80252 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

recommendations on supplemental 

biologics license application 125586/ 

546 from AstraZeneca AB, submitted to 

confirm the clinical benefit of Andexxa 

(coagulation factor Xa (recombinant), 

inactivated -zhzo), for patients treated 

with rivaroxaban or apixaban when 

reversal of anticoagulation is needed 

due to life-threatening or uncontrolled 

bleeding. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

November 14, 2024, will be provided to 

the Committee. Oral presentations from 

the public will be scheduled between 

approximately 1:10 p.m. and 2:10 p.m. 

Eastern Time on November 21, 2024. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, along with the names, email 

addresses, and direct contact phone 

numbers of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before 12 p.m. Eastern Time on 

November 6, 2024. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by 6 p.m. Eastern Time 

on November 8, 2024. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Cicely Reese at 

CBERCTGTAC@fda.hhs.gov (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22561 Filed 10–1–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3653] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Promotion of 

Prescription Drugs Within a Talk Show 

Format 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with a proposed 

study entitled ‘‘Promotion of 

Prescription Drugs Within a Talk Show 

Format.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 2, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

December 2, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80253 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–3653 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Promotion of Prescription Drugs Within 

a Talk Show Format.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAstaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Promotion of Prescription Drugs Within 

a Talk Show Format 

(OMB Control Number 0910—NEW) 

This information collection request 

supports Agency research authorized by 

section 1701(a)(4) of the Public Health 

Service Act (42 U.S.C. 300u(a)(4)) and 

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

Food, Drug, and Cosmetic Act (FD&C 

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

The mission of the Office of 

Prescription Drug Promotion (OPDP) is 

to protect the public health by helping 

to ensure that prescription drug 

promotion is truthful, balanced, and 

accurately communicated so that 

patients and healthcare providers can 

make informed decisions about 

treatment options. 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, 

focusing 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 the 

characteristics of the disease and 

product 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. Our focus on research quality 

aims at maximizing the quality of 

research data through analytical 

methodology development and 

investigation of sampling and response 

issues. This study will inform the first 

topic area, advertising features, by 

examining a form of advertising known 

as native advertising. 

Because we recognize that the 

strength of data and the confidence in 

the robust nature of the findings are 

improved through the results of 

multiple converging studies, we 

continue to develop evidence to inform 

our thinking. We evaluate the results 

from our studies within the broader 

context of research and findings from 

other sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

home page at https://www.fda.gov/ 

about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which 

includes links to the latest Federal 

Register notices and peer-reviewed 

publications produced by our office. 

The objective of this present research 

is to conduct experimental studies to 

examine issues related to endorsers in 

direct-to-consumer prescription drug 

promotion that occurs within a talk 

show format. This study complements 

and builds upon two prior FDA studies 

on endorsement issues (OMB control 

numbers 0910–0894 and 0910–0918). 

The first study examined a number of 

different endorser types in print or 

internet settings and focused on 

examining how various disclosures of 

the payment status of the endorser 

influenced audience reactions. The 

second study extended the prior 

research by examining, among other 


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80254 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

things, audience reactions to actual-use 

disclosures (e.g., ‘‘actor portrayal’’ 

versus ‘‘actual patient’’) in a different 

medium, television ads. The currently 

proposed study will focus on endorsers 

in a native advertising format (i.e., talk 

show). 

Native advertising is a form of 

advertisement where marketers present 

paid content in a format designed to 

look and feel like the surrounding 

media format and content in which it 

appears (Refs. 1 and 2). Native 

advertisements have become an 

increasingly popular form of 

advertising. In 2023, advertisers in the 

United States were expected to spend 

$97.46 billion on native display 

advertising in all product categories 

(showing a product in a combination of 

image, text, and graphics), accounting 

for 59.7 percent of total display 

advertising spending (Ref. 2). The intent 

of native advertising is to minimize the 

disruption in the consumer’s regular 

media intake experience (Ref. 3). 

Recently, FDA has issued compliance 

letters to pharmaceutical firms for 

misleading promotion of prescription 

drug products within talk show formats 

(Refs. 11 and 12). 

Research on the native advertising 

format extends the theoretical 

understanding of persuasion knowledge 

(Refs. 4 to 6) and advertisement 

recognition (Ref. 7) and has evaluated 

policy implications around deceptive 

advertising across different media 

platforms (Refs. 8 and 9). However, 

there has been less study of perceptions 

and attitudes resulting from native 

advertising, such as the impact on 

viewer perceptions toward the product, 

the advertisement, the endorser, or the 

interaction of these factors (Ref. 10). 

Moreover, the majority of research on 

native advertising appears to focus on 

advertorials in print or product 

placement (Refs. 1 to 7). In the 

literature, we did not find peerreviewed studies examining attitudes 

and perceptions in reaction to native 

advertising in a talk show format. 

In the research described here, we 

will investigate a native advertisement 

for a fictitious prescription drug for type 

2 diabetes embedded in a health-themed 

television talk show. This examination 

will help close the gap in the literature. 

We will examine the impacts of three 

independent variables—(1) sponsorship 

prominence (none, once, periodic, 

constant); (2) endorser type (the guest 

on the talk show: patient, physician); 

and (3) risk prominence (lower, 

higher)—on the recall and 

comprehension of risks and benefits 

depicted in the advertisement, 

perceptions of endorser characteristics, 

perceptions of drug qualities, and 

behavioral intentions. The four 

sponsorship prominence conditions will 

be: (1) no disclosure; (2) disclosure once 

at the beginning of the segment ([GUEST 

NAME] is a paid spokesperson for 

DRUG X); (3) periodic disclosure at the 

beginning, middle, and end of the 

segment (A reminder that [GUEST 

NAME] is a paid spokesperson for 

DRUG X); and (4) constant disclosure in 

text at the bottom of the screen through 

the entire segment ([GUEST NAME] is a 

paid spokesperson for DRUG X). The 

two endorser type conditions will vary 

by type of talk show guest: a patient or 

a physician. Studying sponsorship 

prominence and endorser type allows us 

to extend our prior research on 

endorsers in print and online promotion 

(OMB control numbers 0910–0894 and 

0910–0918) to native advertisements in 

a talk show format. Another factor that 

could affect whether viewers perceive a 

native advertisement for a prescription 

drug in a talk show format as 

advertising is the prominence of the risk 

disclosure. The two risk prominence 

conditions will vary by lower or higher 

prominence: (1) discussed in questionand-answer format during the interview 

or (2) text scroll with voiceover after the 

interview has concluded. 

To ensure that the study is operating 

as planned, we will conduct a pretest 

prior to launching the main study. Both 

the pretest and main study will use a 2 

× 4 × 2 factorial design (table 1). 

Through the use of an online survey, 

each respondent will view 1 of 16 

experimental variations of a fictitious 

health-themed television show. This 

base program will be consistent across 

experimental conditions and will 

feature content that blends health, 

wellness, and lifestyle topics. The target 

native advertisement segment will be 

embedded between the base program 

segments, varying across the three 

independent variables. 

Respondents will be recruited from 

web panels and include those who have 

been diagnosed with type 2 diabetes, 

live in the United States, and are fluent 

in English. Participation in the study is 

voluntary. We will not select 

respondents who work for the U.S. 

Department of Health and Human 

Services or a pharmaceutical, 

advertising, or market research 

company. 

TABLE 1—STUDY EXPERIMENTAL DESIGN

Sponsorship prominence 

Endorser type and risk prominence 

Patient guest Physician guest 

Higher risk 

prominence 

Lower risk 

prominence 

Higher risk 

prominence 

Lower risk 

prominence 

None. 

Once. 

Periodic. 

Constant. 

Following the video, respondents will 

be asked questions pertaining to their 

recall and comprehension of risks and 

benefits depicted in the advertisement, 

perceptions of endorser characteristics, 

perceptions of drug qualities, and 

behavioral intentions. 

We estimate the burden of this 

collection of information as follows: 


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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80255 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 2 Total hours 

Pretest 

Pretest Screener Completes .................................................................. 400 1 400 0.03 (2 minutes) ......... 12 

Pretest Questionnaire Completes .......................................................... 80 1 80 0.30 (18 minutes) ....... 24 

Main Study 

Main Study Screener Completes ........................................................... 3,200 1 3,200 0.03 (2 minutes) ......... 96 

Main Study Questionnaire Completes ................................................... 640 1 640 0.30 (18 minutes) ....... 192 

Total ................................................................................................ .......................... .......................... ........................ ..................................... 324 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format. 

References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

1. Wojdynski, B.W. and G.J. Golan, ‘‘Native 

Advertising and the Future of Mass 

Communication,’’ American Behavioral 

Scientist, vol. 60, pp. 1403–1407, 2016, 

https://doi.org/10.1177/ 

0002764216660134. 

2. King, J., ‘‘Native Advertising: What It Is 

and How It Benefits Advertisers and 

Publishers,’’ EMARKETER, October 11, 

2023. Available at: https://

www.emarketer.com/insights/native-adspending. Accessed on June 12, 2024. 

3. Campbell, C. and L.J. Marks, ‘‘Good Native 

Advertising Isn’t a Secret,’’ Business 

Horizons, vol. 58, pp. 599–606, 2015, 

https://doi.org/10.1016/ 

j.bushor.2015.06.003. 

4. Campbell, C. and P.E. Grimm, ‘‘The 

Challenges Native Advertising Poses: 

Exploring Potential Federal Trade 

Commission Responses and Identifying 

Research Needs,’’ Journal of Public 

Policy & Marketing, vol. 38, pp. 110–123, 

2019, https://doi.org/10.1177/ 

0743915618818576. 

5. Campbell, M.C. and A. Kirmani, 

‘‘Consumers’ Use of Persuasion 

Knowledge: The Effects of Accessibility 

and Cognitive Capacity on Perceptions of 

an Influence Agent,’’ Journal of 

Consumer Research, vol. 27, pp. 69–83, 

2000, https://doi.org/10.1086/314309. 

6. Wei, M.-L., E. Fischer, and K.J. Main, ‘‘An 

Examination of the Effects of Activating 

Persuasion Knowledge on Consumer 

Response to Brands Engaging in Covert 

Marketing,’’ Journal of Public Policy & 

Marketing, vol. 27, pp. 34–44, 2008, 

https://doi.org/10.1509/jppm.27.1.34. 

7. Pierre, L., ‘‘The Effect of Covert 

Advertising Recognition on Consumer 

Attitudes: A Systematic Review,’’ 

Journal of Marketing Communications, 

pp. 1–22, 2023, https://doi.org/10.1080/ 

13527266.2023.2184851. 

8. Hastak, M. and M.B. Mazis, ‘‘Deception by 

Implication: A Typology of Truthful but 

Misleading Advertising and Labeling 

Claims,’’ Journal of Public Policy & 

Marketing, vol. 30, pp. 157–167, 2011, 

http://www.jstor.org/stable/23209271. 

9. Cain, R.M., ‘‘Embedded Advertising on 

Television: Disclosure, Deception, and 

Free Speech Rights,’’ Journal of Public 

Policy & Marketing, vol. 30, pp. 226–238, 

2011, https://doi.org/10.1509/ 

jppm.30.2.226. 

10. Lee, S.S., H. Chen, and Y.-H. Lee, ‘‘How 

Endorser-Product Congruity and SelfExpressiveness Affect Instagram MicroCelebrities’ Native Advertising 

Effectiveness,’’ Journal of Product & 

Brand Management, vol. 31, pp. 149– 

162, 2022, https://www.emerald.com/ 

insight/content/doi/10.1108/JPBM-02- 

2020-2757/full/html. 

*11. Untitled Letter to Aclaris Therapeutics, 

Inc. (June 14, 2019). Available at: https:// 

www.fda.gov/media/128151/ 

download?attachment. 

*12. Untitled Letter to Biohaven 

Pharmaceuticals (March 8, 2021). 

Available at: https://www.fda.gov/media/ 

146528/download?attachment. 

Dated: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22575 Filed 10–1–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1105] 

Electronic Systems, Electronic 

Records, and Electronic Signatures in 

Clinical Investigations: Questions and 

Answers; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Electronic Systems, Electronic 

Records, and Electronic Signatures in 

Clinical Investigations: Questions and 

Answers.’’ The guidance provides 

information for sponsors, clinical 

investigators, institutional review 

boards (IRBs), contract research 

organizations (CROs), and other 

interested parties on the use of 

electronic systems, electronic records, 

and electronic signatures in clinical 

investigations of foods, medical 

products, tobacco products, and new 

animal drugs. The guidance provides 

recommendations regarding the 

requirements in our regulations, 

pursuant to which FDA considers 

electronic systems, electronic records, 

and electronic signatures to be 

trustworthy, reliable, and generally 

equivalent to paper records and 

handwritten signatures executed on 

paper. This guidance finalizes the draft 

guidance of the same title issued on 

March 16, 2023, and supersedes the 

guidance for industry entitled 

‘‘Computerized Systems Used in 

Clinical Investigations’’ issued in May 

2007. 


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