Agency Information Collection Activities; Proposed Collection; Comment Request; National Direct-to-Consumer Advertising Survey, 10257-10259 [2016-04220]
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Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Brian Kehoe, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–8913.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
I. Background
Under Executive Order 13175 of
November 6, 2000, executive
departments and Agencies are charged
with engaging in regular and meaningful
consultation and collaboration with
tribal officials in the development of
Federal policies that have tribal
implications and are responsible for
strengthening the government-togovernment relationship between the
United States and Indian tribes. The
Department of Health and Human
Services (HHS) Tribal Consultation
Policy, revised on December 14, 2010,
further clarifies that each HHS
Operating and Staff Division must have
an accountable consultation process to
ensure meaningful and timely input by
Tribal officials in the development of
policies that have Tribal implications.
To date, FDA has followed the HHS
Tribal Consultation Policy (available at
https://www.hhs.gov/about/agencies/iea/
tribal-affairs/consultation/).
The draft FDA Tribal Consultation
Policy is based on the HHS Tribal
Consultation Policy and includes
Agency-specific consultation guidelines
that complement the Department-wide
efforts.
The purpose of the draft FDA Tribal
Consultation Policy, when finalized, is
to establish clear policies to further the
government-to-government relationship
between FDA and Indian Tribes and
facilitate tribal consultation with FDA.
The draft policy provides background
on FDA’s mission and organizational
structure and sets out principles and
guidelines for the tribal consultation
process. FDA intends for its Tribal
Consultation Policy to serve as a
platform for the Agency to create
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consistent and meaningful tribal
consultation across FDA Centers and
Offices.
FDA is announcing the establishment
of a docket to receive comments on the
draft FDA Tribal Consultation Policy.
We invite tribal officials, tribal
organizations, individual tribal
members and other interested persons to
comment on the draft FDA Tribal
Consultation Policy. We are interested
in any general comments or concerns
that would help us improve our policy
as well as suggestions on how can we
improve our communication and
outreach with Indian Tribes. FDA also
intends to consult with Indian Tribal
officials on the draft FDA Tribal
Consultation Policy and summaries of
these consultations will be placed in the
docket.
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
ForFederalStateandLocalOfficials/
TribalAffairs/default.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
document.
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04276 Filed 2–26–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0544]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; National Direct-toConsumer Advertising Survey
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, ‘‘National Direct-toConsumer Advertising Survey.’’ The
objective of this research is to survey the
SUMMARY:
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10257
public about their experiences with and
attitudes toward direct-to-consumer
(DTC) advertising of prescription drugs.
DATES: Submit either electronic or
written comments on the collection of
information by April 29, 2016.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–0544 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; National
Direct-to-Consumer Advertising
Survey.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
10258
Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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
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Jkt 238001
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.
National Direct-to-Consumer
Advertising Survey
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes 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.
FDA last surveyed patients about their
experiences with and attitudes toward
DTC advertising in 2002 (Ref. 1).
Numerous changes have affected the
DTC landscape since 2002, including
declines in print readership, the rise in
online prescription drug promotion, and
self-imposed industry guidelines for
DTC advertising (Ref. 2). These changes
may have affected consumers’ exposure
to different kinds of DTC advertising
and its influence on their attitudes and
behaviors. The purpose of the National
Direct-to-Consumer Advertising Survey
is to collect updated insights on
consumer experiences with and
attitudes towards DTC promotion of
prescription drugs. This study will
build on previous research by recruiting
a wider range of respondents, weighting
the data to make it nationally
representative, and ask a wider range of
questions about DTC promotion,
including in online formats.
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We plan to use an address-based
mixed-mode methodology that will
direct one randomly-chosen member of
sampled households to complete a 20minute online survey, with nonrespondents receiving a paper
questionnaire. The sample will be
representative of the U.S. population. A
sample of U.S. households will be
drawn from the U.S. Postal Service
Computerized Delivery Sequence File.
Adults aged 18 or over will be eligible
for participation. Up to five contacts
will be sent to respondents by U.S. mail.
The contacts will include the URL for
the online survey and a unique personal
identification number (PIN). This
unique PIN will be used to track
completed surveys without the use of
personally identifying information. The
contact method, based on recent
recommendations (Ref. 3), includes a
notification letter (Day 1), a reminder/
thank-you postcard (Day 5), a second
letter sent to nonresponders (Day 12), a
paper version of the survey mailed to
nonresponders (Day 19), and a reminder
postcard sent to nonresponders (Day
24).
Based on previous research (Refs. 4, 5,
and 6), we plan to recruit using two $1
bills ($2 total per sampled respondent)
mailed in advance with the initial
invitation letter as a gesture to
encourage response and maintain data
quality. Offering a small token of value
to participants establishes a latent social
contract and subsequent reciprocity
(Ref. 3). In the second contact attempt,
we will conduct an experiment to test
whether a short statement mentioning
the previously paid incentive increases
survey response, thereby testing
whether social exchange can be
extended past the initial contact
attempt. Half the sample will be
provided language that reminds them
they received a cash incentive in the
previous letter; the remaining half will
be reminded they received a letter but
will not be specifically reminded about
the incentive.
We estimate a 35 percent response
rate, based on recent work on similar
studies (Ref. 7). Prior to the main study,
a pilot study will be conducted to test
the data collection process. We estimate
35 respondents will complete the pilot
study and 1,765 will complete the main
study (see table 1).
The survey contains questions about
respondents’ knowledge of FDA’s
authority with respect to prescription
drug advertising, their exposure to DTC
advertising, their beliefs and attitudes
about DTC advertising, and the
influence of DTC advertising on further
information search and patientphysician interactions. At the end of the
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Federal Register / Vol. 81, No. 39 / Monday, February 29, 2016 / Notices
survey, respondents will be randomly
assigned to view one of two ads for
fictional prescription drugs intended to
treat high cholesterol. They will be
asked questions about FDA’s authority
regarding specific claims within the ad.
The survey will include a debriefing to
inform respondents that the advertised
drug was fictitious. We will also
measure other potentially important
nonresponse. We will examine the
frequencies for survey items and the
relation between survey items and
demographic and health characteristics.
We also plan to compare responses
between this survey and FDA’s 2002
survey for repeated items.
FDA estimates the burden of this
collection of information as follows:
characteristics such as demographics,
insurance coverage, and prescription
drug use. The survey is available upon
request.
We will test for any differences
between modes (online versus mail
survey) and will account for any mode
effects in our analyses. We will weigh
the data to account for different
probability of selection and
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Pilot Study
Survey invitation letter ..........................................
Reminder postcard ...............................................
Non-response letter ..............................................
Non-response questionnaire letter .......................
Second postcard ..................................................
Survey ..................................................................
100
100
82
81
60
35
1
1
1
1
1
1
100
100
82
81
60
35
.08
.03
.08
.08
.03
.33
(5 min.) ....................
(2 min.) ....................
(5 min.) ....................
(5 min.) ....................
(2 min.) ....................
(20 min.) ..................
8
3
7
7
2
12
.08
.03
.08
.08
.03
.33
(5 min.) ....................
(2 min.) ....................
(5 min.) ....................
(5 min.) ....................
(2 min.) ....................
(20 min.) ..................
403
151
334
326
92
582
.......................................
1927
Main Study
Survey invitation letter ..........................................
Reminder postcard ...............................................
Non-response letter ..............................................
Non-response questionnaire letter .......................
Second postcard ..................................................
Survey ..................................................................
5,042
5,042
4,173
4,073
3,063
1,765
1
1
1
1
1
1
5,042
5,042
4,173
4,073
3,063
1,765
Total ..............................................................
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
asabaliauskas on DSK5VPTVN1PROD with NOTICES
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated With DTC
Promotion of Prescription Drugs—
Summary of FDA Survey Research
Results’’ (2004). (https://www.fda.gov/
downloads/Drugs/ScienceResearch/
ResearchAreas/DrugMarketing
AdvertisingandCommunications
Research/ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-toConsumer Advertisements About
Prescription Medicines (2008). (https://
phrma.org/sites/default/files/pdf/phrma
guidingprinciplesdec08final.pdf).
3. Dillman, D.A., J.D. Smyth, and L.M.
Christian, Internet, Phone, Mail, and
Mixed-Mode Surveys: The Tailored
Design Method, 4th ed. Hoboken, NJ:
John Wiley & Sons, Inc. (2014).
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19:23 Feb 26, 2016
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4. American Association for Public Opinion
Research, ‘‘Address-based Sampling’’
(2016). (https://www.aapor.org/AAPOR_
Main/media/MainSiteFiles/AAPOR_
Report_1_7_16_CLEAN–COPY–
FINAL.pdf).
5. Millar, M.M. and D.A. Dillman,
‘‘Improving Response to Web and MixedMode Surveys,’’ Public Opinion
Quarterly 1–21 (2011).
6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and
S.A. Adlis, ‘‘The Use of Monetary
Incentives in a Community Survey:
Impact on Response Rates, Data Quality,
and Cost,’’ Health Services Research
35:1339–1346 (2011).
7. Montaquila, J.M., J.M. Brick, D. Williams,
K. Kim, et al., ‘‘A Study of Two-Phase
Mail Survey Data Collection Methods,
Journal of Survey Statistics and
Methodology 1(1), 66–87 (2013).
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04220 Filed 2–26–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Medical Devices—Quality Systems
Survival: Success Strategies for
Production and Process Controls/
Corrective and Preventative Action;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), Office of
Regulatory Affairs, Southwest Regional
Office, in co-sponsorship with the FDA
Medical Device Industry Coalition, Inc.
(FMDIC), is announcing a public
workshop entitled ‘‘Medical Devices—
Quality Systems Survival: Success
Strategies for Production and Process
Controls/Corrective and Preventative
Action’’. The public workshop is
intended to seek input from
representatives of medical device
manufacturers and other stakeholders,
on best practices, what has worked for
them and what FDA can do to inspire
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10257-10259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04220]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0544]
Agency Information Collection Activities; Proposed Collection;
Comment Request; National Direct-to-Consumer Advertising Survey
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, ``National Direct-to-
Consumer Advertising Survey.'' The objective of this research is to
survey the public about their experiences with and attitudes toward
direct-to-consumer (DTC) advertising of prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by April 29, 2016.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0544 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; National Direct-to-Consumer
Advertising Survey.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 10258]]
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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.
National Direct-to-Consumer Advertising Survey
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes 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.
FDA last surveyed patients about their experiences with and
attitudes toward DTC advertising in 2002 (Ref. 1). Numerous changes
have affected the DTC landscape since 2002, including declines in print
readership, the rise in online prescription drug promotion, and self-
imposed industry guidelines for DTC advertising (Ref. 2). These changes
may have affected consumers' exposure to different kinds of DTC
advertising and its influence on their attitudes and behaviors. The
purpose of the National Direct-to-Consumer Advertising Survey is to
collect updated insights on consumer experiences with and attitudes
towards DTC promotion of prescription drugs. This study will build on
previous research by recruiting a wider range of respondents, weighting
the data to make it nationally representative, and ask a wider range of
questions about DTC promotion, including in online formats.
We plan to use an address-based mixed-mode methodology that will
direct one randomly-chosen member of sampled households to complete a
20-minute online survey, with non-respondents receiving a paper
questionnaire. The sample will be representative of the U.S.
population. A sample of U.S. households will be drawn from the U.S.
Postal Service Computerized Delivery Sequence File. Adults aged 18 or
over will be eligible for participation. Up to five contacts will be
sent to respondents by U.S. mail. The contacts will include the URL for
the online survey and a unique personal identification number (PIN).
This unique PIN will be used to track completed surveys without the use
of personally identifying information. The contact method, based on
recent recommendations (Ref. 3), includes a notification letter (Day
1), a reminder/thank-you postcard (Day 5), a second letter sent to
nonresponders (Day 12), a paper version of the survey mailed to
nonresponders (Day 19), and a reminder postcard sent to nonresponders
(Day 24).
Based on previous research (Refs. 4, 5, and 6), we plan to recruit
using two $1 bills ($2 total per sampled respondent) mailed in advance
with the initial invitation letter as a gesture to encourage response
and maintain data quality. Offering a small token of value to
participants establishes a latent social contract and subsequent
reciprocity (Ref. 3). In the second contact attempt, we will conduct an
experiment to test whether a short statement mentioning the previously
paid incentive increases survey response, thereby testing whether
social exchange can be extended past the initial contact attempt. Half
the sample will be provided language that reminds them they received a
cash incentive in the previous letter; the remaining half will be
reminded they received a letter but will not be specifically reminded
about the incentive.
We estimate a 35 percent response rate, based on recent work on
similar studies (Ref. 7). Prior to the main study, a pilot study will
be conducted to test the data collection process. We estimate 35
respondents will complete the pilot study and 1,765 will complete the
main study (see table 1).
The survey contains questions about respondents' knowledge of FDA's
authority with respect to prescription drug advertising, their exposure
to DTC advertising, their beliefs and attitudes about DTC advertising,
and the influence of DTC advertising on further information search and
patient-physician interactions. At the end of the
[[Page 10259]]
survey, respondents will be randomly assigned to view one of two ads
for fictional prescription drugs intended to treat high cholesterol.
They will be asked questions about FDA's authority regarding specific
claims within the ad. The survey will include a debriefing to inform
respondents that the advertised drug was fictitious. We will also
measure other potentially important characteristics such as
demographics, insurance coverage, and prescription drug use. The survey
is available upon request.
We will test for any differences between modes (online versus mail
survey) and will account for any mode effects in our analyses. We will
weigh the data to account for different probability of selection and
nonresponse. We will examine the frequencies for survey items and the
relation between survey items and demographic and health
characteristics. We also plan to compare responses between this survey
and FDA's 2002 survey for repeated items.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pilot Study
----------------------------------------------------------------------------------------------------------------
Survey invitation letter...... 100 1 100 .08 (5 min.).... 8
Reminder postcard............. 100 1 100 .03 (2 min.).... 3
Non-response letter........... 82 1 82 .08 (5 min.).... 7
Non-response questionnaire 81 1 81 .08 (5 min.).... 7
letter.
Second postcard............... 60 1 60 .03 (2 min.).... 2
Survey........................ 35 1 35 .33 (20 min.)... 12
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
Survey invitation letter...... 5,042 1 5,042 .08 (5 min.).... 403
Reminder postcard............. 5,042 1 5,042 .03 (2 min.).... 151
Non-response letter........... 4,173 1 4,173 .08 (5 min.).... 334
Non-response questionnaire 4,073 1 4,073 .08 (5 min.).... 326
letter.
Second postcard............... 3,063 1 3,063 .03 (2 min.).... 92
Survey........................ 1,765 1 1,765 .33 (20 min.)... 582
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1927
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs--Summary of FDA Survey Research Results'' (2004).
(https://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-to-Consumer Advertisements About
Prescription Medicines (2008). (https://phrma.org/sites/default/files/pdf/phrmaguidingprinciplesdec08final.pdf).
3. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone,
Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed.
Hoboken, NJ: John Wiley & Sons, Inc. (2014).
4. American Association for Public Opinion Research, ``Address-based
Sampling'' (2016). (https://www.aapor.org/AAPOR_Main/media/MainSiteFiles/AAPOR_Report_1_7_16_CLEAN-COPY-FINAL.pdf).
5. Millar, M.M. and D.A. Dillman, ``Improving Response to Web and
Mixed-Mode Surveys,'' Public Opinion Quarterly 1-21 (2011).
6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and S.A. Adlis, ``The Use of
Monetary Incentives in a Community Survey: Impact on Response Rates,
Data Quality, and Cost,'' Health Services Research 35:1339-1346
(2011).
7. Montaquila, J.M., J.M. Brick, D. Williams, K. Kim, et al., ``A
Study of Two-Phase Mail Survey Data Collection Methods, Journal of
Survey Statistics and Methodology 1(1), 66-87 (2013).
Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04220 Filed 2-26-16; 8:45 am]
BILLING CODE 4164-01-P
