[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24997-25000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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

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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-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 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, 
[email protected].

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 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/117573/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 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 [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 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
                                          --------------------------------------------------------------------------------------------------------------
    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 https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. 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. (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: 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