[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]
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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.
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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\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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
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Total................................. .............. .............. 4,331 ............................................ 488
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\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