[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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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