
[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 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


