[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]
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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.
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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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected].
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\
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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.
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.
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 http://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).
(http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-to-Consumer Advertisements About
Prescription Medicines (2008). (http://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). (http://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]
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