Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70669 

evaluation of diagnostic 

radiopharmaceuticals in this 

information collection is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical trials. 

In table 1, row 2, we estimate the 

annual reporting burden for preparing 

the safety and effectiveness sections of 

a supplement to an approved 

application. This estimate does not 

include the time needed to conduct 

studies and clinical trials or other 

research from which the reported 

information is obtained. 

Based on past submissions of human 

drug applications, new indication 

supplements for diagnostic 

radiopharmaceuticals, or both, we 

estimate that one submission will be 

received annually. We estimate the total 

time needed to prepare complete 

applications for supplements to new 

applications for diagnostic 

radiopharmaceuticals as approximately 

between 500 and 1,000 hours. We 

calculated the median of this estimate to 

arrive at approximately 750 hours. We 

further estimate that the total time 

needed to prepare the portions of the 

application that would be affected by 

this information collection as 750 hours. 

As previously stated, this information 

collection does not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 750 hours, 

because safety and effectiveness 

information is already required in 

§ 314.50 and has been approved under 

OMB control number 0910–0001. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR

DIAGNOSTIC RADIOPHARMACEUTICALS 1

Manufacturers’ activity 

(21 CFR section) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

NDAs (§§ 315.4, 315.5, and 315.6) ..................................... 3 1 3 2,000 6,000 

Supplements to Approved NDAs (§§ 315.4, 315.5, and 

315.6) ............................................................................... 1 1 1 750 750 

Total .............................................................................. ........................ ........................ ........................ ........................ 6,750 

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

Since our last OMB approval, our 

estimated burden for the information 

collection reflects an overall decrease of 

11 responses with a corresponding 

decrease of 12,000 burden hours. We 

attribute this adjustment to a decrease in 

the number of submissions for NDAs for 

diagnostic radiopharmaceuticals and 

new indication supplements for 

diagnostic radiopharmaceuticals we 

received over the past few years. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22460 Filed 10–11–23; 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; Proposed Collection; 

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 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 a proposed study 

entitled ‘‘Adherence Potential and 

Patient Preference in Prescription Drug 

Promotion.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 11, 2023. 

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 11, 2023. 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 

Staff, FDA will post your comment, as 


ddrumheller on DSK120RN23PROD with NOTICES1
70670 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

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– 

2023–N–3768 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Adherence Potential and Patient 

Preference in Prescription Drug 

Promotion.’’ 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: 

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: 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. 

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 

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, which 

includes links to the latest Federal 

Register notices and peer-reviewed 

publications produced by our office. 

This study 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70671 

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. 3–5). 

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 6), 

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. We 

have the following specific questions: 

Research questions: 

1. Does the presence or absence of an 

implied-adherence claim affect 

consumers’ behavioral intentions or 

risk, benefit, and adherence 

perceptions? 

2. Does the presence or absence of an 

adherence-related patient preference 

claim affect consumers’ 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’ 

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’ 

behavioral intentions or risk, benefit, 

and adherence perceptions? 

To complete this research, we will 

show participants a website for a 

fictitious prescription drug product for 

type 2 diabetes. We propose the design 

in table 1, which varies based on 

whether the fictitious prescription drug 

promotional communication includes a 

claim about: 

• implied adherence; 

• patient preference; and 

• a disclosure that there is no 

conclusive research on adherence. 

TABLE 1—DESIGN 2 (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 conclusive research to suggest better adherence to Drug X compared with Drug Y.’’ 

Recruitment will occur by email 

through an internet panel, and 

participant eligibility will be 

determined with a screener at the 

beginning of the online survey. For the 

pretest, we expect to screen 253 

consumers and 294 primary care 

physicians (PCPs) to reach our desired 

number of completed surveys. We will 

conduct complete pretest surveys with 

160 consumers who self-identify as 

having been diagnosed with diabetes 

and 160 PCPs who treat diabetes (both 

obtained from a web-based research 

vendor) to ensure that the questionnaire 

programming works as expected. For the 

main study, we expect to screen 566 

consumers and 660 PCPs to reach our 

desired number of completed surveys. 

Thus, for the main study final sample, 

we will recruit 360 adult voluntary 

participants aged 18 years or older who 

self-identify as having been diagnosed 

with diabetes and 360 voluntary 

participants who are employed as PCPs 

who treat diabetes. We will exclude 

individuals who work in healthcare 

settings, employees of the Department of 

Health and Human Services, and 

individuals who work in the marketing, 

advertising, or pharmaceutical 

industries. 

The total annual estimated burden 

imposed by this collection of 

information is 520 hours (table 2). These 

estimates account for over-recruitment 

of 10 percent to account for survey 

incompletes. 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. 

Each participant will see one of eight 

versions of a consumer web page for a 

fictitious prescription diabetes 

treatment, as reflected in table 1. They 

will answer a questionnaire designed to 

take no more than 20 minutes regarding 

benefit and risk perceptions, adherence 

perceptions, behavioral intentions, 

adherence claim retention, and patient 

preference claim retention. The survey 

is available upon request at 

DTCresearch@fda.hhs.gov. 

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: 

Consumers: pretest screener completes (assumes 70% eligible).253 1 253 0.08 (5 min.) ......... 20 

Consumers: number of completes, pretest ........... 176 1 176 0.33 (20 min.) ....... 58 

PCPs: pretest screener completes (assumes 

60% eligible).

294 1 294 0.08 (5 min.) ......... 24 

PCPs: number of completes, pretest .................... 176 1 176 0.33 (20 min.) ....... 58 


ddrumheller on DSK120RN23PROD with NOTICES1
70672 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 2

Total hours 

Main Study: 

Consumers: number of main study screener completes (assumes 70% eligible).566 1 566 0.08 (5 min.) ......... 45 

Consumers: number of completes, main study .... 396 1 396 0.33 (20 min.) ....... 131 

PCPs: number of main study screener completes 

(assumes 60% eligible).

660 1 660 0.08 (5 min.) ......... 53 

PCPs: number of completes, main study ............. 396 1 396 0.33 (20 min.) ....... 131 

Total (rounded) .............................................. ........................ ........................ ........................ ............................... 520 

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 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, 

2019a. 

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, 2019b. 

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. 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. 

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

M.L. Bouvy, et al. ‘‘Trade-Off Preferences 

Regarding Adjuvant Endocrine Therapy 

Among Women With Estrogen ReceptorPositive Breast Cancer,’’ Annals of 

Oncology, 24(9), 2324–2329, 2013. 

6. 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. 

Dated: October 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22586 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations for Voting 

Members for the Digital Health 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting nominations for voting 

members, excluding consumer and 

industry representatives, to serve on the 

Digital Health Advisory Committee (the 

Committee) in the Center for Devices 

and Radiological Health. Nominations 

will be accepted for current vacancies 

effective with this notice. FDA seeks to 

include the views of members of all 

gender groups, members of all racial and 

ethnic groups, and individuals with and 

without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Nominations received on or 

before December 11, 2023 will be given 

first consideration for membership on 

the Committee. Nominations received 

after December 11, 2023 will be 

considered for nomination to the 

committee as later vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Committee Membership 

Nomination Portal (https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm) and 

selecting Academician/Practitioner from 

the dropdown menu (regardless of 

whether Academician/Practitioner 

accurately describes the nominee), or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Office of Management, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5211, Silver Spring, MD 20993– 

0002, 301–796–6313, James.Swink@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members to fill current vacancies on the 

Digital Health Advisory Committee. 

This notice does not include consumer 

and industry representative 

nominations. The Agency will publish 

two separate notices announcing the 

vacancy of a representative of consumer 

interests and a vacancy of 

representatives of interests of the device 

manufacturing industry. 

I. General Description of the Committee 

Duties 

The Committee provides advice on 

complex scientific and technical issues 

related to Digital Health Technologies 

(DHTs). This also may include advice 

on the regulation of DHTs, and/or their 

use, including use of DHTs in clinical 

trials or postmarket studies subject to 

FDA regulation. Topics relating to 

DHTs, such as artificial intelligence/ 

machine learning, augmented reality, 

virtual reality, digital therapeutics, 

wearables, remote patient monitoring, 


ddrumheller on DSK120RN23PROD with NOTICES1