Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Provider Perception of Boxed Warning Information Survey, 38996-38998 [2019-16935]
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38996
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information under 21 CFR part 312
(Investigational New Drug Application)
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16994 Filed 8–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3018]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Healthcare
Provider Perception of Boxed Warning
Information Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 (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 Healthcare
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
16:51 Aug 07, 2019
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
Notice.
VerDate Sep<11>2014
Provider Perception of Boxed Warning
Information Survey.
DATES: Submit either electronic or
written comments on the collection of
information by October 7, 2019.
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 October 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 7, 2019. 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.
Jkt 247001
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.’’
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Fmt 4703
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Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3018 for ‘‘Healthcare Provider
Perception of Boxed Warning
Information Survey.’’ 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/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, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
E:\FR\FM\08AUN1.SGM
08AUN1
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
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.
SUPPLEMENTARY INFORMATION:
jbell on DSK3GLQ082PROD with NOTICES
Healthcare Provider Perception of
Boxed Warning Information Survey
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 proposed collection of
information will investigate healthcare
providers’ (HCPs’) awareness,
perceptions and beliefs about the
benefits and risks of an FDA-approved
product that carries a boxed warning.
The prescribing information for an FDAapproved drug or biologic (sometimes
referred to as the ‘‘PI’’, ‘‘package insert’’,
or ‘‘prescription drug labeling’’)
provides a summary of the essential
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
information needed for the safe and
effective use of that medication,
described in FDA guidance entitled
‘‘Warnings and Precautions,
Contraindications, and Boxed Warning
Sections of Labeling for Human
Prescription Drug and Biologic
Products—Content and Format,’’
published in October 2011 (https://
www.fda.gov/media/71866/download).
In certain situations, a drug’s
prescribing information may include a
boxed warning in addition to other
sections of the labeling to highlight
important safety information about
specific serious risks of that drug. Boxed
warning information may be included as
part of prescribing information at the
time of FDA approval. Boxed warning
information may also be added or
modified to the prescribing information
of drugs already on the market on the
basis of new safety information.
Boxed warnings are an important and
frequently used communication tool. A
review of literature has suggested that
the addition or modification of boxed
warning information in the postmarket
setting (after a drug has been approved)
has had varying effects on HCPs’
practices regarding prescribing, dosing,
and patient monitoring (Ref. 1).
However, this review and others have
identified several gaps in the existing
literature, including the limited number
of drugs or drug classes studied (Ref. 2).
Further, little research has focused
under understanding how HCPs receive,
process, and use boxed warning
information to support their treatment
decisions and patient counseling.
To address this research gap, we
propose conducting a web-based survey
of HCPs. The proposed collection of
information will strengthen FDA’s
understanding of how HCPs may
receive, process, and use boxed warning
and other safety labeling information.
This survey will be conducted as part of
a mixed methods research approach to
explore HCPs’ beliefs (or ‘‘mental
models’’) about the benefits and risks of
a drug that carries a boxed warning and
how the drug’s boxed warning
information may influence their
communication with patients, their
treatment decisions and related
decisions such as prescreening for risk
factors or monitoring for adverse events
(Ref. 3). This survey research will build
upon preliminary qualitative research
FDA has conducted, under OMB control
number 0910–0695, with HCPs in this
target population, through indepth
individual interviews.
The general research questions in this
data collection are as follows:
1. What awareness, knowledge, and
beliefs do HCPs have regarding boxed
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38997
warning information for a prescription
drug or class of drugs?
2. When making prescribing
decisions, how do HCPs consider boxed
warning information about a potential
treatment? How does boxed warning
information factor into their
assessments of a drug’s potential
benefits and risks to their patients?
3. How do HCPs communicate with
their patients about boxed warning
information?
4. What factors (e.g., experience
treating a condition) are associated with
HCPs’ awareness, knowledge, and
beliefs about boxed warning
information?
In order to explore a range of potential
perceptions and uses of boxed warning
information that may exist under
different contexts, this survey research
will evaluate two medical product
scenarios involving an FDA-approved
medication or class of medications that
include boxed warning information. The
scenarios will include pertinent
prescribing information from the FDAapproved labeling for these medications.
We plan to conduct one pretest survey
with 25 voluntary participants and one
main survey with 1,156 voluntary
participants. The survey will be
conducted online. Survey response is
estimated to take no longer than 20
minutes.
Participants in the pretest survey and
main survey will be recruited online
through a web-based HCP survey
research panel. Participants will be
HCPs with prescribing authority who
prescribe medications to treat one of
medical conditions in the medical
product scenarios. Participants will
include primary care providers
(including internal medicine, family
medicine, and general medicine, as well
as nurse practitioners, and physician
assistants) and relevant medical
specialists. Participants will be screened
for their current amount of time spent
in direct patient care, prescribing
volume, and experience treating the
relevant medical condition.
Demographic soft quotas will be used to
help ensure that the survey population
is generally reflective of the
demographic composition of physicians
in the United States, according to the
American Medical Association.
The pretest and main studies will
have the same design and will follow
the same procedure. In advance of the
pretest survey, we will conduct
cognitive testing of the survey
questionnaire to refine the survey
instruments. The main survey will be
refined as necessary following the
pretest survey.
E:\FR\FM\08AUN1.SGM
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38998
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Pretest Screener .................................................
Pretest Informed Consent ...................................
Pretest Survey Completes ..................................
Main Survey Screener .........................................
Main Survey Informed Consent ..........................
Main Survey Completes ......................................
42
25
25
1,927
1,156
1,156
1
1
1
1
1
1
42
25
25
1,927
1,156
1,156
0.05
0.05
0.28
0.05
0.05
0.28
(3 minutes) .............
(3 minutes) .............
(17 minutes) ...........
(3 minutes) .............
(3 minutes) .............
(17 minutes) ...........
2
1
7
96
58
324
Total .............................................................
........................
........................
4,331
........................................
488
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references are on
display with 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 not available
electronically at https://
www.regulations.gov as these references
are copyright protected. 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. Dusetzina, S.B., et al., ‘‘Impact of FDA
Drug Risk Communications on Health
Care Utilization and Health Behaviors: A
Systematic Review.’’ Medical Care,
50(6):466–478, 2012.
2. Briesacher, B.A., et al., ‘‘A Critical Review
of Methods to Evaluate the Impact of
FDA Regulatory Actions.’’
Pharmacoepidemiology Drug and Safety.
22(9):986–994, 2013.
3. Morgan, M.G. et al., Risk Communication:
A Mental Models Approach. Cambridge
University Press, 2002.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16935 Filed 8–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 7, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
SUMMARY:
OMB No. 0915–0149—Revision
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Scholarships
for Disadvantaged Students Program
OMB No. 0915–0149—Revision
AGENCY:
ACTION:
Information Collection Request Title:
Scholarships for Disadvantaged
Students Program
Health Resources and Services
Administration
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Number of
responses
per
respondent
Number of
respondents
Activity
Abstract: HRSA seeks to update the
Scholarships for Disadvantaged
Students (SDS) program-specific form to
collect 3 years of student data instead of
1 year of student data from SDS program
applicants. This will assist the agency in
making funding decisions for SDS
program awards. The form will reflect
programmatic changes to the SDS
program, made after consideration of the
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Fmt 4703
Sfmt 4703
comments received in response to the
request for public comment, published
at 84 FR 23571, which will be finalized
in the forthcoming SDS Policy Change
Federal Register Notice.
Need and Proposed Use of the
Information: The purpose of the SDS
Program is to make grant awards to
eligible schools to provide scholarships
to full-time, financially needy students
from disadvantaged backgrounds
enrolled in health professions programs.
To qualify for participation in the SDS
program, a school must be carrying out
a program for recruiting and retaining
students from disadvantaged
backgrounds, including students who
are members of racial and ethnic
minority groups (section 737(d)(1)(B) of
the Public Health Service (PHS) Act). To
meet this requirement, a school must
show that at least 20 percent of the
school’s full-time enrolled students and
graduates are from a disadvantaged
background. HRSA previously required
schools to demonstrate this percentage
by submitting 1 year of data; a school
must now provide this data for the most
recent 3-year period. The proposed
revisions to the SDS program-specific
form will require applicants to provide
the percentage of full-time enrolled
students and graduates from a
disadvantaged background over a 3-year
period, consistent with this policy
change.
An additional change to the SDS
program is that a 3-year average, instead
of a 1-year average, will be used to
calculate priority points, which are
provided to eligible schools based on
the proportion of graduating students
going into primary care, the proportion
of underrepresented minority students,
and the proportion of graduates working
in medically underserved communities
(section 737(c) of the PHS Act). The
proposed revisions to the SDS programspecific form will require applicants to
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38996-38998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16935]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3018]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Healthcare Provider Perception of Boxed Warning
Information Survey
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
(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 Healthcare Provider Perception of Boxed Warning
Information Survey.
DATES: Submit either electronic or written comments on the collection
of information by October 7, 2019.
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 October 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 7, 2019. 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 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-2019-N-3018 for ``Healthcare Provider Perception of Boxed Warning
Information Survey.'' 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
[[Page 38997]]
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.
Healthcare Provider Perception of Boxed Warning Information Survey
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 proposed collection of information will investigate healthcare
providers' (HCPs') awareness, perceptions and beliefs about the
benefits and risks of an FDA-approved product that carries a boxed
warning. The prescribing information for an FDA-approved drug or
biologic (sometimes referred to as the ``PI'', ``package insert'', or
``prescription drug labeling'') provides a summary of the essential
information needed for the safe and effective use of that medication,
described in FDA guidance entitled ``Warnings and Precautions,
Contraindications, and Boxed Warning Sections of Labeling for Human
Prescription Drug and Biologic Products--Content and Format,''
published in October 2011 (https://www.fda.gov/media/71866/download).
In certain situations, a drug's prescribing information may include a
boxed warning in addition to other sections of the labeling to
highlight important safety information about specific serious risks of
that drug. Boxed warning information may be included as part of
prescribing information at the time of FDA approval. Boxed warning
information may also be added or modified to the prescribing
information of drugs already on the market on the basis of new safety
information.
Boxed warnings are an important and frequently used communication
tool. A review of literature has suggested that the addition or
modification of boxed warning information in the postmarket setting
(after a drug has been approved) has had varying effects on HCPs'
practices regarding prescribing, dosing, and patient monitoring (Ref.
1). However, this review and others have identified several gaps in the
existing literature, including the limited number of drugs or drug
classes studied (Ref. 2). Further, little research has focused under
understanding how HCPs receive, process, and use boxed warning
information to support their treatment decisions and patient
counseling.
To address this research gap, we propose conducting a web-based
survey of HCPs. The proposed collection of information will strengthen
FDA's understanding of how HCPs may receive, process, and use boxed
warning and other safety labeling information. This survey will be
conducted as part of a mixed methods research approach to explore HCPs'
beliefs (or ``mental models'') about the benefits and risks of a drug
that carries a boxed warning and how the drug's boxed warning
information may influence their communication with patients, their
treatment decisions and related decisions such as prescreening for risk
factors or monitoring for adverse events (Ref. 3). This survey research
will build upon preliminary qualitative research FDA has conducted,
under OMB control number 0910-0695, with HCPs in this target
population, through indepth individual interviews.
The general research questions in this data collection are as
follows:
1. What awareness, knowledge, and beliefs do HCPs have regarding
boxed warning information for a prescription drug or class of drugs?
2. When making prescribing decisions, how do HCPs consider boxed
warning information about a potential treatment? How does boxed warning
information factor into their assessments of a drug's potential
benefits and risks to their patients?
3. How do HCPs communicate with their patients about boxed warning
information?
4. What factors (e.g., experience treating a condition) are
associated with HCPs' awareness, knowledge, and beliefs about boxed
warning information?
In order to explore a range of potential perceptions and uses of
boxed warning information that may exist under different contexts, this
survey research will evaluate two medical product scenarios involving
an FDA-approved medication or class of medications that include boxed
warning information. The scenarios will include pertinent prescribing
information from the FDA-approved labeling for these medications. We
plan to conduct one pretest survey with 25 voluntary participants and
one main survey with 1,156 voluntary participants. The survey will be
conducted online. Survey response is estimated to take no longer than
20 minutes.
Participants in the pretest survey and main survey will be
recruited online through a web-based HCP survey research panel.
Participants will be HCPs with prescribing authority who prescribe
medications to treat one of medical conditions in the medical product
scenarios. Participants will include primary care providers (including
internal medicine, family medicine, and general medicine, as well as
nurse practitioners, and physician assistants) and relevant medical
specialists. Participants will be screened for their current amount of
time spent in direct patient care, prescribing volume, and experience
treating the relevant medical condition. Demographic soft quotas will
be used to help ensure that the survey population is generally
reflective of the demographic composition of physicians in the United
States, according to the American Medical Association.
The pretest and main studies will have the same design and will
follow the same procedure. In advance of the pretest survey, we will
conduct cognitive testing of the survey questionnaire to refine the
survey instruments. The main survey will be refined as necessary
following the pretest survey.
[[Page 38998]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener.......................... 42 1 42 0.05 (3 minutes)............................ 2
Pretest Informed Consent.................. 25 1 25 0.05 (3 minutes)............................ 1
Pretest Survey Completes.................. 25 1 25 0.28 (17 minutes)........................... 7
Main Survey Screener...................... 1,927 1 1,927 0.05 (3 minutes)............................ 96
Main Survey Informed Consent.............. 1,156 1 1,156 0.05 (3 minutes)............................ 58
Main Survey Completes..................... 1,156 1 1,156 0.28 (17 minutes)........................... 324
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. 4,331 ............................................ 488
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references are on display with 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 not
available electronically at https://www.regulations.gov as these
references are copyright protected. 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. Dusetzina, S.B., et al., ``Impact of FDA Drug Risk Communications
on Health Care Utilization and Health Behaviors: A Systematic
Review.'' Medical Care, 50(6):466-478, 2012.
2. Briesacher, B.A., et al., ``A Critical Review of Methods to
Evaluate the Impact of FDA Regulatory Actions.''
Pharmacoepidemiology Drug and Safety. 22(9):986-994, 2013.
3. Morgan, M.G. et al., Risk Communication: A Mental Models
Approach. Cambridge University Press, 2002.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16935 Filed 8-7-19; 8:45 am]
BILLING CODE 4164-01-P
