[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61433-61435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3543]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Quantitative Information in Direct-to-Consumer 
Television Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on research entitled ``Quantitative 
Information in Direct-to-Consumer Television Advertisements.'' The 
objective of this research is to test consumers' understanding of 
quantitative information about prescription drugs in DTC television 
advertisements (ads).

DATES: Submit either electronic or written comments on the collection 
of information by December 14, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-3543 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Quantitative Information in 
Direct-to-Consumer Television Advertisements.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including

[[Page 61434]]

the claimed confidential information, in its consideration of comments. 
The second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Quantitative Information in Direct-to-Consumer Television 
Advertisements OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the 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(b)(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.
    A previous FDA study found that simple quantitative information 
could be conveyed in direct-to-consumer (DTC) television ads in ways 
that increased consumer's knowledge about the drug (OMB control number 
0910-0663, ``Experimental Study: Presentation of Quantitative 
Effectiveness Information to Consumers in Direct-to-Consumer (DTC) 
Television and Print Advertisements for Prescription Drugs'').\1\ 
However, this research only tested simple information (e.g., one 
clinical trial, comparison to placebo). Drug information can be much 
more complicated (e.g., complicated endpoints, multiple study arms). 
The following studies are designed to address the question of whether 
consumers can use more complicated information when assessing 
prescription drug information in television DTC ads. These studies will 
build on previous research by: (1) Examining more complicated 
quantitative information, (2) examining quantitative information for 
both benefits and risks, and (3) examining how visuals designed to 
represent efficacy interact with quantitative information.
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    \1\ O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al. 
``Presenting efficacy information in direct-to-consumer prescription 
drug advertisements.'' Patient Education and Counseling, vol. 95(2), 
pp. 271-280, 2014.
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    The objective of this project is to test consumers' understanding 
of quantitative information about prescription drugs in DTC television 
ads. In study 1, we plan to examine experimentally the presence and 
complexity of quantitative benefit and risk information in DTC 
television ads (table 1). We hypothesize that, replicating past 
studies, adding simple quantitative information about benefits and 
risks will lead to increased understanding among consumers. We will 
test whether adding complex quantitative information results in the 
same outcomes as simple quantitative information or whether it is too 
much quantitative information for consumers to process. In study 2, we 
plan to examine experimentally the presence of quantitative benefit 
information and how the ad visually represents efficacy (by having no 
images, images that accurately reflect the improvement in health that 
could be expected with treatment, or images that overstate the 
improvement in health that could be expected with treatment (table 2). 
We hypothesize that overstated images of improvement will lead 
consumers to overestimate the drug's efficacy; however, adding a 
quantitative claim may moderate this effect. To test these hypotheses, 
we will conduct inferential statistical tests such as analysis of 
variance (ANOVA). With the sample sizes described below, we will have 
sufficient power to detect small- to medium-sized effects in each 
study.
    All participants will be 60 years of age or older. We will exclude 
individuals who work in healthcare or marketing. We selected a sample 
of participants 60 years and older to increase the likelihood that 
participants will be interested in the fictitious study drug and 
therefore motivated to pay attention to the ad during the study. The 
studies will be conducted with an Internet panel.
    In both studies, participants will be randomly assigned to one 
experimental condition and view the corresponding television ad. The ad 
will be for a fictitious drug to treat cataracts. The ads will be 
created and pretested to ensure that consumers perceive different 
levels of complexity across the ads in study 1, and different levels of 
image accuracy in study 2. ``Pretests for a Study on Quantitative 
Information in Direct-to-Consumer Television Advertisements'' will be 
submitted under OMB control number 0910-0695. After viewing the ad 
twice, participants will complete a questionnaire that assesses 
consumers' understanding of the drug information, their retention of 
the information, and their perceptions of the drug. We will also 
measure covariates such as demographics and numeracy. The

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questionnaires are available upon request.

                                             Table 1--Study 1 Design
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                                                                        Quantitative risk claim
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                                                       No..............  Yes: General           Yes: Frequencies
                                                                          Statement (e.g.,       for Each Risk
                                                                          seen in less than 1%
                                                                          of patients).
Quantitative Efficacy Claim...  No...................
                                Yes: simple (e.g.,
                                 reduced pain in 83%
                                 of patients).
                                Yes: complex (e.g.,
                                 reduced pain by 30%
                                 in 83% of patients).
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                                             Table 2--Study 2 Design
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                                                                                Images of improvement
                                                                   ---------------------------------------------
 
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                                                  None............  Accurate improvement   Overstated
                                                                     in health conveyed     improvement in
                                                                     in images.             health conveyed in
                                                                                            images.
Quantitative Benefit Claim....  No..............
                                Yes.............
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    FDA estimates the burden of this collection of information as 
follows:

                             Table 3--Estimated Annual Reporting Burden \1\--Study 1
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                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Sample outgo....................          15,130  ..............  ..............  ..............  ..............
Number to complete the screener            1,513               1           1,513    .05 (3 min.)              76
 (10%)..........................
Number eligible for survey (70%)           1,059  ..............  ..............  ..............  ..............
Number to complete the survey                900               1             900   .33 (20 min.)             297
 (85%)..........................
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    Total.......................  ..............  ..............           2,413  ..............             373
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                             Table 4--Estimated Annual Reporting Burden \1\--Study 2
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                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Sample outgo....................          15,130  ..............  ..............  ..............  ..............
Number to complete the screener            1,513               1           1,513    .05 (3 min.)              76
 (10%)..........................
Number eligible for survey (70%)           1,059  ..............  ..............  ..............  ..............
Number to complete the survey                900               1             900   .33 (20 min.)             297
 (85%)..........................
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    Total.......................  ..............  ..............           2,413  ..............             373
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25958 Filed 10-9-15; 8:45 am]
 BILLING CODE 4164-01-P