Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 78859 

redelegations, provided they are 

consistent with this reorganization. 

IV. Funds, Personnel, and Equipment. 

Transfer of organizations and functions 

affected by this reorganization shall be 

accompanied in each instance by direct 

and support funds, positions, personnel, 

records, equipment, supplies, and other 

resources. 

This reorganization will be effective 

upon date of signature. 

Authority: 42 U.S.C. 652 

Dated: December 1, 2020. 

Megan E. Steel, 

Office of the Executive Secretariat, 

Administration for Children and Families. 

[FR Doc. 2020–26778 Filed 12–4–20; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that DANYELZA 

(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research 

LLC., US Agent) meets the criteria for a 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Althea Cuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4061, FAX: 301–796–9856, 

email: althea.cuff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that DANYELZA 

(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research 

LLC., US Agent), meets the criteria for 

a priority review voucher. 

DANYELZA (naxitamab-gqgk) 

indicated, in combination with 

granulocyte-macrophage colonystimulating factor (GM–CSF), for the 

treatment of pediatric patients 1 year of 

age and older and adult patients with 

relapsed or refractory high-risk 

neuroblastoma in the bone or bone 

marrow who have demonstrated a 

partial response, minor response, or 

stable disease to prior therapy. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about DANYELZA 

(naxitamab) go to the ‘‘Drugs@FDA’’ 

website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: December 1, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26801 Filed 12–4–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–5900] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Endorser Status 

and Explicitness of Payment in Directto-Consumer Promotion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 6, 

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 Comment’’ or 

by using the search function. The title 

of this information collection is 

‘‘Endorser Status and Explicitness of 

Payment in Direct-to-Consumer 

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. 

For copies of the questionnaires 

contact: Office of Prescription Drug 

Promotion (OPDP) Research Team, 

DTCresearch@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. 

Endorser Status and Explicitness of 

Payment in Direct-to-Consumer 

Promotion 

OMB Control Number 0910—NEW 

I. Background 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission. Our 

research focuses in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 


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1A ‘‘non-celebrity influencer’’ is a person who 

has gained a following on a blog, a Twitter feed, or 

other social media outlet. In the 60-day notice, the 

term ‘‘influencer’’ was used; we have added 

language to specify influencers who were not 

previously celebrities before their social media 

activities. 

2For case allocation, the literature suggests that 

some proportion of consumers may not recall seeing 

the disclosure statement in the advertisement (see, 

for example, Boerman et al.; Ref. 3). Rather than 

allotting equal numbers of cases to each condition, 

we will assign more cases to the disclosure present 

condition to increase power in these cells. 

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 topic area, 

advertising features. 

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 (DTC) 

advertisements conducted in 1999. 

Advertisers have used celebrity 

endorsers for years, and DTC 

pharmaceutical promotion is no 

different. As researchers studied the 

influence of celebrity endorsers, they 

theorized that a correspondence bias 

occurs in which people believe that 

endorsers truly believe what they are 

saying. LaTour and Smith (Ref. 1) 

examined whether a pharmacist, 

physician, celebrity, or consumer would 

be most persuasive in advertisements 

for four different types of OTC products. 

They found that endorsements by expert 

physicians and pharmacists were the 

most likely to lead to purchase 

intentions, followed by endorsements 

by consumers, and lastly, by celebrities. 

The type of OTC product did not affect 

the persuasiveness of an endorsement. 

Bhutada and Rollins (Ref. 2) recently 

completed a study examining the role of 

endorser type (i.e., celebrity vs. expert 

vs. non-celebrity), and endorser and 

consumer gender in product DTC ads. 

They found, like LaTour and Smith (Ref. 

1), that expert endorsers were thought of 

as higher in credibility and generally 

resulted in the same amount of attention 

as celebrities. The authors did not find 

that endorsement by experts resulted in 

greater consumer intention to pursue 

the drug product. 

We propose to extend previous 

research by examining four types of 

endorsers in two separate studies 

(celebrity, physician, patient, noncelebrity influencer) 1 and examining 

whether the presence of a disclosure of 

their payment status influences 

participant reactions. We propose to 

also test two different types of 

disclosure language—one direct and 

more consumer-friendly, and one less 

direct. 

To complete this research, we propose 

the following concurrent studies.2

Study 1 

TABLE 1a—STUDY 1 DESIGN—PRETEST

[0.80 power, 0.10 alpha, small effect size f=.2] 

Payment disclosure 

Endorser 

Total 

Celebrity Physician Patient 

Present ............................................................................................................. 50 50 50 150 

Absent .............................................................................................................. 33 33 33 99

Total .......................................................................................................... 83 83 83 249 

TABLE 1b—STUDY 1 DESIGN—MAIN STUDY

[0.90 power, 0.05 alpha, small effect size f=.2] 

Payment disclosure 

Endorser 

Total 

Celebrity Physician Patient 

Present ............................................................................................................. 81 81 81 243 

Absent .............................................................................................................. 54 54 54 162 

Total .......................................................................................................... 135 135 135 405 

Study 1 will manipulate endorser 

type (three levels: Celebrity, physician, 

patient) and payment disclosure (two 

levels: Present, absent) within a print 

DTC ad for a fictitious acne product. For 

this study, we will recruit 654 general 

population individuals (249 pretest; 405 

main study) from the Kantar Lightspeed 

national nonprobability internet panel. 

All participants must report familiarity 

with the celebrity to be included in our 

study. The celebrity will be one who has 

publicly spoken out about acne. We are 

not divulging the identity of the 

celebrity in this public forum to 

maintain the integrity of our research 

process. Stock photos will be used to 

depict a physician and a patient in the 

other experimental conditions. 

Participants will be randomly assigned 

to see one of the endorsers and to see 

the ad either with or without a payment 

disclosure. The payment disclosure in 

Study 1 will be determined in cognitive 


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testing but will be similar to: ‘‘[Endorser] has been paid to appear in 

this ad for Drug X.’’ 

Study 2 

TABLE 2a—STUDY 2 DESIGN—PRETEST

[0.80 power, 0.10 alpha, small effect size f=.2] 

Payment disclosure 

Endorser 

Total 

Influencer Patient 

Present-Direct .............................................................................................................................. 50 50 100 

Present-Indirect ............................................................................................................................ 50 50 100 

Absent .......................................................................................................................................... 33 33 66 

Total ...................................................................................................................................... 133 133 266 

TABLE 2b—STUDY 2 DESIGN—MAIN STUDY

[0.90 power, 0.05 alpha, small effect size f=.2] 

Payment disclosure 

Endorser 

Total 

Influencer Patient 

Present-Direct .............................................................................................................................. 81 81 162 

Present-Indirect ............................................................................................................................ 81 81 162 

Absent .......................................................................................................................................... 54 54 108 

Total ...................................................................................................................................... 216 216 432 

In Study 2, we will also manipulate 

endorser type, examining a patient and 

an internet influencer, one who 

provides online content to a number of 

followers. We will also manipulate the 

explicitness of the payment disclosure, 

resulting in a 2 (endorser: Influencer, 

patient) by 3 (payment disclosure: 

Present-direct, present-indirect, absent) 

between-subjects design. The disclosure 

will be direct (e.g., ‘‘Paid ad. . .’’), 

indirect (e.g., #sp for ‘‘sponsored’’), or 

absent. The setting for this study will be 

an Instagram post for a fictitious 

endometriosis product. This study 

partially replicates Study 1 and extends 

it by further examining the explicitness 

of payment as another manipulated 

variable and using a different set of 

endorser types and in a different 

promotional setting. 

For Study 2, we will recruit 698 (266 

pretest; 432 main study) followers of an 

internet influencer who maintains an 

Instagram page with more than 500,000 

followers and has posted about 

endometriosis. As in the first study, we 

are not revealing the influencer’s 

identity in this public forum to maintain 

the integrity of the study. 

In both studies, we are interested in 

the role of endorsement and disclosure 

of payment status on participants’ 

recall, benefit and risk perceptions, and 

behavioral intentions. Participants will 

view one promotional piece and answer 

questions via the internet. The study is 

expected to take less than 20 minutes to 

complete. Dependent variables will 

include attention to disclosure 

statement and risk/benefit information; 

retention of risk/benefit information; 

recognition of piece as promotion and 

endorser as paid; perceived benefits and 

risks, attitudes toward the product, 

endorser, and ad; and behavioral 

intentions, such as asking a doctor about 

the drug. 

In the Federal Register of January 28, 

2020 (85 FR 4994), 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/docketBrowser

?rpp=25&po=0&dct=PS&D=FDA-2019- 

N-5900&refD=FDA-2019-N-5900-0001) 

was a brief statement of support for 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 

reflect the exact language used by the 

commenter. We assure commenters that 

the entirety of their comments was 

considered even if not fully captured by 

our paraphrasing in this document. The 

following acronyms are used here: DTC 

= direct-to-consumer; FDA and ‘‘The 

Agency’’ = Food and Drug 

Administration; OPDP = FDA’s Office of 

Prescription Drug Promotion; and FTC = 

Federal Trade Commission. 

(Comment 1) One comment suggested 

that the proposed research, at least in 

part, is duplicative of information 

otherwise reasonably available to FDA. 

The comment pointed out that the 

Notice cites three scientific references, 

and it does not address the other 

literature that exists on the subject of 

endorsers in advertising. The comment 

recommended that FDA assemble and 

review the relevant literature on 

endorsement to ensure the research 

questions have not already been 

answered. 

(Response) A literature review was 

conducted as part of this project that 

identified relevant literature. We 

identified a significant gap in the 

literature regarding the impact of social 

media influencers in prescription drug 

DTC advertisements, as well as a lack of 

information about the impact of explicit 

payment disclosure. The research 

questions outlined in our proposed 

research were designed to address this 

gap. 

(Comment 2) One comment suggested 

that, although the studies contain clear 

variables, they appear to lack clearly 

defined primary outcomes and 

prespecified hypotheses for testing. The 

comment also noted that the studies do 

not appear to be designed to account for 

Type I error; thus, the results may be 

uninterpretable. The comment 

recommended that FDA propose a 

primary endpoint for each study and 

power each study to test it. 

(Response) Specific hypotheses have 

been developed for each of the outcome 

variables, as described earlier in the 

notice. We will adjust for multiple 

comparisons using the Bonferroni 

correction. 


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(Comment 3) One comment suggested 

that it is unclear how FDA came up 

with the proposed sample sizes for the 

two related studies. For example, the 

comment stated that the chart for pretest 

1 contains the following notation: ‘‘(0.80 

power, 0.10 alpha, small effect size 

f=.2),’’ but it is unclear what f=.2 means 

in this context. The comment requested 

that FDA explain what statistical model 

it used to estimate the study size and 

how it determined that the relevant 

effect size is .2. 

(Response) f=.2 is a common standard 

used to calculate small effect size in 

experimental studies (Ref. 4). We used 

G*Power to estimate study size (Ref. 5). 

(Comment 4) One comment suggested 

that the proposed research is 

unnecessary to the proper performance 

of FDA’s functions because the FTC 

takes the lead on regulating 

endorsement. The comment stated that 

FDA has not addressed the extensive 

framework and guidance available from 

the FTC on this topic. The comment 

further stated that, although use of an 

endorser might conceivably inform an 

assessment of whether advertising or 

promotion is false or misleading, it is 

not clear how FDA views this new 

research on endorser status as fitting 

into its core regulatory jurisdiction or 

activities. 

(Response) FDA and the FTC have a 

long history of working collaboratively 

to protect American consumers. While 

the FTC does regulate endorsement in 

many types of commercial 

advertisements, FDA has authority to 

regulate prescription drug advertising 

with respect to the safety and 

effectiveness of such drugs. In line with 

FDA’s responsibility to ensure that 

prescription drug advertising and other 

promotional communications are 

truthful and non-misleading, the present 

research will provide data on how 

elements related to endorsement 

presentations in prescription drug 

promotion impact audience perception 

and comprehension. Collecting this data 

is critical to FDA’s science-based 

approach to assessing prescription drug 

promotion to determine whether it 

communicates information about 

prescription drugs to consumers in a 

truthful, non-misleading way. We note 

that as part of the process of developing 

the present research, FDA carefully 

evaluated the FTC guidance on endorser 

issues. 

(Comment 5) One comment 

recommended that alignment and input 

should be obtained from the FTC 

regarding the design of the study and 

usability of the results. 

(Response) We evaluated the current 

FTC guidance on endorsement 

disclosure when developing this study 

and all relevant elements of its design, 

including our hypotheses, test stimuli, 

etc. 

(Comment 6) One comment suggested 

that the research may be skewed by the 

influence of a particular celebrity. The 

comment recommended that the study 

be amended so it is not subject to bias 

by the influence of one particular wellknown celebrity. 

(Response) Familiarity with an 

endorser has shown to be an important 

factor in attention to DTC 

advertisements, but the evidence is less 

strong that familiarity uniquely affects 

other outcomes such as behavioral 

intention (see, for example, Refs. 2 and 

6). The celebrity used in Study 1 will 

have high levels of public recognition, 

so we anticipate few participants will be 

filtered out due to low levels of 

familiarity with endorser. We recognize 

that the individual characteristics of the 

celebrity may drive responses. This 

possibility is an unavoidable limitation 

of the study design, and we will be 

transparent when reporting results. 

(Comment 7) One comment 

recommended that FDA use #ad instead 

of #sp. The comment noted that FTC has 

stated that #ad is an effective disclosure 

of sponsorship. 

(Response) Our review of current 

practices shows that vendors continue 

to indicate endorsement by #sp online. 

An indirect disclosure such as #sp 

serves as a useful comparator to a direct 

disclosure such as ‘‘Paid ad. . .’’, 

helping us answer the research question 

of whether direct and indirect 

acknowledgements of endorsement vary 

in their influence on attitudes and 

perceptions. 

(Comment 8) One comment 

recommended that FDA incorporate 

some type of control into each study. 

(Response) We have designed these 

studies to include a control. The 

control, in both studies, is a duplicate 

version of the promotion featuring 

endorsement by a patient, as opposed to 

a celebrity or influencer, without 

inclusion of a payment disclosure. 

(Comment 9) One comment suggested 

that FDA should ensure that the 

hypothetical products used in the 

proposed surveys do not too closely 

resemble real products. For example, 

the conditions of use and the risk of the 

hypothetical products should not mirror 

FDA-approved labeling language for any 

marketed products. In addition, FDA 

should only present hypothetical drug 

advertisements for diseases with many 

treatment options from multiple 

sponsors. Otherwise, the comment 

states that FDA’s research could 

inadvertently harm one particular 

sponsor. 

(Response) The prescription drugs 

used in this study, while based on 

existing prescription treatments, are 

fictitious with names and branding that 

do not mirror any marketed products. 

Although we have created the pieces to 

be as realistic as possible, FDA does not 

intend to single out any real product on 

the basis of our fictional promotion. We 

specifically use fictitious products and 

materials to avoid the confound of prior 

knowledge of actual products. 

Moreover, it is the endorser type and 

messaging around the endorsement 

disclosure that are being investigated. 

The fictional drug is not a study variable 

and therefore is held constant. 

(Comment 10) One comment 

suggested that the route of drug 

administration may influence the 

participants’ responses, as oral 

administration and inhaled medication 

is preferable compared to injections. 

Therefore, the comment suggested that 

the study use fictitious drugs with 

routes of administration that are similar 

to top advertised DTC prescription 

drugs. 

(Response) This is outside the scope 

of study objectives. The goal of the 

studies is to understand the effect of 

endorsement and payment disclosure on 

perceived risks and benefits of DTC 

promotion. Because the same drug is 

being presented in each experimental 

condition, the effects of mode of 

administration are being held constant 

in each study; therefore, any observed 

effects are not related to the route of 

administration chosen. 

(Comment 11) One comment 

suggested that in order to increase 

internal validity, the location of the 

disclosures in the promotional pieces 

should be consistent across endorser 

and/or disclosure type. 

(Response) FDA will ensure that for 

each study, disclosures will appear in 

the same area of the promotional piece, 

using similar font and style treatment. 

(Comment 12) One comment 

suggested that acne and endometriosis 

drugs are not representative of the top 

advertised prescription drugs and that 

the current proposed study design, 

therefore, may not represent the most 

advertised DTC drugs in the market. 

(Response) The purpose of the studies 

is to understand the effect of 

endorsement and payment disclosure on 

perceived risks and benefits of DTC 

promotion. The value of our approach is 

random assignment to experimental 

conditions and control of extraneous 

variables. Choice of drug is not a study 

variable and therefore held constant. 

Although the type of drug may play a 


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role in the perceptions of risks and 

benefits, the value of our study is the 

comparisons between experimental 

conditions. 

(Comment 13) Two comments 

suggested that participants’ 

unfamiliarity with the proposed 

conditions may bias their responses, so 

it may be more useful to include only 

patients with the condition as 

participants in each study. 

(Response) The study population is 

those who are exposed to prescription 

drug advertisements. For Study 1, we 

chose a high incidence condition (acne) 

so that it would be relatable to a large 

segment of the population. Regardless of 

whether or not the condition is 

personally salient, the public is still 

exposed to these advertisements. 

For Study 2, we chose a condition 

that is important to the influencer in the 

study—and this information would be 

known to many of her followers, who 

are the research audience for Study 2. 

Engagement and e-Word of Mouth have 

been shown to be important behavioral 

outcomes from social media promotion 

(Ref. 3). Thus, in a real-world setting, 

audience members may choose to 

comment on or share the advertised 

content with family or friends, 

regardless of whether or not they have 

the health condition themselves. 

For both studies, we ask about 

personal experience and involvement 

with the health condition, and we will 

assess whether these variables have any 

effects. 

(Comment 14) One comment 

suggested ensuring that neutral language 

is used when recruiting for Study 1’s 

general population, so as not to select 

for participants that are more 

susceptible to the celebrity’s influence. 

For example, the comment suggested 

that the study ask participants if they 

‘‘recognize’’ the celebrity vs. if they are 

a ‘‘fan’’ of the celebrity. 

(Response) In screeners for both 

studies, we ask if participants are 

‘‘familiar’’ with celebrities/influencers, 

thus maintaining neutral language. 

(Comment 15) Two comments 

suggested participants’ familiarity with 

the endorser may bias responses and 

limit participant demographics. One 

comment suggested that recruiting 

participants from the follower list of an 

Instagram influencer, as proposed in 

Study 2, may skew the average age of 

the participants to be younger, 

especially if the influencer chosen for 

this study is a ‘‘handheld name’’ versus 

a ‘‘household name.’’ The comment also 

suggested that the participants may have 

a female skew. Another comment 

suggested that the current inclusion 

criteria should be expanded to also 

include followers of influencers with 

similar content, recognition, and 

follower demographics as the endorser 

being tested, which will increase 

external validity by encompassing 

viewers that would likely see the post 

through suggestions via Instagram’s 

algorithm. 

(Response) Familiarity with an 

endorser has been shown to be an 

important factor in attention given to 

DTC advertisements (Ref. 2), and that is 

one driver of an influencer’s value as an 

endorser. By including endorser type as 

an experimental condition, we seek to 

isolate these effects. Thus, the biases 

inherent in these relationships are a 

necessary aspect of this topic area. 

The study design is a betweensubjects design. Because participants are 

only exposed to one promotional piece, 

the specific effects from behavioral bias 

can be isolated. 

We agree with the commenter that 

Study 2 will have a younger, female 

skew. This is consistent with 

Instagram’s audience more generally 

(Ref. 7). Advertisers who use Instagram 

influencers as endorsers will access the 

same audience (i.e., Instagram 

followers) as in our study. To minimize 

confounds, we will limit the sample to 

the influencer’s followers, who are 

likely to be the most influenced by her. 

Future research can be conducted on 

whether our findings extrapolate to men 

and older audiences. 

(Comment 16) One comment 

suggested that to account for the 

potential bias in these studies, it would 

be useful to include questions relating 

to participant demographics in the 

surveys, such as age, gender, and 

attitude toward the celebrity or 

influencer, if they are not already 

included. 

(Response) The survey includes 

questions about participant 

demographics and attitude toward 

endorser. 

(Comment 17) One comment 

suggested that in order to prevent bias, 

the study should exclude consumers 

who work in healthcare or marketing 

settings, primary care providers that 

spend less than 50 percent of their time 

on patient care, and Department of 

Health and Human Service employees. 

(Response) The studies in this 

research do not include physician 

participants. Consumers will be 

excluded if they work for a 

pharmaceutical company, an advertising 

agency, a market research firm, or the 

U.S. Department of Health and Human 

Services. They will also be screened out 

if they are not familiar with the 

celebrity/influencer, and, for Study 2, if 

they are biologically male, as men 

cannot have endometriosis. 

(Comment 18) One comment 

suggested that the questionnaire is too 

long and recommended deleting 

questions or rewording. 

(Response) We have had individuals 

unfamiliar with the study test the 

survey for length, and we found it takes 

less than 20 minutes to complete. 

Moreover, we will also conduct 

pretesting to check timing and make 

adjustments, if necessary, based on the 

data from those pretests. 

(Comment 19) One comment 

suggested we should consistently use 

balanced Likert scales with a neutral 

midpoint. 

(Response) This is a matter of debate 

in the literature and has never been 

resolved. Many of our measures derive 

from previously validated scales, and 

we prefer to maintain the scales on 

which they were validated. However, 

where appropriate, we do use 5-point 

Likert scales with a neutral midpoint. 

(Comment 20) One comment 

recommended rewording Q17 (in both 

study questionnaires) to state ‘‘What do 

you remember about the safety 

information presented?’’ 

(Response) Q17 is a validated (OMB 

control number 0910–0861) closedended item asking how much risk 

information was read (with a thumbnail 

image highlighting the important safety 

information). In order to increase 

quality of response, we will keep the 

closed-ended item. Moreover, openended questions take longer to answer, 

and we want to maintain an appropriate 

length of time to complete the survey. 

(Comment 21) One comment 

suggested that the adjectives that the 

respondent is asked to rank in Q18a– 

Q18e (Study 1) are redundant with only 

nuanced differences that may not be 

distinguishable to respondents, and 

therefore suggested these items be 

deleted. If they are retained, the 

comment suggested labeling answer 

choice #3 with ‘‘Neither unimportant 

nor important.’’ 

(Response) These items were adapted 

from Zaichowsky’s Disease State 

Involvement scale (Ref. 8). The original 

validated items used a 7-point scale 

without a labeled midpoint. To be 

consistent with most of the items and 

with previous comments, we reduced 

the scale to 5 points. However, we did 

not include a labeled midpoint because 

it could result in under-response for 

values 2 and 4. This response applies to 

Q20 (Study 2) as well, where we want 

to ensure that individuals taking Study 

2 on their mobile devices are not 

overwhelmed. 


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78864 Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 

(Comment 22) One comment 

suggested that Q20 and Q21 (Study 1) 

may be redundant, and since Q20 uses 

more consumer-friendly language to 

seek respondent opinion on 

effectiveness of drug, the comment 

recommended removing Q21. This 

comment also applies to Q22 and Q23 

of Study 2. 

(Response) We will remove Q21 

(Study 1) and Q23 (Study 2). 

(Comment 23) One comment 

recommended that Q22 (Study 1) be 

framed differently to help understand 

how endorsers influence the 

understanding of safety and risk and 

that the answer choice should have an 

option for respondents who do not 

know. 

(Response) We decline to make the 

recommended change because this is a 

validated item that FDA has used in 

past survey experiments to measure 

perceived risk likelihood. 

(Comment 24) One comment 

questioned the utility of asking whether 

an endorser is ‘‘Attractive,’’ ‘‘Classy,’’ 

and ‘‘Elegant’’ (Q30, Study 1); whether 

a drug name and endorser name ‘‘go 

together’’ (Q31, Study 1); and how a 

subject feels about the life and values of 

the endorser (Q32, Study 1). The 

comment recommended that FDA 

consider deleting these questions. 

(Response) In the marketing literature 

on celebrity endorsements, these three 

elements are well established as 

important moderators in attitude toward 

advertisement and behavioral intention. 

‘‘Attractive,’’ ‘‘Classy,’’ and ‘‘Elegant’’ 

are elements in a 15-item scale validated 

by Ohanian (1990) to measure endorser 

credibility (Ref. 9). The literature refers 

to ‘‘whether a drug name and endorser 

go together’’ as ‘‘product match-up’’ 

(Ref. 10), and high match-up was 

recently shown to be predictive of 

behavioral intention for e-cigarettes 

(Ref. 11). The level of identification that 

consumers have with a celebrity 

endorser has been shown to influence 

how consumers attend to and process 

information in an advertisement (Refs. 

12 and13). Thus, we will maintain these 

questions. 

(Comment 25) One comment 

suggested that, if the research is 

intended to assess the influence of 

endorsers or their payment status, Q15– 

Q17 in both surveys and Q20–Q27 for 

Study 1 and Q22–Q29 for Study 2 

appear to be outside of the scope. With 

these questions, subjects would be 

asked to assess the risks and benefits of 

a drug based on an advertisement. The 

comment recommended that FDA delete 

these questions or revise them so they 

are focused instead on payment or 

endorsement. 

(Response) As part of the examination 

of the effect of the endorser, one 

purpose of the study is to understand 

the effect of endorsement and payment 

disclosure in DTC promotion on 

perceived risks and benefits of a 

prescription drug. The questions 

mentioned in this comment measure 

these dependent variables—consumer 

perceptions of risk and benefit 

information presented in the promotion. 

We will maintain these questions in 

order to assess if endorsement and the 

payment disclosure have any effects on 

perceptions of risk and benefit 

information. 

(Comment 26) One comment 

suggested that the structure of Q28 

(Study 1) and Q30 (Study 2) should be 

consistent with other questions in this 

survey. It recommended changing each 

question to include ‘‘What is the 

likelihood’’ (e.g., What is the likelihood 

that you would ask your doctor to 

prescribe) and presenting answer 

choices in a 5-point Likert scale. 

(Response) We will assess how this 

item functions in pretesting and make 

any change that is warranted. 

(Comment 27) One comment 

suggested moving Q28a (Study 1) and 

Q30a (Study 2) up in the survey, after 

Q13, as this question could function as 

a priming question after initial viewing 

of ad. 

(Response) Because this item is part of 

a validated scale (Ref. 14), we will 

maintain it at its current location in 

both surveys. 

(Comment 28) One comment 

suggested that Q31 (Study 1) and Q33 

(Study 2) construct and answer choices 

should align with other similarly 

constructed question and answer 

choices in this section of the survey. 

(Response) This is a validated item 

(Ref. 15) to measure endorser-product 

match-up. Therefore, we will maintain 

the current format. 

(Comment 29) One comment 

suggested that Q33 (Study 1) and Q35 

(Study 2) could cause respondent 

confusion regarding what is meant by 

‘‘background,’’ which could lead to 

uninterpretable results. It recommended 

explicitly stating what is meant by 

‘‘background’’ (e.g., ‘‘I prefer a product 

recommended by an endorser because of 

his/her experience with this illness’’). 

(Response) This is a validated item 

(Ref. 16) that measures identification 

with endorser; thus, we will maintain 

its original form in both studies. 

(Comment 30) One comment 

mentioned that Q43–Q45 (Study 1) and 

Q45–Q47 (Study 2) probe the level of 

influence that endorsers have over 

respondents and suggested adding a 

question asking if the respondent has 

followed the advice of an endorser. 

(Response) Q36–Q48 (Study 1) and 

Q45–47 (Study 2) are validated items in 

the celebrity-persona parasocialinvolvement scale (Ref. 17); thus, we 

will maintain the integrity of the scale 

and not add another question in this 

series. 

(Comment 31) One comment 

suggested that the debriefing statements 

in both questionnaires may serve the 

respondent better if placed earlier in the 

document as a disclaimer and suggested 

placing the disclaimer language prior to 

showing the promotional piece. 

(Response) To maximize the attention 

participants give to this survey task, we 

do not wish to inform them of the 

information in the debriefing statement 

until they have completed the survey. 

(Comment 32) One comment 

suggested that Q18 and Q19 (Study 2) 

are redundant, although respondents 

may not define a paid endorser post as 

advertising, and that the items seem 

irrelevant. It recommended removing 

Q18 from the questionnaire. 

(Response) Previous experimental 

studies on social media promotion have 

found that participants did not 

consistently notice a payment 

disclosure or interpret a sponsored post 

as advertising (Ref. 1). These issues are 

central to the question of whether 

consumers process payment disclosures. 

Moreover, participants in cognitive 

testing distinguished between the two 

items. 

(Comment 33) One comment noticed 

that Q20 in Study 2 is similar to Q18 in 

Study 1; however, answer choices are 

not provided in a similar construct. The 

comment recommended utilizing a 5- 

point Likert scale to measure the 

outcome. 

(Response) We simplified the 

response scale for Study 2 items, where 

possible, to account for anticipated 

higher usage of mobile devices. Because 

we prefer a larger number of response 

options in general, we plan to maintain 

the 5-point Likert scale for Study 1, but 

use the 3-point scale in Study 2 to 

account for mobile devices. 

(Comment 34) One comment 

suggested that Q24 (Study 2) could be 

framed differently to help understand 

how endorsers influence the 

understanding of safety and risk. The 

comment recommended asking ‘‘Do you 

recall the risk associated with the 

medication?’’ and suggested that the 

answer choice should have an option for 

respondents who do not know. 

(Response) Q24 and Q25 from Study 

2 are closed-ended questions that ask 

about recall of drug benefits and risks. 

To be balanced, the question stem and 


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Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 78865 

response options should be parallel 

between the two items. Moreover, we 

cannot add additional open-ended 

questions to the survey without 

increasing participant fatigue. Thus, we 

will maintain the closed-ended nature 

of the question. We recognize that this 

will be a difficult question for 

participants, and therefore, we prefer 

not to provide an option for ‘‘don’t 

know.’’ 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Study 1 Screener .............................. 933 1 933 0.08 (5 minutes) ............................... 74.64 

Study 1 Pretest ................................. 249 1 249 0.33 (20 minutes) ............................. 82.17 

Study 1 Main Test ............................. 405 1 405 0.33 (20 minutes) ............................. 133.65 

Study 2 Screener .............................. 1,417 1 1,417 0.08 (5 minutes) ............................... 113.36 

Study 2 Pretest ................................. 266 1 266 0.33 (20 minutes) ............................. 87.78 

Study 2 Main Test ............................. 432 1 432 0.33 (20 minutes) ............................. 142.56 

Total ........................................... ........................ ........................ ........................ ........................................................... 634.16 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

II. References 

The following references are on 

display with 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; these are 

not available electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. 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. LaTour, C. and M. Smith (1986). ‘‘A Study 

of Expert Endorsement of OTC 

Pharmaceutical Products.’’ Journal of 

Pharmaceutical Marketing & 

Management, vol. 1(2), pp. 117–128. 

2. Bhutada, N.S. and B.L. Rollins (2015). 

‘‘Disease-Specific Direct-to-Consumer 

Advertising of Pharmaceuticals: An 

Examination of Endorser Type and 

Gender Effects on Consumers’ Attitudes 

and Behaviors.’’ Research in Social 

Administrative Pharmacy, vol. 11(6), pp. 

891–900. 

3. Boerman, S.C., L.M. Willemsen, and E.P. 

Van Der Aa (2017). ‘‘ ‘This post is 

sponsored’: Effects of Sponsorship 

Disclosure on Persuasion Knowledge and 

Electronic Word of Mouth in the Context 

of Facebook.’’ Journal of Interactive 

Marketing, vol. 38, pp. 82–92. 

4. Cohen, J. (1988), ‘‘Statistical Power 

Analysis for the Behavioral Sciences.’’ 

Routledge. ISBN 978–1–134–74270–7. 

5. Faul, F., E. Erdfelder, A.G. Lang, et al. 

(2007). ‘‘G*Power 3: A Flexible 

Statistical Power Analysis Program for 

the Social, Behavioral, and Biomedical 

Sciences.’’ Behavior Research Methods, 

vol. 39, pp. 175–191. 

6. Woods, C.B., S. Baxter, E. King, et al. 

(2017). ‘‘Celebrity? Doctor? Celebrity 

doctor? Which Spokesperson Is Most 

Effective for Cancer Prevention?’’ In E. 

Kendal and B. Diug (Eds.) Teaching 

Medicine and Medical Ethics Using 

Popular Culture (pp. 71–98). Palgrave 

Studies in Science and Popular Culture. 

Cham, Switzerland: Palgrave Macmillan. 

doi:10.1007/978–3–319–65451–5_5. 

7. https://www.statista.com/statistics/ 

398166/us-instagram-user-agedistribution/. 

8. Zaichkowsky, J.L. (1994). ‘‘The Personal 

Involvement Inventory: Reduction, 

Revision, and Application to 

Advertising.’’ Journal of Advertising, vol. 

23(4), pp. 59–70. 

9. Ohanian, R. (1990). ‘‘Construction and 

Validation of a Scale to Measure 

Celebrity Endorsers’ Perceived Expertise, 

Trustworthiness, and Attractiveness.’’ 

Journal of Advertising, vol. 19(3), pp. 39– 

52. 

10. Kamins, M.A. and K. Gupta (1994). 

‘‘Congruence Between Spokesperson and 

Product Type: A Matchup Hypothesis 

Perspective.’’ Psychology & Marketing, 

vol. 11(6), pp. 569–586. 

11. Phua, J., J.S.E. Lin, and D.J. Lim (2018). 

‘‘Understanding Consumer Engagement 

with Celebrity-Endorsed E-Cigarette 

Advertising on Instagram.’’ Computers in 

Human Behavior, vol. 84, pp. 93–102. 

12. Brown, W.J. and M.C. Bocarnea (2007). 

‘‘Celebrity-Persona Interaction Scale.’’ In 

R.A. Reynolds, R. Woods, and J.D. Baker 

(Eds.) Handbook of Research on 

Electronic Surveys and Measurements 

(pp. 302–305). Hershey, PA: Idea Group 

Reference. 

13. Brown, W.J. and M.A.C. De Matviuk 

(2010). ‘‘Sports Celebrities and Public 

Health: Diego Maradona’s Influence on 

Drug Use Prevention.’’ Journal of Health 

Communication, vol. 15(4), pp. 358–373. 

14. Huh, J., D.E. DeLorme, and L.N. Reid 

(2005). ‘‘Factors Affecting Trust in OnLine Prescription Drug Information and 

Impact of Trust on Behavior Following 

Exposure to DTC Advertising.’’ Journal 

of Health Communication, vol. 10(8), pp. 

711–731. 

15. Till, B.D. and M. Busler (2000). ‘‘The 

Match-Up Hypothesis: Physical 

Attractiveness, Expertise, and the Role of 

Fit on Brand Attitude, Purchase Intent 

and Brand Beliefs.’’ Journal of 

Advertising, vol. 29(3), pp. 1–13. 

16. Biswas, D., A. Biswas, and N. Das (2006). 

‘‘The Differential Effects of Celebrity and 

Expert Endorsements on Consumer Risk 

Perceptions: The Role of Consumer 

Knowledge, Perceived Congruency, and 

Product Technology Orientation.’’ 

Journal of Advertising, vol. 35(2), pp. 17– 

31. 

17. Bocarnea, M.C. and W.J. Brown (2007). 

‘‘Celebrity-Persona Parasocial Interaction 

Scale.’’ In R.A. Reynolds, R. Woods, and 

J.D. Baker (Eds.) Handbook of Research 

on Electronic Surveys and Measurements 

(pp. 309–312). Hershey, PA: Idea Group 

Reference. 

Dated: December 1, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26799 Filed 12–4–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[19X.LLAK930000.L13100000. EI0000.241A] 

Notice of 2021 Coastal Plain Alaska Oil 

and Gas Lease Sale and Notice of 

Availability of the Detailed Statement 

of Sale 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Notice of sale. 

SUMMARY: The Bureau of Land 

Management (BLM) Alaska State Office 

will hold an oil and gas lease sale bid 

opening for tracts in the Coastal Plain of 

the Arctic National Wildlife Refuge. 

DATES: The oil and gas lease sale bid 

opening will be at 10 a.m. Alaska 

Standard Time (AKST) on January 6, 


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