Agency Information Collection Activities; Proposed Collection; Comment Request; Character-Space-Limited Online Prescription Drug Communications, 78163-78166 [2016-26793]
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Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
78163
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Focus Groups About Drug Products ...................................
1,440
1
1,440
1.75
2,520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26794 Filed 11–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3585]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Character-SpaceLimited Online Prescription Drug
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
research entitled, ‘‘Character-SpaceLimited Online Prescription Drug
Communications.’’ The objective of this
research is to test whether a link to
prescription drug risk information can
effectively convey the risks associated
with a drug when benefit claims about
that drug are made within characterspace-limited communications used in
prescription drug promotion.
DATES: Submit either electronic or
written comments on the collection of
information by January 6, 2017.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
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://
VerDate Sep<11>2014
16:02 Nov 04, 2016
Jkt 241001
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): 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–3585 for ‘‘Character-SpaceLimited Online Prescription Drug
Communications.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
E:\FR\FM\07NON1.SGM
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Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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.
Character Space-Limited Online
Prescription Drug Communications,
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.
Prescription drug regulations require
a fair balance of the content and
prominence of risk and benefit
information in prescription drug
product claim promotion. The rise of
Internet communications that have
character space limitations, such as
sponsored link promotion and
microblog messaging, has led to
questions about how to use these
communications for prescription drug
promotion while complying with the
fair balance requirements. In 2014, FDA
released a draft guidance entitled,
‘‘Guidance for Industry Internet/Social
Media Platforms with Character Space
Limitations—Presenting Risk and
Benefit Information for Prescription
Drugs and Medical Devices,’’ (Ref. 1)
which states:
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Regardless of character space constraints
that may be present on certain Internet/social
media platforms, if a firm chooses to make
a product benefit claim, the firm should also
incorporate risk information within the same
character-space-limited communication. The
firm should also provide a mechanism to
allow direct access to a more complete
discussion of the risks associated with its
product.
The concept of linking to risk
information by providing substantive
product risk information on a landing
page (‘‘link to the risk information’’),
rather than presenting risk information
together with product benefit
information within the character-spacelimited communication, has been the
subject of legislation and has been
discussed as an option by some in
industry and media (for example, Refs.
2–5).
The studies are designed to address
the question of whether substantive risk
information in the character-spacelimited communications is effective in
communicating risks when benefit
claims are made, or whether a link to
the risk information is sufficient. Within
each study, we will manipulate whether
or not substantive risk information
appears in the character-space-limited
communication.
Another factor to consider is that
when consumers turn to the Internet for
information, they are driven by different
goals. These goals can affect what
information they pay attention to and
what kind of information they find
(Refs. 6–8). Therefore, we will also
manipulate whether participants are
instructed to browse the information or
to search for specific information.
Two pretests will be conducted to test
the goal instructions, stimuli,
questionnaire, and procedure. In
Studies 1–4, participants will be
randomly assigned to one experimental
condition and will view the
corresponding study materials (Tables
1–4). Across all studies, we will
examine two different character-spacelimited formats and two medical
conditions. For Pretest 1 and Study 1,
the study materials will be a characterspace-limited communication about a
fictional weight loss drug, embedded in
a Google search page about weight loss.
The Study 2 materials will be a
character-space-limited communication
about a fictional drug to treat migraine,
embedded in a Google search page about
migraine. The Study 3 materials will be
a character-space-limited
communication about a fictional weight
loss drug, embedded in a Twitter search
page about weight loss. The Pretest 2
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and Study 4 materials will be a
character-space-limited communication
about a fictional drug to treat migraine,
embedded in a Twitter search page
about migraine.
All study materials will allow for
scrolling and clicking on any links. The
study materials will be accessible by
participants only. After viewing the
study materials, participants will
complete a questionnaire that assesses
participants’ retention of the risk
information and their perceptions of the
drug’s risks and benefits. We will also
measure covariates such as
demographics and literacy. The
questionnaires are available upon
request.
We hypothesize that participants who
see substantive risk information in the
character-space-limited communication,
compared with link-only participants,
will have greater retention of the risk
included in the communication and
higher perceived risk. We will explore
whether including substantive risk
information in the character-spacelimited communication affects the
likelihood that participants notice the
communication or click the link to the
risk information. We hypothesize that
participants with a search goal,
compared with a browse goal, will have
greater retention of the benefit and risk
information and higher perceived risk
because they will be more likely to
notice the character-space-limited
communication and to click the link to
the risk information. We will test these
hypotheses in Studies 1–4 to determine
whether these effects hold across
different medical conditions and
different character-space-limited
platforms. To test these hypotheses, we
will conduct inferential statistical tests
such as logistic regression and analysis
of variance.
All participants will be 18 years of age
or older. We will exclude individuals
who work in healthcare or marketing.
Half of the studies will have a sample
of participants who self-report needing
to lose 30 pounds or more; the other half
will have a sample of participants who
self-report suffering from migraines. We
selected these samples to increase the
likelihood that participants will be
interested in the fictitious study drugs
and therefore motivated to pay attention
during the study. The studies will be
conducted with an Internet panel. With
the sample sizes described below, we
will have sufficient power to detect
small-sized effects in Studies 1–4 (Table
5).
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Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
TABLE 1—STUDY 1: GOOGLE SPONSORED LINK, WEIGHT LOSS
Goal
Browse
Risk Location:
In character-space-limited communication .......................................................................................................
On landing page only .......................................................................................................................................
Search
........................
........................
........................
........................
TABLE 2—STUDY 2: GOOGLE SPONSORED LINK, MIGRAINE
Goal
Browse
Risk Location:
In character-space-limited communication .......................................................................................................
On landing page only .......................................................................................................................................
Search
........................
........................
........................
........................
TABLE 3—STUDY 3: TWITTER, WEIGHT LOSS
Goal
Browse
Risk Location:
In character-space-limited communication .......................................................................................................
On landing page only .......................................................................................................................................
Search
........................
........................
........................
........................
TABLE 4—STUDY 4: TWITTER, MIGRAINE
Goal
Browse
Risk Location:
In character-space-limited communication .......................................................................................................
On landing page only .......................................................................................................................................
Search
........................
........................
........................
........................
FDA estimates the burden of this
collection of information as follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per response
464
464
786
786
786
786
277
277
469
469
469
469
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ...........................................
sradovich on DSK3GMQ082PROD with NOTICES
Pretest 1 screener ............................
Pretest 2 screener ............................
Study 1 screener ...............................
Study 2 screener ...............................
Study 3 screener ...............................
Study 4 screener ...............................
Pretest 1 ............................................
Pretest 2 ............................................
Study 1 ..............................................
Study 2 ..............................................
Study 3 ..............................................
Study 4 ..............................................
6,502
........................
........................
1 There
.08
.08
.08
.08
.08
.08
.33
.33
.33
.33
.33
.33
Total hours
(5 min.) .......................................
(5 min.) .......................................
(5 min.) .......................................
(5 min.) .......................................
(5 min.) .......................................
(5 min.) .......................................
(20 min.) .....................................
(20 min.) .....................................
(20 min.) .....................................
(20 min.) .....................................
(20 min.) .....................................
(20 min.) .....................................
39
39
66
66
66
66
93
93
157
157
157
157
...........................................................
1,156
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and are
VerDate Sep<11>2014
16:02 Nov 04, 2016
Jkt 241001
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
PO 00000
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Sfmt 4703
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
E:\FR\FM\07NON1.SGM
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Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
1. Guidance for Industry: Internet/Social
Media Platforms with Character Space
Limitations—Presenting Risk and Benefit
Information for Prescription Drugs and
Medical Devices, available at: https://
www.fda.gov/downloads/drugs/guidance
complianceregulatoryinformation/
guidances/ucm401087.pdf.
2. https://www.congress.gov/bill/114thcongress/house-bill/2479/text.
3. https://www.fda.gov/AboutFDA/Centers
Offices/OfficeofMedicalProductsand
Tobacco/CDER/ucm184250.htm.
4. https://www.politico.com/story/2015/06/atthe-fda-drugs-and-tweets-dont-mix118693.
5. https://www.dtcperspectives.com/is-oneclick-in-the-cards/.
6. Detlor, B., S. Sproule, and C. Gupta, ‘‘PrePurchase Online Information Seeking:
Search Versus Browse.’’ Journal of
Electronic Commerce Research, vol. 4,
pp. 72–84, 2003.
7. Pieters, R. and M. Wedel, ‘‘Goal Control of
Attention to Advertising: The Yarbus
Implication.’’ Journal of Consumer
Research, vol. 34, pp. 224–233, 2007.
8. Schlosser, A. E., ‘‘Experiencing Products in
the Virtual World: The Role of Goal and
Imagery in Influencing Attitudes Versus
Purchase Intentions.’’ Journal of
Consumer Research, vol. 30, pp. 184–
198, 2003, https://dx.doi.org/10.1086/
376807.
Dated: October 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26793 Filed 11–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–0086]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Potential Tobacco
Product Violations Reporting Form
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information contained
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:02 Nov 04, 2016
Jkt 241001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Food and Drug Administration
AGENCY:
in FDA’s Tobacco Product Violations
Reporting Form.
DATES: Submit either electronic or
written comments on the collection of
information by January 6, 2017.
ADDRESSES: You may submit comments
as follows:
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–
2014–N–0086 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Potential
Tobacco Product Violations Reporting
Form.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
E:\FR\FM\07NON1.SGM
07NON1
]]>Agencies
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78163-78166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3585]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Character-Space-Limited Online Prescription Drug
Communications
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, ``Character-Space-
Limited Online Prescription Drug Communications.'' The objective of
this research is to test whether a link to prescription drug risk
information can effectively convey the risks associated with a drug
when benefit claims about that drug are made within character-space-
limited communications used in prescription drug promotion.
DATES: Submit either electronic or written comments on the collection
of information by January 6, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): 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-3585 for ``Character-Space-Limited Online Prescription Drug
Communications.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the
[[Page 78164]]
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.
Character Space-Limited Online Prescription Drug Communications, 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.
Prescription drug regulations require a fair balance of the content
and prominence of risk and benefit information in prescription drug
product claim promotion. The rise of Internet communications that have
character space limitations, such as sponsored link promotion and
microblog messaging, has led to questions about how to use these
communications for prescription drug promotion while complying with the
fair balance requirements. In 2014, FDA released a draft guidance
entitled, ``Guidance for Industry Internet/Social Media Platforms with
Character Space Limitations--Presenting Risk and Benefit Information
for Prescription Drugs and Medical Devices,'' (Ref. 1) which states:
Regardless of character space constraints that may be present on
certain Internet/social media platforms, if a firm chooses to make a
product benefit claim, the firm should also incorporate risk
information within the same character-space-limited communication.
The firm should also provide a mechanism to allow direct access to a
more complete discussion of the risks associated with its product.
The concept of linking to risk information by providing substantive
product risk information on a landing page (``link to the risk
information''), rather than presenting risk information together with
product benefit information within the character-space-limited
communication, has been the subject of legislation and has been
discussed as an option by some in industry and media (for example,
Refs. 2-5).
The studies are designed to address the question of whether
substantive risk information in the character-space-limited
communications is effective in communicating risks when benefit claims
are made, or whether a link to the risk information is sufficient.
Within each study, we will manipulate whether or not substantive risk
information appears in the character-space-limited communication.
Another factor to consider is that when consumers turn to the
Internet for information, they are driven by different goals. These
goals can affect what information they pay attention to and what kind
of information they find (Refs. 6-8). Therefore, we will also
manipulate whether participants are instructed to browse the
information or to search for specific information.
Two pretests will be conducted to test the goal instructions,
stimuli, questionnaire, and procedure. In Studies 1-4, participants
will be randomly assigned to one experimental condition and will view
the corresponding study materials (Tables 1-4). Across all studies, we
will examine two different character-space-limited formats and two
medical conditions. For Pretest 1 and Study 1, the study materials will
be a character-space-limited communication about a fictional weight
loss drug, embedded in a Google search page about weight loss. The
Study 2 materials will be a character-space-limited communication about
a fictional drug to treat migraine, embedded in a Google search page
about migraine. The Study 3 materials will be a character-space-limited
communication about a fictional weight loss drug, embedded in a Twitter
search page about weight loss. The Pretest 2 and Study 4 materials will
be a character-space-limited communication about a fictional drug to
treat migraine, embedded in a Twitter search page about migraine.
All study materials will allow for scrolling and clicking on any
links. The study materials will be accessible by participants only.
After viewing the study materials, participants will complete a
questionnaire that assesses participants' retention of the risk
information and their perceptions of the drug's risks and benefits. We
will also measure covariates such as demographics and literacy. The
questionnaires are available upon request.
We hypothesize that participants who see substantive risk
information in the character-space-limited communication, compared with
link-only participants, will have greater retention of the risk
included in the communication and higher perceived risk. We will
explore whether including substantive risk information in the
character-space-limited communication affects the likelihood that
participants notice the communication or click the link to the risk
information. We hypothesize that participants with a search goal,
compared with a browse goal, will have greater retention of the benefit
and risk information and higher perceived risk because they will be
more likely to notice the character-space-limited communication and to
click the link to the risk information. We will test these hypotheses
in Studies 1-4 to determine whether these effects hold across different
medical conditions and different character-space-limited platforms. To
test these hypotheses, we will conduct inferential statistical tests
such as logistic regression and analysis of variance.
All participants will be 18 years of age or older. We will exclude
individuals who work in healthcare or marketing. Half of the studies
will have a sample of participants who self-report needing to lose 30
pounds or more; the other half will have a sample of participants who
self-report suffering from migraines. We selected these samples to
increase the likelihood that participants will be interested in the
fictitious study drugs and therefore motivated to pay attention during
the study. The studies will be conducted with an Internet panel. With
the sample sizes described below, we will have sufficient power to
detect small-sized effects in Studies 1-4 (Table 5).
[[Page 78165]]
Table 1--Study 1: Google Sponsored Link, Weight Loss
------------------------------------------------------------------------
Goal
-------------------------------
Browse Search
------------------------------------------------------------------------
Risk Location:
In character-space-limited .............. ..............
communication......................
On landing page only................ .............. ..............
------------------------------------------------------------------------
Table 2--Study 2: Google Sponsored Link, Migraine
------------------------------------------------------------------------
Goal
-------------------------------
Browse Search
------------------------------------------------------------------------
Risk Location:
In character-space-limited .............. ..............
communication......................
On landing page only................ .............. ..............
------------------------------------------------------------------------
Table 3--Study 3: Twitter, Weight Loss
------------------------------------------------------------------------
Goal
-------------------------------
Browse Search
------------------------------------------------------------------------
Risk Location:
In character-space-limited .............. ..............
communication......................
On landing page only................ .............. ..............
------------------------------------------------------------------------
Table 4--Study 4: Twitter, Migraine
------------------------------------------------------------------------
Goal
-------------------------------
Browse Search
------------------------------------------------------------------------
Risk Location:
In character-space-limited .............. ..............
communication......................
On landing page only................ .............. ..............
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener............ 464 1 1 .08 (5 min.).... 39
Pretest 2 screener............ 464 1 1 .08 (5 min.).... 39
Study 1 screener.............. 786 1 1 .08 (5 min.).... 66
Study 2 screener.............. 786 1 1 .08 (5 min.).... 66
Study 3 screener.............. 786 1 1 .08 (5 min.).... 66
Study 4 screener.............. 786 1 1 .08 (5 min.).... 66
Pretest 1..................... 277 1 1 .33 (20 min.)... 93
Pretest 2..................... 277 1 1 .33 (20 min.)... 93
Study 1....................... 469 1 1 .33 (20 min.)... 157
Study 2....................... 469 1 1 .33 (20 min.)... 157
Study 3....................... 469 1 1 .33 (20 min.)... 157
Study 4....................... 469 1 1 .33 (20 min.)... 157
------------------------------------------------ ---------------
Total..................... 6,502 .............. .............. ................ 1,156
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
[[Page 78166]]
1. Guidance for Industry: Internet/Social Media Platforms with
Character Space Limitations--Presenting Risk and Benefit Information
for Prescription Drugs and Medical Devices, available at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401087.pdf.
2. https://www.congress.gov/bill/114th-congress/house-bill/2479/text.
3. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm.
4. https://www.politico.com/story/2015/06/at-the-fda-drugs-and-tweets-dont-mix-118693.
5. https://www.dtcperspectives.com/is-one-click-in-the-cards/.
6. Detlor, B., S. Sproule, and C. Gupta, ``Pre-Purchase Online
Information Seeking: Search Versus Browse.'' Journal of Electronic
Commerce Research, vol. 4, pp. 72-84, 2003.
7. Pieters, R. and M. Wedel, ``Goal Control of Attention to
Advertising: The Yarbus Implication.'' Journal of Consumer Research,
vol. 34, pp. 224-233, 2007.
8. Schlosser, A. E., ``Experiencing Products in the Virtual World:
The Role of Goal and Imagery in Influencing Attitudes Versus
Purchase Intentions.'' Journal of Consumer Research, vol. 30, pp.
184-198, 2003, https://dx.doi.org/10.1086/376807.
Dated: October 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26793 Filed 11-4-16; 8:45 am]
BILLING CODE 4164-01-P
