[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79909-79912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32251]



[[Page 79909]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2163]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Hearing, Aging, and 
Direct-to-Consumer Television Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit either electronic or written comments on the collection 
of information by January 22, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Hearing, Aging, and Direct-to-Consumer Television 
Advertisements.'' Also include the FDA docket number found in brackets 
in the heading of this document.

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

SUPPLEMENTARY INFORMATION:

I. Background

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

Hearing, Aging, and Direct-to-Consumer Television Advertisements

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.
    Older adults use a disproportionate number of prescription drugs 
(Ref. 1) and watch more television than other age groups (Ref. 2). Age-
related changes in hearing are common (Refs. 3-5) and, depending on 
their severity, influence the understanding of speech. Direct-To-
Consumer (DTC) television advertisements (ads) contain large amounts of 
complex information about prescription drug treatments that may be 
particularly relevant to a population that is experiencing some level 
of hearing loss. Moreover, much of the information in these ads is 
conveyed by voiceover, meaning that the audio channel is the only way 
to receive the information. Although people with serious hearing loss 
may compensate by using closed captioning (which may or may not be 
available for ads) or hearing aids, some individuals experience the 
effects of hearing loss without realizing that it is the cause and 
others choose not to use external compensatory aids (Ref. 6). For these 
reasons, FDA is proposing research to investigate how people at various 
ages and levels of hearing ability comprehend DTC ads.
    Sponsors of DTC ads cannot control the hearing abilities of their 
audiences. Nonetheless, researchers have identified several aspects of 
DTC ads within their control that influence the understanding of speech 
in individuals who experience aging-related hearing loss. First, 
frequency thresholds differ as people age--that is, older adults are 
not able to hear higher frequencies as well (Refs. 7, 8). Second, DTC 
television ads contain a risk statement of the most serious and most 
common side effects, called ``the major statement.'' FDA regulations 
require that the major statement must be included in at least the audio 
portion of the ad (Ref. 9). The risks of a medical product often 
include highly technical medical terms that should be transformed into 
consumer-friendly language to convey the risks appropriately. This is 
easier in some cases than in others. In addition, there are techniques 
to help reduce the complexity of the major statement, such as 
maintaining active voice, reducing instances where words need 
clarification from other later words in the broadcast, and using 
shorter sentences. Third, television ad spots are typically bought in 
increments of 15 seconds, leading to a preponderance of 30- and 60-
second ads, and some 75-second ads when risk information is especially 
dense. In order to fit the required information into this time frame, 
the audio presentation speed may be adjusted to be faster or slower. 
Research has shown that fast speech is more difficult to understand 
than slower speech, even for healthy young adults (Ref. 10).
    Thus, we propose to examine the effects of three aspects of DTC ads 
(voice frequency, complexity of major statement, and speed of major 
statement) on the comprehension of the ads among four different age 
groups of individuals. Because hearing losses begin to occur as people 
age, we will examine a group of middle-aged adults (40-50 years), 
young-old adults (60-74 years), and old-old adults (75+ years), and a 
group of young adults (18-25 years) as a control. The use of young 
adults as a control group is common in studies of age changes in 
memory, cognition, and hearing (Refs. 11-14). We expect a progression 
of hearing loss across the lifespan, but that is not the focus of this 
study. Our primary outcomes will be verbatim and gist memory, and 
confidence in memory judgments, but we will also seek to apply findings 
from previous studies showing age changes in hearing ability (Refs. 15, 
16) to the particular situation of DTC ad viewing.
    It is important to note that despite hearing and cognitive losses, 
older adults generally use linguistic context well. That is, they are 
as good as or even better than younger adults at using context to 
determine what they are hearing. They are also skilled at using the 
intonation of words, which words are stressed, where pauses occur, and 
how words are lengthened before pauses, all components of something 
called the prosody of language (Ref. 17). Thus, even though older 
adults generally perform worse than younger adults with rapid speech, 
older adult recall of sentences is still relatively high, at 80 
percent, presumably because older adults use linguistic context. 
Moreover, to approximate real DTC ads, participants will view an ad 
that has a typical amount of superimposed text, some of which may 
repeat the information in the audio. Our task thus involves viewing 
realistic DTC ads, which provide more context than lists of unrelated 
words or sentences, as often found in laboratory experiments. Thus, it 
is an open question whether hearing loss will impede the comprehension 
of DTC ads or whether the ability to make use of context will 
counteract these decrements across the lifespan.

II. General Research Questions

    1. How do hearing and cognitive declines in older adults affect 
comprehension of DTC television ads, and the major statement in 
particular?

[[Page 79910]]

    2. How do the frequency, speed, and complexity of the major 
statement influence the comprehension of the major statement and DTC 
ads as a whole?
    3. How do hearing and cognitive declines interact with the 
frequency, speed, and complexity of the major statement to affect the 
comprehension of DTC ads?

III. Design

    To test these research questions, we will examine four groups of 
adults and manipulate three variables as shown in table 1.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
                                                                       Voiceover frequency
                                                          --------------------------------------------
                                                           Male (low frequency)      Female (high
                                                          ----------------------      frequency)
                Age                         Speed             Organization of   ----------------------   Total
                                                              major statement       Organization of
                                                          ----------------------    major statement
                                                                                ----------------------
                                                             Simple    Complex     Simple    Complex
----------------------------------------------------------------------------------------------------------------
Young Adults (18-25)..............  Low Speed............         33         33         33         33        132
                                    High Speed...........         33         33         33         33        132
Middle-Aged (40-50)...............  Low Speed............         33         33         33         33        132
                                    High Speed...........         33         33         33         33        132
Young-Older (60-75)...............  Low Speed............         33         33         33         33        132
                                    High Speed...........         33         33         33         33        132
Old-Older (OO; 75+)...............  Low Speed............         33         33         33         33        132
                                    High Speed...........         33         33         33         33        132
                                                          ------------------------------------------------------
    Total.........................  .....................        264        264        264        264      1,056
----------------------------------------------------------------------------------------------------------------

    Pretesting will take place before the main study to evaluate the 
hearing assessment procedures and questionnaire measures used in the 
main study. We will recruit adults who fall into one of four age 
brackets shown in table 1. We will exclude individuals who work in 
healthcare or marketing settings because their knowledge and 
experiences may not reflect those of the average consumer. A priori 
power analyses revealed that we need 640 participants for the pretest 
to obtain 80 percent power to detect a small effect size, and 1,056 
participants for the main study to obtain 90 percent power to detect a 
small effect size. Data collection will take place in person.
    For the pretest and main study, within each age group, participants 
will be randomly assigned to one of eight experimental conditions in a 
2 (speed) x 2 (frequency) x 2 (complexity) design, as depicted in table 
1. The study will include audiometric measurement of individual hearing 
ability to help determine if hearing declines account for any age group 
differences in reported comprehension or retention of ad information. 
During the scheduled appointment time, participants will receive a 
complete audiometric test performed by audiologists from the University 
of North Carolina Hearing and Communication Center, watch a fictitious 
DTC television ad twice, and answer questions in a survey. 
Participation is estimated to take approximately 45 minutes.
    Questionnaire measures are designed to assess, for both risk and 
benefit information, verbatim memory, comprehension, gist memory, and 
confidence in memory and comprehension judgments. The draft 
questionnaire is available upon request.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance 
(ANOVA).
    In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice 
for public comment in the Federal Register of June 25, 2015 (80 FR 
36545). Two comments were received. We will address the issues raised 
in each comment subsequently, beginning with those of AbbVie.
    (Comment 1) The Agency should place research results in the context 
that older adults are diverse and increasingly involved in new 
technologies.
    (Response 1) We agree that older adults are not homogenous. 
Regarding our focus on television ads, the fact that older people are 
increasingly able to look at advertisements online does not eliminate 
the fact that many continue to be exposed to television advertising and 
that advertising is not always presented with closed-captioning. We 
will ensure that we frame our research results in the proper context.
    (Comment 2) A bias may exist in asking survey participants to self-
declare ``a hearing loss'' as hearing loss can be viewed as a negative 
consequence/indicator of aging. Thus, those in older age groups may 
underestimate their true hearing loss as well as the need for some type 
of hearing aid or assistance.
    (Response 2) We will not rely solely on self-reported hearing loss. 
We have arranged for trained audiologists to conduct in-person 
audiological assessments with validated approaches as well.
    (Comment 3) As the Agency plans to test multiple variables and age 
groups, it is important to test these variables independently; testing 
only in combination with other variables or aggregating across age 
groups or variables may mask true drivers. Individual cells with a 
sample size of 33 are too small to compare to other individual cells. A 
minimum of 50 is necessary to understand individual variables within 
and across age groups.
    (Response 3) We are aware of no statistical or research standard 
that specifies that groups must contain 50 individuals. We conducted 
power analyses to determine that 33 individuals per cell is adequate 
and statistically defensible for our study goals.
    (Comment 4) The Introduction and Debriefing state that the study 
``involves information about a drug that is not yet available for 
sale.'' However, survey questions 8, 10, 18, and 30 refer to 
respondents having access to the drug with verbiage such as ``even if 
you have never taken the drug,'' ``ask the doctor to prescribe Drug 
X,'' and ``have you seen any advertising for Drug X before today.'' Yet 
none of these could happen if Drug X is not yet available for sale.
    (Response 4) We acknowledge that we are posing hypothetical 
possibilities in some questions that respondents should

[[Page 79911]]

not have previously experienced. We have changed the introduction to 
reference ``advertising for a new product'' rather than ``information 
about a drug that is not yet available for sale.'' However, using 
language such as ``even if you have never taken the drug'' will assure 
respondents that their answers are welcome even if they do not have 
direct experience with the drug. The question about asking the doctor 
to prescribe the drug measures behavioral intentions, not actual 
behavior related to the drug. The question asking whether they have 
seen an ad for the drug will allow us to capture false reporting 
tendencies.
    (Comment 5) Question 13 refers to ``claims''. We suspect ``claim'' 
is not as readily understood by consumers as is the more general term 
``information'' used in Question 17. Also, there are only minor 
differences in the wording of two recognition choices for Questions 13a 
vs. 13b; was this intended?
    (Response 5) Thank you for your close review of the questionnaire. 
The two ad versions (simple and complex) are designed to include the 
same information but stated differently. Thus, these two questions 
(then 13a and 13b; now 14a and 14b) should be similar in nature and 
only two of the sub-items are stated differently (#2 and #4). 
Participants will see either question 14a or 14b depending on their 
experimental condition.
    The next responses address issues raised by Eli Lilly and Company.
    (Comment 6) What are the objectives of the pretest? The proposed 
sample size for the pretest (n = 640) appears excessive to test the 
procedural flow and survey procedures.
    (Response 6) The pretest will be used to assess whether the 
instrument as a whole as well as individual sections work equally well 
across respondent groups (e.g., age). In addition, the pretest will 
include manipulation checks as a main function of the task. The sample 
size for the pretest (640 participants equally split across the four 
age groups) was determined based on an assumption of a need for 80 
percent power with an alpha of 0.10 to detect a small effect size. With 
eight experimental conditions across four age groups, the calculation 
resulted in a need for 20 individuals per cell, or 640 total 
participants.
    (Comment 7) The age groups selected are logical, but why are people 
aged 51-59 excluded and why are 18-25 year olds selected as the 
control? ``Although 18-25 year olds as a control group might be common 
in studies of age changes in memory and hearing, this age group does 
not seem as relevant for pharmaceutical advertisements about 
cholesterol lowering drugs.'' Also, the age group of 60-75 should be 
capped at 74 to make sure the groups are mutually exclusive.
    (Response 7) We agree that there is a likely slow progression of 
age-related hearing loss across the lifespan and if our focus was on 
this progression, we would want to include 50-59 year olds. The 
approach we are taking will ensure that we can see contrasts between 
younger and older people. We also have a middle-aged group to see 
whether any contrast between the youngest and oldest groups appears to 
be relatively linear or is curvilinear. Including the 50-59 year age 
group would not add substantial information to this design, although we 
do acknowledge that we will not be able to address when decline occurs 
if it appears to drop dramatically from our middle-aged group to our 
young-older age group.
    We are including participants between 18-25 years as a baseline for 
our measurement of hearing ability, as that is an integral part of this 
research. The entire sample will be drawn from the general population, 
and although there may be distinct differences in potential interest in 
the advertised drug, we feel the addition of this younger group is 
worth measurement. We have included a question to assess whether 
participants have been diagnosed with high cholesterol and can use that 
as a proxy for interest, regardless of age. Thank you for pointing out 
the need to cap the young-old age group at 74 rather than 75 to ensure 
the groups are mutually exclusive.
    (Comment 8) We advise caution in reporting results for individual 
cells (e.g., 40-50 year old respondents who see an ad with a male 
voice, simple statement, low speed) due to the low sample size (n = 
33). We recommend excluding results for a sample that has fewer than 50 
respondents.
    (Response 8) We are aware of no statistical or research standard 
that specifies that groups must contain 50 individuals. We conducted 
power analyses to determine that 33 individuals per cell is adequate 
and statistically defensible for our study goals.
    (Comment 9) Because the Summary Brief of the project does not 
adequately provide details regarding the individual ads to be tested, 
we seek clarification on whether multiple ads will be tested and the 
variability of ad content. With greater variability of the ads tested, 
there is potential for a new source of bias to be introduced into the 
study.
    (Response 9) We agree that extraneous variability should be kept to 
a minimum. For this study, the same base ad will be manipulated such 
that all else remains constant except for the gender of the voiceover 
announcer, the complexity of the risk information, and the speed at 
which it is stated. The visuals will be as similar as possible except 
for minimal differences in length of time on screen to account for the 
different lengths of the voiceover. The same male and female voice 
actors will record all variations of the ad.

IV. External Reviewers

    In addition to public comment, Office of Prescription Drug 
Promotion solicited peer-review comments from academic researchers in 
fields relevant to the communication of DTC prescription drug 
information. We received responses and incorporated the thoughts of the 
following individuals:

Dr. Susan Blalock, University of North Carolina at Chapel Hill, 
School of Pharmacy
Dr. Robert McKeever, University of South Carolina, School of 
Journalism and Mass Communications

    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance 
(ANOVA). With the sample size described in table 2, 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\
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                                                 Number of
          Activity               Number of     responses per   Total annual   Average burden per    Total hours
                                respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
Cognitive Interview screener              96               1              96    0.08 (5 minutes)               8
Cognitive Interviews........               9               1               9      1 (60 minutes)               9
Pretest screener............           1,280               1           1,280    0.08 (5 minutes)             102

[[Page 79912]]

 
Pretest.....................             640               1             640   0.75 (45 minutes)             480
Main Study Screener.........           2,112               1           2,112    0.08 (5 minutes)             169
Main Study..................           1,056               1           1,056   0.75 (45 minutes)             792
                             -----------------------------------------------------------------------------------
    Total...................           5,193               1           5,193  ..................           1,560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.

V. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
1. Zhong W., H. Maradit-Kremers, J.L. St. Sauver, et al., ``Age and 
Sex Patterns of Drug Prescribing in a Defined American Population.'' 
Mayo Clinic Proceedings. 88(7):697-707, 2013.
2. Depp C.A., D.A. Schkade, W.K. Thompson, D.V. Jeste. ``Age, 
Affective Experience, and Television Use.'' American Journal of 
Preventative Medicine. 39:173-8, 2010.
3. Agrawal Y., E.A. Platz, J.K. Niparko. ``Prevalence of Hearing 
Loss and Differences by Demographic Characteristics Among US 
Adults.'' Archives of Internal Medicine. 168(14):1522-30, 2008.
4. Cruickshanks K.J., T.L. Wiley, T.S. Tweed, et al., ``Prevalence 
of Hearing Loss in Older Adults in Beaver Dam, Wisconsin.'' American 
Journal of Epidemiology. 148(9):879-86, 1998.
5. Lin FR, R. Thorpe, S. Gordon-Salant, L. Ferrucci. ``Hearing Loss 
Prevalence and Risk Factors Among Older Adults in the United 
States.'' The Journals of Gerontology Series A: Biological Sciences 
and Medical Sciences. 66A(5):582-90, 2011.
6. Garstecki DC, S.F. Erler. ``Hearing Loss, Control, and 
Demographic Factors Influencing Hearing Aid Use Among Older 
Adults.'' Journal of Speech, Language, and Hearing Research. 41:527-
37, 1998.
7. Gates G.A., J.C. Cooper. ``Incidence of Hearing Decline in the 
Elderly.'' Acta Oto-laryngol. 111:240-8, 1991.
8. Humes L.E. ``Speech Understanding in the Elderly.'' Journal of 
the American Academy of Audiology. 7:161-7, 1996.
9. U.S. Food and Drug Administration. Code of Federal Regulations. 
Prescription drug advertisements, 21 CFR Sect. 202.1. 2013. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=202.1)
10. Wingfield A., L.W. Poon, L. Lombardi, D. Lowe. ``Speed of 
Processing in Normal Aging: Effects of Speech Rate, Linguistic 
Structure, and Processing Time.'' The Journals of Gerontology. 
40(5):579-85, 1985.
11. Kramer A.F., S. Hahn, D. Gopher. ``Task Coordination and Aging: 
Explorations of Executive Control Processes in the Task Switching 
Paradigm.'' Acta Psychologica. 101:339-78, 1999.
12. Naveh-Benjamin M., J. Guez, A. Kilb, S. Reedy. ``The Associative 
Memory Deficit of Older Adults: Further Support Using Face-Name 
Associations.'' Psychology and Aging. 19(3):541-6, 2004.
13. Sommers M.S., N. Tye-Murray, B. Spehar. ``Auditory-Visual Speech 
Perception and Auditory-Visual Enhancement in Normal-Hearing Younger 
and Older Adults.'' Ear and Hearing. 26(3):263-75, 2005.
14. Watson J.M., K.B. McDermott, D.A. Balota. ``Attempting to Avoid 
False Memories in the Deese/Roediger-McDermott Paradigm: Assessing 
the Combined Influence of Practice and Warnings in Young and Old 
Adults.'' Memory and Cognition. 32(1):135-41, 2004.
15. Gates G.A., M.P. Feeney, D. Mills. ``Cross-Sectional Age-Changes 
of Hearing in the Elderly.'' Ear and Hearing. 29(6):865-74, 2008.
16. Morrell C.H., S. Gordon-Salant, J.D. Pearson, L.J. Brant, J.L. 
Fozard. ``Age- and Gender-Specific Reference Ranges for Hearing 
Level and Longitudinal Changes in Hearing Level.'' Journal of the 
Acoustical Society of America. 100(4)Pt. 1:1949-67, 1996.
17. Cutler A., D. Dahan, W. van Donselaar. ``Prosody in the 
Comprehension of Spoken Language: A Literature Review.'' Language 
and Speech. 40(2):141-201, 1997.

    Dated: December 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32251 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P