Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs, 85968-85972 [2016-28733]
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
made publicly available, you can
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and Accessories Used for Irrigation
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FOR FURTHER INFORMATION CONTACT:
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SUPPLEMENTARY INFORMATION:
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I. Background
Flexible gastrointestinal endoscopes
and accessories (including valves and
other devices used for irrigation) are
class II devices regulated under 21 CFR
876.1500, Endoscope and accessories.
During a colonoscopy or
esophagogastroduodenoscopy (EGD),
clinicians often use an irrigation system
comprised of a water bottle, tubing,
valves, etc., to supply irrigation for the
procedure. Clinicians typically do not
clean and sterilize all components of the
irrigation system after each procedure;
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e.g., they may use a single water bottle
for an entire day of procedures without
reprocessing the water bottle between
patients. This practice raises the risk of
cross-contamination between patients,
because the water bottle and associated
tubing and connectors can become
contaminated with the fluids and
materials (e.g., blood, stool) of patients
that travel back through the irrigation
system channels and tubing during the
procedure.
FDA is providing this guidance to
highlight the cross-contamination risk
posed by specific practices and types of
irrigation valves and accessories; clarify
terminology used to describe irrigation
system components; and outline
recommended mitigation strategies (e.g.,
device design, labeling) meant to reduce
the risk of cross-contamination between
patients from the day-use of irrigation
system tubing, valves, and accessories.
FDA announced the availability of the
draft guidance in the Federal Register of
January 20, 2015 (80 FR 2711).
Interested persons were invited to
comment by April 20, 2015, and the
final guidance includes revisions
intended to address the comments
received.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on Mitigating the Risk
of Cross-Contamination From Valves
and Accessories Used for Irrigation
Through Flexible Gastrointestinal
Endoscopes. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Mitigating the Risk of CrossContamination from Valves and
Accessories Used for Irrigation Through
Flexible Gastrointestinal Endoscopes’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400054 to
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identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; and the collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28604 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0735]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
29, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW nd
title Superimposed Text in Direct-toConsumer Promotion of Prescription
Drugs. Also include the FDA docket
SUMMARY:
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number found in brackets in the
heading of this document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Superimposed Text in Direct-toConsumer Promotion of Prescription
Drugs—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(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
superimposed text (supers) in
advertising to today’s modern direct-toconsumer (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
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
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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 text
information in advertising topics
outside of prescription drugs (Refs. 6, 7,
and 8). These studies all generally found
that text size was associated with
comprehension, such that 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% of
respondents, ‘‘large’’ text size (>1⁄2 inch
size) was associated with
comprehension for 79% 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
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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. Our proposed
study seeks to address these
unanswered questions regarding the use
of supers in prescription drug
promotion.
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?
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 one of 12 experimental
study arms differentiated by:
• Super text size (small, medium,
large);
• Device type (television, tablet);
• Super text contrast (high, low).
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
TABLE 1—DESIGN AND CELL SIZES FOR MAIN STUDY
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Note: The sample will be split evenly across three 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
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 (ANOVA).
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 healthcare 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.
In the Federal Register of March 9,
2016 (81 FR 12503), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received 10 comments
total. Six comments were outside the
scope of the proposed research (‘‘Ban
DTC’’), leaving four substantive
comments.
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1. Abbvie
a. Comment: Mobile users can change
font size and viewing size—we should
incorporate this into our study.
Response: Although the font size for
certain text (such as newspaper articles)
or closed captioning text size can be
changed on a tablet, supers within a
developed video cannot be
manipulated. Participants will be
allowed to hold the tablet as they
normally would, but it is important to
establish experimental control over
many user settings to avoid threats to
internal validity. Thus, font and viewing
size will be standardized for this study.
b. Comment: Recommend looking at
use of TV and mobile devices
concurrently, as some people use them
this way.
Response: This is a good suggestion
for future research, but is out of scope
for the current study.
2. Lilly
a. Comment: Generally supportive;
research objectives and study approach
are reasonable.
Response: Thank you.
b. Comment: Recommend showing
supers in black box at bottom of the
screen and not superimposing them
over moving, contrasting color field to
mimic common practices in television
commercial advertising.
Response: Our high contrast condition
indeed presents the supers in white font
on a black background at the bottom of
the screen. Our low contrast condition
shows lettering over the moving scenes
because not all advertisements show
their supers in a black banner.
c. Comment: Lilly requests clarity
about how the size of text and level of
contrast were developed when the
agency reports the results of the study.
Response: We used cognitive
interviews and will use the pretest to
make these determinations. We will be
sure to include this information when
we report the results of the study.
d. Comment: Recommend qualitative
pre-test instead of quantitative pretest.
Response: We fulfilled this suggested
purpose with a set of nine cognitive
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interviews that were conducted in
April.
e. Comment: Request clarity about
quota sampling and other techniques we
may plan to use to ensure a diverse
sample. Also suggest groups of at least
50 in each cell for analysis purposes.
Response: As this study is not
intended to be nationally representative,
we will not employ strict quota
sampling procedures. However, we will
work closely with our recruitment firms
to monitor recruitment and ensure that
our sample is diverse with regard to
factors including race, education, age
and gender. Further, selection of our
three U.S. cities for data collection (Los
Angeles, Cincinnati and Tampa) was
purposive to help achieve diversity on
these factors.
To answer the second part of the
comment, we are aware of no statistical
or research standard that specifies that
groups must contain 50 individuals.
However, we conducted power analyses
and determined that in order to have
enough power for the proposed
statistical tests, we will exceed this
number per experimental cell.
f. Comment: Recommends replacing
the pre-test question about the
importance of the text information
(Question 5) with a question such as
‘‘how noticeable or legible was the text
information?’’
Response: We agree that the
noticeability and legibility of the text
information is important, and we have
other questions that address this. We are
specifically interested in the perceived
importance of the text information as a
moderator variable.
g. Comment: Recommends removing
semantic differential questions
(Question 9) and essentially any
questions that ask about perceptions
because it is a pretest.
Response: Our pretest study is not
designed to test the main study
questionnaire. Rather, the main
purposes of the pretest are to (1) test
consumer perceptions of superimposedtext size with the aim of choosing
perceptibly different levels of size
(small, medium, large) for use in the
main study; and (2) test our planned
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
procedures for implementation of the
intervention (TV and tablet) and inperson data collection. However, to
make the most use of our resources, we
also plan to test the properties of certain
main study survey items (e.g., means,
ranges, etc.) to ensure the utility of the
items for use in the main study.
h. Comment: Calls out an
inconsistency in terms of how many
times participants will view the ad.
Response: Thank you for noting that
discrepancy. Participants will view the
ad once. We have corrected all materials
to reflect this change. Lilly recommends
showing it twice. We agree that if the
goal is to learn about user experience
(preferences and such, or trying to
improve the presentation) then two or
more viewings makes sense. However,
our goal is to test differences in
cognitive processing based on the varied
size/contrast presentations of the
supers. Thus, we do not want to
artificially enhance the scrutiny
participants pay to the ad above and
beyond the experimental situation. For
example, small supers may interfere
with cognitive processing as
hypothesized, but this interference may
be overcome upon a second viewing. In
a real world viewing situation,
consumers rarely see an ad two times in
a row.
i. Comment: Question 12: Attributes
are very similar and will be duplicative.
Response: The three survey items for
question 12 (attitudes towards the ad)
are conceptually similar and will be
used as a multi-item scale.
Conventionally, three items is the
minimum recommended to assess interitem reliability.
j. Comment: Question 12 and 14:
Suggest bolding or underlining ‘‘drug’’
or ‘‘ad’’ in these questions to
differentiate them for participants.
Response: We agree and have added
language to the survey items to better
make this distinction. For items specific
to attitudes towards the drug we now
begin the item with ‘‘Overall, DRUG X
is . . .’’ whereas items about the ad
begin with ‘‘Overall, the ad was . . .’’
k. Comment: Would be interesting to
include an open-ended question about
whether any additional information
could have or should have been
provided in the ad, such as accessibility
to the drug, information about the
disease, etc.
Response: These are great ideas and
would provide additional information
about various communication issues
relevant to DTC television promotion.
However, we regret that we must make
difficult choices about what to include
and not include in this study and these
issues fall outside the scope of the
current research questions.
3. Merck
a. Comment: FDA’s execution may not
yield useful data. For example, we are
examining TV and tablet use, but people
may be viewing promotion on mobile
devices.
Response: We agree that the ways in
which people view their media are
multiplying and that we have not
captured all of them. However, rather
than simply study superimposed text on
a television screen, we opted to add an
examination of viewing on a tablet,
which is an increasingly popular option
for viewing shows. We regret that we do
not have the opportunity to explore
viewing on all possible new
technologies, but we believe that the
current study will offer insights above
and beyond the television screen.
b. Comment: Prior to the
implementation of results from
individual studies on the content,
format, and presentation of information
in DTC advertisements on television,
FDA should conduct research on the
combination of all of the individual
factors.
Response: This comment is outside
the scope of the present project. It is not
directed at the improvement of the
study and does not appear to require the
abandonment of the current study.
4. GlaxoSmithKline (GSK)
a. Comment: Allowing participants to
view the TV at the distance they usually
view it and to interact with the tablet
the way they ordinarily do would better
reflect a real-world experience.
Response: We agree that these details
are important to consider when
conducting valid research. We must
make a decision between the trade-off of
experimental control and real-world
85971
generalizability. We have attempted to
do this by setting up the television and
chair in the room at the average distance
that people tend to sit from their
televisions in their living room and
instructing participants to wear glasses
or contact lenses if needed. Television
viewing is a more fixed experience than
more modern technologies. We also
agree that allowing individuals to hold
the tablet or place it on a table as they
normally would is appropriate for both
experimental control and ecological
generalizability.
b. Comment: Including a medium
contrast instead of just a high and low
contrast may be informative.
Response: We appreciate this
comment because we considered it
when designing the study. We decided
to use only high and low contrast in the
study because our main variable of
interest in this particular study is the
size of the text. Thus, we are expending
resources to attempt to determine
multiple sizes of text to test in order to
get a fuller appreciation of the role of
text size in DTC promotion. We have
found in past studies that identifying a
medium level is difficult (e.g., OMB
Control No. 0910–0695) and chose in
this study to focus on size rather than
contrast. That said, we do feel that
contrast is valuable enough to add as a
variable of interest, so we are planning
to devote two conditions to it.
c. Comment: It would be useful if the
questionnaire is posted along with the
notice on regulations.gov.
Response: We are happy to provide
the questionnaire to anyone who
requests it.
d. Comment: Suggests an FDAIndustry working group might be
helpful in the furtherance of this
research.
Response: This is an intriguing idea
and may have merit after we obtain
empirical data that is specifically
applicable to DTC promotion. Without
this data, it is unclear what this working
group would contribute. We will
consider this idea in further detail upon
interpretation of results.
FDA estimates the burden of this
collection of information as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
(in hours)
Total hours
Pretesting
Number to complete the screener (assumes 50%
eligible).
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of completes ...............................................
Number of
responses per
respondent
240
Total annual
responses
Average burden
per response
(in hours)
Total hours
1
240
0.42 (25 minutes) ......
101
Main Study
Number to complete the screener (assumes 50%
eligibility).
Number of completes ...............................................
1,785
1
1,785
0.08 (5 minutes) ........
143
1,272
1
1,272
0.42 (25 minutes) ......
534
Total hours ........................................................
........................
........................
........................
....................................
805
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at 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. Hall R.H. and P. Hanna ‘‘The Impact of
Web page Text-background Colour
Combinations on Readability, Retention,
Aesthetics, and Behavioural Intention.’’
Behavior & Information Technology. vol.
23 pp. 183–95, 2004.
2. Baur C and C. Prue ‘‘The CDC Clear
Communication Index is a Tool to
Prepare and Review Health
Information.’’ Health Promotion Practice.
vol.15 pp. 629–37, 2014.
3. Shrank W, J. Avorn, C. Rolon, and
P.Shekelle ‘‘Effect of Content and Format
of Prescription Drug Labels on
Readability, Understanding, and
Medication Use: A Systematic Review.’’
Annals of Pharmacotherapy. vol. 41 pp.
783–801, 2007.
4. Wogalter, M.S. and W.J. Vigilante. ‘‘Effects
of Label Format on Knowledge
Acquisition and Perceived Readability
by Younger and Older Adults.’’
Ergonomics. vol. 46 pp. 327–344, 2003.
5. Smither, J.A.A. and C.C. Braun
‘‘Readability of Prescription Drug Labels
by Older and Younger Adults.’’ Journal
of Clinical Psychology in Medical
Settings. vol. 1 pp. 149–59, 1994.
6. Foxman, E.R., D.D. Muehling and P.A.
Moore. ‘‘Disclaimer Footnotes in Ads:
Discrepancies Between Purpose and
Performance.’’ Journal of Public Policy
and Marketing. vol. 7 pp. 127–37, 1988.
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. vol. 16 pp. 145–170, 1993.
8. Manrai, L.A., A.K. Manrai and N. Murray.
VerDate Sep<11>2014
17:48 Nov 28, 2016
Jkt 241001
‘‘Comprehension of Info-aid Supers in
Television Advertising for Social Ideas:
Implications for Public Policy’’. Journal
of Business Research. vol. 30 pp. 75–84,
1994.
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. vol. 26 pp. 527–36, 2000.
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. vol. 15 pp. 471–
9, 1931.
12. Legge G.E., G.S. Rubin and A. Luebner
‘‘Psychophysics of reading. V. The Role
of Contrast in Normal Vision.’’ Vision
Research vol. 27 pp. 1165–77, 1987.
13. Kaufman D.W., J.P. Kelly, L. Rosenberg,
T.E. Anderson and A.A. Mitchell.
‘‘Recent Patterns of Medication Use in
the Ambulatory Adult Population of the
United States: The Slone Survey.’’
Journal of the American Medical
Association vol. 287 pp. 337–344, 2002.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28733 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–F–3880]
Novus International, Inc.; Filing of
Food Additive Petition (Animal Use);
Correction
AGENCY:
The Food and Drug
Administration is correcting a notice
entitled ‘‘Novus International, Inc.;
Filing of Food Additive Petition
(Animal Use)’’ that appeared in the
Federal Register of November 8, 2016
(81 FR 78528). The document
announced that Novus International,
Inc., has filed a petition proposing that
the food additive regulations be
amended to provide for the safe use of
poly (2-vinylpyridine-co-styrene) as a
nutrient protectant for methionine
hydroxy analog in animal food for beef
cattle, dairy cattle, and replacement
dairy heifers. Additionally, the petition
proposes that the food additive
regulations be amended to provide for
the safe use of ethyl cellulose as a
binder for methionine hydroxy analog to
be incorporated into animal food. The
document was published with the
incorrect docket number. This
document corrects that error.
SUMMARY:
Lisa
Granger, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 3330, Silver Spring, MD 20993–
0002, 301–796–9115, lisa.granger@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of Tuesday, November
8, 2016, in FR Doc. 2016–26922, on page
78528, the following correction is made:
On page 78528, in the first column,
‘‘Docket No. FDA–2014–F–0452’’ is
corrected to read ‘‘Docket No. FDA–
2016–F–3880’’.
SUPPLEMENTARY INFORMATION:
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28656 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS
ACTION:
PO 00000
Notice; correction.
Frm 00053
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]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85968-85972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28733]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0735]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 29, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW nd
title Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs. Also include the FDA docket
[[Page 85969]]
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Superimposed Text in Direct-to-Consumer Promotion of Prescription
Drugs--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(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 superimposed text (supers) in advertising to today's modern direct-
to-consumer (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 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 text information in advertising topics outside of prescription drugs
(Refs. 6, 7, and 8). These studies all generally found that text size
was associated with comprehension, such that 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% of
respondents, ``large'' text size (>\1/2\ inch size) was associated with
comprehension for 79% 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. Our proposed study seeks to address these unanswered questions
regarding the use of supers in prescription drug promotion.
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?
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 one of 12
experimental study arms differentiated by:
Super text size (small, medium, large);
Device type (television, tablet);
Super text contrast (high, low).
[[Page 85970]]
Table 1--Design and Cell Sizes for Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The sample will be split evenly across three 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 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
(ANOVA).
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 healthcare
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.
In the Federal Register of March 9, 2016 (81 FR 12503), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received 10 comments total. Six comments
were outside the scope of the proposed research (``Ban DTC''), leaving
four substantive comments.
1. Abbvie
a. Comment: Mobile users can change font size and viewing size--we
should incorporate this into our study.
Response: Although the font size for certain text (such as
newspaper articles) or closed captioning text size can be changed on a
tablet, supers within a developed video cannot be manipulated.
Participants will be allowed to hold the tablet as they normally would,
but it is important to establish experimental control over many user
settings to avoid threats to internal validity. Thus, font and viewing
size will be standardized for this study.
b. Comment: Recommend looking at use of TV and mobile devices
concurrently, as some people use them this way.
Response: This is a good suggestion for future research, but is out
of scope for the current study.
2. Lilly
a. Comment: Generally supportive; research objectives and study
approach are reasonable.
Response: Thank you.
b. Comment: Recommend showing supers in black box at bottom of the
screen and not superimposing them over moving, contrasting color field
to mimic common practices in television commercial advertising.
Response: Our high contrast condition indeed presents the supers in
white font on a black background at the bottom of the screen. Our low
contrast condition shows lettering over the moving scenes because not
all advertisements show their supers in a black banner.
c. Comment: Lilly requests clarity about how the size of text and
level of contrast were developed when the agency reports the results of
the study.
Response: We used cognitive interviews and will use the pretest to
make these determinations. We will be sure to include this information
when we report the results of the study.
d. Comment: Recommend qualitative pre-test instead of quantitative
pretest.
Response: We fulfilled this suggested purpose with a set of nine
cognitive interviews that were conducted in April.
e. Comment: Request clarity about quota sampling and other
techniques we may plan to use to ensure a diverse sample. Also suggest
groups of at least 50 in each cell for analysis purposes.
Response: As this study is not intended to be nationally
representative, we will not employ strict quota sampling procedures.
However, we will work closely with our recruitment firms to monitor
recruitment and ensure that our sample is diverse with regard to
factors including race, education, age and gender. Further, selection
of our three U.S. cities for data collection (Los Angeles, Cincinnati
and Tampa) was purposive to help achieve diversity on these factors.
To answer the second part of the comment, we are aware of no
statistical or research standard that specifies that groups must
contain 50 individuals. However, we conducted power analyses and
determined that in order to have enough power for the proposed
statistical tests, we will exceed this number per experimental cell.
f. Comment: Recommends replacing the pre-test question about the
importance of the text information (Question 5) with a question such as
``how noticeable or legible was the text information?''
Response: We agree that the noticeability and legibility of the
text information is important, and we have other questions that address
this. We are specifically interested in the perceived importance of the
text information as a moderator variable.
g. Comment: Recommends removing semantic differential questions
(Question 9) and essentially any questions that ask about perceptions
because it is a pretest.
Response: Our pretest study is not designed to test the main study
questionnaire. Rather, the main purposes of the pretest are to (1) test
consumer perceptions of superimposed-text size with the aim of choosing
perceptibly different levels of size (small, medium, large) for use in
the main study; and (2) test our planned
[[Page 85971]]
procedures for implementation of the intervention (TV and tablet) and
in-person data collection. However, to make the most use of our
resources, we also plan to test the properties of certain main study
survey items (e.g., means, ranges, etc.) to ensure the utility of the
items for use in the main study.
h. Comment: Calls out an inconsistency in terms of how many times
participants will view the ad.
Response: Thank you for noting that discrepancy. Participants will
view the ad once. We have corrected all materials to reflect this
change. Lilly recommends showing it twice. We agree that if the goal is
to learn about user experience (preferences and such, or trying to
improve the presentation) then two or more viewings makes sense.
However, our goal is to test differences in cognitive processing based
on the varied size/contrast presentations of the supers. Thus, we do
not want to artificially enhance the scrutiny participants pay to the
ad above and beyond the experimental situation. For example, small
supers may interfere with cognitive processing as hypothesized, but
this interference may be overcome upon a second viewing. In a real
world viewing situation, consumers rarely see an ad two times in a row.
i. Comment: Question 12: Attributes are very similar and will be
duplicative.
Response: The three survey items for question 12 (attitudes towards
the ad) are conceptually similar and will be used as a multi-item
scale. Conventionally, three items is the minimum recommended to assess
inter-item reliability.
j. Comment: Question 12 and 14: Suggest bolding or underlining
``drug'' or ``ad'' in these questions to differentiate them for
participants.
Response: We agree and have added language to the survey items to
better make this distinction. For items specific to attitudes towards
the drug we now begin the item with ``Overall, DRUG X is . . .''
whereas items about the ad begin with ``Overall, the ad was . . .''
k. Comment: Would be interesting to include an open-ended question
about whether any additional information could have or should have been
provided in the ad, such as accessibility to the drug, information
about the disease, etc.
Response: These are great ideas and would provide additional
information about various communication issues relevant to DTC
television promotion. However, we regret that we must make difficult
choices about what to include and not include in this study and these
issues fall outside the scope of the current research questions.
3. Merck
a. Comment: FDA's execution may not yield useful data. For example,
we are examining TV and tablet use, but people may be viewing promotion
on mobile devices.
Response: We agree that the ways in which people view their media
are multiplying and that we have not captured all of them. However,
rather than simply study superimposed text on a television screen, we
opted to add an examination of viewing on a tablet, which is an
increasingly popular option for viewing shows. We regret that we do not
have the opportunity to explore viewing on all possible new
technologies, but we believe that the current study will offer insights
above and beyond the television screen.
b. Comment: Prior to the implementation of results from individual
studies on the content, format, and presentation of information in DTC
advertisements on television, FDA should conduct research on the
combination of all of the individual factors.
Response: This comment is outside the scope of the present project.
It is not directed at the improvement of the study and does not appear
to require the abandonment of the current study.
4. GlaxoSmithKline (GSK)
a. Comment: Allowing participants to view the TV at the distance
they usually view it and to interact with the tablet the way they
ordinarily do would better reflect a real-world experience.
Response: We agree that these details are important to consider
when conducting valid research. We must make a decision between the
trade-off of experimental control and real-world generalizability. We
have attempted to do this by setting up the television and chair in the
room at the average distance that people tend to sit from their
televisions in their living room and instructing participants to wear
glasses or contact lenses if needed. Television viewing is a more fixed
experience than more modern technologies. We also agree that allowing
individuals to hold the tablet or place it on a table as they normally
would is appropriate for both experimental control and ecological
generalizability.
b. Comment: Including a medium contrast instead of just a high and
low contrast may be informative.
Response: We appreciate this comment because we considered it when
designing the study. We decided to use only high and low contrast in
the study because our main variable of interest in this particular
study is the size of the text. Thus, we are expending resources to
attempt to determine multiple sizes of text to test in order to get a
fuller appreciation of the role of text size in DTC promotion. We have
found in past studies that identifying a medium level is difficult
(e.g., OMB Control No. 0910-0695) and chose in this study to focus on
size rather than contrast. That said, we do feel that contrast is
valuable enough to add as a variable of interest, so we are planning to
devote two conditions to it.
c. Comment: It would be useful if the questionnaire is posted along
with the notice on regulations.gov.
Response: We are happy to provide the questionnaire to anyone who
requests it.
d. Comment: Suggests an FDA-Industry working group might be helpful
in the furtherance of this research.
Response: This is an intriguing idea and may have merit after we
obtain empirical data that is specifically applicable to DTC promotion.
Without this data, it is unclear what this working group would
contribute. We will consider this idea in further detail upon
interpretation of results.
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 per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretesting
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50% 338 1 338 0.08 (5 minutes).......................... 27
eligible).
[[Page 85972]]
Number of completes......................... 240 1 240 0.42 (25 minutes)......................... 101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to complete the screener (assumes 50% 1,785 1 1,785 0.08 (5 minutes).......................... 143
eligibility).
Number of completes......................... 1,272 1 1,272 0.42 (25 minutes)......................... 534
-----------------------------------------------------------------------------------------------------------
Total hours............................. .............. .............. .............. .......................................... 805
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at 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. Hall R.H. and P. Hanna ``The Impact of Web page Text-background
Colour Combinations on Readability, Retention, Aesthetics, and
Behavioural Intention.'' Behavior & Information Technology. vol. 23
pp. 183-95, 2004.
2. Baur C and C. Prue ``The CDC Clear Communication Index is a Tool
to Prepare and Review Health Information.'' Health Promotion
Practice. vol.15 pp. 629-37, 2014.
3. Shrank W, J. Avorn, C. Rolon, and P.Shekelle ``Effect of Content
and Format of Prescription Drug Labels on Readability,
Understanding, and Medication Use: A Systematic Review.'' Annals of
Pharmacotherapy. vol. 41 pp. 783-801, 2007.
4. Wogalter, M.S. and W.J. Vigilante. ``Effects of Label Format on
Knowledge Acquisition and Perceived Readability by Younger and Older
Adults.'' Ergonomics. vol. 46 pp. 327-344, 2003.
5. Smither, J.A.A. and C.C. Braun ``Readability of Prescription Drug
Labels by Older and Younger Adults.'' Journal of Clinical Psychology
in Medical Settings. vol. 1 pp. 149-59, 1994.
6. Foxman, E.R., D.D. Muehling and P.A. Moore. ``Disclaimer
Footnotes in Ads: Discrepancies Between Purpose and Performance.''
Journal of Public Policy and Marketing. vol. 7 pp. 127-37, 1988.
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.
vol. 16 pp. 145-170, 1993.
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. vol. 30 pp. 75-
84, 1994.
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. vol. 26 pp. 527-36, 2000.
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. vol. 15 pp.
471-9, 1931.
12. Legge G.E., G.S. Rubin and A. Luebner ``Psychophysics of
reading. V. The Role of Contrast in Normal Vision.'' Vision Research
vol. 27 pp. 1165-77, 1987.
13. Kaufman D.W., J.P. Kelly, L. Rosenberg, T.E. Anderson and A.A.
Mitchell. ``Recent Patterns of Medication Use in the Ambulatory
Adult Population of the United States: The Slone Survey.'' Journal
of the American Medical Association vol. 287 pp. 337-344, 2002.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28733 Filed 11-28-16; 8:45 am]
BILLING CODE 4164-01-P
