Agency Information Collection Activities; Proposed Collection; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs, 12503-12506 [2016-05233]
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Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Information collected
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total ..................................................................................................
2. Testing of HPHC Quantities in Products:
Cigarette Filler .........................................................................................
Roll-Your-Own .........................................................................................
Smokeless ...............................................................................................
........................
........................
........................
..............................
123
78
39
52
0.79
0.21
0.21
62
8
11
9.42 ......................
9.42 ......................
12.06 ....................
584
75
133
Total ..................................................................................................
3. Testing of HPHC Quantities in Mainstream Smoke:
Cigarette: International Oraganization for Standardization (ISO) Regimen.
Cigarette: Health Canada Regimen ........................................................
........................
........................
........................
..............................
792
78
0.79
62
23.64 ....................
1,466
78
0.79
62
23.64 ....................
1,466
Total ..................................................................................................
4. Additional HPHC reports: 2
Cigarette Filler .........................................................................................
Roll-Your-Own .........................................................................................
Smokeless ...............................................................................................
........................
........................
........................
..............................
2,932
78
39
52
2.56
5.12
3.84
200
200
200
1 ...........................
1 ...........................
1 ...........................
200
200
200
Total ..................................................................................................
........................
........................
........................
..............................
600
Total Section 904(c)(1) Reporting Burden Hours .....................
........................
........................
........................
..............................
4,447
1 There
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2 HPHC
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC measures will be the same as the original report.
Table 1 contains estimates for new
product information received annually
under section 904(c)(1) of the FD&C Act.
Manufacturers must report HPHC
information under section 904(c)(1) of
the FD&C Act at least 90 days prior to
delivery for introduction into interstate
commerce. The total annual burden for
this collection of information is
estimated to be 4,447 hours. The burden
estimate for this collection of
information includes the time it will
take to test the products and prepare the
HPHC report. Table 1 indicates that 169
respondents will submit HPHC reports
when new products enter the market.
Section 1 of the table addresses the
time required for manufacturers to
report their company information. We
estimate that the time to report HPHC
information is no more than 1.82 hours
for cigarettes, 0.42 hours for roll-yourown, and 0.63 hours for smokeless
tobacco products for each response
regardless of whether the paper or
electronic form (Form FDA 3787) is
used. (The estimated times to report
smokeless tobacco products (0.63 hour)
and roll-your-own tobacco products
(0.43 hour) are lower than the estimated
reporting time for cigarette products
because fewer HPHCs are normally
reported for these two types of products.
The total annual burden for reporting
company and product information is
123 hours.
Section 2 of the table addresses the
time required for manufacturers to test
quantities of HPHCs in their products.
The burden hour estimates include the
time needed to test the tobacco
products, draft testing reports, and draft
the report for FDA. For cigarette filler,
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smokeless, and roll-your-own products,
we estimate the burden to be 792 annual
burden hours. The burden for each
product type reflects our estimate of the
time to test the tobacco products (i.e.,
carry out laboratory work).
In addition to addressing the time
required to report information and test
quantities of HPHCs in tobacco
products, section 3 of table 1 addresses
the time required for manufacturers to
test quantities of HPHCs in cigarette
smoke. The burden estimates include
testing the tobacco products, drafting
testing reports, and drafting the report
for FDA. We estimate the annualized
burden for this section to be 2,932
hours. The annual burden reflects our
estimate to test the tobacco products
(i.e., carry out laboratory work). The
burden estimate assumes that
manufacturers report HPHC quantities
in cigarette mainstream smoke
according to the two smoking regimens
described in the table.
As stated previously, FDA expects to
receive 600 additional HPHC reports at
1 hour per response for a total of 600
hours. The estimated total annual
burden for the reporting of HPHC under
section 904(c)(1) of the FD&C Act is
4,447 hours.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05213 Filed 3–8–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0735]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Superimposed
Text in Direct-to-Consumer Promotion
of Prescription Drugs
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
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 ‘‘Superimposed Text
in Direct-to-Consumer Promotion of
Prescription Drugs.’’ This study will
examine how the size and presentation
of superimposed text (supers) influences
the comprehension of direct-toconsumer (DTC) television
advertisements for prescription drugs.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 9, 2016.
DATES:
ADDRESSES:
You may submit comments
as follows:
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Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / 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’’).
Lhorne on DSK5TPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–0735 for ‘‘Superimposed Text
in Direct-to-Consumer Promotion of
Prescription Drugs.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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
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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 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: https://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 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 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, PRAStaff@
fda.hhs.gov.
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.
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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.
Superimposed Text in Direct-toConsumer Promotion of Prescription
Drugs—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.
The proposed study seeks to extend
previous research on the effects of
supers in general print and television
advertising to today’s modern DTC
pharmaceutical promotion. Although
earlier research on the effects of supers
in other consumer settings suggests that
altering text size can influence
consumer comprehension of
information, it is unclear if these
findings extend to DTC promotion of
prescription drugs and are applicable
over 20 years later when viewing
promotional materials using today’s
modern technologies (e.g., tablets).
Moreover, other factors such as text/
background contrast may also influence
both the understanding of the
superimposed information (Ref. 1) and
the effects of text size. The proposed
research seeks to update these earlier
findings and also to answer new
questions concerning presentation of
supers.
Part of FDA’s public health mission is
to ensure the safe use of prescription
drugs; therefore, it is important that the
information provided in DTC promotion
is clear and understandable for
consumer audiences, avoids use of
deceptive or misleading claims, and
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achieves ‘‘fair balance’’ in presentation
of benefits and risks. For example,
varying presentation formats including
type size, bulleting, amount of white
space, and use of ‘‘chunking’’ or
headlines can all influence consumer
perceptions of information (Ref. 2). A
systematic review of presentation
formats in prescription drug labeling
found that these ‘‘clear communication’’
characteristics positively influenced
consumer’s comprehension of
information and prescription drug
behaviors (i.e., adherence) (Ref. 3). In
one randomized controlled study, young
and older adults were presented with 12
otherwise identical over-the-counter
drugs bottled with varied container
labels along various dimensions, one of
which was text size (7 vs. 10 point).
While younger participants performed
equally well with both font sizes,
elderly populations had significantly
reduced recall and comprehension
when exposed to the smaller text size
(Ref. 4). Another study found that both
young and older populations preferred
the larger text size and that patients read
labels with larger font more rapidly and
accurately than labels with smaller font
(Ref. 5). Although these studies were
specific to prescription drug container
labels, it is plausible that the effects of
font sizes would be applicable to drug
promotion.
Some early research in the late 1980s
and 1990s examined the size of supers
in print and television advertising
topics outside of prescription drugs
(Refs. 6, 7, and 8). These studies all
generally found that the text size of the
super was associated with
comprehension, such that the larger text
sizes increased understanding of the
material (and, conversely, smaller text
sizes interfered with comprehension).
For example, Foxman and colleagues
(Ref. 6) found that whereas ‘‘small’’ text
size (> 1⁄2 inch size) was associated with
accurate comprehension for 59 percent
of respondents, ‘‘large’’ text size (> 1⁄2
inch size) was associated with
comprehension for 79 percent of
respondents. Studies by other
researchers (Refs. 7 and 8) found similar
patterns such that increasing the text
size of supers generally corresponded
with increased comprehension.
We know of no studies that have
examined other commonly variable
factors, such as text/background
contrast, that may interact with text size
to influence comprehension. Early
research on text readability determined
that the contrast between text and
background has a consistent but small
effect. Specifically, while the contrast of
color has a small effect (Ref. 9), the
contrast in brightness, or luminance,
makes the largest difference (Ref. 10).
These studies showed that black text on
a white background results in the
highest readability (Ref. 11), but that
other effects of color contrasts are
unclear (Ref .1). Some studies have
demonstrated that contrast interacts
with text size, such that contrast
becomes a more important discriminator
as the text size decreases (Ref. 12).
The earlier research on supers is
limited in their applicability to today’s
DTC promotion in several ways. None of
these studies specifically focused on
prescription drug promotion, but rather
explored the effects of superimposed
text in a variety of social and consumer
advertising contexts. Another limitation
is that these earlier studies were
conducted with populations (i.e.,
undergraduate students) that are not
representative of today’s prescription
drug users. It is not clear if the effects
of supers would translate to older adult
populations, who represent the greatest
proportion of prescription drug users
(Ref. 13). Perhaps most importantly, it is
unknown if the effects of supers would
be found today, considering the
prevalent use of modern technologies,
including large (40+ inches) TV screens
and personal tablets for online viewing.
Our proposed study seeks to address
these unanswered questions regarding
the use of supers in prescription drug
promotion.
II. General Research Questions
1. Does the size of the superimposed
text, the contrast behind the
superimposed text, and/or the device
type influence the noticeability, recall,
and perceived importance of the super
information?
2. Does the size of the superimposed
text, the contrast behind the
superimposed text, and/or the device
type influence the recall of and attitudes
toward the promoted drug?
3. Are there any interaction effects
among any combination of independent
variables?
III. Design
To test these research questions, we
will conduct one randomized controlled
study. We will examine reactions to
supers in a fictitious DTC prescription
drug promotional video on two types of
viewing devices with a general
population sample. The study design
will be a 3 × 2 × 2 factorial design,
where participants are randomly
assigned to 1 of 12 experimental study
arms differentiated by:
• Super text size (small, medium,
large);
• Device type (television, tablet);
• Super text contrast (high, low).
TABLE 1—DESIGN AND CELL SIZES FOR MAIN STUDY 1
Device Type
TV
Tablet
Total
Super Size
Small
Medium
Large
Small
Medium
Large
Contrast:
High ...................................................
Low ...................................................
106
106
106
106
106
106
106
106
106
106
106
106
636
636
Total ...........................................
212
212
212
212
212
212
1,272
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1 The
sample will be split evenly across 3 cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.
For both the pretest and main study,
we will work with two market research
firms to recruit adult participants and
conduct in-person data collection in
three U.S. cities: Los Angeles, CA;
Cincinnati, OH; and Tampa, FL. In
addition to our aim for regional
variation, we selected these three cities
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with the aim of recruiting a sample that
is diverse on gender, race/ethnicity,
education, and age characteristics.
Participants from the general
population will be invited to a market
research facility to watch one video for
a fictional prescription drug that treats
asthma. In-person administration of
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study procedures will enable us to
control the television and tablet
watching experience in terms of size,
distance, and other variables.
Participants will watch the video twice
and then answer questions addressing
recall of risks and benefits, perceptions
of risks and benefits, and questions
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regarding the salience of information in
text. The questionnaire is available
upon request. Participation is estimated
to take approximately 20 minutes.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance.
Pretesting will take place before the
main study to select super sizes for the
main study and to evaluate the
procedures and measures that will be
used. We will exclude individuals who
work in health care or marketing
settings because their knowledge and
experiences may not reflect those of the
average consumer. We conducted a
priori power analyses to determine
sample sizes for the pretest and the
main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Pretesting
No. to complete the screener (assumes 50% eligible).
No. of completes ..................................................
338
1
338
0.08 (5 minutes) ............
27
240
1
240
0.33 (20 minutes) ..........
79
Main Study
No. to complete the screener (assumes 50% eligible).
No. of completes ..................................................
1,785
1
1,785
0.08 (5 minutes) ............
143
1,272
1
1,272
0.33 (20 minutes) ..........
420
Total ..............................................................
........................
........................
........................
.......................................
669
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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IV. References
1. Hall, R.H. and P. Hanna, ‘‘The Impact of
Web page Text-Background Colour
Combinations on Readability, Retention,
Aesthetics and Behavioural Intention,’’
Behaviour & Information Technology,
2004;23:183–195.
2. Baur, C. and C. Prue, ‘‘The CDC Clear
Communication Index Is a New
Evidence-Based Tool to Prepare and
Review Health Information,’’ Health
Promotion Practice, 2014;15:629–637.
3. Shrank, W., J. Avorn, C. Rolon, et al.,
‘‘Effect of Content and Format of
Prescription Drug Labels on Readability,
Understanding, and Medication Use: A
Systematic Review,’’ The Annals of
Pharmacotherapy, 2007;41:783–801.
4. Wogalter, M.S. and W.J. Vigilante, Jr.,
‘‘Effects of Label Format on Knowledge
Acquisition and Perceived Readability
by Younger and Older Adults,’’
Ergonomics, 2003;46:327–344.
5. Smither, J.A.A. and C.C. Braun,
‘‘Readability of Prescription Drug Labels
by Older and Younger Adults,’’ Journal
of Clinical Psychology in Medicine
Settings, 1994;1:149–159.
6. Foxman, E.R., D.D. Muehling, and P.A.
Moore, ‘‘Disclaimer Footnotes in Ads:
Discrepancies Between Purpose and
Performance,’’ Journal of Public Policy &
Marketing, 1988;7:127–137.
7. Murray, N.M., L.A. Manrai, and A.K.
Manrai, ‘‘Public Policy Relating to
Consumer Comprehension of Television
Commercials: A Review and Some
Empirical Results,’’ Journal of Consumer
Policy, 1993;16:145–170.
8. Manrai, L.A., A.K. Manrai, and N. Murray,
‘‘Comprehension of Info-Aid Supers in
Television Advertising for Social Ideas:
Implications for Public Policy,’’ Journal
of Business Research, 1994;30:75–84.
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15:08 Mar 08, 2016
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9. Hill, A. and L. Scharff, ‘‘Readability of
Computer Displays as a Function of
Colour, Saturation, and Background
Texture.’’ In: D. Harns (Ed.) Engineering
Psychology and Cognitive Ergonomics,
(Vol. 4) Ashgate, Aldershot, United
Kingdom.
10. Shieh, K.-K. and C.-C. Lin, ‘‘Effects of
Screen Type, Ambient Illumination, and
Color Combination on VDT Visual
Performance and Subjective Preference,’’
International Journal of Industrial
Ergonomics, 2000;26:527–536.
11. Tinker, M.A. and D.G. Paterson, ‘‘Studies
of Typographical Factors Influencing
Speed of Reading. VII. Variations in
Color of Print and Background,’’ Journal
of Applied Psychology, 1931;15:471–479.
12. Legge, G.E., G.S. Rubin, and A. Luebner,
‘‘Psychophysics of Reading—V. The Role
of Contrast in Normal Vision,’’ Vision
Research, 1987;27:1165–1177.
13. Kaufman, D.W., J.P. Kelly, L. Rosenberg,
et al., ‘‘Recent Patterns of Medication
Use in the Ambulatory Adult Population
of the United States: The Slone Survey,’’
The Journal of the American Medical
Association, 2002;287:337–344.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05233 Filed 3–8–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0712]
Evaluating Respiratory Symptoms in
Chronic Obstructive Pulmonary
Disease, a Patient-Reported Outcome,
for the Measurement of Severity of
Respiratory Symptoms in Stable
Chronic Obstructive Pulmonary
Disease: Qualification for Exploratory
Use; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Evaluating Respiratory Symptoms in
Chronic Obstructive Pulmonary Disease,
a Patient-Reported Outcome, for the
Measurement of Severity of Respiratory
Symptoms in Stable Chronic
Obstructive Pulmonary Disease:
Qualification for Exploratory Use.’’ This
draft guidance provides a statement of
qualification for exploratory use for the
evaluating respiratory symptoms in
chronic obstructive pulmonary disease
(E–RS: COPD), a patient-reported
outcome instrument, and summarizes
the concept of interest and context of
use (COU) for which the tool is qualified
through the Center for Drug Evaluation
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12503-12506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0735]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Superimposed Text in Direct-to-Consumer Promotion of
Prescription Drugs
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
(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 ``Superimposed Text in
Direct-to-Consumer Promotion of Prescription Drugs.'' This study will
examine how the size and presentation of superimposed text (supers)
influences the comprehension of direct-to-consumer (DTC) television
advertisements for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by May 9, 2016.
ADDRESSES: You may submit comments as follows:
[[Page 12504]]
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
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FDA-2016-N-0735 for ``Superimposed Text in Direct-to-Consumer Promotion
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FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs--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.
The proposed study seeks to extend previous research on the effects
of supers in general print and television advertising to today's modern
DTC pharmaceutical promotion. Although earlier research on the effects
of supers in other consumer settings suggests that altering text size
can influence consumer comprehension of information, it is unclear if
these findings extend to DTC promotion of prescription drugs and are
applicable over 20 years later when viewing promotional materials using
today's modern technologies (e.g., tablets). Moreover, other factors
such as text/background contrast may also influence both the
understanding of the superimposed information (Ref. 1) and the effects
of text size. The proposed research seeks to update these earlier
findings and also to answer new questions concerning presentation of
supers.
Part of FDA's public health mission is to ensure the safe use of
prescription drugs; therefore, it is important that the information
provided in DTC promotion is clear and understandable for consumer
audiences, avoids use of deceptive or misleading claims, and
[[Page 12505]]
achieves ``fair balance'' in presentation of benefits and risks. For
example, varying presentation formats including type size, bulleting,
amount of white space, and use of ``chunking'' or headlines can all
influence consumer perceptions of information (Ref. 2). A systematic
review of presentation formats in prescription drug labeling found that
these ``clear communication'' characteristics positively influenced
consumer's comprehension of information and prescription drug behaviors
(i.e., adherence) (Ref. 3). In one randomized controlled study, young
and older adults were presented with 12 otherwise identical over-the-
counter drugs bottled with varied container labels along various
dimensions, one of which was text size (7 vs. 10 point). While younger
participants performed equally well with both font sizes, elderly
populations had significantly reduced recall and comprehension when
exposed to the smaller text size (Ref. 4). Another study found that
both young and older populations preferred the larger text size and
that patients read labels with larger font more rapidly and accurately
than labels with smaller font (Ref. 5). Although these studies were
specific to prescription drug container labels, it is plausible that
the effects of font sizes would be applicable to drug promotion.
Some early research in the late 1980s and 1990s examined the size
of supers in print and television advertising topics outside of
prescription drugs (Refs. 6, 7, and 8). These studies all generally
found that the text size of the super was associated with
comprehension, such that the larger text sizes increased understanding
of the material (and, conversely, smaller text sizes interfered with
comprehension). For example, Foxman and colleagues (Ref. 6) found that
whereas ``small'' text size (> \1/2\ inch size) was associated with
accurate comprehension for 59 percent of respondents, ``large'' text
size (> \1/2\ inch size) was associated with comprehension for 79
percent of respondents. Studies by other researchers (Refs. 7 and 8)
found similar patterns such that increasing the text size of supers
generally corresponded with increased comprehension.
We know of no studies that have examined other commonly variable
factors, such as text/background contrast, that may interact with text
size to influence comprehension. Early research on text readability
determined that the contrast between text and background has a
consistent but small effect. Specifically, while the contrast of color
has a small effect (Ref. 9), the contrast in brightness, or luminance,
makes the largest difference (Ref. 10). These studies showed that black
text on a white background results in the highest readability (Ref.
11), but that other effects of color contrasts are unclear (Ref .1).
Some studies have demonstrated that contrast interacts with text size,
such that contrast becomes a more important discriminator as the text
size decreases (Ref. 12).
The earlier research on supers is limited in their applicability to
today's DTC promotion in several ways. None of these studies
specifically focused on prescription drug promotion, but rather
explored the effects of superimposed text in a variety of social and
consumer advertising contexts. Another limitation is that these earlier
studies were conducted with populations (i.e., undergraduate students)
that are not representative of today's prescription drug users. It is
not clear if the effects of supers would translate to older adult
populations, who represent the greatest proportion of prescription drug
users (Ref. 13). Perhaps most importantly, it is unknown if the effects
of supers would be found today, considering the prevalent use of modern
technologies, including large (40+ inches) TV screens and personal
tablets for online viewing. Our proposed study seeks to address these
unanswered questions regarding the use of supers in prescription drug
promotion.
II. General Research Questions
1. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the noticeability,
recall, and perceived importance of the super information?
2. Does the size of the superimposed text, the contrast behind the
superimposed text, and/or the device type influence the recall of and
attitudes toward the promoted drug?
3. Are there any interaction effects among any combination of
independent variables?
III. Design
To test these research questions, we will conduct one randomized
controlled study. We will examine reactions to supers in a fictitious
DTC prescription drug promotional video on two types of viewing devices
with a general population sample. The study design will be a 3 x 2 x 2
factorial design, where participants are randomly assigned to 1 of 12
experimental study arms differentiated by:
Super text size (small, medium, large);
Device type (television, tablet);
Super text contrast (high, low).
Table 1--Design and Cell Sizes for Main Study \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Device Type TV Tablet
-------------------------------------------------------------------------------------------------------------------------------------------- Total
Super Size Small Medium Large Small Medium Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contrast:
High..................................................... 106 106 106 106 106 106 636
Low...................................................... 106 106 106 106 106 106 636
------------------------------------------------------------------------------------------
Total................................................ 212 212 212 212 212 212 1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The sample will be split evenly across 3 cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.
For both the pretest and main study, we will work with two market
research firms to recruit adult participants and conduct in-person data
collection in three U.S. cities: Los Angeles, CA; Cincinnati, OH; and
Tampa, FL. In addition to our aim for regional variation, we selected
these three cities with the aim of recruiting a sample that is diverse
on gender, race/ethnicity, education, and age characteristics.
Participants from the general population will be invited to a
market research facility to watch one video for a fictional
prescription drug that treats asthma. In-person administration of study
procedures will enable us to control the television and tablet watching
experience in terms of size, distance, and other variables.
Participants will watch the video twice and then answer questions
addressing recall of risks and benefits, perceptions of risks and
benefits, and questions
[[Page 12506]]
regarding the salience of information in text. The questionnaire is
available upon request. Participation is estimated to take
approximately 20 minutes.
To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance.
Pretesting will take place before the main study to select super
sizes for the main study and to evaluate the procedures and measures
that will be used. We will exclude individuals who work in health care
or marketing settings because their knowledge and experiences may not
reflect those of the average consumer. We conducted a priori power
analyses to determine sample sizes for the pretest and the main study.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretesting
----------------------------------------------------------------------------------------------------------------
No. to complete the screener 338 1 338 0.08 (5 minutes) 27
(assumes 50% eligible).
No. of completes.............. 240 1 240 0.33 (20 79
minutes).
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
No. to complete the screener 1,785 1 1,785 0.08 (5 minutes) 143
(assumes 50% eligible).
No. of completes.............. 1,272 1 1,272 0.33 (20 420
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 669
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
IV. References
1. Hall, R.H. and P. Hanna, ``The Impact of Web page Text-Background
Colour Combinations on Readability, Retention, Aesthetics and
Behavioural Intention,'' Behaviour & Information Technology,
2004;23:183-195.
2. Baur, C. and C. Prue, ``The CDC Clear Communication Index Is a
New Evidence-Based Tool to Prepare and Review Health Information,''
Health Promotion Practice, 2014;15:629-637.
3. Shrank, W., J. Avorn, C. Rolon, et al., ``Effect of Content and
Format of Prescription Drug Labels on Readability, Understanding,
and Medication Use: A Systematic Review,'' The Annals of
Pharmacotherapy, 2007;41:783-801.
4. Wogalter, M.S. and W.J. Vigilante, Jr., ``Effects of Label Format
on Knowledge Acquisition and Perceived Readability by Younger and
Older Adults,'' Ergonomics, 2003;46:327-344.
5. Smither, J.A.A. and C.C. Braun, ``Readability of Prescription
Drug Labels by Older and Younger Adults,'' Journal of Clinical
Psychology in Medicine Settings, 1994;1:149-159.
6. Foxman, E.R., D.D. Muehling, and P.A. Moore, ``Disclaimer
Footnotes in Ads: Discrepancies Between Purpose and Performance,''
Journal of Public Policy & Marketing, 1988;7:127-137.
7. Murray, N.M., L.A. Manrai, and A.K. Manrai, ``Public Policy
Relating to Consumer Comprehension of Television Commercials: A
Review and Some Empirical Results,'' Journal of Consumer Policy,
1993;16:145-170.
8. Manrai, L.A., A.K. Manrai, and N. Murray, ``Comprehension of
Info-Aid Supers in Television Advertising for Social Ideas:
Implications for Public Policy,'' Journal of Business Research,
1994;30:75-84.
9. Hill, A. and L. Scharff, ``Readability of Computer Displays as a
Function of Colour, Saturation, and Background Texture.'' In: D.
Harns (Ed.) Engineering Psychology and Cognitive Ergonomics, (Vol.
4) Ashgate, Aldershot, United Kingdom.
10. Shieh, K.-K. and C.-C. Lin, ``Effects of Screen Type, Ambient
Illumination, and Color Combination on VDT Visual Performance and
Subjective Preference,'' International Journal of Industrial
Ergonomics, 2000;26:527-536.
11. Tinker, M.A. and D.G. Paterson, ``Studies of Typographical
Factors Influencing Speed of Reading. VII. Variations in Color of
Print and Background,'' Journal of Applied Psychology, 1931;15:471-
479.
12. Legge, G.E., G.S. Rubin, and A. Luebner, ``Psychophysics of
Reading--V. The Role of Contrast in Normal Vision,'' Vision
Research, 1987;27:1165-1177.
13. Kaufman, D.W., J.P. Kelly, L. Rosenberg, et al., ``Recent
Patterns of Medication Use in the Ambulatory Adult Population of the
United States: The Slone Survey,'' The Journal of the American
Medical Association, 2002;287:337-344.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05233 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P
