Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 84889 

necessary information, prepare, and 

submit to FDA. We estimate that 

sponsors with inactive applications will 

spend 2 hours preparing their annual 

antimicrobial animal drug sales and 

distribution reports, whether 

electronically or on paper. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Recordkeeping required by section 512(l)(3) of the FD&C 

Act .................................................................................... 23 1 23 2 46 

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

Animal drug manufacturers are 

already required to maintain 

distribution records for their animal 

drug products to comply with FDA’s 

current good manufacturing regulations 

for periodic drug reports under 

§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), 

approved under OMB control number 

0910–0284. Section 512(l)(3) of the 

FD&C Act differs from § 514.80(b)(4)(i) 

in that it requires that records include 

separate information for each month of 

the calendar year. In addition, under 21 

CFR 211.196 (approved under OMB 

control number 0910–0139), 

manufacturers currently are required to 

maintain distribution records that 

include dosage form, and date drug is 

distributed. Based on these 

requirements, FDA believes that 

manufacturers already keep detailed 

records of the dates when antimicrobial 

drugs are distributed for marketing and 

recall purposes from which monthly 

reports can be prepared as part of usual 

and customary business practices. 

However, FDA estimates an additional 

recordkeeping burden of 46 hours for 

further compliance with section 

512(l)(3), as detailed in table 2. 

After a review of the information 

collection since our last request for 

OMB approval, we have adjusted our 

estimates based on our experience with 

the antimicrobial animal drug 

distribution reports program. Our 

estimated burden for the information 

collection reflects a decrease of 54 

burden hours and a corresponding 

decrease of 27 total annual responses. 

We attribute this to respondents who 

submitted by paper in previous years 

and are now reporting electronically. 

Dated: October 18, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24721 Filed 10–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3768] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adherence 

Potential and Patient Preference in 

Prescription Drug 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 November 

25, 2024. 

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 

‘‘Adherence Potential and Patient 

Preference in Prescription Drug 

Promotion.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Adherence Potential and Patient 

Preference in 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 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 


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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 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. The website 

includes links to the latest Federal 

Register notices and peer-reviewed 

publications produced by our office. 

The study described in this notice 

builds on OPDP’s portfolio of research 

on market claims and disclosures to 

explore the influence of statements 

around patient adherence and 

preference in prescription drug 

promotion. Previous FDA-funded 

research has shown that market claims 

that advertise drug characteristics 

unrelated to medicinal properties, such 

as ‘‘#1 Prescribed,’’ influence consumer 

and provider perceptions about a drug’s 

efficacy (Ref. 1). In the same study, 

results of a tradeoff analysis suggested 

that patients prefer a drug over a 

competitor when this type of claim is 

present, and a drug without this claim 

required at least 1.23 percent greater 

efficacy to be chosen over a drug with 

this claim (Ref. 2). Treatment 

preferences may also be influenced by 

other drug characteristics, including its 

impact on quality of life, complexity of 

dosage regimens, administration mode, 

and cost to family and self (Refs. 3, 6, 

and 8). 

It is not known how claims that 

appeal to the possibility for greater 

adherence or to social norms around 

what other patients or healthcare 

providers prefer influence perceptions 

of a drug. A related question is whether 

including a disclosure stating the 

uncertainty around such claims (e.g., 

there is no conclusive research on 

whether DRUG A results in better 

adherence) can mitigate any misleading 

perceptions or influence preferences. 

Some evidence suggests that disclosures 

in prescription drug promotion are 

typically noticed and may help 

consumers and healthcare providers 

understand information (Refs. 2 and 4), 

but this topic has not been investigated 

in the context of adherence claims. 

The present research is designed to 

complement previous research by 

experimentally examining the role of 

adherence and patient preference claims 

in prescription drug promotion. 

Research questions: 

1. Does the presence or absence of an 

implied adherence claim affect 

consumers’ and primary care 

physicians’ (PCPs’) behavioral 

intentions or risk, benefit, and 

adherence perceptions? 

2. Does the presence or absence of an 

adherence-related patient preference 

claim affect consumers’ and PCPs’ 

behavioral intentions or risk, benefit, 

and adherence perceptions? 

3. Does the presence of both types of 

claims (adherence and preference) have 

a cumulative impact on consumers’ and 

PCPs’ behavioral intentions or risk, 

benefit, and adherence perceptions? 

4. Does a disclosure of information to 

the effect that there is no conclusive 

research on whether the drug results in 

better adherence mitigate consumers’ 

and PCPs’ behavioral intentions or risk, 

benefit, and adherence perceptions? 

To complete this research, we propose 

the following design for a total of 8 

study conditions: 2 (patient preference 

claim) × 2 (adherence claim) × 2 

(disclosure). 

TABLE 1—STUDY DESIGN (IMPLIED ADHERENCE CLAIM) × 2 (PATIENT PREFERENCE CLAIM) × 2 (DISCLOSURE) 

With disclosure 1 Without disclosure 

Patient preference claim Patient preference claim 

Yes No Yes No 

Implied Adherence Claim Yes.

No.

1E.g., ‘‘There is no evidence to suggest better adherence to Drug X compared with Drug Y.’’ 

We will recruit the following numbers 

of participants for the pretest and main 

study surveys: 

• 320 individuals for the pretest (n = 

160 consumers and n = 160 PCPs); 

and 

• 720 individuals for the main study (n 

= 360 consumers and n = 360 PCPs) 

Each participant will see one of eight 

versions of a static web page for a 

fictitious prescription type 2 diabetes 

treatment, as reflected in table 1. They 

will answer a survey designed to take no 

more than 15 minutes to complete 

regarding their perception of the 

product’s benefits, risks, and effect on 

adherence. Consumers and PCPs will 

receive slightly different versions of the 

web page and survey, and their data will 

be analyzed separately. 

In the Federal Register of October 12, 

2023 (88 FR 70669), FDA published a 

60-day notice entitled ‘‘Agency 

Information Collection Activities; 

Proposed Collection; Comment Request; 

Adherence Potential and Patient 

Preference in Prescription Drug 

Promotion,’’ requesting public comment 

on the proposed collection of 

information. FDA received two 

submissions, one of which included 

multiple comments. Responses to all 

comments follow. For brevity, some 

public comments are paraphrased and, 

therefore, may not state the exact 

language used by the commenter. All 

comments were considered even if not 

fully captured by our paraphrasing in 

this document. The following acronyms 

are used here: healthcare professional 

(HCP); Food and Drug Administration 

(FDA or Agency); and FDA’s Office of 

Prescription Drug Promotion in the 

Center for Drug Evaluation and Research 

(OPDP). 

(Comment 1) One comment supported 

the OPDP research program and the 

current proposed study, with a question 

as to whether research on disclosures 

has been previously conducted. 

(Response 1) We appreciate this 

comment for its support of this research 

and our research program. In response 

to the query in this comment, OPDP has 

conducted studies on the topic of 

disclosures in prescription drug 

promotion (found at the website listed 

previously in this document), but none 

that have addressed disclosures specific 

to adherence or preference claims. 

(Comment 2) One comment inquired 

whether the Agency intends to publish 


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the results of this study. If so, the 

comment inquired whether publication 

will be in the form of a publicly 

available report or a peer-reviewed 

publication. 

(Response 2) The exact timing and 

nature of any such dissemination has 

not been determined but may include 

presentations at trade and academic 

conferences, publications, articles, and 

an internet posting. 

(Comment 3) One comment inquired 

whether the Agency intends to seek an 

approval or exemption from an 

Institutional Review Board (IRB) or 

ethics committee. 

(Response 3) The research will be 

reviewed for exemption by the IRB of 

record, which will be the FDA 

contractor’s (Westat’s) IRB. 

(Comment 4) One comment inquired 

how the Agency will ensure that the 

samples are representative of the 

relevant populations, and it asked 

whether there will be stratification of 

the sample by specific demographic or 

clinical characteristics. 

(Response 4) The project will recruit 

individuals from two populations: adult 

consumers diagnosed with type 2 

diabetes and PCPs. For each study 

segment, internet vendor AllGlobal will 

recruit study participants using their 

proprietary panels. Several 

methodologies are used by AllGlobal to 

recruit panelists, including opt-in email, 

co-registration, e-newsletter campaigns, 

and internal and external affiliate 

networks. To recruit consumers, 

AllGlobal will use their LifePoints panel 

of more than 5.5 million consumers. To 

recruit PCPs, AllGlobal will use its 

Global Professional Panel, which 

includes access to over 2 million 

physicians, nurses, and other interested 

healthcare parties across a wide range of 

therapy areas. AllGlobal uses various 

metrics to track panel member activity 

and engagement, which enhances the 

efficiency of recruitment and quality of 

survey data from their panelists. 

Participants will be drawn from 

convenience samples, rather than 

probability-based samples. We will aim 

for a diverse mix of participants in 

terms of race/ethnicity, gender, age, and 

other characteristics, but we will not 

specifically stratify the data before 

collecting it. Moreover, no weighting of 

the data will be required because the 

objective of the studies is to estimate the 

causal effects of experimental 

manipulations rather than to estimate 

descriptive statistics for these 

populations. 

(Comment 5) One comment notes that 

Questions 7 and 8 of the questionnaire 

ask respondents whether HCPs and 

patients prefer FENTIVA. Considering 

these questions, the comment suggests 

that the web page include such 

statements with appropriate context. For 

example, the web page might post 

language such as ‘‘more patients prefer 

FENTIVA versus [Insert product].’’ In 

addition, the comment suggests it would 

be appropriate for the web page to also 

include a statement referencing the 

study from which this information was 

derived. For example, the comment 

notes that the preference information 

presented on the website for RITUXAN 

HYCELA (rituximab and hyaluronidase 

human) injection includes the following 

statement: ‘‘In a study of previously 

untreated DLBCL and follicular 

lymphoma patients, 77 percent of 

patients preferred subcutaneous 

administration of RITUXAN HYCELA 

over intravenous rituximab as it 

required less time in clinic.’’ 

The comment states that without 

seeing the stimulus to which 

participants will be asked to respond, 

there is uncertainty about the purpose of 

these questions. If these questions are 

meant to assess participants’ 

understanding of the information on the 

web page, then the comment suggests 

that the question ask the participant to 

choose the correct statement from a set 

of statements in which all but one is 

incorrect. The comment further suggests 

that if these questions are meant to 

assess the impression that a participant 

gets from the information presented on 

the web page, then responses to these 

questions likely cannot be interpreted 

directly. 

Lastly, the comment recommends that 

the Agency clarify the purpose of 

Questions 7 and 8 and ensure that the 

conclusions that will be drawn by the 

responses to these questions can be 

supported based on the questions 

themselves and the response options 

provided to participants. 

(Response 5) We appreciate these 

comments and offer a few points of 

clarification. Questions 3–11 are 

intended to assess participants’ recall of 

information provided in the stimuli 

(website). For example, the statement 

‘‘Doctors prefer FENTIVA over other 

medications to control blood sugar.’’ 

Question 7 was not mentioned on the 

website and is asked as a foil. These 

questions will allow us to determine 

whether participants’ read the stimuli 

carefully and thus serve as an attention 

check. 

Participants’ gist comprehension of 

the information will be assessed through 

a different series of questions using a 

True/False format. 

We also address the suggestion to 

include a statement referencing the 

study from which the preference 

information is derived (as is done with 

the RITUXAN HYCELA website). A key 

aim of our study is to test the effect of 

a disclosure statement on perceptions 

when no such evidence on adherence 

exists (e.g., ‘‘There is no clinical 

evidence suggesting better treatment 

adherence with once-monthly FENTIVA 

injection compared to daily tablets’’). 

For this reason, we chose not to provide 

clinical information on preference or 

adherence in our study stimuli, 

although we acknowledge that some 

promotions indeed include this 

information when available. 

(Comment 6) One comment notes that 

Question 7 reads, ‘‘Doctors prefer 

FENTIVA over other medications to 

control blood sugar.’’ The comment 

suggests clarifying the wording. 

Specifically, the comment suggests that 

doctors do not have preferences for 

medications. Instead, doctors ‘‘would be 

more likely to choose to prescribe one 

option over another.’’ In addition, 

doctors prescribe medications to 

patients with a condition. Therefore, the 

comment suggests revising 

‘‘medications to control blood sugar’’ to 

read, ‘‘for patients who need to control 

their blood sugar.’’ 

(Response 6) We appreciate the 

second point and have changed 

Question 7 to read: ‘‘Doctors prefer 

FENTIVA over other medications for 

patients who need to control their blood 

sugar.’’ We also refer to our previous 

explanation (Response 5) about the 

intent of this item, which is to test recall 

of information on the website, where the 

statement about doctors’ preferences for 

FENTIVA was not mentioned on the 

website and thus included in this 

survey as a foil. 

(Comment 7) One comment suggests 

that Question 9 is difficult to evaluate 

without seeing the materials that will be 

presented to participants. Specifically, 

the comment notes that if the web page 

does not say explicitly that the patient 

doesn’t have to think about taking 

medication every day, but instead says 

that FENTIVA is taken once a month 

rather than every day, whether a patient 

‘‘no longer has to think about taking 

medication’’ could be considered 

leading, and interpreting the results of 

this question could be problematic. 

Therefore, the comment recommends 

that the Agency clarify the purpose of 

Question 9 and ensure that there is no 

ambiguity in how the responses to the 

question will be interpreted. 

(Response 7) As explained above, 

items 3–11 assess recall of information 

that may or may not have been 

presented on the website. The statement 

‘‘With once-monthly FENTIVA 

injections, I no longer have to think 


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about taking medication every day’’ is 

presented on the website. The intent of 

the question is to assess whether 

participants read and paid attention to 

key statements. 

(Comment 8) One comment opines 

that Questions 10 and 11 are difficult to 

interpret without seeing the information 

that will be provided to participants. 

However, the comment continues, the 

pair of questions taken together seem to 

indicate that one statement is correct 

while the other is not. If the purpose of 

the questions is to test recall, then it 

would be more appropriate to include 

both statements in a single question and 

ask respondents which is correct. If the 

purpose of the questions is to test the 

impression that participants get from 

the information presented in the web 

page, then there may be no objectively 

correct answer to the question that does 

not mirror exactly what is stated in the 

web page. Therefore, the comment 

recommends that the Agency clarify the 

purpose of Questions 10 and 11 and 

ensure that there is no ambiguity in how 

the answers to these questions will be 

interpreted. 

(Response 8) We refer to our previous 

explanation (Response 5) about the 

intent of these items. To clarify further, 

consumers and PCPs will receive 

slightly different versions of the same 

disclosure statement on the website. 

Thus, only the consumer group will be 

asked Question 10 and only the PCP 

group will be asked Question 11. 

(Comment 9) One comment notes that 

Question 14 asks whether it is true or 

false that ‘‘FENTIVA is given as a shot 

with a needle.’’ The comment states that 

this statement could be interpreted that 

FENTIVA is administered using a 

syringe with an exposed needle. If the 

web page states that the medication is 

given using an autoinjector, pen, or 

another device, it may be technically 

true that the medication is given as a 

shot with a needle. But it is also 

plausible that a reasonable person 

would say that this is untrue because 

they interpret ‘‘shot with a needle’’ to 

describe only a syringe with an exposed 

needle. The comment recommends that 

the Agency review this question to 

ensure that there is no ambiguity in 

participant’s interpretation of the 

statement or in the Agency’s 

interpretation of the results. 

(Response 9) We agree with the 

concern raised in this comment and 

have since revised this item to read: 

‘‘FENTIVA is given as an injection 

under the skin’’ (True/False) as a 

measure of comprehension. 

(Comment 10) One comment notes 

that Question 15 asks participants to 

indicate ‘‘what you know.’’ The 

comment states that because FENTIVA 

is a hypothetical product and 

participants are responding to a specific 

set of information, asking participants 

‘‘what you know’’ may be an imprecise 

question. Therefore, the comment 

recommends that the Agency consider 

revising the question to read: ‘‘Please 

indicate which of the following 

statements best describes what you 

understand about FENTIVA based on 

the information provided in the web 

page.’’ 

(Response 10) We have revised the 

question to read: ‘‘Please indicate which 

of the phrases below best completes this 

statement about FENTIVA, based on 

what you read on the website.’’ 

(Comment 11) One comment notes 

that Question 16 presents two 

statements which are suggested to come 

from the stimulus material. The 

comment notes that both statements 

could be considered incomplete because 

they mention a specific injection 

product (‘‘FENTIVA’’) contrasted with 

an unnamed oral medication. The 

implication is that the oral tablets are an 

alternative to FENTIVA for achieving 

the same clinical outcome. However, the 

comment notes that this conclusion is 

not included in the stimulus material 

and recommends that the use of the oral 

tablet as an alternative for the same 

condition be stated explicitly. 

(Response 11) The language presented 

in Question 16 refers to the disclosure 

statements as they appear on the 

stimuli: ‘‘There is no evidence that 

patients who choose once-monthly 

FENTIVA injections are more likely to 

follow their prescribed treatment plan 

compared to those who choose daily 

tablets’’ (consumer version) or ‘‘There is 

no clinical evidence suggesting better 

treatment adherence with once-monthly 

FENTIVA injection compared to daily 

tablets’’ (HCP version). We intentionally 

do not state that FENTIVA injection 

achieves the same clinical benefit as 

oral daily tablets, as we ask later about 

participants’ perceptions of comparative 

efficacy, based on the information 

provided in the stimuli. 

(Comment 12) One comment notes 

that in Questions 17–19, the questions 

related to importance and usefulness 

likely require context—important in 

what way and/or useful in what way? 

The comment suggests that without 

clarification, the interpretation of the 

responses to these questions would be 

subject to ambiguity and recommends 

changing ‘‘useful’’ to ‘‘useful in . . .’’ 

and ‘‘important’’ to ‘‘important for 

. . . .’’ 

(Response 12) These questions are 

derived from theory and validated 

scales on ‘‘perceived message 

effectiveness.’’ This construct is often 

measured as a set of close-ended 

judgments such as ‘‘useful/not useful’’ 

and estimate the degree to which 

recipients of that message will favorably 

(or unfavorably) evaluate a message. 

Identifying why or how the message is 

considered useful/relevant could be 

assessed with further questions but is 

not a focus of this research. Rather, we 

are interested in participants’ more 

general perceptions of message 

effectiveness and will compare 

responses across study arms (Ref. 5). 

(Comment 13) One comment suggests 

that Questions 20–24 include language 

that could be considered leading. 

Therefore, the comment recommends 

changing the questions to capture 

whether the participant assessed the 

statement to be true or false and 

changing the response options to ‘‘true,’’ 

‘‘false,’’ or ‘‘I don’t know.’’ 

(Response 13) We have chosen to use 

a Likert scale (1 = would not help at all/ 

5 = would help very much) rather than 

a true/false scale for these items as the 

intent is to assess the extent to which 

participants perceive the drug to be 

beneficial/efficacious. We also note that 

these items were adapted from validated 

scales on perceived benefit and risk 

(Ref. 7). 

(Comment 14) One comment suggests 

that Question 27 includes language that 

could be considered leading and 

recommends changing the question to 

capture whether the participant 

assessed the statement to be true or false 

and changing the response options to 

‘‘true,’’ ‘‘false,’’ or ‘‘I don’t know.’’ 

(Response 14) See Response 13 and 

the referenced citation above. We have 

chosen to measure benefit and risk 

perception using Likert scales and note 

that these measures come from 

validated scales. 

(Comment 15) One comment suggests 

clarifying whether in Questions 29 and 

30, ‘‘other daily prescription drugs that 

treat type 2 diabetes,’’ includes insulin 

or other injectable options or is limited 

to oral options only. 

(Response 15) These questions are 

intended to assess perceptions of the 

convenience of FENTIVA compared to 

any other type 2 diabetes drug taken 

daily. 

(Comment 16) One comment suggests 

that the language in Question 31 could 

be considered leading. The question 

asks about likely adherence to a 

medication over a long period of time 

during which a patient may experience 

side effects or lack of efficacy. 

Therefore, a likelihood to get injections 

every month assumes that a patient does 

not have a reason for discontinuing. In 

addition, the comment notes that it is 


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not clear whether the injections are 

prescribed instead of an alternative or in 

addition to an alternative. The comment 

recommends that the Agency make the 

assumptions behind the question 

explicit to the participant. 

(Response 16) The reasons mentioned 

in this comment are the reasons OPDP 

found it valuable to conduct this study. 

Those are possible reasons that it could 

be misleading to suggest that receiving 

a monthly injection is easier or results 

in greater adherence than a daily pill. 

FDA has designed this study to keep our 

questions as simple as possible, 

consistent with good practices, to 

reduce burden on participants. We 

specifically keep extraneous factors out 

of the questions to glean what we intend 

to study. Here, we are interested to 

know if behavioral intentions around 

adherence vary by experimental arm. 

Would information on the website 

around patient preference or disclosure 

about the lack of evidence on adherence 

influence behavioral intentions? 

(Comment 17) One comment suggests 

that Questions 33–35 likely overstate 

the type of evidence that would be used 

for this purpose and recommends 

rephrasing the question in each case to 

read, ‘‘Knowing that more patients 

preferred FENTIVA monthly injections 

than other daily prescription drugs 

. . . .’’ 

(Response 17) We have removed these 

items from the survey. 

The total annual estimated burden 

imposed by this collection of 

information is 1,293 hours (table 2). As 

with most online and mail surveys, it is 

always possible that some participants 

are in the process of completing the 

survey when the target number is 

reached and that those surveys will be 

completed and received before the 

survey is closed out. To account for this, 

we have estimated approximately 10 

percent overage for both participant 

samples in the study. 

Note that this burden chart differs in 

certain respects from the chart 

published in the 60-day Federal 

Register notice. The previous burden 

chart assumed a 70 percent estimated 

eligibility for the consumer group; the 

current chart has adjusted this estimate 

to 5 percent. The previous chart 

incorrectly assumed that the vendor 

already had eligibility information for 

this panel, and we could specifically 

target those with this medical condition. 

Thus, the larger burden estimate is the 

more accurate, as we will need to screen 

a larger number of people. We also 

adjusted the HCP estimate to reflect 

what we believe is a more accurate 

projected eligibility of 50 percent. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

Total 

hours 

PCPs: 

Pretest screener completes (assumes 50 

percent eligibility rate).

352 1 352 0.08 (5 min.) ................. 28 

Pretest number of completes ....................... 176 1 176 0.25 (15 min.) ............... 44 

Main study screener completes (assumes 

50 percent eligibility rate).

792 1 792 0.08 (5 min.) ................. 63 

Main study number of completes ................ 396 1 396 0.25 (15 min.) ............... 99 

Consumers: 

Pretest screener completes (assumes 5 percent 

eligibility rate).

3,520 1 3,520 0.08 (5 min.) ................. 282 

Pretest number of completes ....................... 176 1 176 0.25 (15 min.) ............... 44 

Main study screener completes (assumes 5 

percent eligibility rate).

7,920 1 7,920 0.08 (5 min.) ................. 634 

Main study number of completes ................ 396 1 396 0.25 (15 min.) ............... 99 

Total ...................................................... ........................ .......................... ........................ ...................................... 1,293 

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

References 

The following references are on 

display with 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; 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. Aikin, K.J., K.R. Betts, A. Keisler, and K.S. 

Ziemer, ‘‘Market Claims and Efficacy 

Information in Direct-to-Consumer 

Prescription Drug Print Advertisements,’’ 

Psychology & Marketing, 36(8), 747–757 

(2019). 

2. Aikin, K.J., K.R. Betts, K.S. Ziemer, and A. 

Keisler, ‘‘Consumer Tradeoff of 

Advertising Claim Versus Efficacy 

Information in Direct-to-Consumer 

Prescription Drug Ads,’’ Research in 

Social and Administrative Pharmacy, 

15(12), 1484–1488 (2019). 

3. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, D. 

Prefasi, et al., ‘‘Conjoint Analysis To 

Understand Preferences of Patients With 

Multiple Sclerosis for Disease-Modifying 

Therapy Attributes in Spain: A CrossSectional Observational Study,’’ BMJ 

Open, 7(3), e014433 (2017). 

4. Betts, K.R., V. Boudewyns, K.J. Aikin, C. 

Squire, et al., ‘‘Serious and Actionable 

Risks, Plus Disclosure: Investigating an 

Alternative Approach for Presenting Risk 

Information in Prescription Drug 

Television Advertisements,’’ Research in 

Social and Administrative Pharmacy, 

14(10), 951–963 (2018). 

5. Dillard, J.P., K.M. Weber, and R.G. Vail, 

‘‘The Relationship Between the 

Perceived and Actual Effectiveness of 

Persuasive Messages: A Meta-Analysis 

With Implications for Formative 

Campaign Research,’’ Journal of 

Communication, 57(4), 613–631 (2007). 

6. Fraenkel, L., L. Suter, C.E. Cunningham, 

and G. Hawker, ‘‘Understanding 

Preferences for Disease-Modifying Drugs 

in Osteoarthritis,’’ Arthritis Care 

Research, 66(8), 1186–1192 (2014). 

7. Kelly, B.J., D.J. Rupert, K.J. Aikin, H.W. 

Sullivan, et al., ‘‘Development and 

Validation of Prescription Drug Risk, 

Efficacy, and Benefit Perception 

Measures in the Context of Direct-toConsumer Prescription,’’ Research in 

Social and Administrative Pharmacy, 

17(5), 942–955 (2021). 

8. Wouters, H., G.A. Maatman, L. Van Dijk, 

M.L. Bouvy, et al., ‘‘Trade-Off 

Preferences Regarding Adjuvant 

Endocrine Therapy Among Women With 

Estrogen Receptor-Positive Breast 

Cancer,’’ Annals of Oncology, 24(9), 

2324–2329 (2013). 


lotter on DSK11XQN23PROD with NOTICES1
84894 Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 

Dated: October 18, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24720 Filed 10–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4732] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) announces 

a forthcoming public advisory 

committee meeting of the Vaccines and 

Related Biological Products Advisory 

Committee (the Committee). The general 

function of the Committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The Committee will 

discuss Considerations for Respiratory 

Syncytial Virus (RSV) Vaccine Safety in 

Pediatric Populations and will also hear 

overviews of the Laboratory of 

Immunoregulation (LI) and Laboratory 

of Retroviruses (LR) research programs 

in the Center for Biologics Evaluation 

and Research. At least one portion of the 

meeting will be closed to the public. 

FDA is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held 

virtually on December 12, 2024, from 

8:30 a.m. to 5:30 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting: https://

youtube.com/live/f0bNPpqAy-M. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4732. 

The docket will close on December 11, 

2024. 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 11, 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. 

Comments received on or before 

December 4, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

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 

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–4732 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ FDA 

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 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 the 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: 

Sussan Paydar or Kathleen Hayes, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 


lotter on DSK11XQN23PROD with NOTICES1