Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Healthcare Provider Perception of Boxed Warning Information Survey, 40292-40296 [2020-14377]
Download as PDF
<![CDATA[
40292
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
(a) Evaluate whether the proposed
collection of information is necessary for the
proper performance of the functions of the
agency, including whether the information
will have practical utility;
(b) Evaluate the accuracy of the agencies
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and assumptions
used;
(c) Enhance the quality, utility, and clarity
of the information to be collected;
(d) Minimize the burden of the collection
of information on those who are to respond,
including, through the use of appropriate
automated, electronic, mechanical, or other
technological collection techniques or other
forms of information technology, e.g.,
permitting electronic submission of
responses; and
(e) Assess information collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Validated Follow-up Interview of
Clinicians on Outpatient Antibiotic
Stewardship Interventions—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Code of Federal Regulations
under subsections C and D of section
247d–5 authorizes education of medical
and health services personnel in
antimicrobial resistance and appropriate
use of antibiotics and the funding of
eligible entities to increase capacity to
detect, monitor, and combat
antimicrobial resistance. Through the
Centers for Disease Control and
Prevention’s (CDC) SHEPheRD funding
mechanism, the University of Utah has
been awarded a contract to perform
such work as stated above within a
research framework in the urgent care
setting, with interventions based on the
Core Elements of Outpatient Antibiotic
Stewardship. Intermountain Healthcare
is the subcontractor for this work, and
operates the clinics participating in the
intervention arm of this research study.
The proposed request for data
collection will allow Intermountain
Healthcare to explore knowledge,
attitudes, and practices among
clinicians to identify barriers and
facilitators after the implementation of
the antibiotic stewardship program in
the urgent care setting of participating
clinics. CDC requests approval for 207
estimated annualized burden hours.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Urgent Care Clinician ..................................
Urgent Care Clinician ..................................
Interview Guide ...........................................
Survey .........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–14330 Filed 7–2–20; 8:45 am]
BILLING CODE 4163–18–P
Food and Drug Administration
[Docket No. FDA–2019–N–3018]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Healthcare
Provider Perception of Boxed Warning
Information Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
04:41 Jul 03, 2020
Submit written comments
(including recommendations) on the
collection of information by August 5,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comment’’ or
by using the search function. The title
of this information collection is
‘‘Healthcare Provider Perception of
Boxed Warning Information Survey.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
Notice.
VerDate Sep<11>2014
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
Jkt 250001
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
40
250
Average burden
per response
(in hours)
1
1
1
40/60
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Healthcare Provider Perception of
Boxed Warning Information Survey
OMB Control Number 0910—NEW
I. Background
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
E:\FR\FM\06JYN1.SGM
06JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
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 on
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.
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
40293
questionnaire to refine the survey
instruments. The main survey will be
refined as necessary following the
1. What awareness, knowledge, and
pretest survey.
beliefs do HCPs have regarding boxed
In the Federal Register of August 8,
warning information for a prescription
2019 (84 FR 38996), FDA published a
drug or class of drugs?
60-day notice requesting public
2. When making prescribing decisions,
comment on the proposed collection of
how do HCPs consider boxed warning
information. FDA received three
information about a potential
comments that were PRA related. Below
treatment? How does boxed warning
is a response to each of the commenters’
information factor into their
questions. For brevity, some public
assessments of a drug’s potential
comments are paraphrased and
benefits and risks to their patients?
therefore may not reflect the exact
3. How do HCPs communicate with their language used by the commenter. The
entirety of the public comments was
patients about boxed warning
considered even if not fully captured by
information?
our paraphrasing in this document.
4. What factors (e.g., experience treating
(Comment 1) The first public
a condition) are associated with HCPs’
comment ‘‘agrees with the data
awareness, knowledge, and beliefs about collection,’’ but finds the intent of the
boxed warning information?
data collection unclear and expresses
In order to explore a range of potential concern that ‘‘the data will be collecting
in the survey will be used adversarially
perceptions and uses of boxed warning
[sic] [against providers]’’. The
information that may exist under
commenter described experiences ‘‘as a
different contexts, this survey research
healthcare provider, [battling] daily
will evaluate two medical product
with both ends of the spectrum,’’
scenarios involving an FDA-approved
including patients who want a ‘‘brand
medication or class of medications that
include boxed warning information. The new drug’’ even though it will likely
provide little therapeutic benefit, as
scenarios will include pertinent
well as patients who would benefit from
prescribing information from the FDAapproved labeling for these medications. a product but ‘‘adamantly refuse based
on a [boxed warning].’’ The commenter
We plan to conduct one pretest survey
further stated that ‘‘As a provider, I can
with 50 voluntary participants and one
present the information I have at hand,
main survey with 1,156 voluntary
but how do I combat new information
participants. The survey will be
that is identified specifically, a [boxed
conducted online. Survey response is
warning] post prescribing a new
estimated to take no longer than 20
medication?’’
minutes.
(Response 1) FDA appreciates the
Participants in the pretest survey and
commenter’s experience, which is
main survey will be recruited online
relevant to the research question that
through a web-based HCP survey
the proposed data collection is intended
research panel. Participants will be
to inform: how HCPs consider boxed
HCPs with prescribing authority who
warning information when making
prescribe medications to treat one of
treatment decisions and how they
medical conditions in the medical
communicate boxed warning
product scenarios. Participants will
information to their patients. As
include primary care providers
described in Section A.2, the intent of
(including internal medicine, family
medicine, and general medicine, as well the data collection to better understand
the range of HCPs’ experiences and
as nurse practitioners, and physician
informational needs regarding boxed
assistants) and relevant medical
specialists. Participants will be screened warning information.
(Comment 2) The second public
for their current amount of time spent
comment expressed concern regarding
in direct patient care, prescribing
how ‘‘[a] voluntary commitment to
volume, and experience treating the
participating in a professional
relevant medical condition.
Demographic soft quotas will be used to assessment survey demonstrates some
level engagement and awareness [and
help ensure that the survey population
therefore this] survey will assess an
is generally reflective of the
demographic composition of physicians already engaged section of providers,
potentially skewing the data.’’
in the United States, according to the
(Response 2) In accordance with the
American Medical Association.
requirements set forth by institutional
The pretest and main studies will
review boards and OMB, any research
have the same design and will follow
must involve voluntary participation of
the same procedure. In advance of the
research participants. FDA
pretest survey, we will conduct
acknowledges there may be a coverage
cognitive testing of the survey
The general research questions in this
data collection are as follows:
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
E:\FR\FM\06JYN1.SGM
06JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
40294
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
bias from the use of an opt-in web panel
as a sample frame (i.e., HCPs who
choose to be part of a research panel
may differ from HCPs who do not
choose to be part of a research panels).
As a basic check, in our analysis of the
study findings, we will compare the
demographic characteristics of the
population of survey respondents to the
population of U.S. prescribers within
the relevant medical specialties. We will
document the nature and limitations of
our sampling frame and the potential
implications of that on the
interpretation of the research findings.
(Comment 3) The third public
comment comprised 2 overarching
comments (3a and 3b below) and 13
additional (3c to 3p) comments on
individual items on the questionnaire,
to which we have responded below.
(Comment 3a) We recommend
considering two different ‘‘archetypes’’
for the medical product scenarios to
gain insight on different situations.
Consideration should be given to a
drug/class with specific risk factors
identified in a BW [boxed warning], a
drug/class launched with a BW, or drug/
class with a BW that was established
post approval.
(Response 3a) FDA agrees with the
importance of capturing different
archetypes (e.g., characteristics or
features) of the medical scenario and of
the boxed warning. The identified
scenarios, vaginal inserts to treat vulvovaginal atrophy (VVA) in postmenopausal women and direct-acting
antivirals to treat chronic hepatitis C
viral (HCV) infection were identified
because they differ along some
important characteristics. These
characteristics include seriousness of
condition, characteristics of the safety
concerns, length and nature of the
boxed warning information, and length
of time since the boxed warning was
included.
(Comment 3b): We also recommend
that FDA consider additional study
designs such as retrospective analysis
on prescribing habits. Data could be
collected on prescribing habits of
medications before and after inclusion
of a BW in labeling. This study could be
used as a complementary evaluation on
the understanding the impact of BW.
(Response 3b): FDA agrees that there
is value in complementary research
approaches using the same scenarios
and appreciate the suggestion. We will
explore the feasibility of undertaking a
related outcomes-focused study looking
at prescribing behaviors in future
studies.
(Comment 3c): In an effort to
streamline the questionnaire, [we]
recommend considering the removal of
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
[Question 1] and relying on Questions 2
to 6 to assess the level of experience.
(Response 3c): FDA appreciates
feedback suggesting opportunities to
streamline the questionnaire, and we
have considered appropriate ways to
streamline. Q1 elicits a self-assessment
of their level of experience treating the
scenario condition, which provides very
important context for understanding
HCPs’ perceptions. This concept is
distinct from concepts elicited in Q2 to
6. For example, a self-assessment of
experience with a condition may not be
associated with the number of patients
the HCP currently sees.
(Comment 3d): [We] recommend
consolidating Q5 and Q6 into a single
question. . . [and] including the drug of
interest in the list of options [and]
adjusting the [choice] selections so that
they become mutually exclusive. [We]
would further recommend screening out
physicians from taking remainder of the
survey that do not prescribe drugs with
BW based on their responses to Q4 to
6.
(Response 3d): In the questionnaire
draft that the commenter reviewed, Q5
asks respondents how often they
prescribe the scenario drug and Q6 ask
how often they prescribe a number of
other types of products that FDA
believes providers may be using to treat
the condition. In the revised
questionnaire (now Q4 and Q5), we
keep the two questions as separate, but
we have greatly simplified the latter
(now Q5) so that it does not elicit
prescribing rates, but rather asks
respondents to indicate which
treatments they have used in a typical
month. The elicitation of the frequency
(‘‘a few times per month, a few times a
year, etc.’’) is important with respect to
the scenario drug. We have modified the
response items to be mutually exclusive.
Potential participants are screened
based on their experience with treating
each of the medical conditions, but not
based on their prescribing behavior
regarding any the particular product.
For the purposes of this research,
exclusion due to not prescribing the
specific product with the boxed warning
is not appropriate, as long as the
healthcare provide meets the other
criteria. If, for example, a provider
chooses categorically not to prescribe a
particular product that has a boxed
warning, it could be driven in part by
his or her perception of the boxed
warning information. We are still
interested in this prescriber’s perception
of the benefits and risks of the scenario
product.
(Comment 3e): There may be a need
to differentiate HCPs who initiate vs.
those that refill, therefore [we]
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
recommend including a question to ask
what % of prescriptions are initiated vs.
refill.
(Response 3e): FDA agrees that there
may be a need to differentiate HCPs who
initiate vs. those who only prescribe
refills for the scenario drug. The revised
questionnaire (question 4a) now allows
differentiation between HCPs who
initiate prescriptions versus HCPs who
have only prescribed a refill for the
scenario drug.
(Comment 3f): The description of
patient and condition will likely
influence the responses and the
physicians’ consideration of the BW.
[We] recommend taking into
consideration where the patient is in the
treatment journey and where the drug
with the BW is in the treatment
algorithm. The instructions also imply
that this treatment must only be
prescribed to females. If the treatment is
not limited to females [we] recommend
modifying the instructions to be more
general neutral.
(Response 3f): Where the patient is in
the treatment journey and where the
treatment is within the treatment
algorithm are important concepts. The
descriptions of the patient and
condition in the revised questionnaire
[preceding Q6] identify where the
patient is in the journey, and the
scenarios were constructed such that the
scenario drug with the BW would be
considered a commonly considered
treatment option for patients who fit the
patient description. One of the scenarios
[estrogens to treat VVA] is only
applicable to females. The patient
description in the HCV scenario
questionnaire has been modified to be
gender neutral and to apply to patients
in general that the responder sees, not
a specific patient.
(Comment 3g): [We] recommend
asking an additional question after Q7
and 8 to assess reasoning by respondent.
This approach can provide an initial
indicator of unaided awareness and
impact of BW for HCPs. For example,
[we] propose: ‘‘what are your safety
concerns when considering [drug] for
patients [open end].’’
(Response 3g): FDA agrees that
eliciting this type of information from
respondents is very important. The
questionnaire includes a very similar
open-ended question [Q11 in the
revised questionnaire] to elicit the
potential rare but serious side effects
that the respondent discusses with
patients. In an attempt to minimize
respondent burden, we therefore did not
add the suggested questions because it
would be redundant.
(Comment 3h): A physician’s
response may be dependent on the
E:\FR\FM\06JYN1.SGM
06JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
condition and the contributions of
symptoms to the condition. [We] request
rational for inclusion of Q9 to 11 on
earlier phase of condition and Q7 to 8
related to more specific patient and
condition descriptions.
(Response 3h): In the questionnaire
draft that the commenter reviewed
included two descriptions. The first
description referenced an individual
patient with specific characteristics of
relevance to the prescribing scenario.
With the second description,
respondents were asked to think about
a broader patient population. Based on
the commenter’s feedback as well as the
results of the cognitive interviewing, we
have revised the scenario description to
have a single prototypical description of
a population of patients of relevance to
the prescribing scenario. For example,
the scenario used for the VVA
questionnaire states: ‘‘For the next few
questions, we would like you to
consider your patients who are
postmenopausal women complaining of
symptoms such as vaginal itching and
discomfort or pain during intercourse.
They have previously tried over-thecounter ointments with little success.’’
(Comment 3i): [Regarding Q12]
Because risk/benefit considerations will
likely be a key factor in deciding
whether to prescribe the drug, [we]
recommend including risk/benefit as a
possible selection. Relevant for
inclusion of the selection ‘‘This
patient’s preference about mode of
administration’’ will be depending on
the available treatment options for
condition selected. [We] recommend
adding an option in Q12 of ‘‘other
(specify)’’ instead of including Q12OTH
as a separate question. This approach
will enable respondents to rank another
option.
(Response 3i): FDA agrees that risk/
benefit is a critical assessment and
factor into HCPs’ decisions whether to
prescribe a drug, and there are multiple
questions in the questionnaire designed
to get at this overarching judgment of
the respondent. In the questionnaire
draft that the commenter reviewed, Q12
(Question 11 in the revised
questionnaire) asks respondents to
indicate the specific factors that play the
most important role when deciding
whether or not to prescribe the scenario
drug. These factors include separate
considerations on both the risks and
benefits, such as ‘‘patient’s
understanding of and comfort with the
risks of this medication’’ and medical
history as part of ‘‘patient’s medical and
health context.’’ We did not include a
risk/benefit as an option because that
would be redundant. We did, however,
address the commenter’s
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
recommendation about Q12OTH (a
question to allow for the respondent to
identify other factors). Question 11 in
the revised questionnaire now includes
an option: ‘‘other (please specify)’’,
rather than asking it as a separate
question. Should the survey respondent
feel that we left out risk/benefit
assessment as a separate factor, they
may input this in the ‘‘other (specify)’’
field.
(Comment 3j): [Regarding Q12l] [We]
recommend inclusion of a description of
the specific risks in BW instead of the
proposed option ‘‘risks outlined in the
boxed warning.’’
(Response 3j): FDA believes the
commenter meant to reference Question
15l. In the questionnaire draft that the
commenter reviewed, question 15l asks
respondents to indicate specific risks
(multiple choice) they discuss with the
patient about the product. In the revised
question, we modified this to an openended question, intentionally designed
to elicit spontaneous response about the
rare but serious side effects that they
discus. Further on in the survey is a
specific recall question asking
respondents to identify the risks
(multiple choice) they recall being
discussed in the boxed warning for the
specific product.
(Comment 3k): [We] recommend
moving Question 17 and 18 to the end
of the survey, as they seem less
important than the following questions
19–22.
(Response 3k): In the questionnaire
draft that the commenter reviewed, Q17
and Q18 ask respondents to indicate
where they typically look for
information about the scenario drug or
other similar products (medical
journals, search engines, etc.). In the
revised draft, we have simplified Q17
and Q18 into a single question (now
Q15). In light of this comment, we
considered other placements for this
question. We believe placement of this
question is justified as the last question
respondents’ answer regarding their
overall perceptions regarding the
scenario drug before they move to
focusing their attention on the boxed
warning information specifically. We
could not determine a better place later
in the questionnaire to include this
question because it would require the
respondent to go back to thinking
broadly about information sources.
(Comment 3l): Consider moving this
general perception question 19 about
BW earlier in the survey.
(Response 3l): The placement of this
question is deliberate. In the
questionnaire draft that the commenter
reviewed, Q19 ask respondents their
opinion of the primary role of a boxed
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
40295
warning (e.g., ‘‘to highlight the most
serious potential risks of the product; to
disclose clinical trial and other product
safety testing information.’’). This
questionnaire has been specifically
designed to not prime respondents to
think about boxed warnings at the start
of the questionnaire. We do not disclose
that the scenario product carries a boxed
warning, nor does it elicit respondents’
perception of boxed warnings until they
have provided their overall perceptions
of the safety and benefit-risk profile of
the scenario product. The intent is to
generate and see if concerns about the
information relayed in the boxed
warning spontaneously arises. The first
mention of boxed warning appears
immediately before Q19 (now Q16 in
the revised questionnaire): ‘‘The next
questions refers to the boxed warning
information on the product labeling for
[drug].’’ Because of this, we have left the
question as is in the revised
questionnaire.
(Comment 3m): Assuming the drug
with the BW referenced in the rest of the
survey is the BW explicitly shown at
this point in the survey, [we]
recommend not allowing respondents to
go back to ‘‘correct’’ previous answers.
(Response 3m): FDA agrees with the
commenter’s suggestion, and we have
set the programming language of the
web-based questionnaire to not allow
respondents to go back and change their
answers.
(Comment 3n): Please provide
rationale for the relevance of asking
Question 28_H.
(Response 3n): In the questionnaire
draft that the commenter reviewed,
Q28_H asks respondents to provide
their estimate of how many prescription
drugs they think carry a boxed warning.
The question has less relevance
compared to other questions in the
questionnaire, and it did not add value
in the cognitive interviews. Therefore,
to address this comment, we excluded
the question in the revised
questionnaire.
(Comment 3o): Assessing
‘‘favorability’’ of a BW is an awkward
question. Recommend revising Q29 to
an agreement statement. For example,
‘‘BW provides important information to
me.’’ If Question 29 is revised, then
recommend removing Q30.
(Response 3o): In the questionnaire
draft that the commenter reviewed, Q29
asks the respondent to rate how
favorable their opinion is of boxed
warnings in general. This question is
intended to provide an overall
assessment of boxed warnings. The
question was not confusing to
participants in the cognitive interviews.
In addition, another question (Q23 in
E:\FR\FM\06JYN1.SGM
06JYN1
40296
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
the revised questionnaire) asks level-ofagreement questions very similar to the
type of question the commenter
proposes (e.g., ‘‘I counsel my patients
differently when prescribing a product
with a boxed warning.’’). The revised
questionnaire, however, excludes the
open-ended Q30 in the revised
questionnaire, in an effort to streamline
the survey and reduce respondent
burden.
(Comment 3p): [We] recommend
adding an option ‘‘I’m not sure/I don’t
know/I’m not familiar’’ to Questions 2,
3, 4, 7, 8, 12, 14, 15, 23, 24, 25, 28, 29.
(Response 3p): FDA reviewed the
survey and added an Unsure/Don’t
know option where we deemed
appropriate: Qs 2, 3, 4, 28, 29. Questions
8 and 25 were removed. Q23 has an
‘‘Other (specify)’’ option where
participants can elaborate if they are
unable to choose an answer. For certain
key questions that elicits respondents’
opinions (Qs 7, 12, 14, 15, 24), we did
not add Unsure/Don’t know in order to
encourage them to thoughtfully pick an
answer. However, participants can
proceed through the questions without
providing an answer, if they wish.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Pretest Screener ..................................................
Pretest Informed Consent ....................................
Pretest Survey Completes ...................................
Main Survey Screener .........................................
Main Survey Informed Consent ...........................
Main Survey Completes .......................................
84
50
50
1,927
1,156
1,156
1
1
1
1
1
1
84
50
50
1,927
1,156
1,156
Total ..............................................................
4,423
........................
........................
1
Average burden
per response
0.05
0.05
0.28
0.05
0.05
0.28
Total hours
(3 minutes) ............
(3 minutes) ............
(17 minutes) ..........
(3 minutes) ............
(3 minutes) ............
(17 minutes) ..........
4
2
14
96
58
324
.......................................
498
There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display with the Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 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.
1. Dusetzina, S.B., A.S. Higashi, E.R. Dorsey,
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., S.B. Soumerai, F. Zhang,
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: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of responses
per respondent
[FR Doc. 2020–14377 Filed 7–2–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2020–N–1228]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Multiple
Indications in Direct-to-Consumer
Television Advertisements
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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 a proposed study
entitled ‘‘Study of Multiple Indications
in Direct-to-Consumer Television
Advertisements.’’
SUMMARY:
Submit either electronic or
written comments on the collection of
information by September 4, 2020.
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 September 4,
DATES:
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 4, 2020.
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
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40292-40296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3018]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 5, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comment'' or by using the search function. The title of this
information collection is ``Healthcare Provider Perception of Boxed
Warning Information Survey.'' Also include the FDA docket number found
in brackets in the heading of this document.
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].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Healthcare Provider Perception of Boxed Warning Information Survey
OMB Control Number 0910--NEW
I. Background
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
[[Page 40293]]
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 on
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 50 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.
In the Federal Register of August 8, 2019 (84 FR 38996), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments that were PRA
related. Below is a response to each of the commenters' questions. For
brevity, some public comments are paraphrased and therefore may not
reflect the exact language used by the commenter. The entirety of the
public comments was considered even if not fully captured by our
paraphrasing in this document.
(Comment 1) The first public comment ``agrees with the data
collection,'' but finds the intent of the data collection unclear and
expresses concern that ``the data will be collecting in the survey will
be used adversarially [sic] [against providers]''. The commenter
described experiences ``as a healthcare provider, [battling] daily with
both ends of the spectrum,'' including patients who want a ``brand new
drug'' even though it will likely provide little therapeutic benefit,
as well as patients who would benefit from a product but ``adamantly
refuse based on a [boxed warning].'' The commenter further stated that
``As a provider, I can present the information I have at hand, but how
do I combat new information that is identified specifically, a [boxed
warning] post prescribing a new medication?''
(Response 1) FDA appreciates the commenter's experience, which is
relevant to the research question that the proposed data collection is
intended to inform: how HCPs consider boxed warning information when
making treatment decisions and how they communicate boxed warning
information to their patients. As described in Section A.2, the intent
of the data collection to better understand the range of HCPs'
experiences and informational needs regarding boxed warning
information.
(Comment 2) The second public comment expressed concern regarding
how ``[a] voluntary commitment to participating in a professional
assessment survey demonstrates some level engagement and awareness [and
therefore this] survey will assess an already engaged section of
providers, potentially skewing the data.''
(Response 2) In accordance with the requirements set forth by
institutional review boards and OMB, any research must involve
voluntary participation of research participants. FDA acknowledges
there may be a coverage
[[Page 40294]]
bias from the use of an opt-in web panel as a sample frame (i.e., HCPs
who choose to be part of a research panel may differ from HCPs who do
not choose to be part of a research panels). As a basic check, in our
analysis of the study findings, we will compare the demographic
characteristics of the population of survey respondents to the
population of U.S. prescribers within the relevant medical specialties.
We will document the nature and limitations of our sampling frame and
the potential implications of that on the interpretation of the
research findings.
(Comment 3) The third public comment comprised 2 overarching
comments (3a and 3b below) and 13 additional (3c to 3p) comments on
individual items on the questionnaire, to which we have responded
below.
(Comment 3a) We recommend considering two different ``archetypes''
for the medical product scenarios to gain insight on different
situations. Consideration should be given to a drug/class with specific
risk factors identified in a BW [boxed warning], a drug/class launched
with a BW, or drug/class with a BW that was established post approval.
(Response 3a) FDA agrees with the importance of capturing different
archetypes (e.g., characteristics or features) of the medical scenario
and of the boxed warning. The identified scenarios, vaginal inserts to
treat vulvo-vaginal atrophy (VVA) in post-menopausal women and direct-
acting antivirals to treat chronic hepatitis C viral (HCV) infection
were identified because they differ along some important
characteristics. These characteristics include seriousness of
condition, characteristics of the safety concerns, length and nature of
the boxed warning information, and length of time since the boxed
warning was included.
(Comment 3b): We also recommend that FDA consider additional study
designs such as retrospective analysis on prescribing habits. Data
could be collected on prescribing habits of medications before and
after inclusion of a BW in labeling. This study could be used as a
complementary evaluation on the understanding the impact of BW.
(Response 3b): FDA agrees that there is value in complementary
research approaches using the same scenarios and appreciate the
suggestion. We will explore the feasibility of undertaking a related
outcomes-focused study looking at prescribing behaviors in future
studies.
(Comment 3c): In an effort to streamline the questionnaire, [we]
recommend considering the removal of [Question 1] and relying on
Questions 2 to 6 to assess the level of experience.
(Response 3c): FDA appreciates feedback suggesting opportunities to
streamline the questionnaire, and we have considered appropriate ways
to streamline. Q1 elicits a self-assessment of their level of
experience treating the scenario condition, which provides very
important context for understanding HCPs' perceptions. This concept is
distinct from concepts elicited in Q2 to 6. For example, a self-
assessment of experience with a condition may not be associated with
the number of patients the HCP currently sees.
(Comment 3d): [We] recommend consolidating Q5 and Q6 into a single
question. . . [and] including the drug of interest in the list of
options [and] adjusting the [choice] selections so that they become
mutually exclusive. [We] would further recommend screening out
physicians from taking remainder of the survey that do not prescribe
drugs with BW based on their responses to Q4 to 6.
(Response 3d): In the questionnaire draft that the commenter
reviewed, Q5 asks respondents how often they prescribe the scenario
drug and Q6 ask how often they prescribe a number of other types of
products that FDA believes providers may be using to treat the
condition. In the revised questionnaire (now Q4 and Q5), we keep the
two questions as separate, but we have greatly simplified the latter
(now Q5) so that it does not elicit prescribing rates, but rather asks
respondents to indicate which treatments they have used in a typical
month. The elicitation of the frequency (``a few times per month, a few
times a year, etc.'') is important with respect to the scenario drug.
We have modified the response items to be mutually exclusive.
Potential participants are screened based on their experience with
treating each of the medical conditions, but not based on their
prescribing behavior regarding any the particular product. For the
purposes of this research, exclusion due to not prescribing the
specific product with the boxed warning is not appropriate, as long as
the healthcare provide meets the other criteria. If, for example, a
provider chooses categorically not to prescribe a particular product
that has a boxed warning, it could be driven in part by his or her
perception of the boxed warning information. We are still interested in
this prescriber's perception of the benefits and risks of the scenario
product.
(Comment 3e): There may be a need to differentiate HCPs who
initiate vs. those that refill, therefore [we] recommend including a
question to ask what % of prescriptions are initiated vs. refill.
(Response 3e): FDA agrees that there may be a need to differentiate
HCPs who initiate vs. those who only prescribe refills for the scenario
drug. The revised questionnaire (question 4a) now allows
differentiation between HCPs who initiate prescriptions versus HCPs who
have only prescribed a refill for the scenario drug.
(Comment 3f): The description of patient and condition will likely
influence the responses and the physicians' consideration of the BW.
[We] recommend taking into consideration where the patient is in the
treatment journey and where the drug with the BW is in the treatment
algorithm. The instructions also imply that this treatment must only be
prescribed to females. If the treatment is not limited to females [we]
recommend modifying the instructions to be more general neutral.
(Response 3f): Where the patient is in the treatment journey and
where the treatment is within the treatment algorithm are important
concepts. The descriptions of the patient and condition in the revised
questionnaire [preceding Q6] identify where the patient is in the
journey, and the scenarios were constructed such that the scenario drug
with the BW would be considered a commonly considered treatment option
for patients who fit the patient description. One of the scenarios
[estrogens to treat VVA] is only applicable to females. The patient
description in the HCV scenario questionnaire has been modified to be
gender neutral and to apply to patients in general that the responder
sees, not a specific patient.
(Comment 3g): [We] recommend asking an additional question after Q7
and 8 to assess reasoning by respondent. This approach can provide an
initial indicator of unaided awareness and impact of BW for HCPs. For
example, [we] propose: ``what are your safety concerns when considering
[drug] for patients [open end].''
(Response 3g): FDA agrees that eliciting this type of information
from respondents is very important. The questionnaire includes a very
similar open-ended question [Q11 in the revised questionnaire] to
elicit the potential rare but serious side effects that the respondent
discusses with patients. In an attempt to minimize respondent burden,
we therefore did not add the suggested questions because it would be
redundant.
(Comment 3h): A physician's response may be dependent on the
[[Page 40295]]
condition and the contributions of symptoms to the condition. [We]
request rational for inclusion of Q9 to 11 on earlier phase of
condition and Q7 to 8 related to more specific patient and condition
descriptions.
(Response 3h): In the questionnaire draft that the commenter
reviewed included two descriptions. The first description referenced an
individual patient with specific characteristics of relevance to the
prescribing scenario. With the second description, respondents were
asked to think about a broader patient population. Based on the
commenter's feedback as well as the results of the cognitive
interviewing, we have revised the scenario description to have a single
prototypical description of a population of patients of relevance to
the prescribing scenario. For example, the scenario used for the VVA
questionnaire states: ``For the next few questions, we would like you
to consider your patients who are postmenopausal women complaining of
symptoms such as vaginal itching and discomfort or pain during
intercourse. They have previously tried over-the-counter ointments with
little success.''
(Comment 3i): [Regarding Q12] Because risk/benefit considerations
will likely be a key factor in deciding whether to prescribe the drug,
[we] recommend including risk/benefit as a possible selection. Relevant
for inclusion of the selection ``This patient's preference about mode
of administration'' will be depending on the available treatment
options for condition selected. [We] recommend adding an option in Q12
of ``other (specify)'' instead of including Q12OTH as a separate
question. This approach will enable respondents to rank another option.
(Response 3i): FDA agrees that risk/benefit is a critical
assessment and factor into HCPs' decisions whether to prescribe a drug,
and there are multiple questions in the questionnaire designed to get
at this overarching judgment of the respondent. In the questionnaire
draft that the commenter reviewed, Q12 (Question 11 in the revised
questionnaire) asks respondents to indicate the specific factors that
play the most important role when deciding whether or not to prescribe
the scenario drug. These factors include separate considerations on
both the risks and benefits, such as ``patient's understanding of and
comfort with the risks of this medication'' and medical history as part
of ``patient's medical and health context.'' We did not include a risk/
benefit as an option because that would be redundant. We did, however,
address the commenter's recommendation about Q12OTH (a question to
allow for the respondent to identify other factors). Question 11 in the
revised questionnaire now includes an option: ``other (please
specify)'', rather than asking it as a separate question. Should the
survey respondent feel that we left out risk/benefit assessment as a
separate factor, they may input this in the ``other (specify)'' field.
(Comment 3j): [Regarding Q12l] [We] recommend inclusion of a
description of the specific risks in BW instead of the proposed option
``risks outlined in the boxed warning.''
(Response 3j): FDA believes the commenter meant to reference
Question 15l. In the questionnaire draft that the commenter reviewed,
question 15l asks respondents to indicate specific risks (multiple
choice) they discuss with the patient about the product. In the revised
question, we modified this to an open-ended question, intentionally
designed to elicit spontaneous response about the rare but serious side
effects that they discus. Further on in the survey is a specific recall
question asking respondents to identify the risks (multiple choice)
they recall being discussed in the boxed warning for the specific
product.
(Comment 3k): [We] recommend moving Question 17 and 18 to the end
of the survey, as they seem less important than the following questions
19-22.
(Response 3k): In the questionnaire draft that the commenter
reviewed, Q17 and Q18 ask respondents to indicate where they typically
look for information about the scenario drug or other similar products
(medical journals, search engines, etc.). In the revised draft, we have
simplified Q17 and Q18 into a single question (now Q15). In light of
this comment, we considered other placements for this question. We
believe placement of this question is justified as the last question
respondents' answer regarding their overall perceptions regarding the
scenario drug before they move to focusing their attention on the boxed
warning information specifically. We could not determine a better place
later in the questionnaire to include this question because it would
require the respondent to go back to thinking broadly about information
sources.
(Comment 3l): Consider moving this general perception question 19
about BW earlier in the survey.
(Response 3l): The placement of this question is deliberate. In the
questionnaire draft that the commenter reviewed, Q19 ask respondents
their opinion of the primary role of a boxed warning (e.g., ``to
highlight the most serious potential risks of the product; to disclose
clinical trial and other product safety testing information.''). This
questionnaire has been specifically designed to not prime respondents
to think about boxed warnings at the start of the questionnaire. We do
not disclose that the scenario product carries a boxed warning, nor
does it elicit respondents' perception of boxed warnings until they
have provided their overall perceptions of the safety and benefit-risk
profile of the scenario product. The intent is to generate and see if
concerns about the information relayed in the boxed warning
spontaneously arises. The first mention of boxed warning appears
immediately before Q19 (now Q16 in the revised questionnaire): ``The
next questions refers to the boxed warning information on the product
labeling for [drug].'' Because of this, we have left the question as is
in the revised questionnaire.
(Comment 3m): Assuming the drug with the BW referenced in the rest
of the survey is the BW explicitly shown at this point in the survey,
[we] recommend not allowing respondents to go back to ``correct''
previous answers.
(Response 3m): FDA agrees with the commenter's suggestion, and we
have set the programming language of the web-based questionnaire to not
allow respondents to go back and change their answers.
(Comment 3n): Please provide rationale for the relevance of asking
Question 28_H.
(Response 3n): In the questionnaire draft that the commenter
reviewed, Q28_H asks respondents to provide their estimate of how many
prescription drugs they think carry a boxed warning. The question has
less relevance compared to other questions in the questionnaire, and it
did not add value in the cognitive interviews. Therefore, to address
this comment, we excluded the question in the revised questionnaire.
(Comment 3o): Assessing ``favorability'' of a BW is an awkward
question. Recommend revising Q29 to an agreement statement. For
example, ``BW provides important information to me.'' If Question 29 is
revised, then recommend removing Q30.
(Response 3o): In the questionnaire draft that the commenter
reviewed, Q29 asks the respondent to rate how favorable their opinion
is of boxed warnings in general. This question is intended to provide
an overall assessment of boxed warnings. The question was not confusing
to participants in the cognitive interviews. In addition, another
question (Q23 in
[[Page 40296]]
the revised questionnaire) asks level-of-agreement questions very
similar to the type of question the commenter proposes (e.g., ``I
counsel my patients differently when prescribing a product with a boxed
warning.''). The revised questionnaire, however, excludes the open-
ended Q30 in the revised questionnaire, in an effort to streamline the
survey and reduce respondent burden.
(Comment 3p): [We] recommend adding an option ``I'm not sure/I
don't know/I'm not familiar'' to Questions 2, 3, 4, 7, 8, 12, 14, 15,
23, 24, 25, 28, 29.
(Response 3p): FDA reviewed the survey and added an Unsure/Don't
know option where we deemed appropriate: Qs 2, 3, 4, 28, 29. Questions
8 and 25 were removed. Q23 has an ``Other (specify)'' option where
participants can elaborate if they are unable to choose an answer. For
certain key questions that elicits respondents' opinions (Qs 7, 12, 14,
15, 24), we did not add Unsure/Don't know in order to encourage them to
thoughtfully pick an answer. However, participants can proceed through
the questions without providing an answer, if they wish.
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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest Screener.............. 84 1 84 0.05 (3 minutes) 4
Pretest Informed Consent...... 50 1 50 0.05 (3 minutes) 2
Pretest Survey Completes...... 50 1 50 0.28 (17 14
minutes).
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 (17 324
minutes).
---------------------------------------------------------------------------------
Total..................... 4,423 .............. .............. ................ 498
----------------------------------------------------------------------------------------------------------------
\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 with the Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 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.
1. Dusetzina, S.B., A.S. Higashi, E.R. Dorsey, 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., S.B. Soumerai, F. Zhang, 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: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14377 Filed 7-2-20; 8:45 am]
BILLING CODE 4164-01-P
