81_FR_51600 81 FR 51450 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to-Consumer Advertising Survey

81 FR 51450 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to-Consumer Advertising Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 150 (August 4, 2016)

Page Range51450-51453
FR Document2016-18425

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.

Federal Register, Volume 81 Issue 150 (Thursday, August 4, 2016)
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51450-51453]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18425]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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

[[Page 51452]]

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                                   Pilot Study
----------------------------------------------------------------------------------------------------------------
Survey invitation letter........             100               1             100    .08 (5 min.)               8
Reminder postcard...............             100               1             100    .03 (2 min.)               3
Non-response letter.............              82               1              82    .08 (5 min.)               7
Non-response questionnaire                    81               1              81    .08 (5 min.)               7
 letter.........................

[[Page 51453]]

 
Second postcard.................              60               1              60    .03 (2 min.)               2
Survey..........................              35               1              35   .33 (20 min.)              12
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
Survey invitation letter........           5,042               1           5,042    .08 (5 min.)             403
Reminder postcard...............           5,042               1           5,042    .03 (2 min.)             151
Non-response letter.............           4,173               1           4,173    .08 (5 min.)             334
Non-response questionnaire                 4,073               1           4,073    .08 (5 min.)             326
 letter.........................
Second postcard.................           3,063               1           3,063    .03 (2 min.)              92
Survey..........................           1,765               1           1,765   .33 (20 min.)             582
                                                                                                 ---------------
    Total.......................  ..............  ..............  ..............  ..............            1927
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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



                                                51450                        Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices

                                                and Drug Administration, 5630 Fishers                     Submit written requests for single                  these facilities and potential problems
                                                Lane, Rm. 1061, Rockville, MD 20852.                    copies of the draft guidance to the                   with their drug products, or conditions
                                                   • For written/paper comments                         Division of Drug Information, Center for              and practices, unless it receives a
                                                submitted to the Division of Dockets                    Drug Evaluation and Research, Food                    complaint such as a report of a serious
                                                Management, FDA will post your                          and Drug Administration, 10001 New                    adverse event or visible contamination.
                                                comment, as well as any attachments,                    Hampshire Ave., Hillandale Building,                  It is critical that compounding facilities
                                                except for information submitted,                       4th Floor, Silver Spring, MD 20993–                   avoid the presence of insanitary
                                                marked and identified, as confidential,                 0002. Send one self-addressed adhesive                conditions and identify and remediate
                                                if submitted as detailed in                             label to assist that office in processing             any insanitary conditions at their
                                                ‘‘Instructions.’’                                       your requests. See the SUPPLEMENTARY                  facilities before the conditions result in
                                                   Instructions: All submissions received               INFORMATION section for electronic                    drug contamination and patient injury.
                                                must include the Docket No. FDA–                        access to the draft guidance document.                   FDA is issuing this draft guidance to
                                                2016–D–2268 for ‘‘Insanitary Conditions                 FOR FURTHER INFORMATION CONTACT: Sara                 assist compounding facilities in
                                                at Compounding Facilities.’’ Received                   Rothman, Center for Drug Evaluation                   identifying insanitary conditions so that
                                                comments will be placed in the docket                                                                         they can implement appropriate
                                                                                                        and Research, Food and Drug
                                                and, except for those submitted as                                                                            corrective actions, and to assist State
                                                                                                        Administration, 10903 New Hampshire
                                                ‘‘Confidential Submissions,’’ publicly                                                                        regulatory agencies in understanding
                                                                                                        Ave., Bldg. 51, Rm. 5197, Silver Spring,
                                                viewable at http://www.regulations.gov                                                                        some examples of what FDA considers
                                                                                                        MD 20993, 301–796–3110.
                                                or at the Division of Dockets                                                                                 to be insanitary conditions.
                                                Management between 9 a.m. and 4 p.m.,                   SUPPLEMENTARY INFORMATION:                               This draft guidance is being issued
                                                Monday through Friday.                                  I. Background                                         consistent with FDA’s good guidance
                                                   • Confidential Submissions—To                                                                              practices regulation (21 CFR 10.115).
                                                submit a comment with confidential                         FDA is announcing the availability of
                                                                                                                                                              The draft guidance, when finalized, will
                                                information that you do not wish to be                  a draft guidance for industry entitled
                                                                                                                                                              represent the current thinking of FDA
                                                made publicly available, submit your                    ‘‘Insanitary Conditions at Compounding
                                                                                                                                                              on insanitary conditions at
                                                comments only as a written/paper                        Facilities.’’ Under section 501(a)(2)(A)
                                                                                                                                                              compounding facilities. It does not
                                                submission. You should submit two                       of the Federal Food, Drug, and Cosmetic
                                                                                                                                                              establish any rights for any person and
                                                copies total. One copy will include the                 Act (the FD&C Act) (21 U.S.C.
                                                                                                                                                              is not binding on FDA or the public.
                                                information you claim to be confidential                351(a)(2)(A)), a drug is deemed to be
                                                                                                                                                              You can use an alternative approach if
                                                with a heading or cover note that states                adulterated if it has been prepared,
                                                                                                                                                              it satisfies the requirements of the
                                                ‘‘THIS DOCUMENT CONTAINS                                packed, or held under insanitary
                                                                                                                                                              applicable statutes and regulations.
                                                CONFIDENTIAL INFORMATION.’’ The                         conditions whereby it may have been
                                                Agency will review this copy, including                 contaminated with filth, or whereby it                II. Electronic Access
                                                the claimed confidential information, in                may have been rendered injurious to                      Persons with access to the Internet
                                                its consideration of comments. The                      health. Drug products compounded                      may obtain the draft guidance at either
                                                second copy, which will have the                        under insanitary conditions could                     http://www.fda.gov/Drugs/Guidance
                                                claimed confidential information                        become contaminated and cause serious                 ComplianceRegulatoryInformation/
                                                redacted/blacked out, will be available                 adverse events in patients, including                 Guidances/default.htm or http://
                                                for public viewing and posted on http://                death. Although sections 503A and                     www.regulations.gov.
                                                www.regulations.gov. Submit both                        503B of the FD&C Act (21 U.S.C. 353a
                                                                                                                                                                Dated: July 29, 2016.
                                                copies to the Division of Dockets                       and 353b) provide exemptions for
                                                                                                        compounded drugs from specified                       Leslie Kux,
                                                Management. If you do not wish your
                                                                                                        provisions of the FD&C Act if certain                 Associate Commissioner for Policy.
                                                name and contact information to be
                                                made publicly available, you can                        conditions are met, neither section                   [FR Doc. 2016–18461 Filed 8–3–16; 8:45 am]
                                                provide this information on the cover                   provides an exemption from section                    BILLING CODE 4164–01–P

                                                sheet and not in the body of your                       501(a)(2)(A) of the FD&C Act. Any drug
                                                comments and you must identify this                     that is prepared, packed, or held under
                                                information as ‘‘confidential.’’ Any                    insanitary conditions is deemed to be                 DEPARTMENT OF HEALTH AND
                                                information marked as ‘‘confidential’’                  adulterated under the FD&C Act,                       HUMAN SERVICES
                                                will not be disclosed except in                         including drugs produced by a
                                                                                                                                                              Food and Drug Administration
                                                accordance with 21 CFR 10.20 and other                  compounding facility.
                                                applicable disclosure law. For more                        Since the 2012 fungal meningitis                   [Docket No. FDA–2016–N–0544]
                                                information about FDA’s posting of                      outbreak associated with injectable drug
                                                comments to public dockets, see 80 FR                   products that a compounding facility                  Agency Information Collection
                                                56469, September 18, 2015, or access                    produced and shipped across the                       Activities; Submission for Office of
                                                the information at: http://www.fda.gov/                 country, FDA has identified insanitary                Management and Budget Review;
                                                regulatoryinformation/dockets/                          conditions at many of the compounding                 Comment Request; National Direct-to-
                                                default.htm.                                            facilities that it has inspected, and                 Consumer Advertising Survey
                                                   Docket: For access to the docket to                  numerous compounding facilities have                  AGENCY:    Food and Drug Administration,
                                                read background documents or the                        voluntarily recalled drug products                    HHS.
                                                electronic and written/paper comments                   intended to be sterile and temporarily or             ACTION:   Notice.
                                                received, go to http://                                 permanently ceased sterile operations as
sradovich on DSK3GMQ082PROD with NOTICES




                                                www.regulations.gov and insert the                      a result of these findings. However, FDA              SUMMARY:   The Food and Drug
                                                docket number, found in brackets in the                 does not inspect the vast majority of                 Administration (FDA) is announcing
                                                heading of this document, into the                      compounding facilities in the United                  that a proposed collection of
                                                ‘‘Search’’ box and follow the prompts                   States because they generally do not                  information has been submitted to the
                                                and/or go to the Division of Dockets                    register with FDA unless they elect to                Office of Management and Budget
                                                Management, 5630 Fishers Lane, Rm.                      become outsourcing facilities.                        (OMB) for review and clearance under
                                                1061, Rockville, MD 20852.                              Therefore, FDA is often not aware of                  the Paperwork Reduction Act of 1995.


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                                                                             Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices                                          51451

                                                DATES:  Fax written comments on the                        We plan to use an address-based                    survey, respondents will be randomly
                                                collection of information by September                  mixed-mode methodology that will                      assigned to view one of two ads for
                                                6, 2016.                                                direct one randomly-chosen member of                  fictional prescription drugs intended to
                                                ADDRESSES: To ensure that comments on
                                                                                                        sampled households to complete a 20-                  treat high cholesterol. They will be
                                                the information collection are received,                minute online survey, with non-                       asked questions about FDA’s authority
                                                OMB recommends that written                             respondents receiving a paper                         regarding specific claims within the ad.
                                                comments be faxed to the Office of                      questionnaire. The sample will be                     The survey will include a debriefing to
                                                Information and Regulatory Affairs,                     representative of the U.S. population. A              inform respondents that the advertised
                                                OMB, Attn: FDA Desk Officer, FAX:                       sample of U.S. households will be                     drug was fictitious. We will also
                                                202–395–7285, or emailed to oira_                       drawn from the U.S. Postal Service                    measure other potentially important
                                                submission@omb.eop.gov. All                             Computerized Delivery Sequence File.                  characteristics such as demographics,
                                                                                                        Adults aged 18 or over will be eligible               insurance coverage, and prescription
                                                comments should be identified with the
                                                                                                        for participation. Up to five contacts                drug use. The survey is available upon
                                                OMB control number 0910–NEW and
                                                                                                        will be sent to respondents by U.S. mail.             request.
                                                title National Direct-to-Consumer                                                                                We will test for any differences
                                                                                                        The contacts will include the URL for
                                                Advertising Survey. Also include the                                                                          between modes (online versus mail
                                                                                                        the online survey and a unique personal
                                                FDA docket number found in brackets                                                                           survey) and will account for any mode
                                                                                                        identification number (PIN). This
                                                in the heading of this document.                                                                              effects in our analyses. We will weight
                                                                                                        unique PIN will be used to track
                                                FOR FURTHER INFORMATION CONTACT: FDA                    completed surveys without the use of                  the data to account for different
                                                PRA Staff, Office of Operations, Food                   personally identifying information. The               probability of selection and
                                                and Drug Administration, Three White                    contact method, based on recent                       nonresponse. We will examine the
                                                Flint North 10A63, 11601 Landsdown                      recommendations (Ref. 3), includes a                  frequencies for survey items and the
                                                St., North Bethesda, MD 20852,                          notification letter (Day 1), a reminder/              relation between survey items and
                                                PRAStaff@fda.hhs.gov.                                   thank-you postcard (Day 5), a second                  demographic and health characteristics.
                                                SUPPLEMENTARY INFORMATION: In                           letter sent to non-responders (Day 12), a             We also plan to compare responses
                                                compliance with 44 U.S.C. 3507, FDA                     paper version of the survey mailed to                 between this survey and FDA’s 2002
                                                has submitted the following proposed                    non-responders (Day 19), and a                        survey for repeated items.
                                                collection of information to OMB for                    reminder postcard sent to non-                           In the Federal Register of February
                                                review and clearance. National Direct-                  responders (Day 24).                                  29, 2016 (81 FR 10257), FDA published
                                                                                                           Based on previous research (Refs. 4, 5,            a 60-day notice requesting public
                                                to-Consumer Advertising Survey—OMB
                                                                                                        and 6), we plan to recruit using two $1               comment on the proposed collection of
                                                Control Number 0910–NEW
                                                                                                        bills ($2 total per sampled respondent)               information. Nine comments were
                                                I. Background                                           mailed in advance with the initial                    received. Five comments did not
                                                                                                        invitation letter as a gesture to                     address any of the information
                                                   Section 1701(a)(4) of the Public
                                                                                                        encourage response and maintain data                  collection topics solicited and therefore
                                                Health Service Act (42 U.S.C.                                                                                 we do not discuss them in this
                                                                                                        quality. Offering a small token of value
                                                300u(a)(4)) authorizes FDA to conduct                                                                         document (four called for a ban on
                                                                                                        to respondents establishes a latent social
                                                research relating to health information.                                                                      direct-to-consumer prescription drug
                                                                                                        contract and subsequent reciprocity
                                                Section 1003(d)(2)(C) of the Federal                                                                          advertising and one discussed FDA’s
                                                                                                        (Ref. 3). In the second contact attempt,
                                                Food, Drug, and Cosmetic Act (the                                                                             response to public comments in
                                                                                                        we will conduct an experiment to test
                                                FD&C Act) (21 U.S.C. 393(d)(2)(c))                                                                            general). No comments addressed Topic
                                                                                                        whether a short statement mentioning
                                                authorizes FDA to conduct research                                                                            2—accuracy of our estimate.
                                                                                                        the previously paid incentive increases
                                                relating to drugs and other FDA                         survey response, thereby testing                         Topic 1—practical utility. One
                                                regulated products in carrying out the                  whether social exchange can be                        comment suggested that we increase the
                                                provisions of the FD&C Act.                             extended past the initial contact                     practical utility of the survey by (1)
                                                   FDA last surveyed patients about their               attempt. Half the sample will be                      including teenagers 14–18 years of age,
                                                experiences with and attitudes toward                   provided language that reminds them                   and (2) skewing the survey to include a
                                                DTC advertising in 2002 (Ref. 1).                       they received a cash incentive in the                 disproportionate number of Americans
                                                Numerous changes have affected the                      previous letter; the remaining half will              over 50 years of age. Another comment
                                                DTC landscape since 2002, including                     be reminded they received a letter but                suggested we use a quota to ensure that
                                                declines in print readership, the rise in               will not be specifically reminded about               limited literacy respondents are
                                                online prescription drug promotion, and                 the incentive.                                        included. One of our main goals is to
                                                self-imposed industry guidelines for                       We estimate a 35 percent response                  survey a nationally representative
                                                DTC advertising (Ref. 2). These changes                 rate, based on recent work on similar                 sample of U.S. adults about their
                                                may have affected consumers’ exposure                   studies (Ref. 7). Prior to the main study,            experiences with and attitudes towards
                                                to different kinds of DTC advertising                   a pilot study will be conducted to test               DTC promotion of prescription drugs.
                                                and its influence on their attitudes and                the data collection process. We estimate              Note that we have designed other
                                                behaviors. The purpose of the National                  35 respondents will complete the pilot                studies that specifically examine
                                                Direct-to-Consumer Advertising Survey                   study and 1,765 will complete the main                adolescent and older adults’ responses
                                                is to collect updated insights on                       study (see table 1).                                  to prescription drug advertising (FDA–
                                                consumer experiences with and                              The survey contains questions about                2013–N–1151–0004, ‘‘Experimental
                                                attitudes towards DTC promotion of                      respondents’ knowledge of FDA’s
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                                                                                                                                                              Study of Direct-to-Consumer Promotion
                                                prescription drugs. This study will                     authority with respect to prescription                Directed at Adolescents’’; FDA–2015–
                                                build on previous research by recruiting                drug advertising, their exposure to DTC               N–2163–000, ‘‘Hearing, Aging, and
                                                a wider range of respondents, weighting                 advertising, their beliefs and attitudes              Direct-to-Consumer Television
                                                the data to make it nationally                          about DTC advertising, and the                        Advertisements’’). We will measure
                                                representative, and asking a wider range                influence of DTC advertising on further               health literacy within the survey.
                                                of questions about DTC promotion,                       information search and patient-                          One comment suggested that
                                                including in online formats.                            physician interactions. At the end of the             respondents should watch a


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                                                51452                               Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices

                                                prescription drug television ad and then                            In response we added questions about                    respondents to confuse it with the
                                                answer questions about benefit and risk                             whether prescription drug advertising                   option, ‘‘a prescription drug Web site.’’
                                                recall. Although this design is beyond                              has caused respondents to talk with                        Finally, three comments had
                                                what we can accomplish within a                                     their healthcare provider about                         suggestions for how we ask our
                                                nationally representative survey, we                                symptoms or side effects they’ve                        questions. One comment recommended
                                                have conducted studies that use this                                experienced, or to look for information
                                                                                                                                                                            reducing or eliminating the number of
                                                design (for examples, see http://                                   about a prescription drug they thought
                                                                                                                                                                            open-ended questions. The main survey
                                                www.fda.gov/AboutFDA/CentersOffices/                                might be helpful for a friend of family
                                                OfficeofMedicalProductsandTobacco/                                  member. We also added a question                        has only two questions with an open-
                                                CDER/ucm090276.htm).                                                about the respondents’ primary                          ended option (allowing respondents to
                                                   Topic 3—ways to enhance quality,                                 language. Finally, we now ask whether                   specify another response). If pilot
                                                clarity, utility. Four comments suggested                           respondents have seen prescription drug                 testing reveals potential closed-ended
                                                changes to the survey to enhance its                                promotion on streaming services and                     response options for these two questions
                                                quality, clarity, and utility. Three                                whether they have looked for                            we will add them to the main survey.
                                                comments suggested changing our                                     information on medical association Web                  One comment suggested changing our
                                                terminology throughout the survey for                               sites.                                                  scale for how we measure exposure to
                                                clarity. As suggested, we changed                                      One comment suggested adding                         prescription drug promotion. We
                                                ‘‘television’’ to ‘‘TV,’’ ‘‘advertisement’’                         places where consumers could see or                     changed this scale from qualitative
                                                to ‘‘ad,’’ used ‘‘health care provider’’                            hear advertisements (e.g., ‘‘on television              frequency to a yes/no scale. Similarly,
                                                throughout the survey, and specified                                at the doctor’s office,’’ ‘‘in a pharmacy’’)            one comment asked us to consider how
                                                that by Internet we mean Internet                                   to a question that asks about the type of               we measure how much of an ad
                                                accessed by computer, phone, or tablet.                             medium where they saw or heard an ad                    respondents saw or read because there
                                                We changed ‘‘small print’’ to                                       (e.g., ‘‘TV,’’ ‘‘print’’). We chose not to              may be many variables that affect this.
                                                ‘‘additional information.’’ We did not                              take this suggestion because the                        We have chosen not to change this scale
                                                change ‘‘prescription drug’’ to                                     question concerns medium, not                           but will consider this point when
                                                ‘‘medicine.’’ Respondents in cognitive                              location. We are also concerned about                   interpreting the data. One comment
                                                interviews understood the term                                      measurement error. For instance, some                   suggested that we randomize response
                                                ‘‘prescription drug,’’ and we are                                   doctor’s offices have magazines with                    order for the paper-based surveys. We
                                                concerned that ‘‘medicine’’ is too broad.                           DTC print ads, TVs playing broadcast                    plan to create multiple versions of the
                                                We also chose not to highlight or bold                              television, or TVs playing videos. This
                                                                                                                                                                            paper-based scale to account for
                                                ‘‘prescription drug’’ as cognitive                                  also relies on having gone to a doctor or
                                                                                                                                                                            household sampling and viewing of the
                                                interview respondents understood the                                pharmacist in the last 3 months.
                                                purpose of the survey and we do not                                    One comment suggested adding                         ad, so we are concerned that creating
                                                want to overuse highlighting.                                       additional response options to a                        different versions to account for
                                                   Also, two comments suggested                                     question about where consumers might                    response option randomization will be
                                                deleting survey questions. Two                                      attain more information about                           too complex for a survey of this scale.
                                                comments questioned the utility of a                                prescription drugs. Because this                        However, we agree that response option
                                                series of questions about the safety and                            question is focused on adequate                         order is important to take into account
                                                efficacy of certain products. We agree                              provision in DTC television ads, we                     when interpreting results.
                                                that these questions are not as central to                          chose not to add any additional                            Topic 4—ways to minimize burden.
                                                the survey topic and have deleted them.                             response options beyond those specific                  One comment suggested we conduct the
                                                They also recommended deleting a                                    to adequate provision (i.e., branded Web                survey with an online consumer survey
                                                series of questions about FDA approval                              site, manufacturer’s toll-free number,                  panel to reduce time and costs and
                                                of DTC promotion. These questions will                              print ad, and health care provider).                    increase response rates. Although we
                                                highlight claims within the ad to                                      We note that the survey contains a                   agree that online survey panels can be
                                                determine whether consumers believe                                 series of questions about various new                   an efficient way to collect data, this
                                                that advertising in general as well as                              media, including social media, Web
                                                                                                                                                                            survey is designed to be nationally
                                                specific claims are approved by FDA.                                sites, and online videos. It also asks
                                                                                                                                                                            representative. Following OMB’s advice,
                                                Therefore, we have chosen to keep these                             about respondents’ attitudes about how
                                                                                                                                                                            therefore, we will use the Internet as
                                                questions on the survey. One comment                                benefits and risks are presented,
                                                                                                                    whether they have seen information                      one mode of data collection but will not
                                                recommended deleting a question
                                                                                                                    about the medical condition in TV ads,                  rely on an online survey panel for
                                                perceived to be too negative whereas
                                                                                                                    and whether they’ve looked for                          sampling (https://www.whitehouse.gov/
                                                another comment recommended adding
                                                                                                                    information on government Web sites.                    sites/default/files/omb/inforeg/pmc_
                                                positive answer choices to balance the
                                                question; we chose the latter option.                               We chose not to ask whether they’ve                     survey_guidance_2006.pdf).
                                                   In addition, four comments suggested                             looked for information on manufacturer                     FDA estimates the burden of this
                                                additional topics for survey questions.                             Web sites because we don’t want                         collection of information as follows:

                                                                                                         TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                          Number of                             Average
                                                                                                                                      Number of                            Total annual
                                                                                    Activity                                                            responses per                         burden per          Total hours
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                                                                                                                                     respondents                            responses
                                                                                                                                                          respondent                           response

                                                                                                                                         Pilot Study

                                                Survey invitation letter .........................................................                100                 1              100       .08   (5   min.)                 8
                                                Reminder postcard ...............................................................                 100                 1              100       .03   (2   min.)                 3
                                                Non-response letter .............................................................                  82                 1               82       .08   (5   min.)                 7
                                                Non-response questionnaire letter .......................................                          81                 1               81       .08   (5   min.)                 7



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                                                                                       Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices                                                                                               51453

                                                                                                  TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
                                                                                                                                                                           Number of                                                Average
                                                                                                                                                Number of                                            Total annual
                                                                                       Activity                                                                          responses per                                            burden per              Total hours
                                                                                                                                               respondents                                            responses
                                                                                                                                                                           respondent                                              response

                                                Second postcard ..................................................................                                60                          1                         60          .03 (2 min.)                     2
                                                Survey ..................................................................................                         35                          1                         35        .33 (20 min.)                     12

                                                                                                                                                      Main Study

                                                Survey invitation letter .........................................................                           5,042                            1                    5,042            .08 (5     min.)               403
                                                Reminder postcard ...............................................................                            5,042                            1                    5,042            .03 (2     min.)               151
                                                Non-response letter .............................................................                            4,173                            1                    4,173            .08 (5     min.)               334
                                                Non-response questionnaire letter .......................................                                    4,073                            1                    4,073            .08 (5     min.)               326
                                                Second postcard ..................................................................                           3,063                            1                    3,063            .03 (2     min.)                92
                                                Survey ..................................................................................                    1,765                            1                    1,765          .33 (20      min.)               582

                                                      Total ..............................................................................    ........................   ........................   ........................   ........................          1927
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.


                                                II. References                                                             Journal of Survey Statistics and Methodology                                 and Supplement Facts Label and
                                                                                                                           1(1), 66–87. 2013.                                                           Reference Amounts Customarily
                                                   The following references are on
                                                display in the Division of Dockets                                           Dated: July 29, 2016.                                                      Consumed Per Eating Occasion’’ to
                                                Management (HFA–305), Food and Drug                                        Leslie Kux,                                                                  OMB for review and clearance under 44
                                                Administration, 5630 Fishers Lane, Rm.                                     Associate Commissioner for Policy.                                           U.S.C. 3507. An Agency may not
                                                1061, Rockville, MD 20852 and are                                          [FR Doc. 2016–18425 Filed 8–3–16; 8:45 am]
                                                                                                                                                                                                        conduct or sponsor, and a person is not
                                                available for viewing by interested                                                                                                                     required to respond to, a collection of
                                                                                                                           BILLING CODE 4164–01–P
                                                persons between 9 a.m. and 4 p.m.,                                                                                                                      information unless it displays a
                                                Monday through Friday; they are also                                                                                                                    currently valid OMB control number.
                                                available electronically at http://                                        DEPARTMENT OF HEALTH AND                                                     OMB has now approved the information
                                                www.regulations.gov. FDA has verified                                      HUMAN SERVICES                                                               collection and has assigned OMB
                                                the Web site addresses, as of the date                                                                                                                  control number 0910–0813. The
                                                this document publishes in the Federal                                     Food and Drug Administration                                                 approval expires on July 31, 2019. A
                                                Register, but Web sites are subject to                                                                                                                  copy of the supporting statement for this
                                                                                                                           [Docket Nos. FDA–2012–N–1210; FDA–
                                                change over time.                                                                                                                                       information collection is available on
                                                                                                                           2004–N–0258]
                                                                                                                                                                                                        the Internet at http://www.reginfo.gov/
                                                   1. Aikin, K.J., J.L. Swasy, and A.C. Braman,                                                                                                         public/do/PRAMain.
                                                ‘‘Patient and Physician Attitudes and                                      Agency Information Collection
                                                Behaviors Associated With DTC Promotion of                                 Activities; Announcement of Office of                                          Dated: August 1, 2016.
                                                Prescription Drugs—Summary of FDA                                          Management and Budget Approval;                                              Leslie Kux,
                                                Survey Research Results,’’ 2004. (http://                                  Food Labeling: Nutrition Facts and                                           Associate Commissioner for Policy.
                                                www.fda.gov/downloads/Drugs/Science                                        Supplement Facts Label and Reference                                         [FR Doc. 2016–18509 Filed 8–3–16; 8:45 am]
                                                Research/ResearchAreas/DrugMarketing                                       Amounts Customarily Consumed per
                                                AdvertisingandCommunicationsResearch/                                                                                                                   BILLING CODE 4164–01–P
                                                                                                                           Eating Occasion
                                                ucm152860.pdf).
                                                   2. PhRMA Guiding Principles: Direct-to-                                 AGENCY:           Food and Drug Administration,
                                                Consumer Advertisements About                                              HHS.                                                                         DEPARTMENT OF HEALTH AND
                                                Prescription Medicines 2008. (http://                                                                                                                   HUMAN SERVICES
                                                phrma.org/sites/default/files/pdf/                                         ACTION:       Notice.
                                                phrmaguidingprinciplesdec08final.pdf).                                                                                                                  Food and Drug Administration
                                                   3. Dillman, D.A., J.D. Smyth, and L.M.
                                                                                                                           SUMMARY:    The Food and Drug
                                                Christian, Internet, Phone, Mail, and Mixed-                               Administration (FDA) is announcing                                           [Docket Nos. FDA–2016–M–1122, FDA–
                                                Mode Surveys: The Tailored Design Method,                                  that a collection of information entitled                                    2016–M–1123, FDA–2016–M–1124, FDA–
                                                4th ed. Hoboken, NJ: John Wiley & Sons, Inc.,                              ‘‘Food Labeling: Nutrition Facts and                                         2016–M–1125, FDA–2016–M–1165, FDA–
                                                2014.                                                                      Supplement Facts Label and Reference                                         2016–M–1166, FDA–2016–M–1167, FDA–
                                                   4. American Association for Public                                      Amounts Customarily Consumed Per                                             2016–M–1168, FDA–2016–M–1222, FDA–
                                                Opinion Research, ‘‘Address-based                                                                                                                       2016–M–1223, FDA–2016–M–1400, FDA–
                                                                                                                           Eating Occasion’’ has been approved by                                       2016–M–1401, FDA–2016–M–1455, FDA–
                                                Sampling,’’ 2016. (http://www.aapor.org/                                   the Office of Management and Budget
                                                AAPOR_Main/media/MainSiteFiles/AAPOR_                                                                                                                   2016–M–1459, FDA–2016–M–1754, and
                                                                                                                           (OMB) under the Paperwork Reduction                                          FDA–2016–M–1755]
                                                Report_1_7_16_CLEAN-COPY-FINAL.pdf).
                                                   5. Millar, M.M. and D.A. Dillman,
                                                                                                                           Act of 1995.
                                                ‘‘Improving Response to Web and Mixed-                                     FOR FURTHER INFORMATION CONTACT: FDA                                         Medical Devices; Availability of Safety
                                                Mode Surveys,’’ Public Opinion Quarterly 1–                                PRA Staff, Office of Operations, Food                                        and Effectiveness Summaries for
                                                21. 2011.                                                                  and Drug Administration, Three White                                         Premarket Approval Applications
sradovich on DSK3GMQ082PROD with NOTICES




                                                   6. Shaw, M.J., T.J. Beebe, H.L. Jensen, and                             Flint North 10A–12M, 11601
                                                S.A. Adlis, ‘‘The Use of Monetary Incentives                                                                                                            AGENCY:         Food and Drug Administration,
                                                                                                                           Landsdown St., North Bethesda, MD                                            HHS.
                                                in a Community Survey: Impact on Response                                  20852, PRAStaff@fda.hhs.gov.
                                                Rates, Data Quality, and Cost,’’ Health                                                                                                                 ACTION:        Notice.
                                                Services Research 35:1339–1346. 2011.                                      SUPPLEMENTARY INFORMATION: On May
                                                   7. Montaquila, J.M., J.M. Brick, D.                                     27, 2016, the Agency submitted a                                             SUMMARY:   The Food and Drug
                                                Williams, K. Kim, et al., ‘‘A Study of Two-                                proposed collection of information                                           Administration (FDA) is publishing a
                                                Phase Mail Survey Data Collection Methods,’’                               entitled ‘‘Food Labeling: Nutrition Facts                                    list of premarket approval applications


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Document Created: 2016-08-04 02:53:15
Document Modified: 2016-08-04 02:53:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by September 6, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 51450 

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