Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Conference Attendees' Observations About Prescription Drug Promotion

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

July 14, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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

Full Text

<html>
<head>
<title>Federal Register, Volume 86 Issue 132 (Wednesday, July 14, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37160-37165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14936]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1644]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Conference
Attendees' Observations About Prescription Drug Promotion

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

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

DATES: Submit written comments (including recommendations) on the
collection of information by August 13, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 ``Medical Conference Attendees' Observations
About 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, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#124240534166737474527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b">[email&#160;protected]</span></a>.

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.

Medical Conference Attendees' Observations About Prescription Drug
Promotion

OMB Control Number 0910--NEW

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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

[[Page 37161]]

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 our 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 that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing 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: <a href="https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm">https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm</a>. 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 on direct-to-
consumer advertisements conducted in 1999.
The current study focuses on understanding the landscape of
healthcare provider (HCP)-directed promotion of prescription drugs at
medical conferences in general and, more specifically, how elements of
pharmaceutical booths in medical conference exhibit halls impact HCP
attendees' perceptions of the drugs that are promoted at those booths.
We will first ask attendees who are prescribers within different
disciplines (primary care physicians, specialists, nurse practitioners,
and physician assistants) general questions about their attendance at
medical conferences, including questions about their motivations for
attending, activities they participate in (e.g., symposia, poster
sessions, social events, exhibit halls), and their opinions about the
prescription drug treatments promoted at medical conferences. These
questions will allow us to capture the viewpoint of prescribers who
attend medical conferences where prescription treatments are discussed
and promoted.
The second part of our study will allow us to get more detailed
information about interactions in medical conference exhibit halls. A
2006 study found that at least 80 percent of physicians attended at
least 1 medical conference each year and spent an average of 7 hours on
the exhibit hall floor at each event (Ref. 1). The length of time spent
at each booth--between 12 and 21 minutes (Ref. 1)--was comparatively
longer than detailing visits in HCP offices, which range from 5 to 10
minutes on average (Refs. 2 and 3). Thus, medical conference exhibit
booths provide opportunities for pharmaceutical companies to market to
large numbers of HCPs and potentially engage in more lengthy
interactions.
Promotional booths for prescription drugs and the promotional
materials disseminated at those booths fall within the regulatory
purview of OPDP. As with other promotional materials for prescription
drugs, pharmaceutical companies may voluntarily submit draft versions
of their exhibit panels and exhibit materials for FDA review (Ref. 4).
This study is designed to provide insights to inform the advisory
comments that OPDP provides to pharmaceutical companies that
voluntarily seek FDA review. OPDP also monitors prescription drug
promotional booths and materials as part of its surveillance program.
Recent compliance letters issued by OPDP described booth or panel
displays that communicated misleading information regarding drug
efficacy and safety, provided insufficient information on drug risks,
and omitted ``material facts'' about the promoted drug (Ref. 5). A
primary reason that physicians and other medical professionals report
visiting specific exhibitors at conferences is to obtain product
information (Ref. 1), and it is important that the information provided
by exhibitors to HCPs regarding the risks and efficacy of prescription
medications not be false or misleading. Thus, investigating the impact
of pharmaceutical booth promotions among medical conference attendees
has valuable practical implications for the public health.
As part of our specific exhibit booth research, we will simulate
interactions that HCPs may have at medical conference booths promoting
prescription drugs, so that FDA can examine the effects of the booth
representative's background (scientist/medical professional versus
business professional) and disclosure of data limitations (present
versus absent). In a recent survey, HCP conference attendees reported
that interacting with company representatives was the most important
element of their booth visits, followed by the availability and quality
of clinical information (Ref. 4). Thus, the perceived credibility of
the booth representative and the availability of information on data
limitations could ultimately inform HCPs' perceptions of the risks and
benefits of drugs presented at exhibit booths and their decisions to
prescribe drugs to patients.
Indeed, literature suggests that credibility and disclosures are
relevant elements to study in the context of prescription drug
conference booths. Credibility is linked to extrinsic (physical
attractiveness, power) and intrinsic (delivery factors, linguistic
cues) factors. For example, one extrinsic feature of source credibility
is similarity between the source and recipient. Research on the effects
of source similarity has been mixed, but a classic field experiment by
Brock in 1965 found that customers buying paint were more likely to
follow recommendations of a salesperson they perceived as having
painting experiences similar to their own (Ref. 6). More recent studies
have examined the effects of endorsers with professional expertise
versus those with product experience on attitudes toward the brand and
promotion (Refs. 7 and 8). These past studies are relevant to our
manipulations of booth representative background in this study given
that representatives with a medical/science background may reflect
professional expertise, whereas representatives with a business
background may reflect product experience.
There is little empirical evidence on the impact of disclosing data
limitations during promotional detailing or other sales promotion. On
one hand, providing important information (e.g., key limitations) about
the data/drug should help increase comprehension and decrease
inaccurate or unjustified interpretations of the data. On the other
hand, seeing the disclosure of data limitations--essentially tempering
the study findings and providing a sort of two-sided information that
is not necessarily in favor of the drug's effects--may improve the
material's credibility and appeal by signifying more transparency on
the sponsor's part (Ref. 9), and therefore lead to greater interest in
the drug (regardless of accurate comprehension). Conversely, not seeing
any qualifying or clarifying information could raise red flags among
providers, resulting in the lowest levels of perceived credibility.
Whether the booth representative has a medical/science background or
business background may shape perceptions of credibility even further,
thereby influencing HCPs' perceptions of the drug. Thus, while
disclosure of data

[[Page 37162]]

limitations and credibility of the booth representative may have
independent effects on HCPs' comprehension and perceptions, these
variables could also interact in their effects.

I. Research Questions

With this background in mind, we plan to address the issue of how
firms communicate about prescription drugs from the perspective of
medical conference/exhibit hall attendees. Specifically, we will ask
for attendees' general observations of:
a. Disclosures or disclaimers accompanying exhibit hall
presentations and/or symposia (about data limitations, contrary data,
FDA approval status, financial/affiliation sponsorship, etc.);
b. Publications or references accompanying the presentation of
information (PI for approved indications, contrary data references,
etc.);
c. What type of studies are being reported (real world evidence,
pharmacokinetic/pharmacodynamic studies, meta-analyses, etc.).
d. Who makes the presentations (field of study, training); and
e. Where the presentations are made (poster session, scientific
floor, exhibit hall); and
We will also address exhibit hall pharmaceutical booth interactions
specifically:
a. How does the presence or absence of information about the
limitations of data influence perceptions of the promoted product?
b. How does the background of the booth representative influence
perceptions of the promoted product?
c. Do these two variables interact?

II. Method

To complete this research, we will recruit attendees of large
medical conferences in the United States over the course of 1 year.
These conferences will represent a variety of specialties to reflect
medical areas that have prescription treatments that may be promoted to
HCPs. Specifically, we will enroll HCPs who attended one of 12 selected
medical conferences into an online survey within 7 days of conference
attendance. Exhibit 1 summarizes our approach to: (1) Determining the
conference sampling frame; (2) determining the attendee sampling frame;
and (3) recruiting and enrolling the target sample in the online
survey.
[GRAPHIC] [TIFF OMITTED] TN14JY21.000

In the first step, we will select conferences that focused on
therapeutic areas that have the following attributes:
<bullet> High number of currently promoted branded medications;
<bullet> high volume of prescriptions written;
<bullet> large patient population; and
<bullet> high amount of new drug development and promotional
spending.
Exhibit 2 shows the final criterion for conference inclusion.
Conferences that meet these criteria will be selected based on an
environmental scan.

Exhibit 2--Conference Eligibility Criteria
------------------------------------------------------------------------
Criterion Parameters
------------------------------------------------------------------------
Therapeutic area.................. Associated with one of the
prioritized therapeutic areas.
Conference attendance............. Estimated attendance of 5,000 or
more individuals.
Target audience................... Focused on prescribers and
clinicians (e.g., not insurers).
Event date........................ Scheduled during August 2021-August
2022.
Event location.................... Domestic (within United States).
------------------------------------------------------------------------

Following conference selection, medical conference attendees at
each conference will be randomly selected, invited to participate, and
screened to ensure they are HCPs with prescribing authority who
responded to the survey invitation within 7 days of attending the
target conference. HCPs will be limited to physicians, nurse
practitioners, and

[[Page 37163]]

physician assistants who spend 20 percent or more time in direct
patient care, are able to read and speak English, are not currently
employed by the Federal government or a pharmaceutical company (not
including occasional consulting), and have not participated in another
wave of the project.
The online survey will be broken into two main parts: (1) A cross-
sectional survey designed to capture HCP observations from the medical
conference and (2) an experimental study designed to assess how data
disclosures and exhibit booth representative background influence HCP
perceptions of promoted prescription drugs. The cross-sectional part of
the survey will contain a series of close- and open-ended questions.
The experimental study part of the survey will ask participants to view
a brief video simulating a conference exhibit hall interaction between
an HCP attendee and a booth employee and then answer questions about a
fictitious prescription drug featured in the video. Exhibit 3 shows our
proposed study design and sample size across 12 conferences.

Exhibit 3--Study Design and Target Sample Sizes
----------------------------------------------------------------------------------------------------------------
Booth employee background
Disclosure -------------------------------- Total
Business Medical
----------------------------------------------------------------------------------------------------------------
Present......................................................... n=92 n=92 184
Absent.......................................................... n=92 n=92 184
-----------------------------------------------
Total....................................................... 184 184 368
----------------------------------------------------------------------------------------------------------------

In the Federal Register of September 18, 2020 (85 FR 58366), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six submissions that were PRA-
related. One submission (<a href="https://www.regulations.gov/document/FDA-2020-N-1644-0005">https://www.regulations.gov/document/FDA-2020-N-1644-0005</a>) was outside the scope of the research and is not addressed
further. Within the remaining five submissions, FDA received multiple
comments that the Agency has addressed below. For brevity, some public
comments are paraphrased and therefore may not include the exact
language used by the commenter. We assure commenters that the entirety
of their comments was considered even if not fully captured by our
paraphrasing in this document. The following acronyms are used here:
HCP = healthcare provider; FDA = Food and Drug Administration; OPDP =
FDA's Office of Prescription Drug Promotion.
(Comment 1) Five comments expressed support for conducting this
research.
(Response 1) Thank you.
(Comment 2) Three comments noted that changes to the research will
be necessary due to changes in medical conferences as a result of the
emergence of the COVID-19 pandemic, such as the move to all-virtual
conferences.
(Response 2) We agree with these comments. Section 1 of the
questionnaire (Video observation) is unaffected by whether participants
have recently attended a conference, so we have not changed this
section. Section 3 (Typical Conference Behaviors) is also unaffected by
recent conference attendance. However, we added an instruction that
participants should answer about their behavior prior to COVID-19
restrictions. Most of the questions in Section 4 (Participant
Characteristics) are unaffected by recent conference attendance.
However, we updated questions about patient load and prescription
volume to include both in-person and telemedicine visits. Section 2
(Recent Conference Behavior) does assume participants have recently
attended a conference. We have replaced some of the questions that are
less likely to be relevant (e.g., receipt of materials) with open-ended
questions asking about the exhibit hall experience and interactions
with pharmaceutical company representatives during a virtual
conference.
(Comment 3) One comment suggested adding a control arm comprised of
physicians who have not attended a medical conference during the same
period and asking them about their perceptions of the same products in
order to determine to what extent medical conferences are influencing
physician perceptions of products.
(Response 3) This comment is outside the scope of the current
research. Researchers may want to explore additional questions in this
area for future studies.
(Comment 4) One comment suggested that because the video is not
interactive, it may not capture all possible questions that a
conference attendee may have.
(Response 4) The comment is correct that the video consists of a
prerecorded interaction between a conference attendee and a booth
representative. We recognize that this does not cover all possible
communications at a conference. We appreciate the suggestion about the
use of interactive simulation, but it would disrupt the experimental
design by creating unnecessary variation in the stimuli. The
limitations of the current method will be transparent in the
dissemination of our findings.
(Comment 5) Two comments mentioned that, if we are concerned about
subject bias, differences in age, gender, and race/ethnicity between
the pharmaceutical representative and the prescriber in the video
should be controlled for.
(Response 5) The videos are identical in every way except for the
job description of the booth representative and whether a disclosure is
present to the data described. This means that not only are the actors
the same, but almost all footage in the video is the same.
Additionally, participants will be randomly assigned to experimental
conditions. Thus, age, gender, and race/ethnicity will not factor into
our assessment of whether a booth representative's job description or
the presence of a disclosure influences participant responses.
(Comment 6) Two comments cautioned FDA against drawing conclusions
about all promotional details based on survey responses for one video.
These comments suggested that FDA use multiple videos, rather than just
one, to depict different approaches to promotion and re-design the
study to conduct a post-conference message recall study to allow FDA to
better meet the objectives of the study.
(Response 6) The current study is largely a survey about medical
conference attendance in general and more specifically at a recent
conference. Our objective, as outlined in the text of the 60-day
notice, is to use those questions to assess self-reported opinions
about participants' experiences at a variety of conferences. Within the
study is an embedded experimental

[[Page 37164]]

manipulation to address two very specific questions: whether the
credentials of a booth representative make a difference in terms of the
observers' perceptions of the promoted product, and whether a
disclosure of information is processed by observers. In this part,
participants will see one of four videos that are identical except for
the credentials of the booth representative and the presence or absence
of a disclosure. FDA will not use the video to generalize beyond these
questions. Because participants will be randomly assigned to video
conditions, we will be able to make causal claims--but only about the
specific items (credentials and disclosure) we vary.
(Comment 7) One comment requested that we provide the public with
an opportunity to preview and comment on the videos to be used in
future research proposals.
(Response 7) 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. In our research proposals, we describe the
purpose of the study, the design, the population of interest, and the
estimated burden.
(Comment 8) One comment mentioned that although limiting
participants to those who respond to the survey within 7 days creates a
selection bias, it is a feasible method. The comment suggested that we
also screen for amount of time participants spent on the exhibit hall
floor, rather than relying on average numbers of hours spent at
exhibition halls.
(Response 8) We are limiting the sample to participants who
attended a medical conference within 7 days to minimize retrospective
errors that may occur as time passes. We appreciate the suggestion that
we add a question about how much time is spent at the exhibition hall,
and we have incorporated it into the questionnaire.
(Comment 9) One comment suggested that, given the international
scope of many conferences, the screener should ensure that HCPs
practice in the United States.
(Response 9) Our sample will be limited to U.S.-based HCPs with
prescribing authority.
(Comment 10) One comment suggested that specific knowledge of OPDP
regulatory requirements may be limited and, if known, it may increase
credibility of booth representatives. The commenter suggests adding
questions about regulatory knowledge.
(Response 10) Past OPDP studies have examined HCPs' familiarity
with promotional regulation (e.g., OMB control number 0910-0869). We
have consistently found that only a small percentage of providers know
whether FDA regulates prescription drug promotion, and we believe even
fewer would have specific knowledge of OPDP's particular regulatory
authorities. Given that we have investigated this topic in the past and
we find most providers to be unfamiliar with regulatory roles, we will
leave such questions out of the study to reduce burden.
(Comment 11) One comment suggested the inclusion of additional
questions about the perceived credibility of the booth representative,
the likelihood of recommending the prescription drug, or the desire to
conduct further inquiries for the product.
(Response 11) We have included questions about booth representative
credibility and intention to prescribe.
(Comment 12) One comment suggested that it would be useful to add
questions about the participants' backgrounds, such as familiarity with
prescription drug promotion, age, specialty, personal medical/
professional school debt, exposure to pharmaceutical marketing
practices, and whether they practice in an urban or rural area.
(Response 12) We have questions about age, medical specialty, and
exposure to pharmaceutical marketing practices. We will include a
question about the rural versus urban location of their practices. We
decline to ask about personal medical school debt because it is not
clear how this will influence pharmaceutical promotions in a conference
exhibit hall.
(Comment 13) One comment suggested adding questions about aspects
of promotional exhibit halls other than the booth representative.
(Response 13) This comment is outside the scope of the current
research. Researchers may want to explore additional questions in this
area for future studies.
(Comment 14) One comment noted that it would be helpful to track
whether advertisements outside of the exhibit hall encouraged providers
to visit certain booths within the exhibit halls.
(Response 14) This comment is outside the scope of the current
research. Researchers may want to explore additional questions in this
area for future studies.
(Comment 15) One comment recommended keeping the focus of Section 2
(recent conference behaviors) on general conference behaviors and
moving all product perception questions to Section 1.
(Response 15) Section 1 involves the specific manipulation of booth
representative credentials and the presence/absence of a disclosure.
Section 2 involves asking participants about a recent conference
experience. The advantage of this approach is that we can get more
specific information not influenced by retrospective guessing. The
opportunity to ask specific questions is one of the strengths of the
current study.
(Comment 16) One comment mentioned that the questions make use of
the term ``booth,'' while the Federal Register notice speaks to
``promotional booth'' and suggested that the survey questions use the
term ``promotional booth'' for clarity and consistency.
(Response 16) We have made this change.
(Comment 17) One comment mentioned that the questions use the term
``industry representative'' or ``drug representative'' and suggested
the survey employ the term ``industry representative'' exclusively to
ensure clarity and consistency.
(Response 17) We have revised the questionnaire to consistently use
the term ``industry representative.''
(Comment 18) One comment suggested we change the wording of
questions using the term ``exhibit hall'' to refer instead to
``promotional booths located in the exhibit hall,'' which is more
focused.
(Response 18) We have made this change.
(Comment 19) One comment suggested that for Questions 6-11, the
survey taker's responses can be influenced by other factors not
necessarily related to the content provided in the video, thus leading
to inconclusive results about the video presented.
(Response 19) Questions 6-11 refer to the experimental manipulation
in the video (see Response 6). Because we will have random assignment
to condition and the only differences in the videos will be the
credentials of the booth representative and the presence or absence of
a disclosure, we will be able to make causal claims if we see
differences in responses across conditions.
(Comment 20) One comment suggested that to eliminate the risk of
bias in the survey questions related to safety and efficacy, study
participants should be asked whether they think that the promoted drug
is safer and whether they think that the promoted drug is more
efficacious as compared to another drug.
(Response 20) This comment appears to refer to Questions 8 and 9.
These are

[[Page 37165]]

validated questions that have been used in previous studies (Ref. 10).
Development and validation of prescription drug risk, efficacy, and
benefit perception measures in the context of direct-to-consumer
prescription drug advertising. Research in Social and Administrative
Pharmacy). Moreover, the scale ranges from ``Strongly Agree'' to
``Strongly Disagree,'' so no bias is implied.
(Comment 21) One comment suggested that Questions 13 and 14 are
specific to one risk and that this risk may not pertain to all
situations, such as treatments for serious and life-threatening
conditions. The comment expressed confusion regarding how conclusions
from these questions can be applied to all drugs promoted at a
convention.
(Response 21) We specifically ask questions about this risk because
this is the risk that relates to the disclosure manipulation. These
questions will be used to determine if the presence of a disclosure
influences participants' responses to the relevant information in the
ad.
(Comment 22) One comment suggested that Questions 22 and 23 should
be reworded to define what part of the conference (poster session,
exhibit hall, oral sessions, etc.) the words ``conference sessions''
are referring to.
(Response 22) We have now specified ``oral and poster sessions'' in
these questions.
(Comment 23) One comment suggested that followup questions should
be added for participants that answer ``Yes'' to Question 24 as
follows:
What was the background of the person who made this presentation?
<bullet> Answer Options: Scientific background, Business
background.
What part of the conference was this presentation presented at?
<bullet> Answer Options: Symposia/Oral sessions, Workshops, Poster
sessions, Exhibit hall.
(Response 23) We considered adding these questions to the
questionnaire. However, after adapting the survey for a current and
post-COVID-19 world, these questions were ultimately not included so
that the information collection could stay within the proposed burden
estimate.
(Comment 24) One comment suggested that Question 30 should be
reworded so that it is specific to the particular types of materials
checked in Question 29.
(Response 24) We have removed Question 30 from the questionnaire
due to time constraints.
(Comment 25) One comment recommended the addition of a choice that
reads, ``met with the sales representative virtually,'' for Question
51, as this has been occurring more frequently during the COVID-19
pandemic.
(Response 25) This response option was added.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener...................................... 933 1 933 .08 (5 minutes)......................... 74.64
Pretest....................................... 25 1 25 .33 (20 minutes)........................ 8.25
Main test..................................... 368 1 368 .33 (20 minutes)........................ 121.44
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 204.33
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500) and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they also are available
electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without
asterisks are not on public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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. Mack, J. (2006, March). ``Effective Physician Marketing at
Medical Meeting Exhibits.'' Pharma Marketing News, 5(3).
2. * Industry Standard Report. (2014). ``Pharmaceutical Detailing:
In-Person vs. Electronic vs. Phone.'' Retrieved from <a href="https://www.isrreports.com/wp-content/uploads/2014/08/ISR-Pharmaceutical-Detailing-In-Person-vs.-Electronic-vs.-Phone-Preview-Aug2014.pdf">https://www.isrreports.com/wp-content/uploads/2014/08/ISR-Pharmaceutical-Detailing-In-Person-vs.-Electronic-vs.-Phone-Preview-Aug2014.pdf</a>.
3. * Steinman, M.A., G.M. Harper, M.M. Chren, et al. (2007, April).
``Characteristics and Impact of Drug Detailing for Gabapentin.''
PLoS Med, 4(4), e134. <a href="http://dx.doi.org/10.1371/journal.pmed.0040134">http://dx.doi.org/10.1371/journal.pmed.0040134</a>.
4. * Adler, D., Manager Marketing Analytics, A. Sherman, Client
Services, and M. Walz. (2017). ``Medical Conference Presence: Is it
Worth it for your Brand?'' Retrieved from <a href="https://www.pharmavoice.com/article/2017-9-medical-conferences/">https://www.pharmavoice.com/article/2017-9-medical-conferences/</a>.
5. * FDA. Warning letters and notice of violation letters to
pharmaceutical companies. Retrieved from <a href="https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies">https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies</a>.
6. Brock, T.C. (1965, June). ``Communicator-Recipient Similarity and
Decision Change.'' Journal of Personality & Social Psychology, 1,
650-654.
7. Braunsberger, K. and J.M. Munch (1998). ``Source Expertise Versus
Experience Effects in Hospital Advertising.'' Journal of Services
Marketing, 12(1), 23-38.
8. Siemens, J.C., S. Smith, D. Fisher, and T.D. Jensen (2008).
``Product Expertise Versus Professional Expertise: Congruency
Between an Endorser's Chosen Profession and the Endorsed Product.''
Journal of Targeting, Measurement and Analysis for Marketing, 16(3),
159-168.
9. Pechmann, C. (1992). ``Predicting When Two-Sided Ads Will Be More
Effective Than One-Sided Ads: The Role of Correlational and
Correspondent Inferences.'' Journal of Marketing Research, 29(4),
441-453.
10. Kelly, B.J., D.J. Rupert, K.J. Aikin, et al. (2021).
``Development and Validation of Prescription Drug Risk, Efficacy,
and Benefit Perception Measures in the Context of Direct-to-Consumer
Prescription Drug Advertising.'' Research in Social and
Administrative Pharmacy, 17(5), 942-955.

Dated: July 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14936 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on July 14, 2021.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.