80 FR 36545 - Agency Information Collection Activities; Proposed Collection; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 122 (June 25, 2015)

Page Range		36545-36547
FR Document		2015-15557

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.

Federal Register, Volume 80 Issue 122 (Thursday, June 25, 2015)

[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36545-36547]
From the Federal Register Online [www.thefederalregister.org]
[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 http://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 http://www.regulations.gov.

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 Oto-laryngol, 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: http://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
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 Face-Name
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 Normal-Hearing 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, Cross-Sectional 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 Gender-Specific 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

Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices 36545

Therefore, the estimated annual SUPPLEMENTARY INFORMATION: Under the experiencing some level of hearing loss.
reporting burden for this information is PRA (44 U.S.C. 3501–3520), Federal Moreover, much of the information in
25,000 hours and the estimated annual Agencies must obtain approval from the these ads is conveyed by voiceover,
recordkeeping burden is 100,000 hours. Office of Management and Budget meaning that the audio channel is the
Dated: June 22, 2015. (OMB) for each collection of only way to receive the information.
information they conduct or sponsor. Although people with serious hearing
Leslie Kux,
‘‘Collection of information’’ is defined loss may compensate by using closed
Associate Commissioner for Policy.
in 44 U.S.C. 3502(3) and 5 CFR captioning (which may or may not be
[FR Doc. 2015–15638 Filed 6–24–15; 8:45 am] 1320.3(c) and includes Agency requests available for ads) or hearing aids, some
BILLING CODE 4164–01–P or requirements that members of the individuals experience the effects of
public submit reports, keep records, or hearing loss without realizing that it is
provide information to a third party. the cause and others choose not to use
DEPARTMENT OF HEALTH AND Section 3506(c)(2)(A) of the PRA (44 external compensatory aids (Ref. 6). For
HUMAN SERVICES U.S.C. 3506(c)(2)(A)) requires Federal these reasons, FDA is proposing
Agencies to provide a 60-day notice in research to investigate how people at
Food and Drug Administration
the Federal Register concerning each various ages and levels of hearing ability
[Docket No. FDA–2015–N–2163]
proposed collection of information comprehend DTC ads.
before submitting the collection to OMB Sponsors of DTC ads cannot control
Agency Information Collection for approval. To comply with this the hearing abilities of their audiences.
Activities; Proposed Collection; requirement, FDA is publishing notice Nonetheless, researchers have identified
Comment Request; Hearing, Aging, of the proposed collection of several aspects of DTC ads within their
and Direct-to-Consumer Television information set forth in this document. control that influence the understanding
Advertisements With respect to the following of speech in individuals who experience
collection of information, FDA invites aging-related hearing loss. First,
AGENCY: Food and Drug Administration, comments on these topics: (1) Whether frequency thresholds differ as people
HHS. the proposed collection of information age; older adults are not able to hear
ACTION: Notice. is necessary for the proper performance higher frequencies as well (Ref. 7 and 8).
of FDA’s functions, including whether Second, DTC television ads contain a
SUMMARY: The Food and Drug the information will have practical risk statement of the most serious and
Administration (FDA) is announcing an utility; (2) the accuracy of FDA’s most common side effects, called ‘‘the
opportunity for public comment on the estimate of the burden of the proposed major statement’’. FDA regulations
proposed collection of certain collection of information, including the require that the major statement must be
information by the Agency. Under the validity of the methodology and included in at least the audio portion of
Paperwork Reduction Act of 1995 (the assumptions used; (3) ways to enhance the ad (Ref. 9). The risks of a medical
PRA), Federal Agencies are required to the quality, utility, and clarity of the product often include highly technical
publish notice in the Federal Register information to be collected; and (4) medical terms that must be transformed
concerning each proposed collection of ways to minimize the burden of the into consumer-friendly language to
information and to allow 60 days for collection of information on convey the risks appropriately. This is
public comment in response to the respondents, including through the use easier in some cases than in others. In
notice. This notice solicits comments on of automated collection techniques, addition, there are techniques to help
research entitled, ‘‘Hearing, Aging, and when appropriate, and other forms of reduce the complexity of the major
Direct-to-Consumer Television information technology. statement, such as maintaining active
Advertisements’’. This study will voice, reducing instances where words
Hearing, Aging, and Direct-to-
examine how changes to hearing across need clarification from other later words
Consumer Television Advertisements—
the lifespan affect the comprehension of in the broadcast, and using shorter
(OMB Control Number 0910–NEW)
direct-to-consumer (DTC) television sentences. Third, television ad spots are
advertisements for prescription drugs. Section 1701(a)(4) of the Public typically bought in increments of 15
Health Service Act (42 U.S.C. seconds, leading to many 30- and 60-
DATES: Submit either electronic or
300u(a)(4)) authorizes the FDA to second ads, and some 75-second ads
written comments on the collection of
conduct research relating to health when risk information is especially
information by August 24, 2015.
information. Section 1003(d)(2)(C) of the dense. In order to fit the required
ADDRESSES: Submit electronic Federal Food, Drug, and Cosmetic Act information into this time frame, the
comments on the collection of (21 U.S.C. 393(b)(2)(c)) authorizes FDA audio presentation speed may be
information to http:// to conduct research relating to drugs adjusted to be faster or slower. Research
www.regulations.gov. Submit written and other FDA regulated products in has shown that fast speech is more
comments on the collection of carrying out the provisions of the FD&C difficult to understand than slower
information to the Division of Dockets Act. speech, even for healthy young adults
Management (HFA–305), Food and Drug Older adults use a disproportionate (Ref. 10).
Administration, 5630 Fishers Lane, Rm. number of prescription drugs (Ref. 1) Thus, we propose to examine the
1061, Rockville, MD 20852. All and watch more television than other effects of three aspects of DTC ads
comments should be identified with the age groups (Ref. 2). Age-related changes (voice frequency, complexity of major
asabaliauskas on DSK5VPTVN1PROD with NOTICES

docket number found in brackets in the in hearing are common (Ref. 3, 4, and statement, speed of major statement) on
heading of this document. 5) and, depending on their severity, the comprehension of the ads among
FOR FURTHER INFORMATION CONTACT: FDA influence the understanding of speech. four different age groups of individuals.
PRA Staff, Office of Operations, Food DTC television advertisements (ads) Because hearing losses begin to occur as
and Drug Administration, 8455 contain large amounts of complex people age, we will examine a group of
Colesville Rd., COLE–14526, Silver information about prescription drug middle-aged adults (40–50 years),
Spring, MD 20993–0002, PRAStaff@ treatments that may be particularly young-old adults (60–75 years), and old-
fda.hhs.gov. relevant to a population that is old 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. pauses, all components of something General Research Questions
The use of young adults as a control called the prosody of language (Ref. 17).
group is common in studies of age Thus, even though older adults 1. How do hearing and cognitive
changes in memory, cognition, and generally perform worse than younger declines in older adults affect
hearing (Ref. 11, 12, 13, and 14). Our adults with rapid speech, older adult comprehension of DTC television ads,
primary outcomes will be verbatim and recall of sentences is still relatively and the major statement in particular?
gist memory, and confidence in memory high, at 80 percent, presumably because 2. How do the frequency, speed, and
judgments, but we will also seek to older adults use linguistic context. complexity of the major statement
apply findings from previous studies Moreover, to approximate real DTC ads, influence the comprehension of the
showing age changes in hearing ability participants will view an ad that has a major statement and DTC ads as a
(Ref. 15 and 16) to the particular typical amount of superimposed text, whole?
situation of DTC ad viewing. some of which may repeat the 3. How do hearing and cognitive
It is important to note that despite information in the audio. Our task thus declines interact with the frequency,
hearing and cognitive losses, older involves viewing realistic DTC ads, speed, and complexity of the major
adults generally use linguistic context which provide more context than lists of statement to affect the comprehension of
well. That is, they are as good as or even unrelated words or sentences, as often DTC ads?
better than younger adults at using found in laboratory experiments. Thus, Design
context to determine what they are it is an open question whether hearing
hearing. They are also skilled at using loss will impede the comprehension of To test these research questions, we
the intonation of words, which words DTC ads or whether the ability to make will examine four groups of adults and
are stressed, where pauses occur, and use of context will counteract these manipulate three variables as shown in
how words are lengthened before decrements across the lifespan. Table 1.

TABLE 1—PROPOSED RESEARCH DESIGN
Voiceover frequency

Male (low frequency) Female (high frequency)
Age Speed Total
Organization of 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 (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 Within each age group, participants fictitious DTC television ad twice, and
main study to evaluate the procedures will be randomly assigned to one of answer questions in a survey.
and measures used in the main study. eight experimental conditions in a 2 Participation is estimated to take
We will recruit adults who fall into one (speed) × 2 (frequency) × 2 (complexity) approximately 60 minutes.
of four age brackets shown in Table 1. design, as depicted in Table 1. The
Questionnaire measures are designed
We will exclude individuals who work study will include audiometric
to assess, for risk and benefit
in healthcare or marketing settings measurement of individual hearing
because their knowledge and ability to help determine if hearing information, verbatim memory,
experiences may not reflect those of the declines account for any age group comprehension, gist memory, and
average consumer. A prior power differences in reported comprehension confidence in memory and
analyses revealed that we need 640 or retention of ad information. During comprehension judgments. The draft
participants for the pretest to obtain 80 the scheduled appointment time, questionnaire is available upon request.
percent power to detect a small effect participants will receive a complete To examine differences between
size, and 1,056 participants for the main audiometric test performed by experimental conditions, we will
study to obtain 90 percent power to audiologists from the University of conduct inferential statistical tests such
detect a small effect size. Data collection North Carolina Hearing and as analysis of variance.
will take place in person. Communication Center, watch a
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of
Number of Total annual
Activity responses per Average burden per response Total hours
respondents responses
respondent

Pretesting:
Number to Complete the 1,280 1 1,280 0.08 (5 minutes) ............................... 102.4
Screener (Assumes 50% Eli-
gible).

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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 2,112 1 2,112 0.08 (5 minutes) .............................. 169
(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 Structure, and Processing Time, The Journals ACTION: Notice.
placed on display in the Division of of Gerontology, 1985;40(5):579–85.
Dockets Management (see ADDRESSES) 11. Kramer AF, Hahn S, Gopher D. Task SUMMARY: The Food and Drug
Coordination and Aging: Explorations of Administration (FDA) is announcing the
and may be seen by interested persons
Executive Control Processes in the Task availability of a guidance for industry
between 9 a.m. and 4 p.m., Monday Switching Paradigm, Acta Psychologica,
through Friday, and are available entitled ‘‘Allowable Excess Volume and
1999;101:339–78.
electronically at http:// Labeled Vial Fill Size in Injectable Drug
12. Naveh-Benjamin M, Guez J, Kilb A,
www.regulations.gov. Reedy S. The Associative Memory Deficit of and Biological Products.’’ It replaces the
Older Adults: Further Support Using Face- draft of the same name that was
References Name Associations, Psychology and Aging, published on March 14, 2014. This
1. Zhong W, Maradit-Kremers H, St. Sauver 2004;19(3):541–6. guidance clarifies FDA requirements
JL, Yawn BP, Ebbert JO, Roger VL, Jacobson 13. Sommers MS, Tye-Murray N, Spehar B, and regulations pertaining to allowable
DJ, McGree ME, Brue SM, Rocca WA, Age Auditory-Visual Speech Perception and excess volume in injectable vials and
and Sex Patterns of Drug Prescribing in a Auditory-Visual Enhancement in Normal- reinforces the importance of appropriate
Defined American Population, Mayo Clinc Hearing Younger and Older Adults, Ear and
fill volumes and labeled vial fill sizes
Proceedings, 2013;88(7):697–707. Hearing, 2005;26(3):263–75.
14. Watson JM, McDermott KB, Balota DA, for injectable drug and biological
2. Depp CA, Schkade DA, Thompson WK,
Jeste DV, Age, Affective Experience, and Attempting to Avoid False Memories in the products.
Television Use, American Journal of Deese/Roediger-McDermott Paradigm: DATES: Submit either electronic or
Preventative Medicine, 2010;39:173–8. Assessing the Combined Influence of Practice written comments on Agency guidances
3. Agrawal Y, Platz EA, Niparko JK, and Warnings in Young and Old Adults,
at any time.
Prevalence of Hearing Loss and Differences Memory and Cognition, 2004;32(1):135–41.
15. Gates GA, Feeney MP, Mills D, Cross- ADDRESSES: Submit written requests for
by Demographic Characteristics Among US
Adults, Archives of Internal Medicine, Sectional Age-Changes of Hearing in the single copies of this guidance to the
2008;168(14):1522–30. Elderly, Ear and Hearing, 2008;29(6):865–74. Division of Drug Information, Center for
4. Cruickshanks KJ, Wiley TL, Tweed TS, 16. Morrell CH, Gordon-Salant S, Pearson Drug Evaluation and Research, Food
Klein BEK, Klein R, Mares-Perlman JA, JD, Brant LJ, Fozard JL, Age- and Gender- and Drug Administration, 10001 New
Nondahl DM, Prevalence of Hearing Loss in Specific Reference Ranges for Hearing Level Hampshire Ave., Hillandale Building,
Older Adults in Beaver Dam, Wisconsin, and Longitudinal Changes in Hearing Level,
4th Floor, Silver Spring, MD 20993–
American Journal of Epidemiology. Journal of the Acoustical Society of America,
1996;100(4)Pt. 1:1949–67. 0002; or Center for Biologics Evaluation
1998;148(9):879–86. and Research, Food and Drug
5. Lin FR, Thorpe R, Gordon-Salant S, 17. Cutler A, Dahan D, van Donselaar W.,
Prosody in the Comprehension of Spoken Administration, 10903 New Hampshire
Ferrucci L. Hearing Loss Prevalence and Risk
Factors Among Older Adults in the United Language: A Literature Review, Language Ave., Bldg. 71, Rm. 7301, Silver Spring,
States, The Journals of Gerontology Series A: and Speech, 1997;40(2):141–201. MD 20993–0002, 240–402–7911. Send
Biological Sciences and Medical Sciences, Dated: June 18, 2015. one self-addressed adhesive label to
2011;66A(5):582–90. Leslie Kux, assist that office in processing your
6. Garstecki DC, Erler SF. Hearing Loss, requests. The guidance may also be
Associate Commissioner for Policy.
Control, and Demographic Factors obtained by mail by calling CBER at 1–
Influencing Hearing Aid Use Among Older [FR Doc. 2015–15557 Filed 6–24–15; 8:45 am]
800–835–4709 or 240–402–7800. See
Adults, Journal of Speech, Language, and BILLING CODE 4164–01–P
the SUPPLEMENTARY INFORMATION section
Hearing Research, 1998;41:527–37.
for electronic access to the guidance
7. Gates GA, Cooper JC. Incidence of
Hearing Decline in the Elderly, Acta Oto- document.
DEPARTMENT OF HEALTH AND Submit electronic comments on the
laryngol, 1991;111:240–8. HUMAN SERVICES
8. Humes LE, Speech Understanding in the guidance to http://www.regulations.gov.
Elderly, Journal of the American Academy of Food and Drug Administration Submit written comments to the
Audiology, 1996; 7:161–7. Division of Dockets Management (HFA–
asabaliauskas on DSK5VPTVN1PROD with NOTICES

9. U.S. Food and Drug Administration. [Docket No. FDA–2014–D–0248] 305), Food and Drug Administration,
Code of Federal Regulations, Prescription 5630 Fishers Lane, Rm. 1061, Rockville,
Drug Advertisements, 21 CFR Sect. 202.1. Allowable Excess Volume and Labeled MD 20852.
2013. Retrieved from: http:// Vial Fill Size in Injectable Drug and
FOR FURTHER INFORMATION CONTACT:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/ Biological Products; Guidance for
cfCFR/CFRSearch.cfm?fr=202.1 Pallavi Nithyanandan, Center for Drug
Industry; Availability
10. Wingfield A, Poon LW, Lombardi L, Evaluation and Research, Food and
Lowe D. Speed of Processing in Normal AGENCY: Food and Drug Administration, Drug Administration, 10903 New
Aging: Effects of Speech Rate, Linguistic HHS. Hampshire Ave., Silver Spring, MD

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 24, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 36545

80 FR 36545 - Agency Information Collection Activities; Proposed Collection; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 122 (June 25, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration