[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40295-40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17360]



[[Page 40295]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 (the PRA).

DATES: Fax written comments on the collection of information by 
September 13, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#57383e2536082422353a3e24243e383917383a357932382779303821"><span class="__cf_email__" data-cfemail="f29d9b8093ad8187909f9b81819b9d9cb29d9f90dc979d82dc959d84">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910--New and 
title ``Experimental Study of Risk Information Amount and Location in 
Direct-to-Consumer Print Ads.'' Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office 
of Operations, Food and Drug Administration, Three White Flint North, 
10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#46161407153227202006202227682e2e3568212930"><span class="__cf_email__" data-cfemail="2e7e7c6f7d5a4f48486e484a4f0046465d00494158">[email protected]</span></a>.

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.

Experimental Study of Risk Information Amount and Location in Direct-
to-Consumer Print Ads

OMB Control Number 0910--NEW

I. Background

    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.'' This is clarified further in the prescription drug 
advertising regulations. The brief summary shall include a true 
statement of information relating to side effects, contraindications, 
warnings, precautions, and any such information under such headings as 
cautions, special considerations, important notes, etc., as well as 
effectiveness (Sec.  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 side effects, warnings, 
precautions, and contraindications (Sec.  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 (Sec.  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. 4-6). 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 limited empirical research in the area of DTC advertising for 
prescription drugs 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 presentation of 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, various 
combinations of the ISI and brief summary. We propose to test two 
levels of the ISI (short versus long) and the presence of a consumer 
brief summary (absent versus present) in two different medical 
conditions (overactive bladder (OAB) and rheumatoid arthritis). The 
consumer brief summary will follow the draft recommendations for 
language, readability, content, and format described in ``Brief Summary 
and Adequate Directions for Use: Disclosing Risk Information in 
Consumer-Directed Print Advertisements and Promotional Labeling for 
Prescription Drugs: Guidance for Industry, Revised Draft Guidance'' 
(Ref. 7). The ``long'' ISI is a selection of risks from the brief 
summary and is typical of what would appear in current DTC ads for each 
condition. The ``short'' ISI was created by applying the ideas from 
recent FDA work on the major statement in broadcast ads (see Refs. 8 
and 9).

[[Page 40296]]

Figures 1 and 2 describe the study design. This will be investigated in 
DTC print ads for prescription drugs.
[GRAPHIC] [TIFF OMITTED] TN14AU18.002

    This project is designed to use eye-tracking technology. 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 voluntary 
participants' attention to the following: (1) The ISI, (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, employees of the U.S. Department 
of Health and Human Services (HHS), 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 various kinds of 
eyeglasses, hard contact lenses, or colored contact lenses, or have 
certain vision disorders.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance. 
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 voluntary participants each (50 
participants in each cell), for a total of 400 main study voluntary 
participants. The studies will be conducted in person in at least five 
different cities across the United States. These locations include 
Chicago, IL, Tampa, FL, Phoenix, AZ, Houston, TX, and Marlton, NJ. 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 OAB. 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.
    In the Federal Register of June 19, 2017 (82 FR 27842), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Five public comments were received. Comments 
received along with our responses to the comments are provided below. 
For brevity, some public comments are paraphrased and therefore may not 
reflect the exact language used by the commenter. We assure commenters 
that the entirety of their comments was considered even if not fully 
captured by our paraphrasing in this document. The following acronyms 
are used here: FRN = Federal Register Notice; DTC = direct-to-consumer; 
FDA and the Agency = Food and Drug Administration; OPDP = FDA's Office 
of Prescription Drug Promotion.
    (Comment 1a, regulations.gov tracking number 1k1-8xet-419m 
(verbatim)) The research methodology that is outlined here, does not 
take into consideration prior exposure to ads and the fact that it is 
known to take about seven exposures to anything before the information 
sticks. Exposing the respondents to an hour-long eye-tracking research 
study does not take this into consideration.
    (Response) We are not testing long-term retention of information. 
We are recruiting participants who have the medical condition of 
interest and may currently be under treatment. Also, Question 21 asks 
about familiarity with treatments for the targeted condition, which can 
be used as a covariate in analyses. We do not expect participants to 
have prior exposure to advertising for the product in the study because 
the ad is for a fictional product.
    (Comment 1b (verbatim)) A sample of 400 is what is considered 
robust for comparative analysis. Although you will have enough to do 
some comparison with 200 respondents in each group, it would be better 
to increase to 400 per group.
    (Response) Analysis will be conducted within medical condition. 
This yields a sample size within each study of 200, which will be used 
to

[[Page 40297]]

examine the main effect of length of ISI, the main effect of the 
presence of a brief summary, and the interaction effects of the two. 
The sample size of 200 was determined through a power analysis using an 
alpha level of 0.05, a power of 0.90 and a medium effect size (f = 
0.25). The power to detect a medium effect size (f = 0.25) is 0.999 
given an alpha of 0.05 if the sample size for each study was increased 
to 400. The increase in sample size would not substantially improve our 
ability to detect differences.
    (Comment 1c (verbatim, edited for length)) It seems like the 
research is front loaded to give the answer that the FDA is looking 
for--give less information to consumers so that they think less about 
the side effects of the product and buy more product. Consumers should 
be given all the information to make an informed choice by themselves 
not determined by what the FDA or other governmental organization feels 
is what they can handle.
    (Response) Please see our responses to Comments 2i and 5a. This 
research is intended to develop scientific evidence to help inform 
policy decisions and ensure that our policies related to prescription 
drug promotion will have the greatest benefit to public health. OPDP 
seeks to ensure that prescription drug promotional materials provide 
truthful, balanced and accurately communicated information that helps 
patients make informed decisions about their treatment options. In each 
study, the ads will all include the same risk concepts and we will 
measure comprehension of these risks. We will vary the amount of detail 
about each risk concept in the ISI section of the ad and we will test 
the effects of repeating information across the ISI and the consumer 
brief summary.
    (Comment 2a, regulations.gov tracking number 1k1-8xz7-z732 
(verbatim)) Do the exclusion criteria adequately account for all 
potential subjects that have vision impairments that can affect how 
their eyes move as they read? Additional exclusions may be needed to 
address these (e.g. blindness in one eye, artificial eye, etc.).
    (Response) The study design currently calls for excluding potential 
participants with vision impairments that interfere with the 
capabilities of the eye-tracking glasses. This includes wearing regular 
glasses, bifocals, trifocals, progressive lenses, hard contact lenses, 
and colored contact lenses. We will also add exclusion criteria for 
potential participants who have cataracts, amblyopia (lazy eye/blind in 
one eye), strabismus (cross-eyed), mydriasis (permanent pupil 
dilation), nystagmus (involuntary eye movements), an ocular prosthesis 
(glass eye), and who are designated as legally blind.
    (Comment 2b (verbatim)) Consider adding an arm to the design that 
shows an ad without any specific risk content or a brief summary, but 
alternatively consists of a statement that informs a potential patient 
that the drug in question has risks, including serious risks, 
associated with its use, and that it is very important that a patient 
talk with his/her doctor about these risks, prior to use, to determine 
if the drug is appropriate for the patient. It would be interesting to 
see what type of recall and what type of eye movement data would occur 
for this type of statement.
    (Response) FDA regulations state that prescription drug 
advertisements must contain ``a true statement of information in brief 
summary relating to side effects, contraindications (. . .[to] include 
side effects, warnings, precautions, and contraindications and include 
any such information under such headings as cautions, special 
considerations, important notes, etc.) and effectiveness'' (Sec.  
202.1(e)(1)). Additionally, advertisements must also ``present a fair 
balance between information relating to side effects and 
contraindications and . . . effectiveness. . . .'' (Sec.  
202.1(e)(5)(ii)). We decline the suggestion to test the proposed 
statement at this time.
    (Comment 2c (verbatim)) Question 1: The relevance of asking a 
subject to assess how many risks are presented in comparison to how 
many benefits is not apparent. We recommend that FDA consider deleting 
the question or alternatively rewording it to get data on how many 
risks the subjects think are presented in the ad. Response options 
should be quantitative, such as: No risks, 1-3 risks, 4-6 risks, 
<ls-thn-eq>6 risks.
    (Response) The purpose of Question 1 is to assess participants' 
initial impressions of balance of risks versus benefits in the ad. 
Additionally, Question 4 has been revised based on the results of 
cognitive testing to collect risks that participants can recall. This 
provides both a quantitative measure and an accuracy evaluation. We 
believe this approach will yield richer data as far as how many risks 
the participant recalls from the ad.
    (Comment 2d (verbatim)) Question 4: If subjects are going to be 
asked to recall, using free text, the risks presented in the ad, it 
would similarly be interesting to add a similar question to recall, 
using free text, which benefits were presented in the ad.
    (Response) The questionnaire contains several questions about 
benefit/efficacy (Questions 3, 10, and 11). We also have questions that 
measure the perceived risk/benefit tradeoff (Questions 1, 18, and 19). 
Although it would be interesting from a conceptual standpoint to 
include an open-ended recall question about product benefits, our focus 
in this study is on the risk information. Further, we are concerned 
about adding length to the questionnaire as we have worked to minimize 
the burden of the collection of information on respondents.
    (Comment 2e (verbatim)) Questions 8, 10, and 11: Suggest rewording 
the questions so that they describe the likelihood that a person taking 
the drug experiences a side effect or a benefit.
    (Response) The items used in this section were developed through 
scale validation research. Thus, we prefer to retain them in their 
original form.
    (Comment 2f (verbatim)): Questions 12-15: It may be confusing for 
the reader to discern differences between the terms ``main ad'', ``page 
following the main ad'', and ``advertisement''. These terms might need 
to be accompanied by further explanatory text.
    (Response) Cognitive testing revealed participants did have 
difficulty discerning the differences in the ad components based on the 
descriptive terms provided. To address this problem and help with data 
quality, thumbnail images will be provided next to Questions 13-15, so 
that participants will have a visual cue of what portion of the ad the 
question is asking about without allowing them to re-read the ad 
stimulus.
    (Comment 2g (verbatim)) Questions 16 and 17: Randomize the order in 
which the personal involvement adjectives/tasks are presented to 
minimize bias.
    (Response) Question 16 is The Personal Involvement Inventory, a 
validated measure with high internal consistency (coefficient [alpha] = 
.88) and has been used in prior studies to provide useful information 
about personal relevance (Refs. 10 and 11). The author of the inventory 
confirmed that it was developed and has been administered without 
randomization of these items. For the current study, values across 
items will be averaged in order to produce an overall personal 
involvement score for comparison across participants. Since this 
question is a validated measure and will be used only as a moderator 
variable, the item order will not change. Question 17 is a measure of 
self-efficacy, which will serve as an additional outcome of interest. 
We will randomize Question 17.

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    (Comment 2h (verbatim)) Question 18: It is not clear what the term 
``leave'' means. It may mean ``take time off from work.'' Please 
clarify.
    (Response) Question 18 was developed through scale validation 
research. ``Leave'' does in fact mean ``take time off from work.'' We 
did not encounter any confusion on the part of respondents during 
cognitive testing of the questionnaire. We prefer to retain this 
question in its original form.
    (Comment 2i (verbatim)) Question 19: A consumer should not be 
expected to make a risk/benefit assessment of a drug simply by reading 
an ad. Such an assessment can occur only after a patient has had a 
discussion with his/her healthcare provider. Thus, we suggest deletion 
of this question.
    (Response) An important purpose of communicating the drug's 
specific risk and benefit information in DTC advertising is to position 
consumers as active and well-informed participants in their health care 
decisionmaking. FDA seeks to improve our understanding of what baseline 
judgements about product risks and benefits individuals make on the 
basis of advertising. Question 19 does not indicate that FDA expects 
that the advertisement will be the sole basis for individuals to assess 
benefit and risk or make ultimate healthcare decisions. Rather, 
Question 19, which was developed through scale validation research, 
measures one aspect of the consumer's perception of the drug's risk-
benefit tradeoff. Further, we did not encounter any confusion on the 
part of respondents during cognitive testing of the questionnaire.
    (Comment 2j (verbatim)) Questions 28-33: We note these questions 
assess the ability of the respondent to answer questions using an ice 
cream nutrition facts label. We assume the inclusion of these questions 
is to assess how well respondents are capable of comprehending complex 
numeric information. However, we note that some respondents may not be 
able to comprehend and apply numeric information or be motivated to do 
so, regardless of how it appears. The format may not matter when this 
is the case. Therefore, we suggest that FDA consider analyzing results 
based on those who can vs. cannot answer the ice cream questions. 
Alternatively, the ice cream questions could be used at the start of 
the survey to screen out those who are unable to answer the questions, 
thereby further focusing the sample on persons who are able to 
comprehend numeric presentations likely to be found in drug promotion.
    (Response) Questions 28-33 make up the Newest Vital Sign (NVS), 
developed by Pfizer. (See https://www.pfizer.com/health/literacy/public-policy-researchers/nvs-toolkit). The NVS is a valid and reliable 
measure of health literacy and numeracy that was used and recommended 
by two studies (Refs. 12 and 13). In this study, the NVS will be used 
as a covariate that measures risk of low health literacy/numeracy. It 
is important that potential participants of various health literacy 
levels are included, because level of health literacy/numeracy of the 
individual has been shown to play a particularly strong role in viewing 
and processing health information (Ref. 14).
    For the stated reasons, no change to the analysis or use of the 
questions to filter the sample of participants is planned.
    (Comment 3a, regulations.gov tracking number 1k1-8y5u-ecif 
(verbatim)) One omitted variable in the study design is recall after 
viewing the ad and ISI/brief summary. It would seem potential negative 
effects of overwarning and habituation would be even more apparent 
after a lapse of time. The commenter suggests incorporating a parameter 
to capture this, for example, including a re-contact option to test 
recall and interpretation after a period of 2-4 days. For this recall 
option, we suggest that a quota of ~ 30 respondents per cell in order 
to ensure a robust sample for statistical testing.
    (Response) Question 4 captures open-ended recall of risks and 
negative effects. The comment proposes an interesting research idea. 
However, testing long-term retention of information is beyond the scope 
of this study.
    (Comment 3b (summarized)) The commenter suggests ensuring a 
representative sample of respondents with the conditions of interest is 
collected (~ 30 per cell). Analysis of these respondents compared to 
those without the conditions would act as a control.
    (Response) The study design calls for only including individuals 
who have the medical condition targeted for each study. This is based 
on the rationale that, relative to the general population, individuals 
who suffer from a specific medical condition pay more attention to DTC 
ads related to that medical condition (Refs. 15-17). Thus, we do not 
plan to add a general population sample.
    (Comment 3c (verbatim)) Neither the full stimuli nor specific 
examples of the disclosure language were provided. The lack of access 
to these makes full interpretation of the study objectives difficult as 
well as leaves us unable to provide suggestions or comments on the 
stimuli to be tested.
    (Response) We have described the purpose of the study, the design, 
the population of interest, and have provided the questionnaire to 
numerous individuals upon request. The brief summary for each ad 
contains a summary of the product risks, side effects, and 
contraindications. The ``long'' ISI is a selection of risks from the 
brief summary and is typical of what would appear in current DTC ads 
for each condition. The ``short'' ISI was created by applying the ideas 
from recent FDA work on the major statement in broadcast ads (see Refs. 
16 and 17). Our full stimuli are under development during the PRA 
process. We do not make draft stimuli public during this time because 
of concerns that this may contaminate our participant pool and 
compromise the research.
    (Comment 3d (summarized)) The commenter suggests that the data and 
information collected with eye-tracking be used as secondary evidence 
of attention. This is due to both difficulty of interpretation inherent 
in eye-tracking data along with subjectivity introduced by the ad copy 
stimuli under examination, as stimuli can be manipulated to increase/
decrease attractiveness to a respondents' eye. The commenter believes 
these limitations make use of this data to direct policy difficult. 
Additionally, the briefing document does not expand upon exactly how 
the eye-tracking data will be analyzed other than tracking attention. 
There are various ways to analyze eye-tracking data, such as order of 
attention, number of multiple viewings, and possibly pupil dilation as 
a measure of attention. The commenter has traditionally added 
qualitative elements to its use of eye-tracking technology in research, 
by discussing what the respondent saw after viewing the stimuli and 
even reviewing a respondents' eye-tracking map with them to get further 
insights.
    (Response) To clarify, two types of data will be collected in each 
study. Both data types are considered useful evidence. Self-report 
measures will be collected via a web-based questionnaire, and physical 
measures of attention will be collected via eye-tracking glasses. 
Existing research has relied on self-report measures to determine how 
much and what parts of the risk and benefit information consumers are 
reading. Because of the known unreliability of self-report measures 
(Ref. 18), research is needed to accurately determine what and how much 
consumers are reading when they see risk and benefit statements in 
prescription drug ads.

[[Page 40299]]

    During the debriefings for the pilot study, respondents will be 
shown their eye-gaze data and asked to comment on the elements of the 
stimuli they attended to, the elements they did not attend to, and why. 
These data in aggregate form will be reviewed to determine whether to 
modify the stimuli prior to the main studies. Eye-tracking data (both 
heat maps and gaze plots) will be used in the analyses to identify 
general patterns across participants and to investigate how those 
relate to questionnaire measures.
    (Comment 3e (verbatim)) The FRN states the location of risk 
information is also an objective of the study. The commenter assumes 
this ``location'' testing will be via testing risk information 
communicated in stimuli having the ISI plus the Brief Summary against 
stimuli having the ISI only. If this is inaccurate, then we are not 
sure the study design as described in the FRN adequately tests for a 
variable of ``location.'' If varying location of risk information 
beyond ISI versus ISI + Brief Summary is desired, the commenter 
suggests this be tested in a subsequent study or that the proposed 
study better specify variation of ``location.''
    (Response) The commenter has correctly interpreted the study 
design. We are not manipulating where the information appears on the 
page. Location, as used here, refers to the presence of information in 
both the brief summary and the ISI, or just the ISI. Within each 
medical condition, we have endeavored to maintain consistency of where 
the information appears on the page, and the order of the information, 
across experimental conditions.
    (Comment 3f (summarized)) Through the survey, the commenter 
suggests maintaining a single scale for all rating questions. For 
example, the commenter generally employs a 5-point scale, which 
includes a midpoint, and is defined at each point. In the current 
questionnaire, the scales switch from 5-point to 6-point scales which 
could cause confusion among some respondents. If the 6-point scales are 
included explicitly to omit a neutral mid-point, the commenter suggests 
that each of the points are defined to ensure that respondents know 
what the point on the scale they are choosing means (similarly to what 
is provided in Question 20 onwards).
    (Response) Many of the items used in the survey were developed 
through scale validation research (i.e., Questions 8-11, 18, and 19). 
These items utilize a six-point scale, so we have attempted to use six-
point scales where possible. In other cases, however, we are using 
items that have been used in prior FDA studies (i.e., Questions 1 and 
24) or are established measurement inventories (Question 16 is the 
Personal Involvement Inventory; Ref. 11). Changing the scale range or 
altering the scale to add definitions to each scale point would 
preclude comparison with prior study results. Thus, we prefer to 
maintain the scale ranges currently in use.
    (Comment 3g (summarized)) For Questions 8-11, the commenter 
suggests adding a ``Don't know'' option as respondents might not be 
able to assess likelihood of side effects, seriousness of side effects, 
efficacy, and potential improvement based on the information presented 
in the ad. The current range of answer choices may force inaccurate or 
speculative responses; a ``Don't Know'' answer would be a legitimate 
choice and informative for the study. The commenter's standard practice 
is to provide a ``Don't Know'' option whenever it could be a valid 
answer.
    (Response) The items used in this section were developed through 
scale validation research. Thus, we prefer to retain them in their 
original form, for this study, though we will consider this for future 
measurement studies.
    (Comment 3h (verbatim)) For Question 12, without ability to review 
the stimuli, it is unclear what content will appear in Area A, B, C and 
D. It is also unclear whether the content will be the same across all 4 
stimuli ads or whether content will change location in the ad.
    (Response) We have endeavored to maintain consistency of 
information location across conditions. Area A is the part of the ad 
with a picture. Areas B, C, and D are all sections of the ISI.
    (Comment 3i (summarized)) The commenter wonders what the utility of 
asking Question 16 is as the question appears to be out of scope with 
the objectives of the study. Whether or not the ad is important, 
boring, or relevant to the respondent seems irrelevant to the stated 
goals. We suggest removing the question.
    (Response) Please see our response to Comment 2g.
    (Comment 3j (summarized) In Question 18, the inclusion of ``. . . 
outweigh all the things I have to do to obtain it (appointments, 
prescriptions, leave)'' seems out of scope when considering the 
objectives of the study. The commenter suggests removing the question.
    (Response) This question measures one aspect of product benefits, 
the benefit-inconvenience tradeoff, which is an important component of 
drug product perceptions. Additionally, please see our response to 
Comment 2h.
    (Comment 3k (summarized)) For Question 19, the commenter suggests a 
minor adjustment to the wording. Instead of saying ``The benefits of 
[DRUG NAME] outweigh any side effects it may have'', the commenter 
suggests saying ``. . . any side effects it is described/indicated as 
having''. ``May have'' could be interpreted subjectively by respondents 
to include side effects not in the ISI and brief summary.
    (Response) Question 19 is a validated question so it will be 
retained as is. Cognitive testing revealed no comprehension or 
reporting issues for this question.
    (Comment 3l (verbatim)) For Questions 22-23 pertaining to 
respondent perception of condition. There does not appear to be any 
skip logic to ensure that only those with one of the specified 
conditions can answer those questions. These questions should not be 
asked of those who do not suffer from one of the specified conditions.
    (Response) We intend to recruit individuals who self-identify as 
having either OAB or rheumatoid arthritis. Those individuals will be 
assigned to view an ad that treats their medical condition. The 
questionnaire will contain questions relevant to that medical condition 
only.
    (Comment 4a, regulations.gov tracking number 1k1-8y4d-os71 
(summarized)) The commenter recommends that greater emphasis be placed 
on the recall/questionnaire metric rather than the eye-tracking metric. 
The eye-tracking data will determine if there is indeed a direct 
correlation between the length (amount) of the risk information and 
length of time spent looking at that information; however, it will not 
differentiate between what content and format is more effective for 
communicating that risk information. The commenter suggests that FDA 
include in the questionnaire (and/or debriefing interview) specific 
inquiries regarding the repetitiveness of the risk information in order 
to further explore the link between the amount and placement of risk 
information and the ultimate recall of this information.
    (Response) Please see our response to Comment 3d. In addition, we 
will add a question regarding repetitiveness to the questionnaire.
    (Comment 4b (summarized)) The commenter believes it is important 
that the fictitious drugs in this study have safety profiles reflecting 
the complex safety profiles of actual, currently-approved and promoted 
products.

[[Page 40300]]

    (Response) The DTC ads to be used in this research were developed 
using actual ads for these medical conditions. Additionally, we 
consulted with expert reviewers in OPDP on content and format to ensure 
the stimuli are realistic.
    (Comment 4c (summarized)) The ``short'' versus ``long'' ISI should 
be defined explicitly. The commenter believes it is critical to know 
the specific ISI content (``short'' and ``long'') in order to fully 
understand the study results. Additionally, OPDP examples of adequate 
``short'' and ``long'' ISIs used in the context of print ads would be 
valuable templates for industry, especially given the lack of consensus 
in acceptable utilization of ``short'' iterations of ISI as observed in 
past OPDP advisory comments and Warning Letters.
    (Response) Please see our responses to comments 1c and 3c. This 
study is not intended to provide specific guidelines on what content 
should be included in the ISI.
    (Comment 4d (summarized)) The commenter proposes the content of the 
brief summary be stated as well so as to understand what risk 
information is repeated from the ISI and what impact this may have on 
the study results.
    (Response) We have described how the consumer brief summary will be 
constructed in the Background section. Please see our responses to 
Comment 1c and 3c.
    (Comment 4e (summarized)) The commenter questions the utility of 
including the control, consumer product ad if the eye-tracking data is 
not utilized. FDA should clarify if the questionnaire will assess the 
recall of the control ad. The commenter recommends FDA fully evaluate 
the data from the control ad in order to provide appropriate context 
for the results obtained from the study, health-related ads.
    (Response) The purpose of participants viewing the consumer product 
ad, otherwise known as the warm-up ad, is to orient them to the ad-
viewing task. In addition, the warm-up ad permits the research team to 
do an initial review and adjustment of the eye-tracking equipment as 
needed before the study task begins. Therefore, there is no plan to 
analyze the warm-up ad data as it is not relevant to the focus of the 
study, and is mainly a procedure to orient the participant to the eye-
tracking task.
    (Comment 5a, regulations.gov tracking number 1k1-8y60-6g3m 
(summarized)) The commenter is concerned with the Agency's recent 
approaches to studies in this area. FDA has proposed to undertake 
projects in a variety of disparate topics without articulating a clear, 
overarching research agenda or adequate rationales on how the proposed 
research related to the goal of further protecting public health. 
Within the last year, the Agency has increased such efforts at an 
exponential pace. At times, FDA proposes new studies seemingly without 
fully appreciating its own previous research published on the OPDP 
website. Proposed studies are often unnecessary in light of existing 
data. The commenter suggests that the Agency publish a comprehensive 
list of its prescription drug advertising and promotion studies from 
the past 5 years and articulate a clear vision for its research 
priorities for the near future. Going forward, FDA should use such 
priorities to explain the necessity and utility of its proposed 
research and should provide a reasonable rationale for the proposed 
research.
    (Response) OPDP's mission is to protect the public health by 
helping to ensure that prescription drug information is truthful, 
balanced, and accurately communicated, so that patients and health care 
providers can make informed decisions about treatment options. OPDP's 
research program supports this mission by providing 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 we believe 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 disease and product 
characteristics 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; and our focus on research 
quality aims at maximizing the quality of research data through 
analytical methodology development and investigation of sampling and 
response issues.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is 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, which 
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website 
includes links to the latest FRNs and peer-reviewed publications 
produced by our office. The website maintains information on studies we 
have conducted, dating back to a survey of DTC attitudes and behaviors 
conducted in 1999.
    (Comment 5b (The commenter provided a summary of their comments 
followed by a more detailed description of the same comments. For 
brevity, the summary of comments has been omitted and only the specific 
comments [5b through 5t] are provided below. The commenter's full 
comments may be accessed at regulations.gov via tracking number 1k1-
8y13-m7td) (summarized)) The PRA Notice states there has been little 
empirical research for the logical supposition that seeing repeated 
warnings will lead to increased selectivity and reduced attention. This 
is not correct. As some authors have commented, ``[h]abituation has 
been found in a variety [of] contexts and domains.'' The commenter is 
aware of at least three empirical research studies, none cited in the 
PRA Notice, that demonstrate the ``habituation effect is a robust 
phenomenon.'' This effect has been documented in ``studies involving 
different contexts and response measures.''
    (Response) We thank the commenter for pointing out this 
mischaracterization. We have revised our introduction to clarify that 
whereas there is an overall body of research relating to habituation, 
there is limited, if any, research on habituation in the specific 
context of DTC print advertising for prescription drugs.
    (Comment 5c (summarized)) FDA should clarify whether the proposed 
study will adopt the brief summary format outlined in ``Guidance for 
Industry--Brief Summary and Adequate Directions for Use: Disclosing 
Risk Information in Consumer-Directed Print Advertisements and 
Promotional Labeling for Prescription Drugs'' (Draft Guidance).
    (Response) We plan to utilize the Question and Answer consumer-
friendly format described in the referenced draft guidance.
    (Comment 5d (summarized)) The commenter requests that the Agency 
make available for public comment the study stimuli, including the non-
study ad for a consumer product unrelated to

[[Page 40301]]

health. In particular, the commenter wishes to provide comments on: (1) 
What constitutes ``short'' and ``long'' length for the ISI and (2) the 
content, format, and design of the Brief Summary.
    (Response) Please see our responses to Comments 1c, 3c, 4c, and 4e.
    (Comment 5e (summarized)) The Agency proposes to use eye tracking 
technology ``to determine how risk presentations in DTC print ads are 
perceived.'' The commenter encourages the Agency to use this technology 
in conjunction with other inputs (for example, qualitative research) to 
understand why subjects are looking at a portion of the proposed 
materials, rather than to draw conclusions that such portions were 
viewed. Additionally, an explanation of the use of eye tracking 
technology should also be included during the subject enrollment 
process.
    (Response) FDA plans to collect and analyze eye-tracking (physical 
measures of attention) data in conjunction with other measures, 
including self-report measures of attention, recall, and comprehension. 
The recall measures will be collected via qualitative (open-ended) 
questions. To avoid the potential for priming effects, the goals of the 
eye-tracking component of the study will not be explained to recruited 
individuals before they report for their in-person sessions. However, 
participants will be made aware of the eye-tracking component during 
the informed consent process. Please also see our response to Comment 
3d.
    (Comment 5f (summarized)) Recall Questions. FDA should capture 
whether subjects comprehend that there are side effects and negative 
outcomes, even if the subject does not recall information on the 
specifics. The commenter suggests adding a question concerning whether 
subjects were aided in the recall of information by the ``short'' or 
``long'' ISI format.
    (Response) Questions 4a-c capture recall of risk in an open-ended 
format. Our approach involves random assignment to experimental 
conditions; each participant will see only one version of the stimuli. 
Because participants will not be aware there is another, different 
format, asking them their impressions of the long versus the short 
format is not feasible.
    (Comment 5g (verbatim)) Recall questions (e.g., Question 4) ask 
test subjects to identify specific side effects and negative outcomes 
of the featured drug products. It is not clear why such questions are 
necessary for the research purpose of the study.
    (Response) An important purpose of communicating the drug's 
specific risk and benefit information in DTC advertising is to position 
consumers as active and well-informed participants in their health care 
decision-making. In this study, we are investigating how different 
presentations of risk information impact perception and comprehension 
of drug risks and benefits. These questions are designed to provide 
information to help us identify effective ways to communicate risk and 
benefit information in DTC advertising. See our response to Comment 2b 
for additional context.
    (Comment 5h (verbatim)) The questionnaires do not define certain 
key terms (e.g., risk, side effect). Subjects may interpret these terms 
based on different standards. FDA might consider providing user-
friendly definitions.
    (Response) We appreciate the importance of ensuring uniform 
interpretation of terms. In cognitive interviews preceding this work, 
we assessed whether individuals interpret key terms similarly and made 
revisions where necessary. We have also considered the additional time 
(burden) that would be required to complete the survey if every term 
were defined in the pilot and main study. With these factors in mind, 
we have chosen not to provide additional definitions.
    (Comment 5i (summarized)) The commenter recommends that: (1) FDA 
replace the phrase ``negative outcomes'' with ``risks and warnings'' 
and (2) insert ``possible'' before the phrase ``side effects.''
    (Response) We have deleted ``negative outcomes'' from the question 
wording in Question 2 and Question 4b. Also, please see our response to 
Comment 3g concerning the proposal to reword the previously validated 
question.
    (Comment 5j (verbatim)) The Agency should consider changing the 
sliding scale to an odd number system to permit a ``neutral'' response. 
Most questions (e.g., Questions 2-3, Questions 8-11) provide six 
choices, not permitting a neutral response.
    (Response) Please see our response to Comment 3f.
    (Comment 5k (verbatim)) FDA should reconsider the inclusion of the 
perceived efficacy likelihood (Question 10) and perceived efficacy 
magnitude (Question 11) questions. It is not apparent what utility 
these specific questions have in the context of the study.
    (Response) We note that this comment is the opposite of Comment 2d, 
which suggests adding recall questions about product benefits. Although 
the main focus of this research is on the risk information, an 
important purpose of communicating the drug's specific risk and benefit 
information in DTC advertising is to position consumers as active and 
well-informed participants in health care decision-making. These 
questions will allow us to assess the impact of our study variables on 
perception and comprehension of drug benefits.
    (Comment 5l (summarized)) The commenter supports a study design 
that includes an analysis of whether the inclusion of the brief 
summary, along with a short or long ISI, presents duplicative 
information to the user, and therefore, introduces overwarning.
    (Response) We thank the commenter for their support of research. We 
reiterate that the purpose of the study is to examine how various means 
of presenting risk information impact consumer comprehension and 
perceptions of product information.
    (Comment 5m (verbatim)) FDA states that it will conduct the studies 
in person in at least five different cities across the United States. 
The Agency should address what efforts it will take to avoid enrichment 
of the sample population when selecting cities.
    (Response) We interpret the commenter's request for FDA to address 
how it will ``avoid enrichment of the sample population when selecting 
cities'' to mean that FDA should address how it will avoid collecting 
data in cities where the medical conditions are more prevalent than in 
other cities. This is not the aim of collecting data in five different 
cities. Rather, the cities have been selected to represent metropolitan 
areas in various geographic areas of the United States, including the 
West, Southwest, Midwest, Southeast, and the mid-Atlantic. These 
locations include Chicago, IL, Tampa, FL, Phoenix, AZ, Houston, TX, and 
Marlton, NJ. Due to the low population prevalence rate of the two 
medical conditions and the need to conduct sessions with 40 individuals 
with the condition in each of 5 areas, testing in rural areas is not 
feasible.
    (Comment 5n (summarized)) Study participants diagnosed with one of 
the medical conditions of interest may be more prone to pay attention 
and read information concerning prescription drugs for these 
conditions. Additionally, the study setting may prompt participants to 
pay closer attention to stimuli. FDA should clarify how it plans to 
limit such response biases.
    (Response) The study method randomly assigns each participant to an 
experimental condition, ensuring that potential pre-existing biases 
will be evenly distributed across the conditions.

[[Page 40302]]

The only aspect of the participants' experiences that will be varied in 
the study will be the manipulations that we have described. Thus, given 
the experimental design of the study, if we find differences between 
and among conditions, we can be reasonably sure that the manipulations 
caused the differences. Similarly, any individual differences in 
attention or ability should be spread across experimental conditions. 
We have not found in the past that our participants spend an inordinate 
amount of time viewing stimuli, but we will be careful to place the 
research in context when we interpret the data.
    (Comment 5o (verbatim)) An ``FDA employee'' category, similar to S6 
and S7, should be added to the Screener Survey. These individuals 
should also be terminated from the study.
    (Response) We have added a category to exclude employees of HHS, 
which includes employees of FDA.
    (Comment 5p (verbatim)) S2 and S3 of the Screener Survey should be 
rewritten as follows: ``Has a doctor or other health care professional 
ever diagnosed you with overactive bladder (OAB)?''
    ``Has a doctor or other health care professional ever diagnosed you 
with rheumatoid arthritis (RA)?''
    (Response) We will leave the wording of the screener questions S2 
and S3 as-is. Cognitive testing results in various contexts have 
indicated comprehension and reporting errors associated with using the 
more formal phrase ``. . . diagnosed you with . . . [condition].'' 
Common practice is to use the wording ``. . . ever told you . . . .''
    (Comment 5q (verbatim)) Question 16 of the Questionnaire and P1 of 
the Pilot Study should be deleted. Whether a subject considers the 
study stimuli to be ``Exciting/Unexciting'' or ``Boring/Interesting'' 
or whether the subject ``likes'' the study stimuli has no apparent 
relevance to FDA's study goals.
    (Response) Please see our response to Comment 2g.
    (Comment 5r (verbatim)) Questions 12-17 should be the first 
questions of the Questionnaire. A subject will likely answer these 
questions most accurately immediately after reviewing the study stimuli 
and before answering other questions that could influence these 
answers.
    (Response) FDA agrees that it is important to position certain 
questions where they will be answered in close proximity to the ad-
viewing time, which may improve reporting accuracy. However, the 
decision was to place the questions that assess recall and recognition 
of risks (Questions 4-7) earliest in the question sequence, so as to 
minimize memory decay and contamination of responses by exposure to 
questions covering other constructs (risk likelihood, risk magnitude). 
The attention (Question 12) and ad reading (Questions 13-15) measures 
will be retained in their current order (in the first half of the 
questionnaire).
    (Comment 5s (verbatim)) Question 18 should include considerations 
for prescription drug access.
    (Response) Please see our response to Comment 2h.
    (Comment 5t (summarized)) It is unclear how FDA plans to utilize 
the non-study ad (related to ice cream). Questions 27-32 appear very 
different in nature, substance, purpose, format, and length than the 
questions concerning the drug ad. FDA should clearly articulate the 
purpose of this stimulus and how it will be used in analyzing study 
results (if at all). If the sole purpose is to ``stimulate normal ad 
viewing,'' the commenter encourages adding another one to two non-study 
ads.
    (Response) The comment suggests that the nutrition facts label was 
interpreted as the ``non-study ad.'' That is not the case. The ice 
cream nutrition facts label and accompanying questions (Questions 27-
33) are included in the questionnaire as skills-based measures of 
health literacy and numeracy and have been adapted for self-
administration in these studies. Please see our response to Comment 2j.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot Screener..............................             120               1             120  .03 (2 minutes)...........................               4
Study 1 Screener............................             600               1             600  .03 (2 minutes)...........................              18
Study 2 Screener............................             600               1             600  .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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 with the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852 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 website addresses, as of the date this document publishes 
in the Federal Register, but websites 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, vol. 22, pp. 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 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm151498.htm.
3. Warnings and Risk Communication (2005). Wogalter, M.S., D.M. 
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, vol. 4(4), pp. 309-322, 
2001.
5. Wogalter, M.S. and K.R. Laughery, ``Warning! Sign and Label 
Effectiveness.'' Current Directions in Psychological Science, vol. 
5(2), pp. 33-37, 1996.
6. Wogalter, M.S., T.L. Smith-Jackson, B.J. Mills, and C.S. Paine, 
``The Effects of

[[Page 40303]]

Print Format in Direct-to-Consumer Prescription Drug Advertisements 
on Risk Knowledge and Preference.'' Drug Information Journal, vol. 
36(3), pp. 693-705, 2002.
7. Brief Summary and Adequate Directions for Use: Disclosing Risk 
Information in Consumer-Directed Print Advertisements and 
Promotional Labeling for Prescription Drugs. Revised Draft Guidance. 
Available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM069984.pdf.
8. ``Content of Risk Information in the Major Statement in 
Prescription Drug Direct-to-Consumer Broadcast Advertisements; 
Establishment of a Public Docket; Request for Information and 
Comments.'' August 21, 2017, 82 FR 39598.
9. Betts, Kevin R., et al., ``Serious and Actionable Risks, Plus 
Disclosure: Investigating an Alternative Approach for Presenting 
Risk Information in Prescription Drug Television Advertisements.'' 
Research in Social and Administrative Pharmacy, 2017.
10. Bhutada, N.S., B.L. Rollins, and M. Perri III, ``Impact of 
Animated Spokes-Characters in Print Direct-to-Consumer Prescription 
Drug Advertising: An Elaboration Likelihood Model Approach.'' Health 
Communication, vol. 32, pp. 391-400, 2017.
11. Zaichkowsky, J.L., ``The Personal Involvement inventory: 
Reduction, Revision, and Application to Advertising.'' Journal of 
Advertising, vol. 23, pp. 59-70, 1994.
12. Mackert, M., S.E. Champlin, K.E. Pasch, and B.D. Weiss, 
``Understanding Health Literacy Measurement Through Eye Tracking.'' 
Journal of Health Communication, vol. 18, pp. 185-196, 2013.
13. Chiang, K.P. and A. Jackson, ``The Impact of Health Literacy on 
Involvement and Attitude Toward Pharmaceutical Print Ads.'' 
International Journal of Healthcare Management, vol. 9(1), pp. 47-
57, 2016.
14. An, S. and N. Muturi, ``Subjective Health Literacy and Older 
Adults' Assessment of Direct-to Consumer Prescription Drug Ads.'' 
Journal of Health Communication, vol. 16(3), pp. 242-255, 2011.
15. Ball, J.G., D. Manika, and P. Stout, ``Consumers Young and Old: 
Segmenting the Target Markets for Direct-to-Consumer Prescription 
Drug Advertising.'' Health Marketing Quarterly, vol. 28(4), pp. 337-
353, 2011.
16. Christensen, T.P., F.J. Ascione, and R.P. Bagozzi, 
``Understanding How Elderly Patients Process Drug Information: A 
Test of a Theory of Information Processing.'' Pharmaceutical 
Research, vol. 14, pp. 1589-1596, 1997.
17. Mehta, A. and S.C. Purvis, ``Consumer Response to Print 
Prescription Drug Advertising.'' Journal of Advertising Research, 
vol. 43(2), pp. 194-206, 2003.
18. Paulhus, D.L. and S. Vazire, ``The Self-Report Method.'' 
Handbook of Research Methods in Personality Psychology, vol. 1, pp. 
224-239, 2007.

    Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17360 Filed 8-13-18; 8:45 am]
 BILLING CODE 4164-01-P


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