37160 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 

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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Loss, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0619, 

christopher.loss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

30, 2019 (84 FR 51594), FDA published 

the notice of availability for a draft 

guidance entitled ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs’’ giving interested 

persons until January 28, 2020, to 

comment on the draft guidance. FDA 

received a few comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. Editorial changes were made 

to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated September 2019. 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on eligibility criteria 

for expanded conditional approval of 

new animal drugs. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: July 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14938 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

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, PRAStaff@

fda.hhs.gov. 

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 


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Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 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/officeofmedicalproducts

andtobacco/cder/ucm090276.htm. The 

website includes links to the latest 

Federal Register notices and peerreviewed 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 


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37162 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 

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. 

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 


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Exhibit 1. Sampling Frame and Participant Recruitment Process . 

Conference Sampling Frame 

Attendee Sampling Frame 

Participant Recruitment and 

Enrollment 

Step 1. Select Priority Therapeutic Areas -----*. Step 2. Conduct Environmental Scan of Conferences 

Step 3. Apply Conference 1:ligibility Criteria 

Step 4. Select Conferences for Sampling/Recruitment 

·---....... ~ 

Step 5. Develop Conference Attendee Erigibility Criteria: 

Step ti. Characterize the Attendee Sampling Frame 

· Step.7. Create and Place Recruitment Advertisements 

1---,...1 Step 8Aicreen Potential Participants 

Step 9.Randomly AssigrrParticipants to· Experimental 

Conditions 
Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 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

Disclosure 

Booth employee background 

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/FDA2020-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 


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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 


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Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 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 lifethreatening 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 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response 

Total 

hours 

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 

1There 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-PharmaceuticalDetailing-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. http://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/enforcementactivities-fda/warning-letters-and-noticeviolation-letters-pharmaceuticalcompanies. 

6. Brock, T.C. (1965, June). ‘‘CommunicatorRecipient 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 


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