Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads, 42823-42825 [2015-17725]
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42823
Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Accomplishments of the
Domestic Violence Hotline, Online
Connections and Text (ADVHOCaT)
Study.
OMB No.: New Collection.
Description: The National Domestic
Violence Hotline (NDVH) and the
National Dating Abuse Helpline or Love
Is Respect (NDAH/LIR), which are
supported by the Division of Family
Violence Prevention and Services
within the Family and Youth Services
Bureau of the Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), serve as partners in the
intervention, prevention, and resource
assistance efforts of the network of
family violence, domestic violence, and
dating violence service providers.
In order to describe the activities and
accomplishments of the NDVH and
NDAH/LIR and develop potential new
or revised performance measures, the
Office of Planning, Research and
Evaluation (OPRE), within ACF/HHS is
proposing data collection activity as
part of the Accomplishments of the
Domestic Violence Hotline, Online
Connections and Text (ADVHOCaT)
Study.
This study will primarily analyze data
previously collected by the NDVH and
NDAH/LIR as part of their ongoing
program activities and monitoring. ACF
proposes to collect additional
information, including information
about the preferred mode (phone, chat,
text), ease of use, and perceived safety
of each mode of contact.
This data is to be collected through
voluntary web-based surveys that are to
be completed by those who access the
NDVH and NDAH/LIR Web sites. This
information will be critical to informing
future efforts to monitor and improve
the performance of domestic violence
hotlines and provide hotline services.
Respondents: Individuals who access
the NDVH and NDAH/LIR Web sites.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Number of
responses per
respondent
Average burden hours per
response
Annual burden
hours
NDVH/LIR Preference of Use Survey .....................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
5000
1
0.041 hours (150 seconds) ....
205
Estimated Total Annual Burden
Hours: 205 hours.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
VerDate Sep<11>2014
16:30 Jul 17, 2015
Jkt 235001
comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2015–17687 Filed 7–17–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2406]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Market Claims in
Direct-to-Consumer Prescription Drug
Print Ads
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, ‘‘Market Claims in
Direct-to-Consumer Prescription Drug
Print Ads.’’ This study will examine the
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
impact of market claim information in
direct-to-consumer (DTC) print
advertising for prescription drugs.
DATES: Submit either electronic or
written comments on the collection of
information by September 18, 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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20JYN1.SGM
20JYN1
42824
Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
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.
Market Claims in Direct-to-Consumer
Prescription Drug Print Ads—OMB
Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(d)(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.
The marketing literature divides
product attributes (‘‘cues’’) into intrinsic
and extrinsic. Intrinsic cues are physical
characteristics of the product (e.g., size,
shape), whereas extrinsic cues are
product-related but not part of the
product (e.g., price and brand name)
(Refs. 1, 2). Research has found that
both intrinsic and extrinsic cues can
influence perceptions of product quality
(Ref. 3). Consumers may rely on product
cues in the absence of explicit quality
information. The objective quality of
prescription drugs is not easily obtained
from promotional claims in DTC ads;
thus consumers may rely upon extrinsic
cues to inform their decisions. Market
claims such as ‘‘#1 prescribed’’ and
‘‘new’’ may act as extrinsic cues about
the product’s quality, independent of
the product’s intrinsic characteristics.
Prior research has found that market
leadership claims can affect consumer
beliefs about product efficacy, as well as
their beliefs about doctors’ judgments
about product efficacy (Ref. 4). One
limitation of these prior studies is the
lack of quantitative information about
product efficacy in the information
provided to respondents. Research
indicates that providing consumers with
efficacy information generally improves
understanding and facilitates
decisionmaking (Refs. 5, 6). Efficacy
information may moderate the effect of
the extrinsic cue by providing insight
into characteristics that would
otherwise be unknown. Other research
has shown that consumers are able to
use information about efficacy to inform
judgments about the product (Refs. 6, 7).
The Office of Prescription Drug
Promotion plans to investigate, through
empirical research, the impact of market
claims on prescription drug product
perceptions with and without
quantitative information about product
efficacy. This will be investigated in
DTC print advertising for prescription
drugs.
The project consists of two parts; a
main study and a followup study.
Pretesting will be conducted to assess
and identify problems with the
questionnaire, stimuli, and procedures.
Participants will be consumers who selfidentify as having been diagnosed with
diabetes. All participants will be 18
years of age or older. We will exclude
individuals from the consumer sample
who work in healthcare or marketing
settings because their knowledge and
experiences may not reflect those of the
average consumer. Recruitment and
administration of the study will take
place over the Internet. Participation is
estimated to take no more than 30
minutes.
In the main study, participants will be
randomly assigned to view one of nine
possible versions of an ad, as depicted
in table 1. The two variables of interest
are type of market claim (#1 Prescribed,
New) and level of efficacy information
(high, low, or none). Efficacy
information will be operationalized in
the form of simple quantitative
information (for example, product X can
provide 50 percent relief for up to 60
percent of patients). We will investigate
memory, perception, and understanding
of product risks and benefits; perception
and understanding of the market claim;
perception of product quality;
perceptions of product acceptance by
doctor, intention to seek more
information about the product; and
perceptions of trust/skepticism
regarding product claims and the
sponsor. To examine differences
between experimental conditions, we
will conduct inferential statistical tests
such as analysis of variance. With the
sample size described below, we will
have sufficient power to detect small- to
medium-sized effects in the main study.
TABLE 1—MAIN STUDY DESIGN TYPE OF MARKET CLAIM
#1 Prescribed
mstockstill on DSK4VPTVN1PROD with NOTICES
Efficacy Level Information:
High ....................................................................................................................
Low .....................................................................................................................
None (control) .....................................................................................................
The followup study will examine the
tradeoff between efficacy level and
market share claim using decision
analysis techniques. Participants will be
asked to choose between two different
VerDate Sep<11>2014
16:30 Jul 17, 2015
Jkt 235001
New
None (control)
A
D
G
B
E
H
C
F
I
DTC print ads over 48 trials. One set of
DTC ads will feature the two claims
from the main study. The other set of
DTC ads will depict 48 different levels
of product efficacy. Participants will be
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
asked to choose one product on one or
more dependent measures.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
42825
TABLE 2—ESTIMATED BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
respondents
Average burden
per response
Total hours
Sample outgo (pretests and main survey) .......................
Screener completes ..........................................................
Eligible ...............................................................................
Completes, Pretest 1 ........................................................
Completes, Pretest 2 ........................................................
Completes, Main Study .....................................................
Completes, Pretest 3 ........................................................
Completes, Followup Study ..............................................
16,384
1,638
1,556
252
252
495
108
216
........................
1
........................
1
1
1
1
1
........................
1,638
........................
252
252
495
108
216
...........................
.03 (2 minutes)
...........................
.5 (30 minutes)
.5 (30 minutes)
.5 (30 minutes)
.25 (15 minutes)
.25 (15 minutes)
........................
49
........................
126
126
248
27
54
Total ...........................................................................
........................
........................
........................
...........................
630
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Lee, M. and Y.C. Lou, ‘‘Consumer Reliance
on Intrinsic and Extrinsic Cues in
Product Evaluations: A Conjoint
Approach,’’ Journal of Applied Business
Research, 12(1), pp. 21–29 (2011).
2. Teas, R.K. and S. Agarwal, ‘‘The Effects of
Extrinsic Product Cues on Consumers’
Perceptions of Quality, Sacrifice, and
Value,’’ Journal of the Academy of
Marketing Science, 28(2), pp. 278–290
(2000).
3. Rao, A.R. and K.B. Monroe, ‘‘The Effect of
Price, Brand Name, and Store Name on
Buyers’ Perceptions of Product Quality:
An Integrative Review,’’ Journal of
Marketing Research, pp. 351–357 (1989).
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ‘‘How
Do Consumers Interpret Market
Leadership Claims in Direct-toConsumer Advertising of Prescription
Drugs?’’ Advances in Consumer
Research, 33, pp. 381–387 (2006).
5. O’Donoghue, A., H.K. Sullivan, D. Aikin,
R. Chowdhury, et al., ‘‘Presenting
Efficacy Information in Direct to
Consumer Prescription Drug
Advertisements,’’ Patient Education
Counsel, 95(2), pp. 271–80 (2014).
6. Schwartz, L.M., S. Woloshin, and H.G.
Welch, ‘‘Using a Drug Facts Box to
Communicate Drug Benefits and
Harmstwo Randomized Trials,’’ Annals
of Internal Medicine, 150(8), pp. 516–527
(2009).
7. Sullivan, H.W., A. C. O’Donoghue, and K.J.
Aikin, ‘‘Presenting Quantitative
Information About Placebo Rates to
Patients,’’ JAMA Internal Medicine, doi:
10.1001/jamainternmed.2013.10399
(2013).
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17725 Filed 7–17–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:30 Jul 17, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Prescription Drug User Fee Act;
Stakeholder Consultation Meetings on
the Prescription Drug User Fee Act
Reauthorization; Request for
Notification of Stakeholder Intention
To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders—including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory
authority for PDUFA expires in
September 2017. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
prescription drug program. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) requires that FDA consult
with a range of stakeholders in
developing recommendations for the
next PDUFA program. The FD&C Act
also requires that FDA hold discussions
(at least every month) with patient and
consumer advocacy groups during
FDA’s negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent stakeholder
representation.
DATES: Submit notification of intention
to participate in these series of meetings
by August 28, 2015. Stakeholder
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
meetings will be held monthly. It is
anticipated that they will commence in
September or October 2015.
ADDRESSES: Submit notification of
intention to participate in monthly
stakeholder meetings by email to
PDUFAReauthorization@fda.hhs.gov.
The meetings will be held at the FDA
campus, 10903 New Hampshire Ave.,
Silver Spring, MD 20993.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993, 301–796–
5003, FAX: 301–847–8443.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public
stakeholders—including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts—notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of PDUFA. PDUFA
authorizes FDA to collect user fees from
the regulated industry for the process
for the review of human drugs. The
authorization for the current program
(PDUFA V) expires in September 2017.
Without new legislation, FDA will no
longer be able to collect user fees for
future fiscal years to fund the human
drug review process.
Section 736B(d) of the FD&C Act (21
U.S.C. 379h–2(d)) requires that FDA
consult with a range of stakeholders,
including representatives from patient
and consumer groups, health care
professionals, and scientific and
academic experts, in developing
recommendations for the next PDUFA
program. FDA will initiate the
reauthorization process by holding a
public meeting on July 15, 2015, where
stakeholders and other members of the
public will be given an opportunity to
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42823-42825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17725]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2406]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Market Claims in Direct-to-Consumer Prescription Drug
Print Ads
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, ``Market Claims in
Direct-to-Consumer Prescription Drug Print Ads.'' This study will
examine the impact of market claim information in direct-to-consumer
(DTC) print advertising for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by September 18, 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
[[Page 42824]]
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.
Market Claims in Direct-to-Consumer Prescription Drug Print Ads--OMB
Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(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.
The marketing literature divides product attributes (``cues'') into
intrinsic and extrinsic. Intrinsic cues are physical characteristics of
the product (e.g., size, shape), whereas extrinsic cues are product-
related but not part of the product (e.g., price and brand name) (Refs.
1, 2). Research has found that both intrinsic and extrinsic cues can
influence perceptions of product quality (Ref. 3). Consumers may rely
on product cues in the absence of explicit quality information. The
objective quality of prescription drugs is not easily obtained from
promotional claims in DTC ads; thus consumers may rely upon extrinsic
cues to inform their decisions. Market claims such as ``#1 prescribed''
and ``new'' may act as extrinsic cues about the product's quality,
independent of the product's intrinsic characteristics. Prior research
has found that market leadership claims can affect consumer beliefs
about product efficacy, as well as their beliefs about doctors'
judgments about product efficacy (Ref. 4). One limitation of these
prior studies is the lack of quantitative information about product
efficacy in the information provided to respondents. Research indicates
that providing consumers with efficacy information generally improves
understanding and facilitates decisionmaking (Refs. 5, 6). Efficacy
information may moderate the effect of the extrinsic cue by providing
insight into characteristics that would otherwise be unknown. Other
research has shown that consumers are able to use information about
efficacy to inform judgments about the product (Refs. 6, 7).
The Office of Prescription Drug Promotion plans to investigate,
through empirical research, the impact of market claims on prescription
drug product perceptions with and without quantitative information
about product efficacy. This will be investigated in DTC print
advertising for prescription drugs.
The project consists of two parts; a main study and a followup
study. Pretesting will be conducted to assess and identify problems
with the questionnaire, stimuli, and procedures. Participants will be
consumers who self-identify as having been diagnosed with diabetes. All
participants will be 18 years of age or older. We will exclude
individuals from the consumer sample who work in healthcare or
marketing settings because their knowledge and experiences may not
reflect those of the average consumer. Recruitment and administration
of the study will take place over the Internet. Participation is
estimated to take no more than 30 minutes.
In the main study, participants will be randomly assigned to view
one of nine possible versions of an ad, as depicted in table 1. The two
variables of interest are type of market claim (#1 Prescribed, New) and
level of efficacy information (high, low, or none). Efficacy
information will be operationalized in the form of simple quantitative
information (for example, product X can provide 50 percent relief for
up to 60 percent of patients). We will investigate memory, perception,
and understanding of product risks and benefits; perception and
understanding of the market claim; perception of product quality;
perceptions of product acceptance by doctor, intention to seek more
information about the product; and perceptions of trust/skepticism
regarding product claims and the sponsor. To examine differences
between experimental conditions, we will conduct inferential
statistical tests such as analysis of variance. With the sample size
described below, we will have sufficient power to detect small- to
medium-sized effects in the main study.
Table 1--Main Study Design Type of Market Claim
----------------------------------------------------------------------------------------------------------------
#1 Prescribed New None (control)
----------------------------------------------------------------------------------------------------------------
Efficacy Level Information:
High............................................ A B C
Low............................................. D E F
None (control).................................. G H I
----------------------------------------------------------------------------------------------------------------
The followup study will examine the tradeoff between efficacy level
and market share claim using decision analysis techniques. Participants
will be asked to choose between two different DTC print ads over 48
trials. One set of DTC ads will feature the two claims from the main
study. The other set of DTC ads will depict 48 different levels of
product efficacy. Participants will be asked to choose one product on
one or more dependent measures.
FDA estimates the burden of this collection of information as
follows:
[[Page 42825]]
Table 2--Estimated Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample outgo (pretests and main survey)........ 16,384 .............. .............. ....................................... ..............
Screener completes............................. 1,638 1 1,638 .03 (2 minutes)........................ 49
Eligible....................................... 1,556 .............. .............. ....................................... ..............
Completes, Pretest 1........................... 252 1 252 .5 (30 minutes)........................ 126
Completes, Pretest 2........................... 252 1 252 .5 (30 minutes)........................ 126
Completes, Main Study.......................... 495 1 495 .5 (30 minutes)........................ 248
Completes, Pretest 3........................... 108 1 108 .25 (15 minutes)....................... 27
Completes, Followup Study...................... 216 1 216 .25 (15 minutes)....................... 54
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 630
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. Lee, M. and Y.C. Lou, ``Consumer Reliance on Intrinsic and
Extrinsic Cues in Product Evaluations: A Conjoint Approach,''
Journal of Applied Business Research, 12(1), pp. 21-29 (2011).
2. Teas, R.K. and S. Agarwal, ``The Effects of Extrinsic Product
Cues on Consumers' Perceptions of Quality, Sacrifice, and Value,''
Journal of the Academy of Marketing Science, 28(2), pp. 278-290
(2000).
3. Rao, A.R. and K.B. Monroe, ``The Effect of Price, Brand Name, and
Store Name on Buyers' Perceptions of Product Quality: An Integrative
Review,'' Journal of Marketing Research, pp. 351-357 (1989).
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ``How Do Consumers
Interpret Market Leadership Claims in Direct-to-Consumer Advertising
of Prescription Drugs?'' Advances in Consumer Research, 33, pp. 381-
387 (2006).
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Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17725 Filed 7-17-15; 8:45 am]
BILLING CODE 4164-01-P
