Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Conference Attendees' Observations About Prescription Drug Promotion, 37160-37165 [2021-14936]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37160-37165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 ``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, 
[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.

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: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website 
includes links to the latest Federal Register notices and peer-reviewed 
publications produced by our office. The website maintains information 
on studies we have conducted, dating back to a survey 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:
     High number of currently promoted branded medications;
     high volume of prescriptions written;
     large patient population; and
     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 (https://www.regulations.gov/document/FDA-2020-N-1644-0005) 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?
     Answer Options: Scientific background, Business 
background.
    What part of the conference was this presentation presented at?
     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 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. 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 https://www.isrreports.com/wp-content/uploads/2014/08/ISR-Pharmaceutical-Detailing-In-Person-vs.-Electronic-vs.-Phone-Preview-Aug2014.pdf.
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. https://dx.doi.org/10.1371/journal.pmed.0040134.
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 https://www.pharmavoice.com/article/2017-9-medical-conferences/.
5. * FDA. Warning letters and notice of violation letters to 
pharmaceutical companies. Retrieved from https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies.
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