80 FR 34672 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

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.

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34672-34677]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1794]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Impact of Ad Exposure 
Frequency on Perception and Mental Processing of Risk and Benefit 
Information in Direct-to-Consumer Prescription Drug 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.

DATES: Fax written comments on the collection of information by July 
17, 2015.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Impact of Ad Exposure Frequency on Perception and Mental 
Processing of Risk and Benefit Information in Direct-To-Consumer 
Prescription Drug Ads.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Impact of Ad Exposure Frequency on Perception and Mental Processing of 
Risk and Benefit Information in Direct-to-Consumer Prescription Drug 
Ads; OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the 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(b)(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.
    In a typical promotional campaign, consumers may be exposed to a 
direct-to-consumer (DTC) prescription drug ad any number of times. 
Perceptual and cognitive effects of increased ad exposure frequency 
have been studied extensively using non-drug ads. For instance, one 
study demonstrated that a commercial message repeated twice generates 
better recall than a message broadcast only once (Ref. 1). Another 
study demonstrated that increased ad exposures improve product 
attitudes and recall for product attributes, particularly when the 
substance of the repeat messages is varied (Ref. 2). Generally, it has 
been argued that first exposure to an ad results in attention, second 
exposure affects learning of the advertised message, and third and

[[Page 34673]]

subsequent exposures reinforce the learning effects of the second 
exposure (Ref. 3). To our knowledge, the literature concerning ad 
exposure frequency has not been extended to include specific attention 
to prescription drug ads. Prescription drug ads are unique in that they 
are required to provide both benefit and risk information whereas other 
ad types tend to include only benefit information. The Office of 
Prescription Drug Promotion (OPDP) plans to examine the effects of 
variation in ad exposure frequency on perception and mental processing 
of risk and benefit information in DTC prescription drug ads through 
empirical research.
    The main study will be preceded by up to two pretests designed to 
delineate the procedures and measures used in the main study. Across 
pretests and the main study, participants will be individuals who have 
been diagnosed with seasonal allergies. All participants will be 18 
years of age or older. We will exclude individuals who work in 
healthcare or marketing settings because their knowledge and 
experiences may not reflect those of the average consumer. Participants 
will be recruited in one of two geographic locations (Washington, DC 
and Raleigh, North Carolina) for in-person administration of protocols.
    The experimental design is summarized below. Participants will be 
randomly assigned to view a prescription drug ad one, two, or four 
times as part of clutter reels embedded in 42 minutes of TV 
programming. They will then answer preprogrammed survey questions on 
laptops. Measures are designed to assess perception, memory, judgments 
about the ad, intentions to use the medication advertised, and possible 
moderators of effects, such as need for cognition and demographics. The 
questionnaire is available upon request.

                                                                  Table 1--Study Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Episode #1                                                  Episode #2
     Experimental arm number     -----------------------------------------------------------------------------------------------------------------------
                                    Clutter Reel 1      Clutter Reel 2      Clutter Reel 3      Clutter Reel 4      Clutter Reel 5      Clutter Reel 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (views ad 1 time).............  ..................  ..................  ..................  ..................  ..................  Mock DTC ad
2 (views ad 2 times)............  ..................  ..................  Mock DTC ad.......  ..................  ..................  Mock DTC ad
3 (views ad 4 times)............  Mock DTC ad.......  ..................  Mock DTC ad.......  Mock DTC ad.......  ..................  Mock DTC ad
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In the Federal Register of November 12, 2014 (79 FR 67172), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received five public submissions. In the 
following section, we outline the observations and suggestions raised 
in the comments and provide our responses. Comments that are not PRA-
relevant (e.g., ``Ban DTC'') or do not relate to the proposed study are 
not included below or addressed in our responses.
    (Comment from Valeant Pharmaceuticals) Develop and publish a 
strategic plan for how FDA will collate and make use of data from all 
FDA-sponsored studies concerning consumer and physician perception and 
comprehension of prescription drug advertising and promotion.
    (Response) The OPDP research Web page (Ref. 4) has recently been 
updated to reflect the current status of completed and ongoing 
research. As stated on our Web page, OPDP maintains an active research 
program designed to investigate applied and theoretical issues in the 
communication of risk and benefit information in DTC and professional 
promotional prescription drug materials. OPDP's research supports FDA's 
goal of science-based policy while maintaining its commitment to 
protect the public health. The research provides FDA management with 
evidence that can be considered along with other relevant research in 
future policy decisions.
    (Comment from Valeant Pharmaceuticals) Provide data to confirm 
limiting the study recruitment to Washington, DC and Raleigh Durham, NC 
area is representative of the entire United States.
    (Response) The research questions examined in this study (e.g., 
risk and benefit recall as a function of the number of target ad 
exposures) are believed to apply to human judgment and decision making 
and not to be contingent upon geographic residence. We acknowledge that 
collecting data across a greater number of geographic locations may 
provide value, but choose to allocate our limited funding in ways we 
believe more appropriately ensure the integrity of the research. For 
example, the requirement that participants view 60 minutes of 
programming led us to collect data in person, which allows for us to 
supervise participant engagement with the survey and therefore ensure 
that stimuli are, in fact, viewed. Although the current research 
includes limited geographic diversity, note that other forms of 
diversity (e.g., gender, age, and race) will be sought during 
recruitment and accounted for in our analyses.
    (Comment from Valeant Pharmaceuticals) Six exposures during the 
same 42-minute television program are not reflective of how advertising 
is delivered and could inadvertently bias the results.
    (Response) The study design has been revised such that the 
experimental groups will view the ad one, two, or four times over the 
course of the 60-minute viewing period. Additional details about this 
change are provided in later responses.
    (Comment from Valeant Pharmaceuticals) Consumer comprehension of 
benefit and risk is not solely based on the viewing of the DTC TV ad in 
isolation. Consumer comprehension should take into account the role of 
the healthcare professional and other materials.
    (Response) We appreciate that consumer judgment and decision making 
often results from multiple information sources. In many cases, DTC TV 
ads serve as the first source of information received, and therefore 
may influence whether or not additional information is sought, and 
ultimately whether or not a product is requested from a healthcare 
professional. Through broad research on DTC advertising, we seek to 
ensure that consumers are appropriately informed about the risks and 
benefits of prescription drugs across all information sources, when 
viewed in isolation or in combination with other sources.
    (Comment from Valeant Pharmaceuticals) Because the study is limited 
to one DTC TV ad and one therapeutic area, the results should not be 
broadly applied to other forms of advertising or other therapeutic 
areas.
    (Response) We agree that results should not be broadly applied to 
other forms of advertising. We do not agree that results necessarily 
need be restricted to the selected therapeutic

[[Page 34674]]

area. Our primary research question for the study is whether increasing 
ad exposure frequency will result in different risk or benefit 
perceptions than less exposure to the ad. This question pertains to 
human perception and judgment and is not thought to be unique to any 
particular therapeutic area. Nonetheless, we agree that replication of 
this research using other forms of advertising and different 
therapeutic areas would be valuable.
    (Comment from Abbvie) It is not clear how the proposed collection 
is necessary for the proper performance of FDA's functions. It is 
difficult to ascertain how the Agency will utilize the results of this 
study within its statutory authority. For example, should the results 
of this study demonstrate that the frequency of ad exposure matters, 
how would the Agency modify the airing frequency of DTC TV ads or the 
frequency at which consumers are exposed to the advertisements in a 
real world setting? Rather than conduct this study, we suggest that FDA 
resources and taxpayer dollars would be better directed to research 
that enhances the quality of how we communicate benefit and risk 
information to consumers regardless of the medium and the frequency of 
the exposure. Guidance is needed on the best practices for 
communicating benefit and risk information to consumers who are 
prescribed prescription drugs. This is particularly important as the 
quality of the communication has the power to result in a better 
informed consumer.
    (Response) This research reflects the need to understand not only 
the message that consumers receive, but also the delivery of those 
messages, and how that delivery influences perception, judgment, and 
decision making. It may be that full comprehension of benefit 
information is achieved upon a single exposure, whereas full 
comprehension of risk information requires multiple exposures. Insight 
on this topic may allow FDA to make more informed judgments regarding 
consumer information processing of DTC television ads.
    (Comment from Abbvie) Should the Agency proceed with this study, 
FDA could enhance the quality, utility, and clarity of the information 
to be collected by avoiding introducing bias into the way the survey is 
conducted. For example, in the draft survey (version 10.22.14), FDA 
creates an artificial setting in which participants are instructed to 
watch the commercials that air during a 90-minute TV program during 
which the same ad airs three to six times. This is very different from 
the airing and viewing frequency of DTC ads that occur today. Hence, we 
question the applicability of the results of this study to a real world 
setting.
    (Response) Please note that stimuli play for 60 minutes (not 90), 
and that the original design involved airing of the ad one, three, or 
six times (not three to six). We appreciate that six viewings would be 
unusual and so the study design has been revised such that the 
experimental groups will view the ad one, two, or four times over the 
course of the 60-minute viewing period. Additional details about this 
change are provided in later responses.
    (Comment from Eli Lilly) The FDA sample does not currently include 
a ``General Population'' control group, as all participants will be 
screened to qualify when identified as suffering from seasonal 
allergies, a condition that could be relieved by the drug described in 
advertisement. It may be helpful to the FDA's analysis plan to include 
a control group.
    (Response) Researching each medical condition, or general 
population sample, requires significant resources. We are committed to 
conducting this research using our available resources while ensuring 
the integrity of the research by collecting data on a high prevalence 
condition for which participants might be thought of as sufficiently 
representative of the average consumer, thus allowing us to draw 
conclusions about broad perceptual and cognitive processing outcomes.
    (Comment from Eli Lilly) In the proposed study design, respondents 
will watch a 42-minute television program with an embedded clutter reel 
of ads. Within this time period, respondents will be exposed to a drug 
ad 1, 3, or 6 times and then administered a survey instrument. While we 
acknowledge that a consumer can be exposed to an ad 6 times or more, we 
do not believe 6 exposures in such a compressed time period represents 
a reasonable real-world experience and is likely to overstate consumer 
reaction, particularly given that such reactions will be tested 
immediately after viewing. We believe the current design imposes a risk 
of creating artificial differences between the study arms by skewing 
perception, judgment, retention of information, intent, etc., 
ultimately leading to erroneous conclusions and unactionable 
expectations.
    Specifically, research data on multiple ad exposures and 
``effective frequency'' is long established. Based upon multiple 
studies, experience, and client preference across industries, a leading 
global media-buying firm with whom we work generally adheres to two (2) 
``units'' per hour as its standard (i.e. a broadcast advertisement is 
delivered to the intended audience in a single program no more than 
twice each hour). While there may be occasions where some advertisers 
allow for increased frequency (such as holiday weeks or the like), the 
norm tends to gravitate to no more than two per hour. This implies that 
in the consumer packaged goods space, 6 exposures in a 42-minute 
television program exceeds standard practice. In the drug advertising 
category, that level of exposure would be well beyond reasonable 
expectations.
    We recommend that FDA limit study arms to more realistic scenarios 
(e.g. 1, 2, and 3 exposures) or, alternatively, to spread out the 
higher frequency arm (e.g. 6) over a longer study period, preferably 
with a longitudinal design, to more closely represent how consumers 
receive and process information in a real-world environment.
    (Response) We appreciate this insight. The study design has been 
revised such that the experimental groups will view the ad one, two, or 
four times over the course of the 60-minute viewing period. We consider 
the one and two exposure conditions to be realistic. The four-exposure 
condition, while limited in its ecological validity, allows for 
experimental examination of ``excessive'' exposures, which may be 
associated with outcomes such as consumer wearout; that is, 
deterioration or diminishment of effects of ad repetition on mental 
processing after a certain amount of exposure. Also, it is important to 
note that in studying advertising effects, it is necessary to create 
enough difference in the manipulations between experimental groups to 
allow for variation in outcomes to be detected. Given the laboratory 
setting, it is not possible to extend the viewing period longer than 1 
hour without significantly increasing the burden on respondents.
    (Comment from Eli Lilly) We were unable to determine if the study 
arms that will see multiple exposures will be exposed to the same 
version of the ad or variations of the ad. We recommend utilizing the 
same version of the ad for consistency between the study arms.
    (Response) These participants will view the same ad across all 
exposures.
    (Comment from Eli Lilly) In the pre-stimulus instructions/
disclosure section, we recommend removing ``on behalf of a public 
health agency.'' This language may trigger the respondent, who would 
see it before being exposed to the clutter reel, to be on the alert for 
health-related content and create bias that is not accurate in a real-
world setting.

[[Page 34675]]

    (Response) We agree with this concern. This language has been 
revised to ``on behalf of a government agency.''
    (Comment from Eli Lilly) In the post-stimulus/survey instrument 
instructions section, we recommend removing references to (a) ``a drug 
ad'' and, (b) specific product name. Introducing this language provides 
the name of the product they are asked to identify in the first survey 
instrument question. It may also create unnecessary bias by identifying 
for the respondent the subject of the survey instrument.
    (Response) These references have been removed.
    (Comment from Eli Lilly) We recommend combining Questions 6 and 7 
(risks and benefits) and randomizing the order. We believe this will 
more accurately represent recall rather than grouping risks together 
and benefits together.
    (Response) In natural settings, consumers may think about drug 
benefits and risks simultaneously or separately. We argue that there 
are empirical advantages to collecting data on these measures 
separately. There is literature to suggest personally relevant 
threatening information may be defensively processed (Refs. 5, 6, and 
7) and thus processed differently than benefit information. We prefer 
to compare responses to benefit and risk items to one another, and 
combining them into one question would hinder this analysis. Moreover, 
note that in related literature, these constructs are typically 
measured with independent scales, or at least independent scales within 
a single scale. This assessment is based on an ongoing literature 
review concerning item and scale measure development.
    Additionally, splitting these measures reduces psychological burden 
on participants. It is believed to be easier for participants to 
respond to seven items concerning benefits in one matrix, followed by 
seven items concerning risks in another matrix, than for participants 
to respond to 14 items about both benefits and risks in a single 
matrix. Omitting items would reduce our ability to adequately measure 
either benefits or risks. Relatedly, collecting data on benefits and 
risks separately may increase the likelihood that participants take 
time to process each item and respond accurately.
    (Comment from Eli Lilly) We recommend adding a ``Don't Know'' 
answer choice for Questions 9, 10, and 13 as respondents may be unable 
to assess the likelihood or seriousness of side effects, or 
effectiveness of the product. The current range of answers may force 
inaccurate or speculative responses; a ``Don't Know'' answer would be a 
legitimate choice and informative for the study. Our standard practice 
is to provide a ``Don't Know'' option whenever it could be a valid 
answer.
    (Response) We understand the value of providing such responses for 
items of a factual nature. The drawback to providing such response 
options to these questions, however, is that we may lose information by 
allowing respondents to choose an easy response instead of giving the 
item some thought. Research by Krosnick et al. (Ref. 8) demonstrated 
that providing ``no opinion'' options likely results in the loss of 
data without any corresponding increase in the quality of the data. 
Thus, we prefer not to add these options to the survey.
    (Comment from Eli Lilly) We recommend randomizing the answers to 
Question 15 to avoid order bias. We note that the answer choices are in 
sequence of probable behavior after being informed by advertising.
    (Response) Indeed, ordering of items was chosen to reflect sequence 
of probable behavior after being informed by advertising. We believe 
maintaining this continuum most appropriately reflects decision making 
on the part of the consumer. Moreover, we have conducted surveys both 
with and without randomizing these items, and no differences in 
responses were observed.
    (Comment from Eli Lilly) For Question 16, we suggest explicitly 
stating ``after being prescribed by a doctor'' to the end of the 
question. The question currently does not provide this context, leaving 
respondents to interpret whether or not they are to consider how they 
feel about ``taking'' Drug X without guidance from a learned 
intermediary. We believe this may render the data on this question 
ambiguous.
    (Response) We have incorporated this suggestion into the revised 
questionnaire.
    (Comment from Eli Lilly) For Questions 20 a and b, we suggest 
spelling out ``FDA.''
    (Response) We have incorporated this suggestion into the revised 
questionnaire.
    (Comment from Eli Lilly) For Questions 20 a and c, we recommend 
eliminating the adverb ``extremely'' as it may create ambiguity. It 
would be reasonable for some people to answer ``false'' to ``extremely 
effective'' while also believing simply ``effective'' was true, while 
other respondents may not see a distinction. This may skew the data 
artificially toward ``false.''
    (Response) Indeed, participants may respond differently depending 
on whether or not the adverb ``extremely'' is included. The item is 
designed to assess perceptions of whether only extremely effective 
products are approved by the FDA (likewise, only ``serious'' risks are 
assessed in Q20b and Q20d.) We prefer to retain this item because it 
captures the intended outcome we wish to measure, whereas an item that 
excludes the adverb ``extremely'' would not. Also note that these items 
have been previously published elsewhere and we prefer to match the 
original language (Ref. 9).
    (Comment from Eli Lilly) We recommend eliminating Question 20 g, 
which seems redundant with 20 f. If respondents were to answer False 
for 20 f but True for 20 g, it would provide no insight but could skew 
perceptions of the data. If the question is retained, we recommend 
eliminating the word ``in'' (i.e. ``believe in''), which in this 
context may connote a broader judgment about the drug industry, for 
which there is ample existing data, than of the regulatory oversight of 
drug advertisements. The language creates bias by implying that 
misleading information is embedded in drug ads, skewing the data toward 
``false.''
    (Response) We have deleted Q20g, and modified Q20f as follows: 
``All of the information in prescription drug commercials is approved 
by the U.S. Food and Drug Administration.'' In addition, we have added 
the following items: ``All of the benefit information in prescription 
drug commercials is approved by the U.S. Food and Drug 
Administration,'' and ``All of the risk information in prescription 
drug commercials is approved by the U.S. Food and Drug 
Administration.''
    (Comment from Eli Lilly) For Question 20 h, we recommend changing 
the word ``safest'' to ``safe,'' which may force respondents to make a 
subjective judgment about what constitutes ``safest'' (i.e. is there a 
set of safest, or simply the single-most safest drug?) even though they 
may believe that all advertised drugs have been deemed to be safe. This 
may strongly skew data toward ``false.''
    (Response) We appreciate that asking about ``safest'' versus 
``safe'' drugs will likely result in different responses. We prefer to 
retain the current language because it captures the intended outcome we 
wish to measure. Nonetheless, we will be careful to restrict our 
interpretation of findings pertaining to this question based on these 
potential differences in responding.

[[Page 34676]]

    (Comment from Eli Lilly) Questions 21 a and b seem to be leading 
questions that may strongly bias respondents to presuppose that the ad 
is misleading and that the survey instrument is simply trying to 
understand the extent to which it is misleading. We acknowledge that 
the answer choices allow respondents to select ``not at all 
misleading,'' but four-fifths of the answer options represent degrees 
of ``misleading,'' which may create strong response bias. Although 21 c 
provides the alternative question, by the time the respondents reach 
this question they will have been biased by the previous two questions 
that the ad is misleading, skewing the data toward ``not truthful.'' We 
recommend this section be revised.
    (Response) These three items were included in the survey for the 
purposes of cognitive testing. Results from cognitive testing suggest 
that participants have difficulty answering the question about 
``truthful'' because they feel they do not know the truth. They 
generally provide the same answer to both questions that ask about how 
misleading the ad is. We therefore will omit questions 21a and 21c.
    (Comment from Eli Lilly) For Questions 24 and 25, we recommend 
adding ``or difficult'' to the question to minimize biasing respondents 
that the product is ``easy'' to use and to make the question and answer 
choices consistent.
    (Response) We have incorporated this suggestion into the revised 
questionnaire.
    (Comment from Eli Lilly) We are concerned that Question 27 has 
potential to create bias and to confuse respondents. It contains 
language that may trigger respondents to believe they should be 
``concerned'' to some extent. The question language combined with the 
inference of doctor's involvement is potentially confusing. We suggest 
revising this question, perhaps to something more simple like: ``If you 
were considering taking [Drug X], how would you feel about the side 
effects mentioned in the ad?''
    (Response) The suggested revised version of Q27 points out to 
participants that the ad notes side effects and so also ``biases'' 
participants but in a slightly different way. The core assumption that 
there are always side effects to be considered in some form seems 
sufficiently reflective of contemporary DTC prescription drugs and thus 
we prefer not to change the language.
    (Comment from Eli Lilly) For Question 28, we recommend using 
``Neither Agree nor Disagree'' as the midpoint of the scale, consistent 
with previous scale language in the survey instrument.
    (Response) This measure of need for cognition has been published 
and validated in the literature (Ref. 10). Thus, we prefer not to 
change the wording.
    (Comment from Eli Lilly) Question 28 b is potentially unclear. We 
recommend revising the question.
    (Response) This measure of need for cognition has been published 
and validated in the literature. Thus, we prefer not to change the 
wording.
    (Comment from Eli Lilly) Question 29 seems to have an omitted word. 
We recommend revising to: ``How confident are you about filling out 
medical forms by yourself?''
    (Response) This is an item that has been used in the literature, 
and thus we prefer not to change the wording (Ref. 11).
    (Comment from Eli Lilly) We recommend revising Question 31 by 
deleting or amending the language ``Below are statements other people 
have made about their medications.'' This language appears unnecessary 
and may bias respondents by implying that, because the statements are 
included in the survey instrument, they are truthful and may warrant 
the respondents to feel that way to some extent.
    (Response) This item has been validated in the literature (Ref. 12) 
and thus we prefer not to change the language.
    (Comment from Eli Lilly) Also for Question 31, we recommend using 
``Neither Agree nor Disagree'' as the language midpoint of the scale, 
consistent with previous scale language in the survey instrument.
    (Response) This item is from the Beliefs in Medicines 
Questionnaire. This item has been validated in the literature and thus 
we prefer not to change the language.
    (Comment from Eli Lilly) In Questions 35 and 36, we believe there 
could be variability in consumers' definition of what constitutes 
``serious'' side effect without additional definition. We recommend the 
survey design consider providing additional context for the consumer in 
the question wording.
    (Response) We agree there is likely to be variability in how 
consumers define serious side effects. We examined these items in 
cognitive testing. Based on results from that cognitive testing, 
respondents generally define ``serious'' side effects as those that 
require medical attention or that are life threatening. It does not 
seem that respondents have trouble answering this question.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance. 
With the sample size described below, we will have sufficient power to 
detect small-to-medium sized effects in the main study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener completes               1,050               1           1,050    .08 (5 min.)              84
 (assumes 10% eligible).........
Pretest 2 screener completes               1,050               1           1,050    .08 (5 min.)              84
 (assumes 10% eligible).........
Number of main study screener               6000               1            6000    .08 (5 min.)             480
 completes (assumes 10%
 eligible)......................
Pretest 1 completes \2\.........             125               1             125             1.5             188
Pretest 2 completes \2\.........             125               1             125             1.5             188
Number of completes, main study              620               1             620             1.5             930
 \2\............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,954
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Note: While target sample sizes for pretests are 105 and for main study is 600, we have accounted for some
  potential overage in the burden table. As data is being collected in two locations simultaneously, it may be
  possible that the target will be exceeded if alternates are included in order to try to achieve the target.


[[Page 34677]]

References

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interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site address in this reference section, but we are 
not responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

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    12. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About 
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    Dated: June 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14880 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P