Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to-Consumer Advertising Survey, 51450-51453 [2016-18425]
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Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
and Drug Administration, 5630 Fishers
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Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ Under section 501(a)(2)(A)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
351(a)(2)(A)), a drug is deemed to be
adulterated if it has been prepared,
packed, or held under insanitary
conditions whereby it may have been
contaminated with filth, or whereby it
may have been rendered injurious to
health. Drug products compounded
under insanitary conditions could
become contaminated and cause serious
adverse events in patients, including
death. Although sections 503A and
503B of the FD&C Act (21 U.S.C. 353a
and 353b) provide exemptions for
compounded drugs from specified
provisions of the FD&C Act if certain
conditions are met, neither section
provides an exemption from section
501(a)(2)(A) of the FD&C Act. Any drug
that is prepared, packed, or held under
insanitary conditions is deemed to be
adulterated under the FD&C Act,
including drugs produced by a
compounding facility.
Since the 2012 fungal meningitis
outbreak associated with injectable drug
products that a compounding facility
produced and shipped across the
country, FDA has identified insanitary
conditions at many of the compounding
facilities that it has inspected, and
numerous compounding facilities have
voluntarily recalled drug products
intended to be sterile and temporarily or
permanently ceased sterile operations as
a result of these findings. However, FDA
does not inspect the vast majority of
compounding facilities in the United
States because they generally do not
register with FDA unless they elect to
become outsourcing facilities.
Therefore, FDA is often not aware of
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these facilities and potential problems
with their drug products, or conditions
and practices, unless it receives a
complaint such as a report of a serious
adverse event or visible contamination.
It is critical that compounding facilities
avoid the presence of insanitary
conditions and identify and remediate
any insanitary conditions at their
facilities before the conditions result in
drug contamination and patient injury.
FDA is issuing this draft guidance to
assist compounding facilities in
identifying insanitary conditions so that
they can implement appropriate
corrective actions, and to assist State
regulatory agencies in understanding
some examples of what FDA considers
to be insanitary conditions.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on insanitary conditions at
compounding facilities. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18461 Filed 8–3–16; 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; Submission for Office of
Management and Budget Review;
Comment Request; National Direct-toConsumer Advertising Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
E:\FR\FM\04AUN1.SGM
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Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
Fax written comments on the
collection of information by September
6, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title National Direct-to-Consumer
Advertising Survey. Also include the
FDA 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, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. National Directto-Consumer Advertising Survey—OMB
Control Number 0910–NEW
DATES:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
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 asking 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 non-responders (Day 12), a
paper version of the survey mailed to
non-responders (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 respondents 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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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 weight
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.
In the Federal Register of February
29, 2016 (81 FR 10257), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Nine comments were
received. Five comments did not
address any of the information
collection topics solicited and therefore
we do not discuss them in this
document (four called for a ban on
direct-to-consumer prescription drug
advertising and one discussed FDA’s
response to public comments in
general). No comments addressed Topic
2—accuracy of our estimate.
Topic 1—practical utility. One
comment suggested that we increase the
practical utility of the survey by (1)
including teenagers 14–18 years of age,
and (2) skewing the survey to include a
disproportionate number of Americans
over 50 years of age. Another comment
suggested we use a quota to ensure that
limited literacy respondents are
included. One of our main goals is to
survey a nationally representative
sample of U.S. adults about their
experiences with and attitudes towards
DTC promotion of prescription drugs.
Note that we have designed other
studies that specifically examine
adolescent and older adults’ responses
to prescription drug advertising (FDA–
2013–N–1151–0004, ‘‘Experimental
Study of Direct-to-Consumer Promotion
Directed at Adolescents’’; FDA–2015–
N–2163–000, ‘‘Hearing, Aging, and
Direct-to-Consumer Television
Advertisements’’). We will measure
health literacy within the survey.
One comment suggested that
respondents should watch a
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Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
prescription drug television ad and then
answer questions about benefit and risk
recall. Although this design is beyond
what we can accomplish within a
nationally representative survey, we
have conducted studies that use this
design (for examples, see https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDER/ucm090276.htm).
Topic 3—ways to enhance quality,
clarity, utility. Four comments suggested
changes to the survey to enhance its
quality, clarity, and utility. Three
comments suggested changing our
terminology throughout the survey for
clarity. As suggested, we changed
‘‘television’’ to ‘‘TV,’’ ‘‘advertisement’’
to ‘‘ad,’’ used ‘‘health care provider’’
throughout the survey, and specified
that by Internet we mean Internet
accessed by computer, phone, or tablet.
We changed ‘‘small print’’ to
‘‘additional information.’’ We did not
change ‘‘prescription drug’’ to
‘‘medicine.’’ Respondents in cognitive
interviews understood the term
‘‘prescription drug,’’ and we are
concerned that ‘‘medicine’’ is too broad.
We also chose not to highlight or bold
‘‘prescription drug’’ as cognitive
interview respondents understood the
purpose of the survey and we do not
want to overuse highlighting.
Also, two comments suggested
deleting survey questions. Two
comments questioned the utility of a
series of questions about the safety and
efficacy of certain products. We agree
that these questions are not as central to
the survey topic and have deleted them.
They also recommended deleting a
series of questions about FDA approval
of DTC promotion. These questions will
highlight claims within the ad to
determine whether consumers believe
that advertising in general as well as
specific claims are approved by FDA.
Therefore, we have chosen to keep these
questions on the survey. One comment
recommended deleting a question
perceived to be too negative whereas
another comment recommended adding
positive answer choices to balance the
question; we chose the latter option.
In addition, four comments suggested
additional topics for survey questions.
In response we added questions about
whether prescription drug advertising
has caused respondents to talk with
their healthcare provider about
symptoms or side effects they’ve
experienced, or to look for information
about a prescription drug they thought
might be helpful for a friend of family
member. We also added a question
about the respondents’ primary
language. Finally, we now ask whether
respondents have seen prescription drug
promotion on streaming services and
whether they have looked for
information on medical association Web
sites.
One comment suggested adding
places where consumers could see or
hear advertisements (e.g., ‘‘on television
at the doctor’s office,’’ ‘‘in a pharmacy’’)
to a question that asks about the type of
medium where they saw or heard an ad
(e.g., ‘‘TV,’’ ‘‘print’’). We chose not to
take this suggestion because the
question concerns medium, not
location. We are also concerned about
measurement error. For instance, some
doctor’s offices have magazines with
DTC print ads, TVs playing broadcast
television, or TVs playing videos. This
also relies on having gone to a doctor or
pharmacist in the last 3 months.
One comment suggested adding
additional response options to a
question about where consumers might
attain more information about
prescription drugs. Because this
question is focused on adequate
provision in DTC television ads, we
chose not to add any additional
response options beyond those specific
to adequate provision (i.e., branded Web
site, manufacturer’s toll-free number,
print ad, and health care provider).
We note that the survey contains a
series of questions about various new
media, including social media, Web
sites, and online videos. It also asks
about respondents’ attitudes about how
benefits and risks are presented,
whether they have seen information
about the medical condition in TV ads,
and whether they’ve looked for
information on government Web sites.
We chose not to ask whether they’ve
looked for information on manufacturer
Web sites because we don’t want
respondents to confuse it with the
option, ‘‘a prescription drug Web site.’’
Finally, three comments had
suggestions for how we ask our
questions. One comment recommended
reducing or eliminating the number of
open-ended questions. The main survey
has only two questions with an openended option (allowing respondents to
specify another response). If pilot
testing reveals potential closed-ended
response options for these two questions
we will add them to the main survey.
One comment suggested changing our
scale for how we measure exposure to
prescription drug promotion. We
changed this scale from qualitative
frequency to a yes/no scale. Similarly,
one comment asked us to consider how
we measure how much of an ad
respondents saw or read because there
may be many variables that affect this.
We have chosen not to change this scale
but will consider this point when
interpreting the data. One comment
suggested that we randomize response
order for the paper-based surveys. We
plan to create multiple versions of the
paper-based scale to account for
household sampling and viewing of the
ad, so we are concerned that creating
different versions to account for
response option randomization will be
too complex for a survey of this scale.
However, we agree that response option
order is important to take into account
when interpreting results.
Topic 4—ways to minimize burden.
One comment suggested we conduct the
survey with an online consumer survey
panel to reduce time and costs and
increase response rates. Although we
agree that online survey panels can be
an efficient way to collect data, this
survey is designed to be nationally
representative. Following OMB’s advice,
therefore, we will use the Internet as
one mode of data collection but will not
rely on an online survey panel for
sampling (https://www.whitehouse.gov/
sites/default/files/omb/inforeg/pmc_
survey_guidance_2006.pdf).
FDA estimates the burden of this
collection of information as follows:
sradovich on DSK3GMQ082PROD with NOTICES
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 .......................................
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100
100
82
81
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1
1
1
1
E:\FR\FM\04AUN1.SGM
100
100
82
81
04AUN1
.08
.03
.08
.08
(5
(2
(5
(5
min.)
min.)
min.)
min.)
8
3
7
7
51453
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Second postcard ..................................................................
Survey ..................................................................................
60
35
Total annual
responses
1
1
60
35
Average
burden per
response
Total hours
.03 (2 min.)
.33 (20 min.)
2
12
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
min.)
min.)
min.)
min.)
min.)
min.)
403
151
334
326
92
582
........................
1927
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852 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.
sradovich on DSK3GMQ082PROD with NOTICES
.08 (5
.03 (2
.08 (5
.08 (5
.03 (2
.33 (20
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/Science
Research/ResearchAreas/DrugMarketing
AdvertisingandCommunicationsResearch/
ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-toConsumer 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 MixedMode 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 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 TwoPhase Mail Survey Data Collection Methods,’’
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Journal of Survey Statistics and Methodology
1(1), 66–87. 2013.
Dated: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18425 Filed 8–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–N–1210; FDA–
2004–N–0258]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food Labeling: Nutrition Facts and
Supplement Facts Label and Reference
Amounts Customarily Consumed per
Eating Occasion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Food Labeling: Nutrition Facts and
Supplement Facts Label and Reference
Amounts Customarily Consumed Per
Eating Occasion’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On May
27, 2016, the Agency submitted a
proposed collection of information
entitled ‘‘Food Labeling: Nutrition Facts
SUMMARY:
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and Supplement Facts Label and
Reference Amounts Customarily
Consumed Per Eating Occasion’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0813. The
approval expires on July 31, 2019. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18509 Filed 8–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–M–1122, FDA–
2016–M–1123, FDA–2016–M–1124, FDA–
2016–M–1125, FDA–2016–M–1165, FDA–
2016–M–1166, FDA–2016–M–1167, FDA–
2016–M–1168, FDA–2016–M–1222, FDA–
2016–M–1223, FDA–2016–M–1400, FDA–
2016–M–1401, FDA–2016–M–1455, FDA–
2016–M–1459, FDA–2016–M–1754, and
FDA–2016–M–1755]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51450-51453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18425]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0544]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; National Direct-to-
Consumer Advertising Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
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DATES: Fax written comments on the collection of information by
September 6, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title National Direct-to-Consumer Advertising Survey. Also include the
FDA 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, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. National Direct-to-Consumer Advertising Survey--
OMB Control Number 0910-NEW
I. Background
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 asking 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 non-
responders (Day 12), a paper version of the survey mailed to non-
responders (Day 19), and a reminder postcard sent to non-responders
(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
respondents 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 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
weight 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.
In the Federal Register of February 29, 2016 (81 FR 10257), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Nine comments were received. Five comments
did not address any of the information collection topics solicited and
therefore we do not discuss them in this document (four called for a
ban on direct-to-consumer prescription drug advertising and one
discussed FDA's response to public comments in general). No comments
addressed Topic 2--accuracy of our estimate.
Topic 1--practical utility. One comment suggested that we increase
the practical utility of the survey by (1) including teenagers 14-18
years of age, and (2) skewing the survey to include a disproportionate
number of Americans over 50 years of age. Another comment suggested we
use a quota to ensure that limited literacy respondents are included.
One of our main goals is to survey a nationally representative sample
of U.S. adults about their experiences with and attitudes towards DTC
promotion of prescription drugs. Note that we have designed other
studies that specifically examine adolescent and older adults'
responses to prescription drug advertising (FDA-2013-N-1151-0004,
``Experimental Study of Direct-to-Consumer Promotion Directed at
Adolescents''; FDA-2015-N-2163-000, ``Hearing, Aging, and Direct-to-
Consumer Television Advertisements''). We will measure health literacy
within the survey.
One comment suggested that respondents should watch a
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prescription drug television ad and then answer questions about benefit
and risk recall. Although this design is beyond what we can accomplish
within a nationally representative survey, we have conducted studies
that use this design (for examples, see https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm).
Topic 3--ways to enhance quality, clarity, utility. Four comments
suggested changes to the survey to enhance its quality, clarity, and
utility. Three comments suggested changing our terminology throughout
the survey for clarity. As suggested, we changed ``television'' to
``TV,'' ``advertisement'' to ``ad,'' used ``health care provider''
throughout the survey, and specified that by Internet we mean Internet
accessed by computer, phone, or tablet. We changed ``small print'' to
``additional information.'' We did not change ``prescription drug'' to
``medicine.'' Respondents in cognitive interviews understood the term
``prescription drug,'' and we are concerned that ``medicine'' is too
broad. We also chose not to highlight or bold ``prescription drug'' as
cognitive interview respondents understood the purpose of the survey
and we do not want to overuse highlighting.
Also, two comments suggested deleting survey questions. Two
comments questioned the utility of a series of questions about the
safety and efficacy of certain products. We agree that these questions
are not as central to the survey topic and have deleted them. They also
recommended deleting a series of questions about FDA approval of DTC
promotion. These questions will highlight claims within the ad to
determine whether consumers believe that advertising in general as well
as specific claims are approved by FDA. Therefore, we have chosen to
keep these questions on the survey. One comment recommended deleting a
question perceived to be too negative whereas another comment
recommended adding positive answer choices to balance the question; we
chose the latter option.
In addition, four comments suggested additional topics for survey
questions. In response we added questions about whether prescription
drug advertising has caused respondents to talk with their healthcare
provider about symptoms or side effects they've experienced, or to look
for information about a prescription drug they thought might be helpful
for a friend of family member. We also added a question about the
respondents' primary language. Finally, we now ask whether respondents
have seen prescription drug promotion on streaming services and whether
they have looked for information on medical association Web sites.
One comment suggested adding places where consumers could see or
hear advertisements (e.g., ``on television at the doctor's office,''
``in a pharmacy'') to a question that asks about the type of medium
where they saw or heard an ad (e.g., ``TV,'' ``print''). We chose not
to take this suggestion because the question concerns medium, not
location. We are also concerned about measurement error. For instance,
some doctor's offices have magazines with DTC print ads, TVs playing
broadcast television, or TVs playing videos. This also relies on having
gone to a doctor or pharmacist in the last 3 months.
One comment suggested adding additional response options to a
question about where consumers might attain more information about
prescription drugs. Because this question is focused on adequate
provision in DTC television ads, we chose not to add any additional
response options beyond those specific to adequate provision (i.e.,
branded Web site, manufacturer's toll-free number, print ad, and health
care provider).
We note that the survey contains a series of questions about
various new media, including social media, Web sites, and online
videos. It also asks about respondents' attitudes about how benefits
and risks are presented, whether they have seen information about the
medical condition in TV ads, and whether they've looked for information
on government Web sites. We chose not to ask whether they've looked for
information on manufacturer Web sites because we don't want respondents
to confuse it with the option, ``a prescription drug Web site.''
Finally, three comments had suggestions for how we ask our
questions. One comment recommended reducing or eliminating the number
of open-ended questions. The main survey has only two questions with an
open-ended option (allowing respondents to specify another response).
If pilot testing reveals potential closed-ended response options for
these two questions we will add them to the main survey. One comment
suggested changing our scale for how we measure exposure to
prescription drug promotion. We changed this scale from qualitative
frequency to a yes/no scale. Similarly, one comment asked us to
consider how we measure how much of an ad respondents saw or read
because there may be many variables that affect this. We have chosen
not to change this scale but will consider this point when interpreting
the data. One comment suggested that we randomize response order for
the paper-based surveys. We plan to create multiple versions of the
paper-based scale to account for household sampling and viewing of the
ad, so we are concerned that creating different versions to account for
response option randomization will be too complex for a survey of this
scale. However, we agree that response option order is important to
take into account when interpreting results.
Topic 4--ways to minimize burden. One comment suggested we conduct
the survey with an online consumer survey panel to reduce time and
costs and increase response rates. Although we agree that online survey
panels can be an efficient way to collect data, this survey is designed
to be nationally representative. Following OMB's advice, therefore, we
will use the Internet as one mode of data collection but will not rely
on an online survey panel for sampling (https://www.whitehouse.gov/sites/default/files/omb/inforeg/pmc_survey_guidance_2006.pdf).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Pilot Study
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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.........................
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Second postcard................. 60 1 60 .03 (2 min.) 2
Survey.......................... 35 1 35 .33 (20 min.) 12
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Main Study
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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
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Total....................... .............. .............. .............. .............. 1927
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852 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: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18425 Filed 8-3-16; 8:45 am]
BILLING CODE 4164-01-P
