Notice2023-08686
Agency Information Collection Activities; Proposed Collection; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
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Published
April 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the proposed study entitled "A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising."
Full Text
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<title>Federal Register, Volume 88 Issue 79 (Tuesday, April 25, 2023)</title>
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[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24997-25000]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0795]
Agency Information Collection Activities; Proposed Collection;
Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer
Prescription Drug Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 the proposed study entitled ``A Survey on
Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising.''
DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 24998]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-0795 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; A Survey on Quantitative Claims
in Direct-to-Consumer Prescription Drug Advertising.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#f6a6a4b7a582979090b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a">[email protected]</span></a>.
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.
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
[[Page 24999]]
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 <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>, 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 <a href="https://www.fda.gov/media/117573/download">https://www.fda.gov/media/117573/download</a>) 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 approximately 5 percent of the sampled addresses will be
postal nondeliverable 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 number 0910-0847). The survey is available
upon request from <a href="/cdn-cgi/l/email-protection#96d2c2d5c4f3e5f3f7e4f5fed6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="82c6d6c1d0e7f1e7e3f0e1eac2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
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 weight the data to account for different probability of selection
and nonresponse.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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
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Total................................ .............. .............. .............. ............................................. 907
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\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 nondeliverables 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. FDA has verified the website addresses, as of
the date this document publishes in the
[[Page 25000]]
Federal Register, but 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. (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459/</a>).
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. (<a href="https://link.springer.com/article/10.1186/s12874-019-0786-9">https://link.springer.com/article/10.1186/s12874-019-0786-9</a>)
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. (<a href="https://doi.org/10.1177/1525822X20915464">https://doi.org/10.1177/1525822X20915464</a>).
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. (<a href="https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1">https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1</a>).
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08686 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P
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