Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 40295 

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. 

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 oira_

submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov. 

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 

(§ 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 (§ 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 (§ 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 directto-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). 


amozie on DSK3GDR082PROD with NOTICES1
40296 Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 

Figures 1 and 2 describe the study design. This will be investigated in DTC 

print ads for prescription drugs. 

This project is designed to use eyetracking 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 eyetracking 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-tomedium 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 eyetracking 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 = directto-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 eyetracking research study does not take 

this into consideration. 

(Response) We are not testing longterm 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 


amozie on DSK3GDR082PROD with NOTICES1EN14AU18.002</GPH>
Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 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’’ 

(§ 202.1(e)(1)). Additionally, 

advertisements must also ‘‘present a fair 

balance between information relating to 

side effects and contraindications and 

. . . effectiveness. . . .’’ 

(§ 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, >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 a = .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. 


amozie on DSK3GDR082PROD with NOTICES1
40298 Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 

(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-policyresearchers/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 openended 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 eyetracking 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 eyetracking 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 selfreport 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. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 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. Eyetracking 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, currentlyapproved and promoted products. 


amozie on DSK3GDR082PROD with NOTICES1
40300 Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 

(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, healthrelated ads. 

(Response) The purpose of 

participants viewing the consumer 

product ad, otherwise known as the 

warm-up ad, is to orient them to the adviewing task. In addition, the warm-up 

ad permits the research team to do an 

initial review and adjustment of the eyetracking 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/officeofmedicalprod

uctsandtobacco/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 consumerfriendly 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 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 (openended) questions. To avoid the potential 

for priming effects, the goals of the eyetracking 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. 


amozie on DSK3GDR082PROD with NOTICES1
40302 Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 

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 asis. 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 selfadministration 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

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

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 

1There 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices 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/ 

GuidanceComplianceRegulatory

Information/Guidances/UCM069984.pdf. 

8. ‘‘Content of Risk Information in the Major 

Statement in Prescription Drug Direct-toConsumer 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 SpokesCharacters 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-toConsumer 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 SelfReport 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

The Biomedical Advanced Research 

and Development Authority (BARDA) 

AGENCY: Assistant Secretary for 

Preparedness and Response, HHS. 

ACTION: Notice. 

SUMMARY: The Biomedical Advanced 

Research and Development Authority 

(BARDA), Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), in the Department of 

Health and Human Services intends to 

provide a Single Source Cooperative 

Agreement to Janssen Research & 

Development, LLC. The Cooperative 

Agreement will support QuickFire 

Challenges to spur innovation in 

respiratory protection. The total 

proposed cost of the Single Source 

Cooperative Agreement is not to exceed 

$100,000 for a total of 12 months. 

DATES: 

Project Period: The period of 

performance is from July 30, 2018 to 

June 30, 2019. 

Award amount: Estimate $100,000. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette.Funn@hhs.gov, 202–795–7714, 

Julie.Schafer@hhs.gov, 202–205–1435. 

SUPPLEMENTARY INFORMATION: The 

Biomedical Advanced Research and 

Development Authority (BARDA) is the 

program office for this Cooperative 

Agreement: 

Single Source Justification: Janssen 

Research & Development, LLC creates 

global challenges to spur innovation in 

health care in partnership with JLABS, 

a global network of open innovation 

ecosystems designed to support 

innovators and entrepreneurs in 

creating and accelerating innovative 

health care solutions. 

Janssen Research & Development, LLC 

and BARDA will collaborate on a global 

challenge for reimagined, transformative 

respiratory protection. Traditional 

respiratory protective devices used to 

protect against inhalation of harmful 

infectious agents were designed for use 

in occupational settings, to guard 

against inhalation of dangerous 

particulates. Disposable versions, such 

as N95 respirators, are only available for 

adults, must be fit-tested to ensure 

proper functioning, and can be 

uncomfortable to wear. In an outbreak of 

a novel or newly emerging respiratory 

disease, respiratory protection may be 

the only countermeasure available to 

protect health care workers and the 

general public. 

Janssen Research & Development, LLC 

will partner with JLABS, which exists to 

foster innovation in health care 

products and executes QuickFire 

Challenges for health care innovation. 

There is no direct equivalent of the 

QuickFire Challenge services for 

innovation specific to health care as is 

provided by JLABS. Its unique service 

will directly benefit BARDA’s mission 

to make available medical 

countermeasures to address health 

security threats. Supporting innovation 

is an authority provided to BARDA 

under the Public Health Service Act and 

partnering with a company providing a 

diverse array of products and leveraging 

its expertise and infrastructure has the 

potential to provide solutions to the 

challenges in developing new 

respiratory devices. 

Reimagined, innovative respiratory 

protection would contribute directly to 

ASPR’s mission to save lives and protect 

Americans against 21st Century health 

security threats. Respiratory protection 

is often the first line of defense, and a 

radically improved approach to protect 

both health care workers and the general 

public, including children, would truly 

improve our ability to respond to public 

health emergencies. By generating 

interest and focusing innovation efforts 

on reimagining respiratory protection, 

BARDA’s goal for the QuickFire 

Challenge is for the resulting innovative 

approaches to be eligible for continued 

testing and development and eventual 

regulatory approval, so that these 

revolutionary products can be widely 

available and used. 

Please submit an inquiry via the 

ASPR–BARDA Program Contact: Dr. 

Julie Schafer, Julie.Schafer@hhs.gov, 

202–205–1435. 

Robert P. Kadlec, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2018–17381 Filed 8–13–18; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Pain Management Best 

Practices Inter-Agency Task Force 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 


amozie on DSK3GDR082PROD with NOTICES1