[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27842-27845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1315]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Risk Information Amount and 
Location in Direct-to-Consumer Print Ads

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 research entitled ``Experimental Study of Risk 
Information Amount and Location in Direct-to-Consumer Print Ads.'' This 
study will examine how repetition and overwarning apply to the 
presentation of risks in the context of direct-to-consumer print 
advertising.

DATES: Submit either electronic or written comments on the collection 
of information by August 18, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must

[[Page 27843]]

be submitted on or before August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 18, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as 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-2017-N-1315 for ``Experimental Study of Risk Information Amount and 
Location in Direct-to-Consumer Print Ads.'' 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected]. For copies of the questionnaire contact: Office 
of Prescription Drug Promotion (OPDP) Research Team, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the PRA (44 U.S.C. 3501-3520), 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.

Experimental Study of Risk Information Amount and Location in Direct-
to-Consumer Print Ads; 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 (the 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.
    Section 502(n) of the FD&C Act (21 U.S.C. 352(n)) specifies that 
advertisements (ads) for prescription drugs and biological products 
must provide a true statement of information ``in brief summary'' 
describing the advertised product's ``side effects, contraindications 
and effectiveness.'' The prescription drug advertising regulations 
provide further clarification on the information to include in brief 
summary a true statement of information in brief summary relating to 
side effects, contraindications to include side effects, warnings, 
precautions, and

[[Page 27844]]

contraindications and include any such information under such headings 
as cautions, special considerations, important notes, etc. and 
effectiveness (21 CFR 202.1(e)(1)). The prescription drug advertising 
regulations also specify that the phrase side effect and 
contraindication refers to all of the categories of risk information 
contained in the required, approved or permitted product labeling 
written for health professionals, including the Warnings, Precautions, 
and Adverse Reactions sections (21 CFR 202.1(e)(3)(iii)). Ads must also 
``present a fair balance between information relating to side effects 
and contraindications and effectiveness. . . .'' An ad must present 
true information relating to side effects and contraindications in 
comparable depth and detail with the claims for effectiveness or safety 
(21 CFR 202.1(e)(5)(ii)).
    To fulfill the regulatory requirements for fair balance and the 
brief summary, sponsors have typically included risk information about 
the product in direct-to-consumer (DTC) print ads both in the main part 
of the ad where the product claims appear, and in a separate brief 
summary page. The section of the main ad where the risks appear is 
often referred to as the ``Important Safety Information'' (ISI). 
Including risks in both the ISI and the brief summary may have 
advantages. Some research has found that repetition of information 
improves recall, especially for older adults (Ref. 1). This might 
result in improved recall for risks that appear both in the ISI and 
brief summary. However, it is possible that risks appearing on the main 
page in the ISI may be more likely to be read than risks appearing in 
the brief summary. Based on FDA survey research, about 27 percent of 
consumers surveyed in 2002 reported reading half or more of the brief 
summary in DTC print ads (Ref. 2). In comparison, when asked how much 
of the ``main'' ad they read, about 78 percent reported reading ``all'' 
or ``almost all'' of the main body portion of the ad.
    One potential downside to including the same warnings in both the 
ISI and again in the brief summary is the potential to overwarn 
consumers. Overwarning is the concept that individuals are exposed to 
so many warnings in the course of daily life that they are less likely 
to pay attention to any one particular warning (Ref. 3). In terms of 
presenting risk information, detailing too many risks may lead 
consumers to discount all risks, or miss the most important risk 
information. Similarly, habituation follows when readers see the same 
warning repeatedly. Upon seeing a particular warning repeatedly, 
consumers may cease to pay attention to it (Refs. 4 to 6). Even if a 
warning has features that make it noticeable, it still has the 
potential for habituation with repeated exposure (Ref. 5). Although 
researchers caution against habituation and overwarning, there appears 
to be little empirical research for the logical supposition that seeing 
repeated warnings will lead to increased selectivity and reduced 
attention by recipients over time. Of note, the Office of Prescription 
Drug Promotion (OPDP) is studying the issue of reduced risk information 
in the context of DTC TV ads (``Disclosure Regarding Additional Risks 
in Direct-to-Consumer Prescription Drug Television Advertisements,'' 
OMB control number. 0910-0785).
    OPDP plans to investigate, through empirical research, how 
repetition and overwarning apply to the presentation of risks in 
promotional prescription drug print pieces. We propose to test two 
levels of the ISI (short versus long) and the presence of the Brief 
Summary (absent versus present) in two different medical conditions 
(overactive bladder and rheumatoid arthritis). Figures 1 and 2 describe 
the study design. This will be investigated in DTC print ads for 
prescription drugs.

                        Figure 1--Study 1 Design
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------------------------------------------------------------------------
                                                         Brief summary
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Rheumatoid Arthritis:
    ISI.............................................       No       Yes
    Short...........................................
    Long............................................
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                        Figure 2--Study 2 Design
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------------------------------------------------------------------------
                                                         Brief summary
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Overactive Bladder:
    ISI.............................................       No       Yes
    Short...........................................
    Long............................................
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    This project is designed to use eye tracking technology to 
determine how these risk presentations in DTC print ads are perceived. 
Eye tracking technology is an effective method to determine the extent 
to which consumers attend to risk information presented in DTC print 
ads. This technology allows researchers to unobtrusively detect and 
measure where a participant looks while viewing a print ad and for how 
long, and the pattern of their eye movements may indicate attention to 
and processing of information in the ad.
    We plan to collect descriptive eye tracking data on participants' 
attention to the following: (1) The important safety information, (2) 
the brief summary, and (3) the indication and benefit claims. All 
participants will be 18 years of age or older. We will exclude 
individuals who are trained as healthcare professionals, or who work in 
pharmaceutical, advertising, or marketing settings because their 
knowledge and experiences may not reflect those of the typical 
consumer. We will also exclude individuals who have photosensitive 
epilepsy; use a medical device that is sensitive to infrared light; or 
wear bifocals, hard contact lenses, or colored contact lenses.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance 
(ANOVA). With the sample size described in this document, we will have 
sufficient power to detect small-to-medium sized effects in the main 
study.
    We plan to conduct one 60-minute pilot study with 40 participants 
and two 60-minute studies with 200 participants each (50 participants 
in each cell), for a total of 400 main study participants. The studies 
will be conducted in person in at least five different cities across 
the United States. The pilot study and main studies will have the same 
design and will follow the same procedure. Participants who self-
identify as having one of the medical conditions of interest will be 
randomly assigned to one of four test conditions. In Study 1, the ad 
will be for a fictitious drug to treat rheumatoid arthritis. In Study 
2, the ad will be for a fictitious drug to treat overactive bladder. 
After obtaining consent, we will explain the study procedure to 
participants and calibrate the eye tracking device. To collect eye 
tracking data, we will use an unobtrusive glasses-based real world eye 
tracker with a minimum speed of 50 Hertz. The test images will be 
presented on paper and sized similarly to how they would appear in 
print materials such as magazines. To simulate normal ad viewing, 
participants will view two ads. One of the ads will be the study ad. 
The non-study ad will be for a consumer product unrelated to health. 
Only eye tracking data from the study ad will be analyzed. Next, 
participants will complete a questionnaire that assesses risk 
perceptions, risk recall, efficacy perceptions, efficacy recall, and 
covariates such as demographics and health literacy. In the pilot 
study, participants will also answer questions as part of a debriefing 
interview to assess the study design and questionnaire.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 27845]]



                                                      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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Pilot screener..............................             120               1             120  0.03 (2 minutes)..........................               4
Study 1 screener............................             600               1             600  0.03 (2 minutes)..........................              18
Study 2 screener............................             600               1             600  0.03 (2 minutes)..........................              18
Completes, Pilot............................              40               1              40  1.........................................              40
Completes, Study 1..........................             200               1             200  1.........................................             200
Completes, Study 2..........................             200               1             200  1.........................................             200
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

    The following references are on display in 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 are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. McGuire, L.C., ``Remembering What the Doctor Said: Organization 
and Older Adults' Memory for Medical Information.'' Experimental 
Aging Research, 22, 403-428 (1996).
2. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician 
Attitudes and Behaviors Associated with DTC Promotion of 
Prescription Drugs: Summary of FDA Survey Research Results'' (2004). 
Available at http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf.
3. Warnings and Risk Communication (2005). Wogalter, M.S., D. DeJoy, 
and K.R. Laughery (Eds.). Philadelphia: Taylor & Francis, Inc.
4. Conzola, V.C., and M.S. Wogalter, ``A Communication-Human 
Information Processing (C-HIP) Approach to Warning Effectiveness in 
the Workplace.'' Journal of Risk Research, 4(4), 309-322; (2001).
5. Wogalter, M.S., and K.R Laughery, ``Warning! Sign and Label 
Effectiveness.'' Current Directions in Psychological Science, 5(2), 
33-37; (1996).
6. Wogalter, M.S., T.L. Smith-Jackson, B.J. Mills, and C.S. Paine, 
``The Effects of Print Format in Direct-to-Consumer Prescription 
Drug Advertisements on Risk Knowledge and Preference.'' Drug 
Information Journal, 36(3), 693-705, 2002.

    Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12600 Filed 6-16-17; 8:45 am]
 BILLING CODE 4164-01-P