[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87431-87433]
[FR Doc No: 2023-27652]

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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.

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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,<PHONE_NUMBER>,
[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

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\
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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 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://

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


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Page 10740]
[FR Doc No: 2012-4190]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 14262-000, 14276-000, 14280-000]

Lock+ Hydro Friends Fund VIII, FFP Project 92, LLC, Riverbank
Hydro No. 24, LLC; Notice Announcing Preliminary Permit Drawing

    The Commission has received three preliminary permit applications
deemed filed on September 1, 2011, at 8:30 a.m.,\1\ for proposed
projects to be located at the U.S. Army Corps of Engineers' Kentucky
River Lock and Dam No. 11, on the Kentucky River in Estill and Madison
Counties, Kentucky. The applications were filed by Lock+ Hydro Friends
Fund VIII for Project No. 14262-000, FFP Project 92, LLC for Project
No. 14276-000, and Riverbank Hydro No. 24, LLC for Project No. 14280-
000.
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    \1\ Under the Commission's Rules of Practice and Procedure, any
document received after regular business hours is considered filed
at 8:30 a.m. on the next regular business day. 18 CFR 385.2001(a)(2)
(2011).
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    On February 28, 2012, at 9 a.m. (eastern time), the Secretary of
the Commission, or her designee, will conduct a random drawing to
determine the filing priority of the applicants identified in this
notice. The Commission will select among competing permit applications
as provided in section 4.37 of its regulations.\2\ The priority
established by this drawing will be used to determine which applicant,
among those with identical filing times, will be considered to have the
first-filed application.
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    \2\ 18 CFR 4.37 (2011).
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    The drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St. NE., Washington, DC
20426. A subsequent notice will be issued by the Secretary announcing
the results of the drawing.

    Dated: February 16, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-4190 Filed 2-22-12; 8:45 am]
BILLING CODE 6717-01-P