[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.

[[Page 51451]]


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 [email protected]. 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, [email protected].

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 http://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
                                                                                                 ---------------
    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 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: 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