Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising, 87431-87433 [2023-27652]
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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0795]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; A Survey on
Quantitative Claims in Direct-toConsumer Prescription Drug
Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 17,
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 ‘‘A
Survey on Quantitative Claims in
Direct-to-Consumer Prescription Drug
Advertising.’’ 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.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
A Survey on Quantitative Claims in
Direct-to-Consumer Prescription Drug
Advertising
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
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
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 our
research data through analytical
methodology development and
investigation of sampling and response
issues. This study will inform the first
topic area, advertising features.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings 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
homepage 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.
Direct-to-consumer (DTC)
prescription drug advertising may make
quantitative claims about the drug’s
efficacy or risks (Ref. 1). Although there
is research and FDA guidance
(‘‘Presenting Quantitative Efficacy and
Risk Information in Direct-to-Consumer
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
87431
Promotional Labeling and
Advertisements,’’ available at https://
www.fda.gov/media/169803/download)
that provides general guidelines for how
to present quantitative information, it is
not fully understood how consumers
will interpret specific quantitative
claims. We conducted a literature
review and found that while some types
of quantitative information are wellstudied (e.g., relative frequencies), many
questions remain on how best to
communicate certain quantitative
information about prescription drugs.
For example, we do not have sufficient
information about how consumers
interpret different claims describing
medians (e.g., ‘‘People treated with Drug
X lived for a median of 8 months’’ alone
or in combination with a definition such
as ‘‘In people receiving Drug X, this
means that about half lived more than
8 months and about half lived less than
8 months’’ or ‘‘A median is the middle
number in a group of numbers ordered
from smallest to largest’’). This study
aims to survey U.S. adults about their
interpretation of specific quantitative
claims.
We plan to use an address-based,
mixed-mode methodology that will
direct one randomly chosen member of
sampled households to complete a 20minute online survey, with
nonrespondents receiving a paper
questionnaire. The sample will be
representative of the U.S. population. A
sample of U.S. households will be
drawn from the U.S. Postal Service
Computerized Delivery Sequence File.
Adults aged 18 or over will be eligible
for participation. Up to four contacts
(mailings) will be sent to respondents by
U.S. mail. The contacts will include the
URL for the online survey and a unique
survey login. This unique survey login
will be used to track completed surveys
without the use of personally
identifying information. The contact
method, based on recent
recommendations (Ref. 2), includes a
prenotification letter (week 1), a web
survey invitation letter (soft launch in
week 2, full launch in week 3), a
reminder postcard sent to
nonresponders (week 5), and a final
mailing with the paper version of the
survey sent to nonresponders (Week 7).
We estimate a 40-percent response rate,
based on recent experience with similar
surveys. We estimate 1,100 respondents
will complete the main study (see table
1).
Based on previous research (Refs. 3, 4,
and 5), we plan to include a small
prepaid incentive in the second mailing
sent to the sampled addresses as a
gesture to encourage response and
maintain data quality. We expect that
E:\FR\FM\18DEN1.SGM
18DEN1
87432
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
approximately 5 percent of the sampled
addresses will be postal non-deliverable
returned letters from the first mailing
(prenotification letter), so the second
mailing is estimated to go out to the
remaining addresses. We also will
conduct an experiment to assess the
efficacy of using a promised post-paid
incentive. Seventy-five percent of the
sample will be sent the promised
incentive upon completion of the
survey, and the remaining 25 percent of
the sample will not be notified of or
provided with any promised incentive.
We opted to split the sample 75–25
rather than 50–50 because the initial
evidence shows the benefits of
including a promised incentive (Refs. 4,
6, and 7), and we aimed to maximize
response rates.
The survey contains questions about
respondents’ perceptions and
understanding of several quantitative
claims drawn from DTC ads in the
marketplace. We will also measure other
potentially important variables, such as
demographics and numeracy. The
survey questions will be informed by
consumer feedback elicited in one-onone interviews (approved under OMB
Control No. 0910–0847). The survey is
available upon request from
DTCResearch@fda.hhs.gov.
We will test whether any variables
differed between modes (online versus
mail survey) and will account for any
mode effects in our analyses. We will
examine the descriptive statistics for the
survey items (e.g., frequencies and
percentages) and explore the
relationship between the survey items
and demographic and health
characteristics. We will weigh the data
to account for different probability of
selection and nonresponse.
In the Federal Register of April 25,
2023 (88 FR 24997), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
submissions that were Paperwork
Reduction Act (PRA) related. Within the
submissions, FDA received multiple
comments that the Agency has
addressed in this notice. 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. Comments and
responses are numbered here for
organizational purposes only.
(Comment 1) One comment suggested
testing claims that are addressed by the
guidance for industry entitled ‘‘Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling—Questions and Answers.’’
(Response 1) The focus of this study
is not to test such claims. In addition,
because these drugs are fictional, there
is no label with which to compare the
claims, which means that the guidance
is not an applicable concept in this
study. These study results could apply
to any quantitative claims similar to
those we will test.
(Comment 2) One comment suggested
recruiting a sufficient number of
individuals with a health condition or
their caregivers because they may be
more familiar with the quantitative
information in the claims than the
general population would be.
(Response 2) Our intent is to conduct
a nationally representative sample to get
a broad sense of how the public
interprets quantitative claims that
appear in prescription drug ads across
drug classes. Moreover, the claims we
are testing refer to several medical
conditions (i.e., colon cancer, arthritis,
seizures, migraine, lung cancer, heart
attack or stroke, eczema), which makes
it impractical to recruit a sufficient
number of patients and caregivers for
each medical condition. However, in
response to this comment, we have
added an item to the survey to assess
whether participants have these
conditions or have cared for someone
with these conditions. This will allow
us to explore associations between
survey responses and experiences with
the medical conditions.
(Comment 3) One comment
recommended determining participants’
comprehension of information regarding
relative risk, absolute risk, relative
benefit, and absolute benefit.
(Response 3) There is a body of
research on many of these topics; see,
for example, the references section in
the guidance for industry entitled
‘‘Presenting Quantitative Efficacy and
Risk Information in Direct-to-Consumer
(DTC) Promotional Labeling and
Advertisements,’’ available at https://
www.fda.gov/media/169803/download.
In this survey, we will examine
participants’ interpretations of relative
benefit.
(Comment 4) One comment requested
information on the number of and
demographic diversity of the one-on-one
interviews.
(Response 4) Since the 60-day Federal
Register notice was published, we
conducted 24 interviews (approved
under OMB Control No. 0910–0847). We
recruited with demographic diversity in
mind. Half (50 percent) of the
participants had some college or more
education, and half (50 percent) had less
education. Overall, 58 percent of the
participants were women, 29 percent
were non-Hispanic White, 29 percent
were non-Hispanic Black, and 25
percent were Hispanic. We also
recruited participants of different ages:
42 percent were between the ages of 18
and 39, 29 percent were between the
ages of 40 and 59, and 29 percent were
60 and older.
FDA estimates the burden of this
collection of information as follows:
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Read prenotification letter ...........................................
Read web survey invitation letter 2 ..............................
Read reminder postcard ..............................................
Respond to survey (web and paper) ...........................
Total ......................................................................
2,993
2,843
2,585
1,100
........................
1
1
1
1
........................
2,993
2,843
2,585
1,100
........................
0.08 (5 min.) ..........
0.08 (5 min.) ..........
0.03 (2 min.) ..........
0.33 (20 min.) ........
................................
Total hours
1 There
239
227
78
363
907
are no capital costs or operating and maintenance costs associated with this collection of information.
numbers assume around 5 percent postal non-deliverables from the prenotification letter and estimates nonrespondents for the subsequent mailings.
2 The
References
The following references marked with
an asterisk (*) are on display at the
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
Dockets Management Staff, (see
and are available for
viewing by interested persons between
ADDRESSES)
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
E:\FR\FM\18DEN1.SGM
18DEN1
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
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. Sullivan, H.W., K.J. Aikin, and L.B.
Squiers, ‘‘Quantitative Information on
Oncology Prescription Drug websites,’’
Journal of Cancer Education, vol. 33,
Issue 2, pp. 371–374, 2018. (https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC5334459)
2. Dillman, D.A., J.D. Smyth, and L.M.
Christian, internet, Phone, Mail, and
Mixed-Mode Surveys: The Tailored
Design Method, 4th ed., John Wiley &
Sons, Inc.: Hoboken, NJ, 2014.
*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et
al., ‘‘Effect of Prepaid and Promised
Financial Incentive on Follow-Up
Survey Response in Cigarette Smokers: A
Randomized Controlled Trial,’’ BMC
Medical Research Methodology, vol. 19,
Article 138, 2019. (https://link.
springer.com/article/10.1186/s12874019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al.,
‘‘How Much Gets You How Much?
Monetary Incentives and Response Rates
in Household Surveys,’’ Public Opinion
Quarterly, vol. 79, pp. 105–129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al.,
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27652 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5323]
Hoffmann-La Roche, Inc., et al.;
Withdrawal of Approval of Two New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Drug
NDA 021455 ......
Boniva (ibandronate sodium) Tablets, equivalent to (EQ) 2.5
milligrams (mg) base and EQ 150 mg base.
Flowtuss (guaifenesin 200 mg/5 milliliters (mL) and
hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 17,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
listed in the table without an approved
NDA violates sections 505(a) and 301(d)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(a) and 331(d)). Drug
products that are listed in the table that
are in inventory on January 17, 2024
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of two new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
January 17, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
NDA 022424 ......
khammond on DSKJM1Z7X2PROD with NOTICES
‘‘What Works, What Doesn’t? Three
Studies Designed to Improve Survey
Response,’’ Field Methods, vol. 32, Issue
3, pp. 235–252, 2020. (https://doi.org/
10.1177/1525822X20915464)
6. Ellis, J., J. Charbonnier, C. Lowenstein, et
al., ‘‘Assessing the Impacts of Different
Incentives and Use of Postal Mail on
Response Rates,’’ American Association
for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
*7. Yu, S., H.E. Alper, A.M. Nguyen, et al.,
‘‘The Effectiveness of a Monetary
Incentive Offer on Survey Response
Rates and Response Completeness in a
Longitudinal Study,’’ BMC Medical
Research Methodology, vol. 17, Article
77, 2017. (https://bmcmedresmethodol.
biomedcentral.com/articles/10.1186/
s12874-017-0353-1)
87433
Applicant
Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080–4990.
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY
10920.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27661 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–3740]
Priority Zoonotic Animal Drug
Designation and Review Process; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
announcing the availability of a draft
guidance for industry (GFI) #283
entitled ‘‘Priority Zoonotic Animal Drug
Designation and Review Process.’’ This
draft guidance is intended to assist
sponsors pursuing priority zoonotic
animal drug (PZAD) designation for a
new animal drug. This draft guidance is
intended to provide the eligibility
criteria for PZAD designation, the
process for requesting PZAD
designation, and enhancements in the
FDA review process for PZADs.
Submit either electronic or
written comments on the draft guidance
by February 16, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87431-87433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27652]
[[Page 87431]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0795]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; A Survey on
Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 17, 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 ``A Survey on Quantitative Claims in Direct-
to-Consumer Prescription Drug Advertising.'' 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,
[email protected].
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.
A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising
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 our research data through analytical
methodology development and investigation of sampling and response
issues. This study will inform the first topic area, advertising
features.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings 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 homepage at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
Direct-to-consumer (DTC) prescription drug advertising may make
quantitative claims about the drug's efficacy or risks (Ref. 1).
Although there is research and FDA guidance (``Presenting Quantitative
Efficacy and Risk Information in Direct-to-Consumer Promotional
Labeling and Advertisements,'' available at https://www.fda.gov/media/169803/download) that provides general guidelines for how to present
quantitative information, it is not fully understood how consumers will
interpret specific quantitative claims. We conducted a literature
review and found that while some types of quantitative information are
well-studied (e.g., relative frequencies), many questions remain on how
best to communicate certain quantitative information about prescription
drugs. For example, we do not have sufficient information about how
consumers interpret different claims describing medians (e.g., ``People
treated with Drug X lived for a median of 8 months'' alone or in
combination with a definition such as ``In people receiving Drug X,
this means that about half lived more than 8 months and about half
lived less than 8 months'' or ``A median is the middle number in a
group of numbers ordered from smallest to largest''). This study aims
to survey U.S. adults about their interpretation of specific
quantitative claims.
We plan to use an address-based, mixed-mode methodology that will
direct one randomly chosen member of sampled households to complete a
20-minute online survey, with nonrespondents receiving a paper
questionnaire. The sample will be representative of the U.S.
population. A sample of U.S. households will be drawn from the U.S.
Postal Service Computerized Delivery Sequence File. Adults aged 18 or
over will be eligible for participation. Up to four contacts (mailings)
will be sent to respondents by U.S. mail. The contacts will include the
URL for the online survey and a unique survey login. This unique survey
login will be used to track completed surveys without the use of
personally identifying information. The contact method, based on recent
recommendations (Ref. 2), includes a prenotification letter (week 1), a
web survey invitation letter (soft launch in week 2, full launch in
week 3), a reminder postcard sent to nonresponders (week 5), and a
final mailing with the paper version of the survey sent to
nonresponders (Week 7). We estimate a 40-percent response rate, based
on recent experience with similar surveys. We estimate 1,100
respondents will complete the main study (see table 1).
Based on previous research (Refs. 3, 4, and 5), we plan to include
a small prepaid incentive in the second mailing sent to the sampled
addresses as a gesture to encourage response and maintain data quality.
We expect that
[[Page 87432]]
approximately 5 percent of the sampled addresses will be postal non-
deliverable returned letters from the first mailing (prenotification
letter), so the second mailing is estimated to go out to the remaining
addresses. We also will conduct an experiment to assess the efficacy of
using a promised post-paid incentive. Seventy-five percent of the
sample will be sent the promised incentive upon completion of the
survey, and the remaining 25 percent of the sample will not be notified
of or provided with any promised incentive. We opted to split the
sample 75-25 rather than 50-50 because the initial evidence shows the
benefits of including a promised incentive (Refs. 4, 6, and 7), and we
aimed to maximize response rates.
The survey contains questions about respondents' perceptions and
understanding of several quantitative claims drawn from DTC ads in the
marketplace. We will also measure other potentially important
variables, such as demographics and numeracy. The survey questions will
be informed by consumer feedback elicited in one-on-one interviews
(approved under OMB Control No. 0910-0847). The survey is available
upon request from [email protected].
We will test whether any variables differed between modes (online
versus mail survey) and will account for any mode effects in our
analyses. We will examine the descriptive statistics for the survey
items (e.g., frequencies and percentages) and explore the relationship
between the survey items and demographic and health characteristics. We
will weigh the data to account for different probability of selection
and nonresponse.
In the Federal Register of April 25, 2023 (88 FR 24997), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two submissions that were
Paperwork Reduction Act (PRA) related. Within the submissions, FDA
received multiple comments that the Agency has addressed in this
notice. 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. Comments and responses are numbered here for
organizational purposes only.
(Comment 1) One comment suggested testing claims that are addressed
by the guidance for industry entitled ``Medical Product Communications
That Are Consistent With the FDA-Required Labeling--Questions and
Answers.''
(Response 1) The focus of this study is not to test such claims. In
addition, because these drugs are fictional, there is no label with
which to compare the claims, which means that the guidance is not an
applicable concept in this study. These study results could apply to
any quantitative claims similar to those we will test.
(Comment 2) One comment suggested recruiting a sufficient number of
individuals with a health condition or their caregivers because they
may be more familiar with the quantitative information in the claims
than the general population would be.
(Response 2) Our intent is to conduct a nationally representative
sample to get a broad sense of how the public interprets quantitative
claims that appear in prescription drug ads across drug classes.
Moreover, the claims we are testing refer to several medical conditions
(i.e., colon cancer, arthritis, seizures, migraine, lung cancer, heart
attack or stroke, eczema), which makes it impractical to recruit a
sufficient number of patients and caregivers for each medical
condition. However, in response to this comment, we have added an item
to the survey to assess whether participants have these conditions or
have cared for someone with these conditions. This will allow us to
explore associations between survey responses and experiences with the
medical conditions.
(Comment 3) One comment recommended determining participants'
comprehension of information regarding relative risk, absolute risk,
relative benefit, and absolute benefit.
(Response 3) There is a body of research on many of these topics;
see, for example, the references section in the guidance for industry
entitled ``Presenting Quantitative Efficacy and Risk Information in
Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,''
available at https://www.fda.gov/media/169803/download. In this survey,
we will examine participants' interpretations of relative benefit.
(Comment 4) One comment requested information on the number of and
demographic diversity of the one-on-one interviews.
(Response 4) Since the 60-day Federal Register notice was
published, we conducted 24 interviews (approved under OMB Control No.
0910-0847). We recruited with demographic diversity in mind. Half (50
percent) of the participants had some college or more education, and
half (50 percent) had less education. Overall, 58 percent of the
participants were women, 29 percent were non-Hispanic White, 29 percent
were non-Hispanic Black, and 25 percent were Hispanic. We also
recruited participants of different ages: 42 percent were between the
ages of 18 and 39, 29 percent were between the ages of 40 and 59, and
29 percent were 60 and older.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Read prenotification letter.................. 2,993 1 2,993 0.08 (5 min.)............................ 239
Read web survey invitation letter \2\........ 2,843 1 2,843 0.08 (5 min.)............................ 227
Read reminder postcard....................... 2,585 1 2,585 0.03 (2 min.)............................ 78
Respond to survey (web and paper)............ 1,100 1 1,100 0.33 (20 min.)........................... 363
Total.................................... .............. .............. .............. ......................................... 907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers assume around 5 percent postal non-deliverables from the prenotification letter and estimates nonrespondents for the subsequent
mailings.
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://
[[Page 87433]]
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. Sullivan, H.W., K.J. Aikin, and L.B. Squiers, ``Quantitative
Information on Oncology Prescription Drug websites,'' Journal of
Cancer Education, vol. 33, Issue 2, pp. 371-374, 2018. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459)
2. Dillman, D.A., J.D. Smyth, and L.M. Christian, internet, Phone,
Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed.,
John Wiley & Sons, Inc.: Hoboken, NJ, 2014.
*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et al., ``Effect of Prepaid
and Promised Financial Incentive on Follow-Up Survey Response in
Cigarette Smokers: A Randomized Controlled Trial,'' BMC Medical
Research Methodology, vol. 19, Article 138, 2019. (https://link.springer.com/article/10.1186/s12874-019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al., ``How Much Gets You
How Much? Monetary Incentives and Response Rates in Household
Surveys,'' Public Opinion Quarterly, vol. 79, pp. 105-129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al., ``What Works, What
Doesn't? Three Studies Designed to Improve Survey Response,'' Field
Methods, vol. 32, Issue 3, pp. 235-252, 2020. (https://doi.org/10.1177/1525822X20915464)
6. Ellis, J., J. Charbonnier, C. Lowenstein, et al., ``Assessing the
Impacts of Different Incentives and Use of Postal Mail on Response
Rates,'' American Association for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
*7. Yu, S., H.E. Alper, A.M. Nguyen, et al., ``The Effectiveness of
a Monetary Incentive Offer on Survey Response Rates and Response
Completeness in a Longitudinal Study,'' BMC Medical Research
Methodology, vol. 17, Article 77, 2017. (https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1)
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27652 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P
