Agency Information Collection Activities; Proposed Collection; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements, 36545-36547 [2015-15557]
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Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
Therefore, the estimated annual
reporting burden for this information is
25,000 hours and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15638 Filed 6–24–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2163]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Hearing, Aging,
and Direct-to-Consumer Television
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Hearing, Aging, and
Direct-to-Consumer Television
Advertisements’’. This study will
examine how changes to hearing across
the lifespan affect the comprehension of
direct-to-consumer (DTC) television
advertisements for prescription drugs.
DATES: Submit either electronic or
written comments on the collection of
information by August 24, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Hearing, Aging, and Direct-toConsumer 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
(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 (Ref. 3, 4, and
5) and, depending on their severity,
influence the understanding of speech.
DTC television advertisements (ads)
contain large amounts of complex
information about prescription drug
treatments that may be particularly
relevant to a population that is
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36545
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; older adults are not able to hear
higher frequencies as well (Ref. 7 and 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 must 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 many 30- and 60second 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, 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 (60–75 years), and oldold adults (75+ years), and a group of
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36546
Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
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 (Ref. 11, 12, 13, and 14). 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
(Ref. 15 and 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.
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?
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?
Design
To test these research questions, we
will examine four groups of adults and
manipulate three variables as shown in
Table 1.
TABLE 1—PROPOSED RESEARCH DESIGN
Voiceover frequency
Male (low frequency)
Female (high frequency)
Organization of major statement
Age
Organization of major statement
Speed
Total
Simple
Young Adults (18–25) .........
Middle-Aged (40–50) ..........
Young-Older (60–75) ..........
Old-Older (75+) ...................
Low Speed
High Speed
Low Speed
High Speed
Low Speed
High Speed
Low Speed
High Speed
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total .............................
Complex
Simple
Complex
.........................
........................
.........................
........................
.........................
........................
.........................
........................
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
33
132
132
132
132
132
132
132
132
........................................
264
264
264
264
1,056
Pretesting will take place before the
main study to evaluate the procedures
and 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 prior 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.
Within each age group, participants
will be randomly assigned to one of
eight experimental conditions in a 2
(speed) × 2 (frequency) × 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 60 minutes.
Questionnaire measures are designed
to assess, for 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.
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Pretesting:
Number
to
Complete
the
Screener (Assumes 50% Eligible).
1,280
1
1,280
0.08 (5 minutes) ...............................
102.4
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Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices
36547
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Completes ......................
640
1
640
1 .......................................................
640
Main Study
Number to Complete the Screener
(Assumes 50% Eligible).
Number of Completes ......................
2,112
1
2,112
0.08 (5 minutes) ..............................
169
1,056
1
1,056
1 .......................................................
1,056
Total ..........................................
........................
........................
........................
..........................................................
1,967.40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 https://
www.regulations.gov.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
References
1. Zhong W, Maradit-Kremers H, St. Sauver
JL, Yawn BP, Ebbert JO, Roger VL, Jacobson
DJ, McGree ME, Brue SM, Rocca WA, Age
and Sex Patterns of Drug Prescribing in a
Defined American Population, Mayo Clinc
Proceedings, 2013;88(7):697–707.
2. Depp CA, Schkade DA, Thompson WK,
Jeste DV, Age, Affective Experience, and
Television Use, American Journal of
Preventative Medicine, 2010;39:173–8.
3. Agrawal Y, Platz EA, Niparko JK,
Prevalence of Hearing Loss and Differences
by Demographic Characteristics Among US
Adults, Archives of Internal Medicine,
2008;168(14):1522–30.
4. Cruickshanks KJ, Wiley TL, Tweed TS,
Klein BEK, Klein R, Mares-Perlman JA,
Nondahl DM, Prevalence of Hearing Loss in
Older Adults in Beaver Dam, Wisconsin,
American Journal of Epidemiology.
1998;148(9):879–86.
5. Lin FR, Thorpe R, Gordon-Salant S,
Ferrucci L. Hearing Loss Prevalence and Risk
Factors Among Older Adults in the United
States, The Journals of Gerontology Series A:
Biological Sciences and Medical Sciences,
2011;66A(5):582–90.
6. Garstecki DC, Erler SF. Hearing Loss,
Control, and Demographic Factors
Influencing Hearing Aid Use Among Older
Adults, Journal of Speech, Language, and
Hearing Research, 1998;41:527–37.
7. Gates GA, Cooper JC. Incidence of
Hearing Decline in the Elderly, Acta Otolaryngol, 1991;111:240–8.
8. Humes LE, Speech Understanding in the
Elderly, Journal of the American Academy of
Audiology, 1996; 7:161–7.
9. U.S. Food and Drug Administration.
Code of Federal Regulations, Prescription
Drug Advertisements, 21 CFR Sect. 202.1.
2013. Retrieved from: https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCFR/CFRSearch.cfm?fr=202.1
10. Wingfield A, Poon LW, Lombardi L,
Lowe D. Speed of Processing in Normal
Aging: Effects of Speech Rate, Linguistic
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16:37 Jun 24, 2015
Jkt 235001
Structure, and Processing Time, The Journals
of Gerontology, 1985;40(5):579–85.
11. Kramer AF, Hahn S, Gopher D. Task
Coordination and Aging: Explorations of
Executive Control Processes in the Task
Switching Paradigm, Acta Psychologica,
1999;101:339–78.
12. Naveh-Benjamin M, Guez J, Kilb A,
Reedy S. The Associative Memory Deficit of
Older Adults: Further Support Using FaceName Associations, Psychology and Aging,
2004;19(3):541–6.
13. Sommers MS, Tye-Murray N, Spehar B,
Auditory-Visual Speech Perception and
Auditory-Visual Enhancement in NormalHearing Younger and Older Adults, Ear and
Hearing, 2005;26(3):263–75.
14. Watson JM, McDermott KB, Balota DA,
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, 2004;32(1):135–41.
15. Gates GA, Feeney MP, Mills D, CrossSectional Age-Changes of Hearing in the
Elderly, Ear and Hearing, 2008;29(6):865–74.
16. Morrell CH, Gordon-Salant S, Pearson
JD, Brant LJ, Fozard JL, Age- and GenderSpecific Reference Ranges for Hearing Level
and Longitudinal Changes in Hearing Level,
Journal of the Acoustical Society of America,
1996;100(4)Pt. 1:1949–67.
17. Cutler A, Dahan D, van Donselaar W.,
Prosody in the Comprehension of Spoken
Language: A Literature Review, Language
and Speech, 1997;40(2):141–201.
Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15557 Filed 6–24–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0248]
Allowable Excess Volume and Labeled
Vial Fill Size in Injectable Drug and
Biological Products; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00048
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Allowable Excess Volume and
Labeled Vial Fill Size in Injectable Drug
and Biological Products.’’ It replaces the
draft of the same name that was
published on March 14, 2014. This
guidance clarifies FDA requirements
and regulations pertaining to allowable
excess volume in injectable vials and
reinforces the importance of appropriate
fill volumes and labeled vial fill sizes
for injectable drug and biological
products.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Pallavi Nithyanandan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36545-36547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15557]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2163]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Hearing, Aging, and Direct-to-Consumer Television
Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled, ``Hearing, Aging, and
Direct-to-Consumer Television Advertisements''. This study will examine
how changes to hearing across the lifespan affect the comprehension of
direct-to-consumer (DTC) television advertisements for prescription
drugs.
DATES: Submit either electronic or written comments on the collection
of information by August 24, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 (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 (Ref. 3, 4, and 5) and, depending
on their severity, influence the understanding of speech. 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; older adults are not able to
hear higher frequencies as well (Ref. 7 and 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 must 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 many 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, 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 (60-75 years), and old-old adults (75+ years), and a
group of
[[Page 36546]]
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 (Ref. 11, 12, 13, and 14). 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 (Ref. 15 and 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.
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?
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?
Design
To test these research questions, we will examine four groups of
adults and manipulate three variables as shown in Table 1.
Table 1--Proposed Research Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voiceover frequency
----------------------------------------------------------------
Male (low frequency) Female (high frequency)
----------------------------------------------------------------
Age Speed Organization of major Organization of major Total
statement 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 (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
procedures and 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 prior 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.
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 60 minutes.
Questionnaire measures are designed to assess, for 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretesting:
Number to Complete the Screener (Assumes 50% 1,280 1 1,280 0.08 (5 minutes).................. 102.4
Eligible).
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36547]]
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Number of Completes........... 640 1 640 1............... 640
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
Number to Complete the 2,112 1 2,112 0.08 (5 minutes) 169
Screener (Assumes 50%
Eligible).
Number of Completes........... 1,056 1 1,056 1............... 1,056
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1,967.40
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 https://www.regulations.gov.
References
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2. Depp CA, Schkade DA, Thompson WK, Jeste DV, Age, Affective
Experience, and Television Use, American Journal of Preventative
Medicine, 2010;39:173-8.
3. Agrawal Y, Platz EA, Niparko JK, Prevalence of Hearing Loss
and Differences by Demographic Characteristics Among US Adults,
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Perception and Auditory-Visual Enhancement in Normal-Hearing Younger
and Older Adults, Ear and Hearing, 2005;26(3):263-75.
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Hearing in the Elderly, Ear and Hearing, 2008;29(6):865-74.
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Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15557 Filed 6-24-15; 8:45 am]
BILLING CODE 4164-01-P
