Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads, 27842-27845 [2017-12600]
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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
Jonnalynn Capezutto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
Guidance for Industry on
Pharmacogenomic Data Submissions;
OMB Control Number 0910–0557—
Extension
The collection of information
supports Agency guidance entitled,
‘‘Guidance for Industry on
Pharmacogenomic Data Submissions.’’
The guidance provides
recommendations to sponsors
submitting or holding investigational
new drug applications (INDs), new drug
applications (NDAs), or biologics
license applications (BLAs) on what
pharmacogenomic data should be
submitted to the Agency during the drug
development process. Sponsors holding,
and applicants submitting, INDs, NDAs,
or BLAs are subject to FDA
requirements for submitting to the
Agency data relevant to drug safety and
efficacy (21 CFR 312.22, 312.23, 312.31,
312.33, 314.50, 314.81, 601.2, and
601.12).
information and independently analyze
the data, verify results, and explore
possible genotype-phenotype
correlations across studies. FDA does
not want the VGDS to be overly
burdensome and time-consuming for the
sponsor.
In the Federal Register of March 17,
2017 (82 FR 14221), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. One comment
was received, however it was not
responsive to the four information
collection topics solicited in the notice
and therefore is not addressed here.
FDA has estimated the burden of
preparing a voluntary submission
described in the guidance that should be
designated as a VGDS based on our
experience with these submissions over
the past few years, and on our
familiarity with sponsors’ interest in
submitting pharmacogenomic data
during the drug development process. In
2013, we received three VGDS. Since
2013, there have been no submission of
VGDS; however, for purposes of this
information collection approval, we are
estimating that we may receive one
submission annually. We estimate each
submission requires approximately 50
hours to prepare and submit to FDA.
We therefore estimate the burden of
this collection of information as follows:
The guidance interprets FDA
regulations for IND, NDA, or BLA
submissions, clarifying when the
regulations require pharmacogenomics
data to be submitted and when the
submission of such data is voluntary.
The pharmacogenomic data submissions
described in the guidance that are
required to be submitted to an IND,
NDA, BLA, or annual report are covered
by the information collection
requirements under 21 CFR parts 312,
314, and 601 (approved under OMB
control numbers 0910–0014 (part 312,
INDs); 0910–0001 (part 314, NDAs and
annual reports); and 0910–0338 (part
601, BLAs)), respectively.
The guidance distinguishes between
pharmacogenomic tests that may be
considered valid biomarkers appropriate
for regulatory decisionmaking, and
other, less well-developed exploratory
tests. The submission of exploratory
pharmacogenomic data is not required
under the regulations, although the
Agency encourages the voluntary
submission of such data.
The guidance describes the voluntary
genomic data submission (VGDS) that
can be used for such a voluntary
submission. The guidance does not
recommend a specific format for the
VGDS, except that such a voluntary
submission be designated as a VGDS.
The data submitted in a VGDS and the
level of detail should be sufficient for
FDA to be able to interpret the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Hours per
response
Total hours
Voluntary Genomic Data Submissions ................................
1
1
1
50
50
1 There
are no capital costs or operating and maintenance costs associated with this collection.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12604 Filed 6–16–17; 8:45 am]
[Docket No. FDA–2017–N–1315]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Risk Information Amount and
Location in Direct-to-Consumer Print
Ads
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
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Paperwork Reduction Act of 1995
(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 ‘‘Experimental Study
of Risk Information Amount and
Location in Direct-to-Consumer Print
Ads.’’ This study will examine how
repetition and overwarning apply to the
presentation of risks in the context of
direct-to-consumer print advertising.
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
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Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
be submitted on or before August 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 18, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–N–1315 for ‘‘Experimental Study
of Risk Information Amount and
Location in Direct-to-Consumer Print
Ads.’’ Received comments, those filed
in a timely manner (see ADDRESSES) will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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https://www.regulations.gov or at the
Dockets Management Staff 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
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov. For copies
of the questionnaire contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
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27843
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.
Experimental Study of Risk
Information Amount and Location in
Direct-to-Consumer Print Ads; OMB
Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
Section 502(n) of the FD&C Act (21
U.S.C. 352(n)) specifies that
advertisements (ads) for prescription
drugs and biological products must
provide a true statement of information
‘‘in brief summary’’ describing the
advertised product’s ‘‘side effects,
contraindications and effectiveness.’’
The prescription drug advertising
regulations provide further clarification
on the information to include in brief
summary a true statement of
information in brief summary relating to
side effects, contraindications to include
side effects, warnings, precautions, and
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contraindications and include any such
information under such headings as
cautions, special considerations,
important notes, etc. and effectiveness
(21 CFR 202.1(e)(1)). The prescription
drug advertising regulations also specify
that the phrase side effect and
contraindication refers to all of the
categories of risk information contained
in the required, approved or permitted
product labeling written for health
professionals, including the Warnings,
Precautions, and Adverse Reactions
sections (21 CFR 202.1(e)(3)(iii)). Ads
must also ‘‘present a fair balance
between information relating to side
effects and contraindications and
effectiveness. . . .’’ An ad must present
true information relating to side effects
and contraindications in comparable
depth and detail with the claims for
effectiveness or safety (21 CFR
202.1(e)(5)(ii)).
To fulfill the regulatory requirements
for fair balance and the brief summary,
sponsors have typically included risk
information about the product in directto-consumer (DTC) print ads both in the
main part of the ad where the product
claims appear, and in a separate brief
summary page. The section of the main
ad where the risks appear is often
referred to as the ‘‘Important Safety
Information’’ (ISI). Including risks in
both the ISI and the brief summary may
have advantages. Some research has
found that repetition of information
improves recall, especially for older
adults (Ref. 1). This might result in
improved recall for risks that appear
both in the ISI and brief summary.
However, it is possible that risks
appearing on the main page in the ISI
may be more likely to be read than risks
appearing in the brief summary. Based
on FDA survey research, about 27
percent of consumers surveyed in 2002
reported reading half or more of the
brief summary in DTC print ads (Ref. 2).
In comparison, when asked how much
of the ‘‘main’’ ad they read, about 78
percent reported reading ‘‘all’’ or
‘‘almost all’’ of the main body portion of
the ad.
One potential downside to including
the same warnings in both the ISI and
again in the brief summary is the
potential to overwarn consumers.
Overwarning is the concept that
individuals are exposed to so many
warnings in the course of daily life that
they are less likely to pay attention to
any one particular warning (Ref. 3). In
terms of presenting risk information,
detailing too many risks may lead
consumers to discount all risks, or miss
the most important risk information.
Similarly, habituation follows when
readers see the same warning
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repeatedly. Upon seeing a particular
warning repeatedly, consumers may
cease to pay attention to it (Refs. 4 to 6).
Even if a warning has features that make
it noticeable, it still has the potential for
habituation with repeated exposure
(Ref. 5). Although researchers caution
against habituation and overwarning,
there appears to be little empirical
research for the logical supposition that
seeing repeated warnings will lead to
increased selectivity and reduced
attention by recipients over time. Of
note, the Office of Prescription Drug
Promotion (OPDP) is studying the issue
of reduced risk information in the
context of DTC TV ads (‘‘Disclosure
Regarding Additional Risks in Direct-toConsumer Prescription Drug Television
Advertisements,’’ OMB control number.
0910–0785).
OPDP plans to investigate, through
empirical research, how repetition and
overwarning apply to the presentation
of risks in promotional prescription
drug print pieces. We propose to test
two levels of the ISI (short versus long)
and the presence of the Brief Summary
(absent versus present) in two different
medical conditions (overactive bladder
and rheumatoid arthritis). Figures 1 and
2 describe the study design. This will be
investigated in DTC print ads for
prescription drugs.
FIGURE 1—STUDY 1 DESIGN
Brief summary
Rheumatoid Arthritis:
ISI ..............................
Short.
Long.
No
Yes
FIGURE 2—STUDY 2 DESIGN
Brief summary
Overactive Bladder:
ISI ..............................
Short.
Long.
No
Yes
This project is designed to use eye
tracking technology to determine how
these risk presentations in DTC print
ads are perceived. Eye tracking
technology is an effective method to
determine the extent to which
consumers attend to risk information
presented in DTC print ads. This
technology allows researchers to
unobtrusively detect and measure where
a participant looks while viewing a
print ad and for how long, and the
pattern of their eye movements may
indicate attention to and processing of
information in the ad.
We plan to collect descriptive eye
tracking data on participants’ attention
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to the following: (1) The important
safety information, (2) the brief
summary, and (3) the indication and
benefit claims. All participants will be
18 years of age or older. We will exclude
individuals who are trained as
healthcare professionals, or who work
in pharmaceutical, advertising, or
marketing settings because their
knowledge and experiences may not
reflect those of the typical consumer.
We will also exclude individuals who
have photosensitive epilepsy; use a
medical device that is sensitive to
infrared light; or wear bifocals, hard
contact lenses, or colored contact lenses.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance (ANOVA). With
the sample size described in this
document, we will have sufficient
power to detect small-to-medium sized
effects in the main study.
We plan to conduct one 60-minute
pilot study with 40 participants and two
60-minute studies with 200 participants
each (50 participants in each cell), for a
total of 400 main study participants.
The studies will be conducted in person
in at least five different cities across the
United States. The pilot study and main
studies will have the same design and
will follow the same procedure.
Participants who self-identify as having
one of the medical conditions of interest
will be randomly assigned to one of four
test conditions. In Study 1, the ad will
be for a fictitious drug to treat
rheumatoid arthritis. In Study 2, the ad
will be for a fictitious drug to treat
overactive bladder. After obtaining
consent, we will explain the study
procedure to participants and calibrate
the eye tracking device. To collect eye
tracking data, we will use an
unobtrusive glasses-based real world
eye tracker with a minimum speed of 50
Hertz. The test images will be presented
on paper and sized similarly to how
they would appear in print materials
such as magazines. To simulate normal
ad viewing, participants will view two
ads. One of the ads will be the study ad.
The non-study ad will be for a consumer
product unrelated to health. Only eye
tracking data from the study ad will be
analyzed. Next, participants will
complete a questionnaire that assesses
risk perceptions, risk recall, efficacy
perceptions, efficacy recall, and
covariates such as demographics and
health literacy. In the pilot study,
participants will also answer questions
as part of a debriefing interview to
assess the study design and
questionnaire.
FDA estimates the burden of this
collection of information as follows:
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27845
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Pilot screener ............................................................
Study 1 screener ......................................................
Study 2 screener ......................................................
Completes, Pilot ........................................................
Completes, Study 1 ..................................................
Completes, Study 2 ..................................................
120
600
600
40
200
200
1
1
1
1
1
1
120
600
600
40
200
200
0.03 (2 minutes) .......
0.03 (2 minutes) .......
0.03 (2 minutes) .......
1 ................................
1 ................................
1 ................................
4
18
18
40
200
200
Total ...................................................................
........................
........................
........................
...................................
480
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
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The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
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. McGuire, L.C., ‘‘Remembering What the
Doctor Said: Organization and Older
Adults’ Memory for Medical
Information.’’ Experimental Aging
Research, 22, 403–428 (1996).
2. 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). Available at https://
www.fda.gov/downloads/Drugs/
ScienceResearch/ResearchAreas/
DrugMarketingAdvertisingand
CommunicationsResearch/
UCM152860.pdf.
3. Warnings and Risk Communication (2005).
Wogalter, M.S., D. DeJoy, and K.R.
Laughery (Eds.). Philadelphia: Taylor &
Francis, Inc.
4. Conzola, V.C., and M.S. Wogalter, ‘‘A
Communication-Human Information
Processing (C–HIP) Approach to Warning
Effectiveness in the Workplace.’’ Journal
of Risk Research, 4(4), 309–322; (2001).
5. Wogalter, M.S., and K.R Laughery,
‘‘Warning! Sign and Label
Effectiveness.’’ Current Directions in
Psychological Science, 5(2), 33–37;
(1996).
6. Wogalter, M.S., T.L. Smith-Jackson, B.J.
Mills, and C.S. Paine, ‘‘The Effects of
Print Format in Direct-to-Consumer
Prescription Drug Advertisements on
Risk Knowledge and Preference.’’ Drug
Information Journal, 36(3), 693–705,
2002.
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Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12600 Filed 6–16–17; 8:45 am]
BILLING CODE 4164–01–P
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1779]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Disclosures of
Descriptive Presentations in
Professional Oncology Prescription
Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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
‘‘Disclosures of Descriptive
Presentations in Professional Oncology
Prescription Drug Promotion.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 18, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 18, 2017.
SUMMARY:
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
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]]>Agencies
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Notices]
[Pages 27842-27845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12600]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1315]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Risk Information Amount and
Location in Direct-to-Consumer Print Ads
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
(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 ``Experimental Study of Risk
Information Amount and Location in Direct-to-Consumer Print Ads.'' This
study will examine how repetition and overwarning apply to the
presentation of risks in the context of direct-to-consumer print
advertising.
DATES: Submit either electronic or written comments on the collection
of information by August 18, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must
[[Page 27843]]
be submitted on or before August 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 18, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-1315 for ``Experimental Study of Risk Information Amount and
Location in Direct-to-Consumer Print Ads.'' Received comments, those
filed in a timely manner (see ADDRESSES) will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
PRAStaff@fda.hhs.gov. For copies of the questionnaire contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
DTCresearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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.
Experimental Study of Risk Information Amount and Location in Direct-
to-Consumer Print Ads; OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
Section 502(n) of the FD&C Act (21 U.S.C. 352(n)) specifies that
advertisements (ads) for prescription drugs and biological products
must provide a true statement of information ``in brief summary''
describing the advertised product's ``side effects, contraindications
and effectiveness.'' The prescription drug advertising regulations
provide further clarification on the information to include in brief
summary a true statement of information in brief summary relating to
side effects, contraindications to include side effects, warnings,
precautions, and
[[Page 27844]]
contraindications and include any such information under such headings
as cautions, special considerations, important notes, etc. and
effectiveness (21 CFR 202.1(e)(1)). The prescription drug advertising
regulations also specify that the phrase side effect and
contraindication refers to all of the categories of risk information
contained in the required, approved or permitted product labeling
written for health professionals, including the Warnings, Precautions,
and Adverse Reactions sections (21 CFR 202.1(e)(3)(iii)). Ads must also
``present a fair balance between information relating to side effects
and contraindications and effectiveness. . . .'' An ad must present
true information relating to side effects and contraindications in
comparable depth and detail with the claims for effectiveness or safety
(21 CFR 202.1(e)(5)(ii)).
To fulfill the regulatory requirements for fair balance and the
brief summary, sponsors have typically included risk information about
the product in direct-to-consumer (DTC) print ads both in the main part
of the ad where the product claims appear, and in a separate brief
summary page. The section of the main ad where the risks appear is
often referred to as the ``Important Safety Information'' (ISI).
Including risks in both the ISI and the brief summary may have
advantages. Some research has found that repetition of information
improves recall, especially for older adults (Ref. 1). This might
result in improved recall for risks that appear both in the ISI and
brief summary. However, it is possible that risks appearing on the main
page in the ISI may be more likely to be read than risks appearing in
the brief summary. Based on FDA survey research, about 27 percent of
consumers surveyed in 2002 reported reading half or more of the brief
summary in DTC print ads (Ref. 2). In comparison, when asked how much
of the ``main'' ad they read, about 78 percent reported reading ``all''
or ``almost all'' of the main body portion of the ad.
One potential downside to including the same warnings in both the
ISI and again in the brief summary is the potential to overwarn
consumers. Overwarning is the concept that individuals are exposed to
so many warnings in the course of daily life that they are less likely
to pay attention to any one particular warning (Ref. 3). In terms of
presenting risk information, detailing too many risks may lead
consumers to discount all risks, or miss the most important risk
information. Similarly, habituation follows when readers see the same
warning repeatedly. Upon seeing a particular warning repeatedly,
consumers may cease to pay attention to it (Refs. 4 to 6). Even if a
warning has features that make it noticeable, it still has the
potential for habituation with repeated exposure (Ref. 5). Although
researchers caution against habituation and overwarning, there appears
to be little empirical research for the logical supposition that seeing
repeated warnings will lead to increased selectivity and reduced
attention by recipients over time. Of note, the Office of Prescription
Drug Promotion (OPDP) is studying the issue of reduced risk information
in the context of DTC TV ads (``Disclosure Regarding Additional Risks
in Direct-to-Consumer Prescription Drug Television Advertisements,''
OMB control number. 0910-0785).
OPDP plans to investigate, through empirical research, how
repetition and overwarning apply to the presentation of risks in
promotional prescription drug print pieces. We propose to test two
levels of the ISI (short versus long) and the presence of the Brief
Summary (absent versus present) in two different medical conditions
(overactive bladder and rheumatoid arthritis). Figures 1 and 2 describe
the study design. This will be investigated in DTC print ads for
prescription drugs.
Figure 1--Study 1 Design
------------------------------------------------------------------------
------------------------------------------------------------------------
Brief summary
------------------------------------------------------------------------
Rheumatoid Arthritis:
ISI............................................. No Yes
Short...........................................
Long............................................
------------------------------------------------------------------------
Figure 2--Study 2 Design
------------------------------------------------------------------------
------------------------------------------------------------------------
Brief summary
------------------------------------------------------------------------
Overactive Bladder:
ISI............................................. No Yes
Short...........................................
Long............................................
------------------------------------------------------------------------
This project is designed to use eye tracking technology to
determine how these risk presentations in DTC print ads are perceived.
Eye tracking technology is an effective method to determine the extent
to which consumers attend to risk information presented in DTC print
ads. This technology allows researchers to unobtrusively detect and
measure where a participant looks while viewing a print ad and for how
long, and the pattern of their eye movements may indicate attention to
and processing of information in the ad.
We plan to collect descriptive eye tracking data on participants'
attention to the following: (1) The important safety information, (2)
the brief summary, and (3) the indication and benefit claims. All
participants will be 18 years of age or older. We will exclude
individuals who are trained as healthcare professionals, or who work in
pharmaceutical, advertising, or marketing settings because their
knowledge and experiences may not reflect those of the typical
consumer. We will also exclude individuals who have photosensitive
epilepsy; use a medical device that is sensitive to infrared light; or
wear bifocals, hard contact lenses, or colored contact lenses.
To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance
(ANOVA). With the sample size described in this document, we will have
sufficient power to detect small-to-medium sized effects in the main
study.
We plan to conduct one 60-minute pilot study with 40 participants
and two 60-minute studies with 200 participants each (50 participants
in each cell), for a total of 400 main study participants. The studies
will be conducted in person in at least five different cities across
the United States. The pilot study and main studies will have the same
design and will follow the same procedure. Participants who self-
identify as having one of the medical conditions of interest will be
randomly assigned to one of four test conditions. In Study 1, the ad
will be for a fictitious drug to treat rheumatoid arthritis. In Study
2, the ad will be for a fictitious drug to treat overactive bladder.
After obtaining consent, we will explain the study procedure to
participants and calibrate the eye tracking device. To collect eye
tracking data, we will use an unobtrusive glasses-based real world eye
tracker with a minimum speed of 50 Hertz. The test images will be
presented on paper and sized similarly to how they would appear in
print materials such as magazines. To simulate normal ad viewing,
participants will view two ads. One of the ads will be the study ad.
The non-study ad will be for a consumer product unrelated to health.
Only eye tracking data from the study ad will be analyzed. Next,
participants will complete a questionnaire that assesses risk
perceptions, risk recall, efficacy perceptions, efficacy recall, and
covariates such as demographics and health literacy. In the pilot
study, participants will also answer questions as part of a debriefing
interview to assess the study design and questionnaire.
FDA estimates the burden of this collection of information as
follows:
[[Page 27845]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot screener.............................. 120 1 120 0.03 (2 minutes).......................... 4
Study 1 screener............................ 600 1 600 0.03 (2 minutes).......................... 18
Study 2 screener............................ 600 1 600 0.03 (2 minutes).......................... 18
Completes, Pilot............................ 40 1 40 1......................................... 40
Completes, Study 1.......................... 200 1 200 1......................................... 200
Completes, Study 2.......................... 200 1 200 1......................................... 200
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://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. McGuire, L.C., ``Remembering What the Doctor Said: Organization
and Older Adults' Memory for Medical Information.'' Experimental
Aging Research, 22, 403-428 (1996).
2. 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).
Available at https://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf.
3. Warnings and Risk Communication (2005). Wogalter, M.S., D. DeJoy,
and K.R. Laughery (Eds.). Philadelphia: Taylor & Francis, Inc.
4. Conzola, V.C., and M.S. Wogalter, ``A Communication-Human
Information Processing (C-HIP) Approach to Warning Effectiveness in
the Workplace.'' Journal of Risk Research, 4(4), 309-322; (2001).
5. Wogalter, M.S., and K.R Laughery, ``Warning! Sign and Label
Effectiveness.'' Current Directions in Psychological Science, 5(2),
33-37; (1996).
6. Wogalter, M.S., T.L. Smith-Jackson, B.J. Mills, and C.S. Paine,
``The Effects of Print Format in Direct-to-Consumer Prescription
Drug Advertisements on Risk Knowledge and Preference.'' Drug
Information Journal, 36(3), 693-705, 2002.
Dated: June 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12600 Filed 6-16-17; 8:45 am]
BILLING CODE 4164-01-P
