[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
                                           -------------------------------------------------------------------------------------------------------------
    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