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: National Fuel Gas Supply Corporation submits Twelfth
Revised Sheet 43 to its FERC Gas Tariff 1R4.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0162.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-128-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits First Revised
Sheet 101 et al to FERC Gas Tariff 1R3, to be effective 1/1/09.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0161.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-129-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits Second Revised
Original Sheet 37 et al to its FERC Gas Tariff 1R3.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0169.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-130-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits First Revised
Sheet 100 et al to its FERC Gas Tariff 1R3.
    Filed Date: 12/1/2008.
    Accession Number: 20081202-0170.

    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-131-000.
    Applicants: Quest Pipelines (KPC).
    Description: Quest Pipelines submits the Annual Interruptible
Revenue Crediting Report.
    Filed Date: 12/2/2008.
    Accession Number: 20081202-0158.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: RP09-132-000.
    Applicants: Northern Border Pipeline Company.
    Description: Northern Border Pipeline Co submits Twelfth Revised
Sheet 1 et al to FERC Gas Tariff, First Revised Volume 1.
    Filed Date: 12/2/2008.
    Accession Number: 20081202-0160.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.

    Docket Numbers: CP09-26-000.
    Applicants: Source Gas Distribution LLC.
    Description: Source Gas Distribution LLC submits application for a
blanket certificate of public convenience and necessity authorizing the
transportation and sale of natural gas pursuant to Section 7 of the
Natural Gas Act.
    Filed Date: 11/26/2008.
    Accession Number: 20081201-0143.
    Comment Date: 5 p.m. Eastern Time on Monday, December 15, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-29337 Filed 12-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18988-18989]
[FR Doc No: 2021-07452]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1736]

Potential Approach for Ranking of Antimicrobial Drugs According
to Their Importance in Human Medicine: A Risk Management Tool for
Antimicrobial New Animal Drugs; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and request for comments; reopening of
the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice announcing a public meeting
and requesting comments that appeared in the Federal Register of
October 13, 2020. In that notice, FDA announced a public meeting, which
was held on November 16, 2020, and requested public input on a
potential revised approach for considering the human medical importance
of antimicrobial new animal drugs when assessing and managing the
antimicrobial resistance risks associated with the use of antimicrobial
drugs in animals. Specifically, the Agency requested comments on the
potential revised process for ranking antimicrobials according to their
relative importance in human medicine, on the potential criteria for
their ranking, and on the resulting ranked list of antimicrobial drugs.
We are taking this action in response to technical difficulties
submitting comments to the Federal eRulemaking portal.

DATES: Submit either electronic or written comments by April 22, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 22, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the

instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1736 for ``Potential Approach for Ranking of Antimicrobial
Drugs According to Their Importance in Human Medicine: A Risk
Management Tool for Antimicrobial New Animal Drugs.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of October 13, 2020,
FDA published a notice announcing a public meeting and requesting
comments on a concept paper entitled ``Potential Approach for Ranking
of Antimicrobial Drugs According to Their Importance in Human Medicine:
A Risk Management Tool for Antimicrobial New Animal Drugs,'' giving
interested persons until January 15, 2021, to comment on the public
meeting and request for comments. In a notice published in the Federal
Register on November 27, 2020 (85 FR 76081), the Agency extended the
comment period to March 16, 2021. The Agency has received several
comments from stakeholders of technical difficulties submitting
comments to the Federal eRulemaking portal. In consideration of these
difficulties, FDA is reopening the comment period for 10 days to allow
these stakeholders the opportunity to submit comments. All comments
previously submitted, do not need to be resubmitted.

    Dated: April 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07452 Filed 4-9-21; 8:45 am]
BILLING CODE 4164-01-P