Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television, 52472-52477 [2018-22567]
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A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
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toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product TREMFYA
(guselkumab). TREMFYA is indicated
for the treatment of adult patients with
moderate-to-severe plaque psoriasis
who are candidates for systemic therapy
or phototherapy. Subsequent to this
approval, the USPTO received patent
term restoration applications for
TREMFYA (U.S. Patent Nos.7,935,344
and 7,993,645) from Janssen Biotech,
Inc., and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated January 9, 2018, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of TREMFYA represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TREMFYA is 2,968 days. Of this time,
2,728 days occurred during the testing
phase of the regulatory review period,
while 240 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 30, 2009. The
applicant claims April 30, 2009, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 30, 2009,
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which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 16, 2016. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for TREMFYA (BLA 761061) was
initially submitted on November 16,
2016.
3. The date the application was
approved: July 13, 2017. FDA has
verified the applicant’s claim that BLA
761061 was approved on July 13, 2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,252 days or 1,203
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
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comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22571 Filed 10–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3516]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Disease
Awareness and Prescription Drug
Promotion on Television
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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,
‘‘Disease Awareness and Prescription
Drug Promotion on Television.’’
DATES: Submit either electronic or
written comments on the collection of
information by December 17, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 17, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3516 for ‘‘Disease Awareness
and Prescription Drug Promotion on
Television.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10:00 a.m.–12:00 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–7726, PRAStaff@
fda.hhs.gov. For copies of the
questionnaire contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
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
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respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Disease Awareness and Prescription
Drug Promotion on Television (OMB
Control Number 0910—NEW)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (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 FDA’s Center for Drug Evaluation
and Research (CDER), Office of
Prescription Drug Promotion (OPDP) is
responsible for ensuring that
prescription drug promotional materials
are truthful, balanced, and accurately
communicated. This project is being
proposed as part of the research
program of OPDP. OPDP’s research
program supports this mission by
providing scientific evidence to help
ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that we believe are most central to our
mission, focusing in particular on three
main topic areas: Advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features we assess how elements such as
graphics, format, and disease and
product characteristics impact the
communication and understanding of
prescription drug risks and benefits;
focusing on target populations allows us
to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience; and our
focus on research quality aims at
maximizing the quality of research data
through analytical methodology
development and investigation of
sampling and response issues. This
study falls under the topic of both target
populations and advertising features.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings is improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
policies as well as our research program.
Our research is documented on our
homepage, which can be found at:
https://www.fda.gov/aboutfda/
centersoffices/officeofmedicalproducts
andtobacco/cder/ucm090276.htm. The
website includes links to the latest
Federal Register notices and peerreviewed publications produced by our
office. The website maintains
information on studies we have
conducted, dating back to a DTC survey
conducted in 1999.
The present research concerns disease
awareness and prescription drug
promotion communications on
television. When pharmaceutical
companies market a new drug, they
often also release disease awareness
communications about the medical
condition the new drug is intended to
treat (Ref. 1; Ref. 2). FDA is interested
in whether and to what extent this
practice may result in consumers
confusing or otherwise misinterpreting
the different information and claims
presented in disease awareness
communications and prescription drug
promotion. Prior research has
documented that in both print (Ref. 3)
and online (Ref. 4) contexts, consumers
tend to conflate the information
presented in prescription drug
promotional materials with information
presented in disease awareness
communications. Specifically, the
results of these studies suggest
consumers incorrectly ascribe benefits
to a prescription drug as a result of
being exposed to information in a
disease awareness communication that
broadly describes the symptoms and
negative consequences of the disease.
There are ways in which this effect can
be attenuated. For example, prior
research has indicated that greater
visual distinctiveness between the two
ad types can ameliorate such confusion
(Ref. 3). The present research seeks to
extend previous studies of print and
online promotion to the context of
television promotion, and broadly
examine how perceptual similarity
between the two communication types,
as well as their temporal proximity and
exposure frequency, may impact the
nature and extent of viewer confusion.
Fors Marsh Group (FMG) is
conducting this research under the
guidance and supervision of FDA to
determine how the similarity, temporal
positioning, and frequency of exposure
to disease awareness communications
and prescription drug television
promotion impact consumer perception
and understanding of the benefits and
risks of a prescription drug product.
These objectives will be achieved using
two experimental studies. The first
study will explore the impact on
consumer perception and
comprehension of different levels of
temporal separation between the disease
awareness communication and
prescription drug promotion within a
single period of television programming,
as well as the level of similarity versus
distinctiveness between these
communication types. Temporal
separation is defined as the spacing or
proximity between the disease
awareness communication and
prescription drug promotion in the
hour-long programming, for example, if
they are shown back-to-back or if they
are separated by other ads or television
programming. Similarity/distinctiveness
is defined by variations between the
disease awareness communication and
prescription drug promotion, including
visual and presentation elements such
as the setting, actors, and colors. The
second study will experimentally
examine the impact of disease
awareness communication temporal
separation and exposure frequency on
consumer perception and
comprehension. Temporal separation in
this second study again refers to the
spacing or proximity between the
disease awareness communication and
prescription drug promotion but is
operationally defined as either one day
or one week. Exposure frequency is
defined as the number of times that
participants will view the disease
awareness communication, either one,
three, or six times. The results of this
latter study will examine the practice of
‘‘seeding the market,’’ in which
pharmaceutical companies release
disease awareness communications
before releasing product promotion
communications. Similarity versus
distinctiveness will also be examined in
this study.
We propose the following hypotheses
for this research:
Study 1:
H1: Increased perceptual similarity
between a disease awareness
communication and a prescription drug
promotion will result in significantly
more conflation of the information
presented in both pieces.
H2: Increased temporal proximity
between a disease awareness
communication and a prescription drug
promotion will result in significantly
more conflation of the information
presented in both pieces.
Study 2:
H1: Increased frequency of exposure
to a disease awareness communication
before exposure to a prescription drug
promotion will result in significantly
more conflation of the information
presented in both pieces.
H2: Increased temporal proximity
between a disease awareness
communication and a prescription drug
promotion will result in significantly
more conflation of the information
presented in both pieces.
H3: Increased perceptual similarity
between a disease awareness
communication and a prescription drug
promotion will result in significantly
more conflation of the information
presented in both pieces.
In each instance, conflation is
operationalized as the extent to which
an individual remembers and attributes
benefits to a product that is based on
information presented in a disease
awareness communication and not in
the drug promotion.
To address these hypotheses, Study 1
will employ a 3x4 factorial design in
which participants are randomly
assigned to one disease awareness
communication condition, plus one
control condition where participants
will not view a disease awareness
communication. The extent to which
the disease awareness communication is
perceptually similar to the product
promotion communication will vary, as
will the temporal separation of the
disease awareness communication and
product promotion communication.
Table 1 depicts our design visually.
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TABLE 1—STUDY 1 EXPERIMENTAL DESIGN
Disease awareness and product ad temporal separation
Disease awareness ad
Yes .............................
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Perceptual similarity
to product ad
Back to back
Within same
commercial pod 1
In neighboring
commercial pods
Similar.
Semi-similar.
Distinct.
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In non-neighboring
commercial pods
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TABLE 1—STUDY 1 EXPERIMENTAL DESIGN—Continued
Disease awareness and product ad temporal separation
Disease awareness ad
No ...............................
Perceptual similarity
to product ad
Back to back
Within same
commercial pod 1
In neighboring
commercial pods
In non-neighboring
commercial pods
N/A.
Study 2 will employ a 2x2x3 factorial
design in which participants are
randomly assigned to one disease
awareness communication condition.
The varying factors in Study 2 are the
temporal separation between the disease
promotion communication. Table 3
visually depicts our design. Of note, to
reduce the overall number of
experimental conditions for Study 2, no
semi-similar experimental condition is
used.
awareness and product promotion
communication, the number of
exposures to the disease awareness
communication, and the perceptual
similarity of the disease awareness
communication to the product
TABLE 3—STUDY 2 EXPERIMENTAL DESIGN
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One Week .........................
One exposure
Three exposures
Six exposures
Similar.
Distinct.
Similar.
Distinct.
Study 1 and 2 Sample. The targeted
voluntary sample for both studies will
comprise adults who self-report a
current asthma diagnosis, a lifetime
incidence of asthma, or experience a
large number of asthma symptoms.
These groups are believed to be very
likely to be targeted by disease
awareness and product promotion
1 A commercial pod refers to a group of ads into
which the test ad is inserted, designed to simulate
an advertising break during a television program.
As depicted in Table 2, by neighboring commercial
pods, we mean commercial pods separated only by
television programming and no other commercial
pods. By non-neighboring commercial pods, we
mean commercial pods separated by both television
programming and one or more (one, as studied
here) other commercial pods.
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EN17OC18.024</GPH>
One Day ............................
Exposures to disease awareness ad
Perceptual similarity of ads
EN17OC18.023</GPH>
Time delay until product ad
exposure
(temporal separation)
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Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
communications for asthma. The
combined incidence rate of these groups
is 22.2% (Ref. 5; Ref. 6). In addition,
several exclusion criteria are specified.
These include: (1) Training or
employment as a healthcare
professional, (2) employment with a
pharmaceutical company, an advertising
agency, a market research company, or
the Department of Health and Human
Services (HHS), and (3) participation in
market research within the past three
months on the topic of prescription
drugs. Pretest participants will also be
ineligible for the main study.
Pretesting. Pretesting will take place
before the main studies to evaluate the
procedures used in the main studies.
Each of the two pretests will have the
same design as its respective main study
(pretest 1 for Study 1 and pretest 2 for
Study 2). The purpose of both pretests
will be to: (1) Ensure that the mock
stimuli are understandable, viewable,
and delivering intended messages; (2)
identify and eliminate any challenges to
embedding the mock stimuli within the
online survey; (3) ensure that survey
questions are appropriate and meet the
analytical goals of the research; and (4)
pilot test the methods, including
examining response rates and timing of
survey. The two pretests will be
conducted simultaneously.2 Based on
pretest findings, we will refine the mock
stimuli, survey questions, and data
collection process, as necessary, to
optimize the full-scale study conditions.
Measurement. Our planned analyses
are designed to address the key
hypotheses. For both Study 1 and Study
2, we anticipate that the primary
analysis will be analysis of variance
(ANOVA) to compare the main and
interaction effects of the experimental
factors.
The focal dependent variable will be
conflation—a measure of memory and
perceptions regarding the promoted
drug relative to the information
presented in the disease awareness
communication. Conflation will be
measured by using the number of
benefits that are incorrectly attributed to
the prescription drug product based on
responses to a number of both openended and closed-ended items.
Other key dependent variables will
reflect perceptions and attitudes toward
the product ad. These include measures
of:
1. Perception of product promotion
effectiveness;
2. Behavioral intentions toward the
drug;
3. Perceived efficacy of the drug; and
4. Perceived risks of the drug.
In addition to the primary variables of
interest, we have also identified
potential covariates that will be
included in the analyses:
1. Knowledge about asthma;
2. Health literacy; and
3. Perceived ad effectiveness.
We expect that knowledge about
asthma and increased health literacy
may moderate any conflation that
results from ad similarity, temporal
proximity, and frequency of exposure.
Perceptions of promotion effectiveness,
on the other hand, can be examined
both as an outcome/dependent variable
but also as a covariate that examines
involvement with the product
promotion. Greater involvement may
attenuate conflation in that it directs
more in-depth processing of both the
disease awareness communication and
product promotion, and therefore more
correct understanding of the claims in
each (Ref. 7; Ref. 8; Ref. 9).
FDA estimates the burden of this
collection of information as follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Study
Study
Study
Study
Study
1
2
1
2
1
Total annual
responses
Average
burden per
response
Pretest screener .....................................................
Pretest screener .....................................................
screener ..................................................................
screener ..................................................................
Pretest ....................................................................
385
329
3,007
2,643
270
1
1
1
1
1
385
329
3,007
2,643
270
Study 2 Pretest ....................................................................
158
1
158
Study 1 .................................................................................
2,105
1
2,105
Study 2 .................................................................................
1,269
1
1,269
0.08 (∼5 min.)
0.08 (∼5 min.)
0.08 (∼5 min.)
0.08 (∼5 min.)
1.33 (∼1 hr 20
min.)
0.53 (∼32
min.)
1.33 (∼1 hr 20
min.)
0.53 (32 min.)
Total ..............................................................................
........................
........................
........................
........................
1 There
Total hours
31
26
241
211
360
84
2,800
673
4,426
are no capital costs or operating and maintenance costs associated with this collection of information.
References
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Number of
responses per
respondent
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
2 Pretesting will be preceded by cognitive
interviewing, not described here. Cognitive
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1. https://www.fiercepharma.com/marketing/
unbranded-pharma-ad-what-are-theygood-for-actually-quite-a-bit-marketerpanelists-say?mkt_tok=eyJpIjoiWkRnel
pUSmlORFpoWkdNMSIsInQiOiJPa
ENIUERpT0tnUmt6Y1BPMk9LT
npreUI3bUtPOVRzRnh1RzNuW
UtYQmp0cWJhcW05UFhlcllwTzI3V0
RJSndjVkZLR3NGUHBLamJOZmJ
SK2FZeWtIVXczeFRFcmtEV0NFaV
dCSjArUmx4dUlRVHZpUzFFOWlVY0d
Nb1RzOU9XayJ9&mrkid=20932234.
2. https://www.fiercepharma.com/marketing/
avanir-launches-nuedexta-brandcampaign-retires-danny-glover-pbadisease-awareness-ad.
3. Aikin, K. J., Sullivan, H. W., & Betts, K.
R. (2016). Disease information in directto-consumer prescription drug print ads.
Journal of Health Communication, 21,
228–239.
4. Sullivan, H. W., O’Donoghue, A. C.,
Rupert, D. J., Willoughby, J. F.,
Amoozegar, J. B., & Aikin, K. J. (2016).
Are disease awareness links on
prescription drug websites misleading?
interviews are used to probe a small sample of
participants on how and why they responded to
various questions as they did, resulting in strong
measurement instruments.
Register, but websites are subject to
change over time.
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17OCN1
Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
A randomized study. Journal of Health
Communication, 21, 1198–1207.
5. Centers for Disease Control and
Prevention. (2018a, May 18). 2016
National Health Interview Survey (NHIS)
data. Retrieved from https://
www.cdc.gov/asthma/nhis/2016/table21.htm.
6. Centers for Disease Control and
Prevention. (2018b, May 15). Most recent
asthma data. Retrieved from https://
www.cdc.gov/asthma/most_recent_
data.htm.
7. Petty, R. E., & Cacioppo, J. T. (1979). Issue
involvement can increase or decrease
persuasion by enhancing messagerelevant cognitive responses. Journal of
Personality and Social Psychology, 37,
1915–1926. doi: 10.1037/00223514.37.10.1915.
8. Petty, R. E., & Cacioppo, J. T. (1986). The
elaboration likelihood model of
persuasion. Advances in Experimental
Social Psychology, 19, 123–205. doi:
10.1016/S0065-2601(08)60214-2.
9. Petty, R. E., Cacioppo, J. T., & Goldman,
R. (1981). Personal involvement as a
determinant of argument-based
persuasion. Journal of Personality and
Social Psychology, 41, 847–855. doi:
10.1037/0022-3514.41.5.847.
Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
potential relevance to the growth or
progression of one or more pediatric
cancers. The latter list details those
targets that are unlikely to be associated
with the growth or progression of
pediatric cancers such that statutory
requirements for early pediatric
evaluation would be waived. These lists
fulfill one of FDA’s obligations under
the FDA Reauthorization Act of 2017
(FDARA) and provide information to
industry in planning for initial pediatric
study plan submissions for certain
oncology drugs or biological products in
accordance with the amended
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act). FDA is
establishing this docket for public
comment on possible additions to or
deletions from the list on the lists
described above.
The lists can be found on the
Oncology Center of Excellence:
Pediatric Oncology website at the
following link: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
OCE/ucm544641.htm.
Submit either electronic or
written comments. This docket will
remain open indefinitely.
DATES:
[FR Doc. 2018–22567 Filed 10–16–18; 8:45 am]
BILLING CODE 4164–01–P
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3633]
Oncology Center of Excellence:
Pediatric Oncology Program;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Oncology Center of
Excellence (OCE) Pediatric Oncology
Program of the Food and Drug
Administration (FDA or the Agency)
announces the creation of a list of
molecular targets that have been
determined to be substantially relevant
to the growth or progression of a
pediatric cancer (Candidate Pediatric
Molecular Target List) and a list of
molecular targets of new cancer drugs
and biological products in development
for which requirements for studies in
pediatric cancers would be
automatically waived. The former list
includes molecular targets for which
prevailing evidence and/or a scientific
rationale exists to determine their
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:46 Oct 16, 2018
Jkt 247001
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 below (see ‘‘Written/
Paper Submissions’’ and
‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3633 for ‘‘Oncology Center of
Excellence: Pediatric Oncology Program;
Establishment of a Public Docket;
Request for Comments.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information 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 the information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
E:\FR\FM\17OCN1.SGM
17OCN1
]]>Agencies
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52472-52477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22567]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3516]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Disease Awareness and Prescription Drug Promotion on
Television
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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, ``Disease Awareness and
Prescription Drug Promotion on Television.''
DATES: Submit either electronic or written comments on the collection
of information by December 17, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 17, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note
[[Page 52473]]
that if you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3516 for ``Disease Awareness and Prescription Drug Promotion
on Television.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10:00 a.m.-12:00
p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected]. For copies of the questionnaire contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
[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.
Disease Awareness and Prescription Drug Promotion on Television (OMB
Control Number 0910--NEW)
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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 FDA's Center for Drug Evaluation and Research (CDER), Office of
Prescription Drug Promotion (OPDP) is responsible for ensuring that
prescription drug promotional materials are truthful, balanced, and
accurately communicated. This project is being proposed as part of the
research program of OPDP. OPDP's research program supports this mission
by providing scientific evidence to help ensure that our policies
related to prescription drug promotion will have the greatest benefit
to public health. Toward that end, we have consistently conducted
research to evaluate the aspects of prescription drug promotion that we
believe are most central to our mission, focusing in particular on
three main topic areas: Advertising features, including content and
format; target populations; and research quality. Through the
evaluation of advertising features we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits; focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience; and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study falls under the topic of both target populations and advertising
features.
Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our
[[Page 52474]]
policies as well as our research program. Our research is documented on
our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm.
The website includes links to the latest Federal Register notices and
peer-reviewed publications produced by our office. The website
maintains information on studies we have conducted, dating back to a
DTC survey conducted in 1999.
The present research concerns disease awareness and prescription
drug promotion communications on television. When pharmaceutical
companies market a new drug, they often also release disease awareness
communications about the medical condition the new drug is intended to
treat (Ref. 1; Ref. 2). FDA is interested in whether and to what extent
this practice may result in consumers confusing or otherwise
misinterpreting the different information and claims presented in
disease awareness communications and prescription drug promotion. Prior
research has documented that in both print (Ref. 3) and online (Ref. 4)
contexts, consumers tend to conflate the information presented in
prescription drug promotional materials with information presented in
disease awareness communications. Specifically, the results of these
studies suggest consumers incorrectly ascribe benefits to a
prescription drug as a result of being exposed to information in a
disease awareness communication that broadly describes the symptoms and
negative consequences of the disease. There are ways in which this
effect can be attenuated. For example, prior research has indicated
that greater visual distinctiveness between the two ad types can
ameliorate such confusion (Ref. 3). The present research seeks to
extend previous studies of print and online promotion to the context of
television promotion, and broadly examine how perceptual similarity
between the two communication types, as well as their temporal
proximity and exposure frequency, may impact the nature and extent of
viewer confusion.
Fors Marsh Group (FMG) is conducting this research under the
guidance and supervision of FDA to determine how the similarity,
temporal positioning, and frequency of exposure to disease awareness
communications and prescription drug television promotion impact
consumer perception and understanding of the benefits and risks of a
prescription drug product. These objectives will be achieved using two
experimental studies. The first study will explore the impact on
consumer perception and comprehension of different levels of temporal
separation between the disease awareness communication and prescription
drug promotion within a single period of television programming, as
well as the level of similarity versus distinctiveness between these
communication types. Temporal separation is defined as the spacing or
proximity between the disease awareness communication and prescription
drug promotion in the hour-long programming, for example, if they are
shown back-to-back or if they are separated by other ads or television
programming. Similarity/distinctiveness is defined by variations
between the disease awareness communication and prescription drug
promotion, including visual and presentation elements such as the
setting, actors, and colors. The second study will experimentally
examine the impact of disease awareness communication temporal
separation and exposure frequency on consumer perception and
comprehension. Temporal separation in this second study again refers to
the spacing or proximity between the disease awareness communication
and prescription drug promotion but is operationally defined as either
one day or one week. Exposure frequency is defined as the number of
times that participants will view the disease awareness communication,
either one, three, or six times. The results of this latter study will
examine the practice of ``seeding the market,'' in which pharmaceutical
companies release disease awareness communications before releasing
product promotion communications. Similarity versus distinctiveness
will also be examined in this study.
We propose the following hypotheses for this research:
Study 1:
H1: Increased perceptual similarity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
H2: Increased temporal proximity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
Study 2:
H1: Increased frequency of exposure to a disease awareness
communication before exposure to a prescription drug promotion will
result in significantly more conflation of the information presented in
both pieces.
H2: Increased temporal proximity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
H3: Increased perceptual similarity between a disease awareness
communication and a prescription drug promotion will result in
significantly more conflation of the information presented in both
pieces.
In each instance, conflation is operationalized as the extent to
which an individual remembers and attributes benefits to a product that
is based on information presented in a disease awareness communication
and not in the drug promotion.
To address these hypotheses, Study 1 will employ a 3x4 factorial
design in which participants are randomly assigned to one disease
awareness communication condition, plus one control condition where
participants will not view a disease awareness communication. The
extent to which the disease awareness communication is perceptually
similar to the product promotion communication will vary, as will the
temporal separation of the disease awareness communication and product
promotion communication. Table 1 depicts our design visually.
Table 1--Study 1 Experimental Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disease awareness and product ad temporal separation
Perceptual similarity --------------------------------------------------------------------------------------------
Disease awareness ad to product ad Within same In neighboring In non-neighboring
Back to back commercial pod \1\ commercial pods commercial pods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Yes................................ Similar...............
Semi-similar..........
Distinct..............
[[Page 52475]]
No................................. N/A...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TN17OC18.023
Study 2 will employ a 2x2x3 factorial design in which participants
are randomly assigned to one disease awareness communication condition.
The varying factors in Study 2 are the temporal separation between the
disease awareness and product promotion communication, the number of
exposures to the disease awareness communication, and the perceptual
similarity of the disease awareness communication to the product
promotion communication. Table 3 visually depicts our design. Of note,
to reduce the overall number of experimental conditions for Study 2, no
semi-similar experimental condition is used.
---------------------------------------------------------------------------
\1\ A commercial pod refers to a group of ads into which the
test ad is inserted, designed to simulate an advertising break
during a television program. As depicted in Table 2, by neighboring
commercial pods, we mean commercial pods separated only by
television programming and no other commercial pods. By non-
neighboring commercial pods, we mean commercial pods separated by
both television programming and one or more (one, as studied here)
other commercial pods.
Table 3--Study 2 Experimental Design
----------------------------------------------------------------------------------------------------------------
Exposures to disease awareness ad
Time delay until product ad Perceptual -----------------------------------------------------------
exposure (temporal separation) similarity of ads One exposure Three exposures Six exposures
----------------------------------------------------------------------------------------------------------------
One Day......................... Similar...........
Distinct..........
One Week........................ Similar...........
Distinct..........
----------------------------------------------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TN17OC18.024
Study 1 and 2 Sample. The targeted voluntary sample for both
studies will comprise adults who self-report a current asthma
diagnosis, a lifetime incidence of asthma, or experience a large number
of asthma symptoms. These groups are believed to be very likely to be
targeted by disease awareness and product promotion
[[Page 52476]]
communications for asthma. The combined incidence rate of these groups
is 22.2% (Ref. 5; Ref. 6). In addition, several exclusion criteria are
specified. These include: (1) Training or employment as a healthcare
professional, (2) employment with a pharmaceutical company, an
advertising agency, a market research company, or the Department of
Health and Human Services (HHS), and (3) participation in market
research within the past three months on the topic of prescription
drugs. Pretest participants will also be ineligible for the main study.
Pretesting. Pretesting will take place before the main studies to
evaluate the procedures used in the main studies. Each of the two
pretests will have the same design as its respective main study
(pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both
pretests will be to: (1) Ensure that the mock stimuli are
understandable, viewable, and delivering intended messages; (2)
identify and eliminate any challenges to embedding the mock stimuli
within the online survey; (3) ensure that survey questions are
appropriate and meet the analytical goals of the research; and (4)
pilot test the methods, including examining response rates and timing
of survey. The two pretests will be conducted simultaneously.\2\ Based
on pretest findings, we will refine the mock stimuli, survey questions,
and data collection process, as necessary, to optimize the full-scale
study conditions.
---------------------------------------------------------------------------
\2\ Pretesting will be preceded by cognitive interviewing, not
described here. Cognitive interviews are used to probe a small
sample of participants on how and why they responded to various
questions as they did, resulting in strong measurement instruments.
---------------------------------------------------------------------------
Measurement. Our planned analyses are designed to address the key
hypotheses. For both Study 1 and Study 2, we anticipate that the
primary analysis will be analysis of variance (ANOVA) to compare the
main and interaction effects of the experimental factors.
The focal dependent variable will be conflation--a measure of
memory and perceptions regarding the promoted drug relative to the
information presented in the disease awareness communication.
Conflation will be measured by using the number of benefits that are
incorrectly attributed to the prescription drug product based on
responses to a number of both open-ended and closed-ended items.
Other key dependent variables will reflect perceptions and
attitudes toward the product ad. These include measures of:
1. Perception of product promotion effectiveness;
2. Behavioral intentions toward the drug;
3. Perceived efficacy of the drug; and
4. Perceived risks of the drug.
In addition to the primary variables of interest, we have also
identified potential covariates that will be included in the analyses:
1. Knowledge about asthma;
2. Health literacy; and
3. Perceived ad effectiveness.
We expect that knowledge about asthma and increased health literacy
may moderate any conflation that results from ad similarity, temporal
proximity, and frequency of exposure. Perceptions of promotion
effectiveness, on the other hand, can be examined both as an outcome/
dependent variable but also as a covariate that examines involvement
with the product promotion. Greater involvement may attenuate
conflation in that it directs more in-depth processing of both the
disease awareness communication and product promotion, and therefore
more correct understanding of the claims in each (Ref. 7; Ref. 8; Ref.
9).
FDA estimates the burden of this collection of information as
follows:
Table 5--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Study 1 Pretest screener........ 385 1 385 0.08 (~5 min.) 31
Study 2 Pretest screener........ 329 1 329 0.08 (~5 min.) 26
Study 1 screener................ 3,007 1 3,007 0.08 (~5 min.) 241
Study 2 screener................ 2,643 1 2,643 0.08 (~5 min.) 211
Study 1 Pretest................. 270 1 270 1.33 (~1 hr 20 360
min.)
Study 2 Pretest................. 158 1 158 0.53 (~32 84
min.)
Study 1......................... 2,105 1 2,105 1.33 (~1 hr 20 2,800
min.)
Study 2......................... 1,269 1 1,269 0.53 (32 min.) 673
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,426
----------------------------------------------------------------------------------------------------------------
\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 Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. https://www.fiercepharma.com/marketing/unbranded-pharma-ad-what-are-they-good-for-actually-quite-a-bit-marketer-panelists-say?mkt_tok=eyJpIjoiWkRnelpUSmlORFpoWkdNMSIsInQiOiJPaENIUERpT0tnUmt6Y1BPMk9LTnpreUI3bUtPOVRzRnh1RzNuWUtYQmp0cWJhcW05UFhlcllwTzI3V0RJSndjVkZLR3NGUHBLamJOZmJSK2FZeWtIVXczeFRFcmtEV0NFaVdCSjArUmx4dUlRVHZpUzFFOWlVY0dNb1RzOU9XayJ9&mrkid=20932234.
2. https://www.fiercepharma.com/marketing/avanir-launches-nuedexta-brand-campaign-retires-danny-glover-pba-disease-awareness-ad.
3. Aikin, K. J., Sullivan, H. W., & Betts, K. R. (2016). Disease
information in direct-to-consumer prescription drug print ads.
Journal of Health Communication, 21, 228-239.
4. Sullivan, H. W., O'Donoghue, A. C., Rupert, D. J., Willoughby, J.
F., Amoozegar, J. B., & Aikin, K. J. (2016). Are disease awareness
links on prescription drug websites misleading?
[[Page 52477]]
A randomized study. Journal of Health Communication, 21, 1198-1207.
5. Centers for Disease Control and Prevention. (2018a, May 18). 2016
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Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22567 Filed 10-16-18; 8:45 am]
BILLING CODE 4164-01-P
