80_FR_34788 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

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)

Page Range34672-34677
FR Document2015-14880

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 Issue 116 (Wednesday, June 17, 2015)
[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 oira_submission@omb.eop.gov. 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, 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.

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

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
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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Internal Medicine, 155, pp. 87-96 (2011).
    10. Cacioppo, J. T. and R. E. Petty, ``The Efficient Assessment 
of Need for Cognition,'' Journal of Personality Assessment, 48, pp. 
306-307 (1984).
    11. Chew, L. D., J. M. Griffin, M. R. Partin, et al., 
``Validation of Screening Questions for Limited Health Literacy in a 
Large VA Outpatient Population,'' Journal of General Internal 
Medicine, 23, pp. 561-566 (2008).
    12. Horne, R., J. Weinman, and M. Hankins, ``The Beliefs About 
Medicines Questionnaire: The Development and Evaluation of a New 
Method for Assessing the Cognitive Representation of Medication,'' 
Psychology & Health, 14, pp. 1-24 (1999).


    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



                                                    34672                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

                                                    annually, for a total of two responses.                 SUMMARY:   The Food and Drug                           DATES:   Fax written comments on the
                                                    We estimate the reporting burden to be                  Administration (FDA) is announcing                     collection of information by July 17,
                                                    2 hours per response, for a total burden                that a collection of information entitled,             2015.
                                                    of 4 hours. We estimate that two                        ‘‘Food and Cosmetic Export Certificate                 ADDRESSES: To ensure that comments on
                                                    respondents will submit one Form FDA                    Applications Process’’ has been                        the information collection are received,
                                                    1993 report annually, for a total of two                approved by the Office of Management                   OMB recommends that written
                                                    responses. We estimate the reporting                    and Budget (OMB) under the Paperwork                   comments be faxed to the Office of
                                                    burden to be 0.5 hours per response, for                Reduction Act of 1995.                                 Information and Regulatory Affairs,
                                                    a total burden of 1 hour. We estimate                   FOR FURTHER INFORMATION CONTACT: FDA                   OMB, Attn: FDA Desk Officer, FAX:
                                                    that two respondents will submit one                    PRA Staff, Office of Operations, Food                  202–395–7285, or emailed to oira_
                                                    Form FDA 1815 report annually, for a                    and Drug Administration, 8455                          submission@omb.eop.gov. All
                                                    total of two responses. We estimate the                 Colesville Rd., COLE–14526, Silver                     comments should be identified with the
                                                    reporting burden to be 0.5 hours per                    Spring, MD 20993–0002,                                 OMB control number 0910-New and
                                                    response, for a total burden of 1 hour.                 PRAStaff@fda.hhs.gov.                                  title ‘‘Impact of Ad Exposure Frequency
                                                       With regard to records maintenance,                                                                         on Perception and Mental Processing of
                                                    we estimate that approximately two                      SUPPLEMENTARY INFORMATION:     On April                Risk and Benefit Information in Direct-
                                                    recordkeepers will spend 0.05 hours                     23, 2015, the Agency submitted a                       To-Consumer Prescription Drug Ads.’’
                                                    annually maintaining the additional                     proposed collection of information                     Also include the FDA docket number
                                                    pasteurization records required by                      entitled, ‘‘Food and Cosmetic Export                   found in brackets in the heading of this
                                                    § 1210.15, for a total of 0.10 hours                    Certificate Applications Process’’ to                  document.
                                                    annually.                                               OMB for review and clearance under 44                  FOR FURTHER INFORMATION CONTACT: FDA
                                                       No burden has been estimated for the                 U.S.C. 3507. An Agency may not                         PRA Staff, Office of Operations, Food
                                                    tagging requirement in § 1210.22                        conduct or sponsor, and a person is not                and Drug Administration, 8455
                                                    because the information on the tag is                   required to respond to, a collection of                Colesville Rd., COLE–14526, Silver
                                                    either supplied by us (permit number)                   information unless it displays a                       Spring, MD 20993–0002, PRAStaff@
                                                    or is disclosed to third parties as a usual             currently valid OMB control number.                    fda.hhs.gov.
                                                    and customary part of the shipper’s                     OMB has now approved the information
                                                                                                            collection and has assigned OMB                        SUPPLEMENTARY INFORMATION: In
                                                    normal business activities (type of
                                                                                                            control number 0910–0793. The                          compliance with 44 U.S.C. 3507, FDA
                                                    product, shipper’s name and address).
                                                                                                            approval expires on May 31, 2018. A                    has submitted the following proposed
                                                    Under 5 CFR 1320.3(c)(2), the public
                                                                                                            copy of the supporting statement for this              collection of information to OMB for
                                                    disclosure of information originally
                                                                                                            information collection is available on                 review and clearance.
                                                    supplied by the Federal Government to
                                                    the recipient for the purpose of                        the Internet at http://www.reginfo.gov/                Impact of Ad Exposure Frequency on
                                                    disclosure to the public is not subject to              public/do/PRAMain.                                     Perception and Mental Processing of
                                                    review by the Office of Management and                    Dated: June 11, 2015.                                Risk and Benefit Information in Direct-
                                                    Budget under the Paperwork Reduction                    Leslie Kux,                                            to-Consumer Prescription Drug Ads;
                                                    Act. Under 5 CFR 1320.3(b)(2)), the                     Associate Commissioner for Policy.
                                                                                                                                                                   OMB Control Number 0910–NEW
                                                    time, effort, and financial resources                                                                             Section 1701(a)(4) of the Public
                                                                                                            [FR Doc. 2015–14879 Filed 6–16–15; 8:45 am]
                                                    necessary to comply with a collection of                                                                       Health Service Act (42 U.S.C.
                                                                                                            BILLING CODE 4164–01–P
                                                    information are excluded from the                                                                              300u(a)(4)) authorizes the FDA to
                                                    burden estimate if the reporting,                                                                              conduct research relating to health
                                                    recordkeeping, or disclosure activities                 DEPARTMENT OF HEALTH AND                               information. Section 1003(d)(2)(C) of the
                                                    needed to comply are usual and                          HUMAN SERVICES                                         Federal Food, Drug, and Cosmetic Act
                                                    customary because they would occur in                                                                          (the FD&C Act) (21 U.S.C. 393(b)(2)(c))
                                                    the normal course of business activities.               Food and Drug Administration                           authorizes FDA to conduct research
                                                      Dated: June 11, 2015.                                                                                        relating to drugs and other FDA-
                                                    Leslie Kux,                                             [Docket No. FDA–2014–N–1794]                           regulated products in carrying out the
                                                    Associate Commissioner for Policy.                                                                             provisions of the FD&C Act.
                                                    [FR Doc. 2015–14888 Filed 6–16–15; 8:45 am]             Agency Information Collection                             In a typical promotional campaign,
                                                                                                            Activities; Submission for Office of                   consumers may be exposed to a direct-
                                                    BILLING CODE 4164–01–P
                                                                                                            Management and Budget Review;                          to-consumer (DTC) prescription drug ad
                                                                                                            Comment Request; Impact of Ad                          any number of times. Perceptual and
                                                    DEPARTMENT OF HEALTH AND                                Exposure Frequency on Perception                       cognitive effects of increased ad
                                                    HUMAN SERVICES                                          and Mental Processing of Risk and                      exposure frequency have been studied
                                                                                                            Benefit Information in Direct-to-                      extensively using non-drug ads. For
                                                    Food and Drug Administration                            Consumer Prescription Drug Ads                         instance, one study demonstrated that a
                                                                                                                                                                   commercial message repeated twice
                                                    [Docket No. FDA–2014–N–2347]                            AGENCY:    Food and Drug Administration,               generates better recall than a message
                                                                                                            HHS.                                                   broadcast only once (Ref. 1). Another
                                                    Agency Information Collection                                                                                  study demonstrated that increased ad
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                                                                                                            ACTION:   Notice.
                                                    Activities; Announcement of Office of                                                                          exposures improve product attitudes
                                                    Management and Budget Approval;                         SUMMARY:   The Food and Drug                           and recall for product attributes,
                                                    Food and Cosmetic Export Certificate                    Administration (FDA) is announcing                     particularly when the substance of the
                                                    Applications Process                                    that a proposed collection of                          repeat messages is varied (Ref. 2).
                                                    AGENCY:    Food and Drug Administration,                information has been submitted to the                  Generally, it has been argued that first
                                                    HHS.                                                    Office of Management and Budget                        exposure to an ad results in attention,
                                                                                                            (OMB) for review and clearance under                   second exposure affects learning of the
                                                    ACTION:   Notice.
                                                                                                            the Paperwork Reduction Act of 1995.                   advertised message, and third and


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                                                                                   Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                                                                            34673

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

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


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                                                    34674                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

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


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                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                              34675

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


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                                                    34676                                  Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

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

                                                                                                                  TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                              Number of                                                Average
                                                                                                                                                   Number of                                            Total annual
                                                                                           Activity                                                                         responses per                                            burden per              Total hours
                                                                                                                                                  respondents                                            responses
                                                                                                                                                                              respondent                                              response

                                                    Pretest 1 screener completes (assumes 10% eligible) .......                                                 1,050                             1                   1,050            .08 (5 min.)                    84
                                                    Pretest 2 screener completes (assumes 10% eligible) .......                                                 1,050                             1                   1,050            .08 (5 min.)                    84
                                                    Number of main study screener completes (assumes 10%
                                                      eligible) .............................................................................                    6000                            1                     6000            .08 (5 min.)                   480
                                                    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 2 .....................................                                       620                            1                      620                    1.5                    930
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                                                          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.




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                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                            34677

                                                    References                                                Dated: June 11, 2015.                                ‘‘Naming of Drug Products Containing
                                                                                                            Leslie Kux,                                            Salt Drug Substances’’ that replaces the
                                                       The following references have been                   Associate Commissioner for Policy.                     draft of the same title that published on
                                                    placed on display in the Division of                    [FR Doc. 2015–14880 Filed 6–16–15; 8:45 am]            December 26, 2013 (78 FR 78366). This
                                                    Dockets Management (see ADDRESSES)                                                                             guidance is being published to explain
                                                                                                            BILLING CODE 4164–01–P
                                                    and may be seen by interested persons                                                                          how CDER is implementing the USP’s
                                                    between 9 a.m. and 4 p.m., Monday                                                                              policy entitled ‘‘Monograph Naming
                                                    through Friday, and are available                       DEPARTMENT OF HEALTH AND                               Policy for Salt Drug Substances in Drug
                                                    electronically at http://                               HUMAN SERVICES                                         Products and Compounded
                                                    www.regulations.gov. (FDA has verified                                                                         Preparations.’’ It is a naming and
                                                    the Web site address in this reference                  Food and Drug Administration                           labeling policy applicable to drug
                                                    section, but we are not responsible for                                                                        products that contain an active
                                                                                                            [Docket No. FDA–2013–D–1566]
                                                    any subsequent changes to the Web site                                                                         ingredient that is a salt. The policy
                                                    after this document publishes in the                    Naming of Drug Products Containing                     stipulates that USP will use the name of
                                                    Federal Register.)                                      Salt Drug Substances; Guidance for                     the active moiety, instead of the name
                                                       1. Singh, S. N., D. Linville, and A.                 Industry; Availability                                 of the salt, when creating a drug product
                                                    Sukhdial, ‘‘Enhancing the Efficacy of Split                                                                    monograph title and the strength will be
                                                                                                            AGENCY:    Food and Drug Administration,               expressed in terms of the active moiety.
                                                    Thirty-Second Television Commercials: An
                                                                                                            HHS.                                                   The policy allows for exceptions under
                                                    Encoding Variability Application,’’ Journal of
                                                    Advertising, 24, pp. 13–23 (1995).                      ACTION:   Notice.                                      specified circumstances. CDER is now
                                                       2. Haugtvedt, C. P., et al., ‘‘Advertising                                                                  applying this policy to new prescription
                                                                                                            SUMMARY:   The Food and Drug
                                                    Repetition and Variation Strategies:                                                                           drug products under development
                                                                                                            Administration (FDA) is announcing the
                                                    Implications for Understanding Attitude                                                                        under section 505 of the Federal Food,
                                                                                                            availability of a guidance for industry
                                                    Strength,’’ Journal of Consumer Research, 21,                                                                  Drug, and Cosmetic Act (the FD&C Act)
                                                                                                            entitled ‘‘Naming of Drug Products
                                                    pp. 176–189 (1994).                                                                                            (21 U.S.C. 355).
                                                                                                            Containing Salt Drug Substances’’                         The USP Salt Policy became official
                                                       3. Naples, M. J., ‘‘Effective Frequency:
                                                                                                            which replaces the draft guidance of the               on May 1, 2013, and USP is now
                                                    Then and Now,’’ Journal of Advertising
                                                                                                            same title that published on December                  applying it to all new drug product
                                                    Research, 37, pp. 7–12 (1997).
                                                                                                            26, 2013. This guidance describes the                  monographs for products that contain
                                                       4. http://www.fda.gov/AboutFDA/
                                                                                                            United States Pharmacopeia’s (USP’s)                   an active ingredient that is a salt. It
                                                    CentersOffices/
                                                    OfficeofMedicalProductsandTobacco/CDER/
                                                                                                            ‘‘Monograph Naming Policy for Salt                     affects the development of new drug
                                                    ucm090276.htm.
                                                                                                            Drug Substances in Drug Products and                   products because a USP monograph title
                                                       5. Janis, I. L. and S. Feshbach, ‘‘Effects of
                                                                                                            Compounded Preparations,’’ which                       for a new drug product, in most
                                                    Fear-Arousing Communications,’’ Journal of              became official on May 1, 2013, and                    instances, serves as the nonproprietary
                                                    Abnormal and Social Psychology, 48, pp. 78–             how the Center for Drug Evaluation and                 or ‘‘established’’ name of the related
                                                    92 (1953).                                              Research (CDER) is implementing it.                    drug product (section 502(e)(3) of the
                                                       6. Liberman, A. and S. Chaiken, ‘‘Defensive          DATES: Submit either electronic or                     FD&C Act) (21 U.S.C. 352(e)). If a drug
                                                    Processing of Personally Relevant Health                written comments on Agency guidances                   product’s label or labeling contains a
                                                    Messages,’’ Personality and Social                      at any time.                                           name that is inconsistent with the
                                                    Psychology Bulletin, 18, pp. 669–679 (1992).            ADDRESSES: Submit written requests for                 applicable monograph title, it risks
                                                       7. Smith, S. M. and R. E. Petty, ‘‘Message           single copies of the guidance to the                   being misbranded (section
                                                    Framing and Persuasion: A Message                       Division of Drug Information, Center for               502(e)(1)(A)(i) of the FD&C Act).
                                                    Processing Analysis,’’ Personality and Social           Drug Evaluation and Research, Food                        This guidance describes the USP
                                                    Psychology Bulletin, 22, pp. 257–268 (1996).            and Drug Administration, 10001 New                     policy and discusses how CDER and
                                                       8. Krosnick, J. A., A. L. Holbrook, M. K.            Hampshire Ave., Hillandale Building,                   industry can implement the policy.
                                                    Berent, et al., ‘‘The Impact of ‘No Opinion’            4th Floor, Silver Spring, MD 20993–                    Following the policy will help reduce
                                                    Response Options on Data Quality: Non-                  0002. Send one self-addressed adhesive                 medication errors caused by a mismatch
                                                    Attitude Reduction or an Invitation to                  label to assist that office in processing              between the established name and
                                                    Satisfice?’’ Public Opinion Quarterly, 66, pp.          your requests. See the SUPPLEMENTARY                   strength on the label of drug products
                                                    371–403 (2002).                                         INFORMATION section for electronic                     that contain a salt. In addition, we
                                                       9. Woloshin, S. and L. M. Schwartz,                  access to the guidance document.                       anticipate that this policy will help
                                                    ‘‘Communicating Data About the Benefits                    Submit electronic comments on the                   health care practitioners calculate
                                                    and Harms of Treatment: A Randomized                    guidance to http://www.regulations.gov.                equivalent doses when changing from
                                                    Trial,’’ Annals of Internal Medicine, 155, pp.          Submit written comments to the
                                                    87–96 (2011).
                                                                                                                                                                   one dosage form to another, even if the
                                                                                                            Division of Dockets Management (HFA–                   products contain active ingredients that
                                                       10. Cacioppo, J. T. and R. E. Petty, ‘‘The
                                                                                                            305), Food and Drug Administration,                    are different salts, because the strengths
                                                    Efficient Assessment of Need for Cognition,’’
                                                                                                            5630 Fishers Lane, Rm. 1061, Rockville,                and names will both be based on the
                                                    Journal of Personality Assessment, 48, pp.
                                                                                                            MD 20852.                                              active moiety.
                                                    306–307 (1984).
                                                       11. Chew, L. D., J. M. Griffin, M. R. Partin,        FOR FURTHER INFORMATION CONTACT:                          In the Federal Register of December
                                                    et al., ‘‘Validation of Screening Questions for         Mamta Gautam-Basak, Center for Drug                    26, 2013 (78 FR 78366), this guidance
                                                                                                            Evaluation and Research (CDER), Food                   was published as a draft guidance. We
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                                                    Limited Health Literacy in a Large VA
                                                    Outpatient Population,’’ Journal of General             and Drug Administration, 10903 New                     have carefully reviewed and considered
                                                    Internal Medicine, 23, pp. 561–566 (2008).              Hampshire Ave., Silver Spring, MD                      the comments that were received on the
                                                       12. Horne, R., J. Weinman, and M.                    20993, 301–796–0712.                                   draft guidance and have made changes
                                                    Hankins, ‘‘The Beliefs About Medicines                  SUPPLEMENTARY INFORMATION:                             for clarification.
                                                    Questionnaire: The Development and                                                                                This guidance is being issued
                                                    Evaluation of a New Method for Assessing                I. Background                                          consistent with FDA’s good guidance
                                                    the Cognitive Representation of Medication,’’              FDA is announcing the availability of               practices regulation 21 CFR 10.115. This
                                                    Psychology & Health, 14, pp. 1–24 (1999).               a guidance for industry entitled                       guidance represents CDER’s current


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Document Created: 2015-12-15 14:22:53
Document Modified: 2015-12-15 14:22:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by July 17, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 34672 

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