[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
----------------------------------------------------------------------------------------------------------------
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
                               ---------------------------------------------------------------------------------
    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]
 BILLING CODE 4164-01-P