Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations, 40663-40666 [2020-14516]
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
negotiates with the regulated industry. If
a stakeholder decides to participate in
these monthly meetings at a later time,
that stakeholder may join the remaining
monthly stakeholder consultation
meetings after notifying FDA of this
intention (see ADDRESSES). These
stakeholder discussions will satisfy the
consultation requirement in section
736B(f)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding PDUFA
reauthorization, please provide
notification by email to
PDUFAReauthorization@fda.hhs.gov by
August 17, 2020. Your email should
contain complete contact information,
including name, title, affiliation,
address, email address, phone number,
and notice of any special
accommodations required because of
disability. Stakeholders will receive
confirmation and additional information
about the first meeting after FDA
receives this notification.
Dated: July 1. 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14585 Filed 7–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5973]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Health Care
Providers’ Understanding of Opioid
Analgesic Abuse Deterrent
Formulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
(PRA).
DATES: Fax written comments on the
collection of information by August 6,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
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SUMMARY:
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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 Comments’’ or
by using the search function. The title
of this information collection is ‘‘Health
Care Providers’ Understanding of
Opioid Analgesic Abuse Deterrent
Formulations.’’ 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:
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:
Health Care Providers’ Understanding
of Opioid Analgesic Abuse Deterrent
Formulations
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.
Prescription opioids play a significant
role in the opioid misuse and abuse
epidemic in the United States. Opioid
analgesics with properties designed to
deter abuse, commonly known as abuse
deterrent formulations (ADFs), may play
a role in helping to curb this epidemic.
Currently available ADFs have been
demonstrated to deter some forms of
abuse (injection, snorting, or, in some
cases, chewing and swallowing). FDA’s
own research and other evidence
suggests considerable variability in
health care providers’ (HCPs)
knowledge of and attitudes toward
prescription opioid products and
practices (Ref. 1), including
understanding of ADFs. ADF
prescription practices may present
opportunities for HCPs to reduce opioid
abuse. Conducting a comprehensive
evaluation of opioid prescribers’
knowledge, attitudes, perceptions,
experiences, and behaviors related to
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ADFs will help to inform FDA’s
approaches to ADFs.
Given the significance and farreaching nature of the opioid crisis,
along with FDA concerns about
potential misunderstanding among
HCPs about ADF terminology and
capabilities, FDA determined that
systematic research was necessary to
provide the detailed and comprehensive
evidence on which to base the Agency’s
ADF-related policy, regulatory, and
communication decisions, including
potential alternative language that may
be necessary to describe and explain
these products. This work aligns with
Priority 1 of the FDA’s Strategic Policy
Roadmap (https://www.fda.gov/aboutfda/reports/healthy-innovation-saferfamilies-fdas-2018-strategic-policyroadmap), and the Department of Health
and Human Services (HHS) and the
Administration have similarly placed
high priorities on addressing the
epidemic of misuse and abuse of opioid
drugs harming U.S. families.
The study’s purpose is to explore and
assess the ADF-related knowledge,
attitudes, and behaviors among opioid
prescribers (physicians, nurse
practitioners and physician assistants)
and dispensers/pharmacists, including
the related terms addiction and abuse
deterrence, and to explore possible
alternative language for describing these
products. Phase 1 consisted of focus
groups (OMB approval under control
number 0910–0695). The research
described in this notice represents
Phases 2 and 3 of the overall project.
Phase 2 will consist of a survey based
on the Phase 1 focus group findings
related to: (1) Health care provider
understanding of addiction, abuse, and
abuse deterrent formulations; (2)
attitudes toward, perceptions about, and
experiences with abuse-deterrent opioid
analgesics and abuse deterrence,
including prescribing decisions and
practices, potential barriers to using
ADFs, the quality and understandability
of the ADF nomenclature, and the
underlying reasons for these
perceptions; and (3) HCPs’ ideas for
minimizing confusion about ADFs, the
kinds of ADF training needed, and
suggested language/terms they believe
would best convey the concept of abuse
deterrence to HCPs. The objective of the
survey will be to determine the
prevalence of HCP knowledge, attitudes,
behaviors, and perceptions identified
through the qualitative discussion
occurring in the Phase 1 focus groups
and to uncover any subgroup
differences among opioid prescribers
and dispensers. We will conduct one
pretest, averaging not longer than 20
minutes, to pilot the main survey
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procedures among the target HCP
populations. The main survey will also
average 20 minutes.
Phase 3 will build on findings from
the Phase 1 focus groups and Phase 2
survey and will consist of an
experimental study examining
variations in descriptive terminology for
abuse deterrent formulation products.
We will conduct two pretests, each
averaging not longer than 20 minutes, to
test the experimental manipulations and
pilot the main study procedures. The
main study procedure will also average
20 minutes in length. Participants will
be randomly assigned to read a
description of abuse deterrent
formulation opioids that contains one of
four terms that could be used to refer to
these products (ADF will function as the
control term) and then complete a
questionnaire that assesses their
comprehension and perceptions of the
information, including terminology, as
well as their attitudes, behavioral
intentions, and experience related to
these types of opioid products.
For all phases of this research, we will
recruit adult health care professional
volunteers 18 years of age or older. We
will exclude individuals who work for
HHS or work in the health care,
marketing, or pharmaceutical industries.
The sample will consist of 10 percent
pharmacists, at least half of whom
dispense ADF opioids. The other 90
percent will be prescribers who, at the
time they are recruited, spend at least 50
percent of their time seeing patients and
who have prescribed opioids to at least
five different patients in the last 30
days, with at least half of the opioids
they prescribe being for chronic noncancer pain. The prescriber sample will
be segmented to include 70 percent
primary care providers (i.e., those
practicing in family practice, or internal
or general medicine) and 30 percent a
mix of specialists practicing in a variety
of fields such as rheumatology,
neurology, anesthesiology, pain
management, emergency medicine,
surgery, orthopedics, and physical
medicine and rehabilitation. In each of
these groups, 60 to 70 percent will
consist of physicians, 15 percent nurse
practitioners, and 15 percent physician
assistants. A minimum of 30 percent
must have experience prescribing an
ADF opioid.
We will use soft quotas to ensure that
our sample includes a diversity of
participants, including related to age,
race/ethnicity, gender, years and
location of practice, and opioid
prescribing levels. We will also exclude
pretest participants from the main
studies, and participants will not be
able to participate in more than one
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phase of the project. With the sample
sizes described below, we will have
sufficient power to detect primarily
small-sized effects for Phases 2 and 3.
In the Federal Register of February 5,
2020 (85 FR 6562), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received three
submissions that were PRA-related.
Within those submissions, FDA
received multiple comments, which the
Agency has addressed below.
(Comment 1) I believe Phase 2 should
include more pharmacists than 10
percent ratio.
(Response 1) We have carefully
planned the sample for the study to
ensure sufficient numbers of
prescribers, including primary care
providers and several types of
specialists (including neurologists, pain
management specialists,
rheumatologists, neurologists, surgeons,
orthopedists, physical medicine and
rehabilitation specialists), physician
assistants and nurse practitioners, as
well as including a group of pharmacists
for analysis. Expanding the sample
further is beyond the scope of what we
have planned for the project. Our power
analysis suggests we will have sufficient
power to ensure comparisons between
groups in the sample. In addition, in the
earlier focus group phase, pharmacists
said they rarely talk with patients about
ADFs and never talk with health care
professionals about them, suggesting the
feedback we would receive from them
would likely be limited.
(Comment 2) Practitioners chosen
should be based on greater prescribing
habits. Those practitioners who are the
larger rate of treating chronic noncancer pain with ADF opioid should be
the target of information gathering.
(Response 2) One of our screening
criteria is that at least half of a
provider’s prescriptions must be for
chronic, non-cancer pain. We plan to
include approximately equal numbers of
low, medium, and high prescribers
across each prescriber type and field of
practice so that comparisons can be
made between groups. In addition, in
the earlier focus group phase, current
prescribers of ADFs were already aware
of and had significant knowledge about
ADFs, so their feedback likely would
not provide the kind of insight needed
about the misunderstanding and
confusion we previously observed
among other prescribers.
(Comment 3) We support FDA’s
decision to conduct a comprehensive
evaluation of opioid prescribers’
knowledge, attitudes, perceptions,
experiences, and behaviors related to
ADFs and agree with the FDA that new
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language is needed to better describe
and explain ADFs.
(Response 3) Thank you for this
comment.
(Comment 4) We strongly encourage
testing the impact of terminology that
more accurately describes the product’s
abuse-deterrent properties. For example,
if a pill is formulated to be difficult to
crush, it should be labeled ‘‘crushresistant.’’
(Response 4) The survey, in part, will
provide HCPs an opportunity to propose
terms they think best describe these
opioids and will test both objectively
and subjectively numerous alternative
terms that were commonly cited as
appropriate by HCP participants in the
earlier focus group phase of this study.
This includes terms that relate to
physical manipulation such as
‘‘alteration-resistant opioids’’ and
‘‘tamper-resistant opioids.’’
(Comment 5) We support FDA’s
efforts to ensure the diversity of the
sample populations for the three
proposed studies. It is important to
study health care providers with varying
opioid prescribing levels, and years and
locations of practice. We particularly
commend the efforts to additionally
account for diverse ages, ethnicities, and
gender of the health care providers, as
all of these factors can affect knowledge,
attitudes, and the patients they serve.
(Response 5) Thank you for this
comment.
(Comment 6) The proposed study
plans to include a wide range of health
care providers, including primary care
providers; specialists from various fields
such as rheumatology, neurology,
anesthesiology, pain management,
emergency medicine, surgery,
orthopedics, and physical medicine and
rehabilitation; nurse practitioners;
physician assistants; as well as
dispensers/pharmacists. However, there
is clear evidence that dentists,
periodontists, and oral surgeons should
also be included, since research has
shown that they often overprescribe
opioids.
(Response 6) While the reviewers
raises an important consideration, the
inclusion of dentists and oral surgeons
is beyond the scope of the current study.
Dentists do not typically prescribe for
long-term pain and are therefore less
likely to prescribe an abuse-deterrent
formulation opioid or ADF, which is the
main focus of this study. For a similar
reason, based on what we heard in the
earlier focus group phase of this study,
we chose to exclude emergency
medicine physicians from the sample
survey populations.
(Comment 7) The proposed study
should explore providers’ knowledge of
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how ADF opioids are used and abused
once they are on the market. Opioids
considered to be abuse-deterrent are still
widely abused through the most
common oral route.
(Response 7) Our survey questions
will include items about provider
knowledge of ADFs, including specific
questions to test whether they are aware
that ADFs can still be abused, as well as
related to their experiences with use,
misuse, and abuse of opioids.
(Comment 8) We applaud the effort to
gather information about HCPs’
understanding of these products. This
effort is consistent with the Agency’s
history of extensive and diverse efforts
to balance the needs of people seeking
relief from severe acute and chronic
pain and the simultaneous need to
avoid worsening of the abuse, addiction,
and diversion of opioid medications in
these times of the opioid overdose
epidemic.
(Response 8) Thank you for this
comment.
(Comment 9) We believe that the
proposed sample design adequately
accounts for current ADF product
prescribers for chronic non-cancer pain.
It is not clear, however, whether the
proposed sample design would
adequately capture the second relevant
population, i.e. appropriate potential
prescribers of ADF products for chronic
non-cancer pain. Commenter
recommends that FDA focus on those
HCPs who specialize in chronic noncancer pain management, because these
relatively few HCPs manage a
disproportionate volume of patients
with chronic non-cancer pain and,
therefore, manage a disproportionate
volume of current and appropriate
potential prescriptions of ADF products
for chronic non-cancer pain.
Suggestions:
• The proposed threshold of 5
patients treated with opioids for chronic
non-cancer pain in a typical month is
too low. A low threshold does not
ensure that pain specialists will be
included, and evidence has shown that
the treatment of chronic non-cancer
pain with opioids has consolidated
under such pain specialists in recent
years.
• Study should focus on HCPs who
specialize in chronic non-cancer pain
management. This small subset of HCPs
manage a disproportionate volume of
patients with chronic non-cancer pain,
and therefore, they manage a
disproportionate volume of current and
appropriate potential ADF
prescriptions.
• Study can capture both intended
populations (current and ‘‘appropriate
potential’’ prescribers) by recruiting
only pain specialists and imposing a
threshold for experience prescribing
ADF products.
(Response 9) Pain management is one
of the specialties included on our
recruitment screener (in addition to
rheumatology, neurology,
anesthesiology, surgery, orthopedics,
and physical medicine and
rehabilitation). Our screening criteria
will ensure an approximately equal
number of low, medium, and highvolume prescribers across each provider
group. We also have included a
requirement that at least 50 percent of
prescriptions must be for chronic, noncancer pain. A key objective of this
study is to gain insight into
misunderstandings about ADF opioids
and the terminology and how to best
address the confusion and
misunderstandings that we found in the
earlier focus group phase of the study as
well as in prior research FDA
conducted. These data indicated pain
management specialists already tend to
have considerable knowledge about and
experience with ADFs, suggesting their
feedback would likely be of limited
usefulness with respect to the study’s
key objectives. This is similarly the case
for ADF prescribers, which is the reason
the study populations were purposely
inclusive of a broad cross-section of
opioid prescribers.
(Comment 10) Include a screening
question with a list of ADF products to
account for respondents’ lack of
knowledge about which products are
and are not ADF.
(Response 10) Thank you for the
suggestion. Our recruitment screener
includes such a question, which asks
respondents to identify which of 17
different listed opioids they have
prescribed, including six abusedeterrent formulations that will not be
identified as such. The survey
questionnaire itself also asks prescribers
to specifically cite in an open-ended
question the ADF opioids they have
prescribed, which will be used, in part,
to asses ADF knowledge.
(Comment 11) Set quotas to ensure
recruitment of representative sample
sizes for both non-specialists and pain
specialists.
(Response 11) Early in the protocol
development we identified the need for
samples of prescribers working in
primary care fields and among those in
specific specialties, which research has
shown generally prescribe the most
opioids overall, and the sample
populations included in the study will
reflect this necessary diversity.
(Comment 12) Lower Ns for Phase 2
and 3 to ensure timely completion. In
the company’s experience, a survey of
200 HCPs takes 5 weeks to complete.
(Response 12) We identified current
sample sizes based on power
calculations. Any reduction in sample
size would reduce our power to find
effects. We have planned a timeline for
the project to complete both phases 2
and 3 based experience collecting data
using these methods but will be
adjusting as necessary given the
COVID–19 pandemic and any other
unforeseen factors. This project is an
FDA priority, and we will prioritize
rigorous methodology that ensures
representativeness and robust data and
evidence even if it means taking a little
more time.
(Comment 13) Implement appropriate
honoraria to ensure feasibility and
timely results.
(Response 13) The financial incentive
rates were based on going rates for
incentives in provider panel surveys
and on recent research on incentives for
physician surveys. These will also
comport with those allowable by OMB.
In addition, our experience has shown
that the topic of this study—opioids and
the national crisis—and the fact that the
research is being undertaken by FDA,
the Federal agency responsible for
regulating these products, are additional
incentives for participation.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 4
Activity
Number of
respondents 3
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Phase 2:
Pretest screener ..
470 ............................
1 ................................
470 ............................
0.17 ...........................
(10 minutes) ..............
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Total hours
79.90
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 4—Continued
Number of
respondents 3
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Pretest .................
235 ............................
1 ................................
235 ............................
77.55
Survey screener ..
2,120 .........................
1 ................................
2,120 .........................
Survey .................
1,060 .........................
1 ................................
1,060 .........................
0.33 ...........................
(20 minutes) ..............
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
732 ............................
1 ................................
732 ............................
124.44
Pretests ...............
366 ............................
1 ................................
366 ............................
Main study
screener.
Main study ...........
2,120 .........................
1 ................................
2,120 .........................
1,060 .........................
1 ................................
1,060 .........................
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
0.17 ...........................
(10 minutes) ..............
0.33 ...........................
(20 minutes) ..............
Total .............
...................................
...................................
...................................
...................................
1,823.07
Activity
Phase 3:
Pretests screener
Total hours
360.40
349.80
120.78
360.40
349.80
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
total burden for project phases 2 and 3.
3 Includes 10 percent overage.
4 With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached.
Those participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With
this in mind, we have included an additional 10 percent over our target number of valid completes to account for some overage.
2 Includes
II. Reference
ACTION:
The following reference is on display
with the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is not available electronically at https://
www.regulations.gov as this reference is
copyright protected.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than August 6, 2020.
ADDRESSES: Written 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 Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Sickle Cell Disease Treatment
Demonstration Regional Collaborative
Program, OMB No. 0906–xxxx—New.
1. Hwang, C.S., L.W. Turner, S.P.
Kruszewski, et al. ‘‘Primary Care Physicians’
Knowledge and Attitudes Regarding
Prescription Opioid Abuse and Diversion.’’
The Clinical Journal of Pain, 32(4), 279–284,
2016.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14516 Filed 7–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Sickle Cell Disease
Treatment Demonstration Regional
Collaborative Program, OMB No. 0906–
xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
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Notice.
SUMMARY:
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Abstract: The Sickle Cell Disease
Treatment Demonstration Regional
Collaborative Program (SCDTDRCP) was
reauthorized by the Sickle Cell Disease
and Other Heritable Blood Disorders
Research, Surveillance, Prevention, and
Treatment Act of 2018 (Pub. L. 115–
327), which added section 1106 of the
Public Health Service Act, 42 U.S.C.
300b–5. The purpose of the proposed
Quality Improvement (QI) and
Performance Measures (N) data
collection is to evaluate the
effectiveness of the SCDTDRCP and how
the program can improve the
coordination of service delivery for
individuals with sickle cell disease
(SCD), train health professionals to
increase access to quality care and
collaborate with various stakeholders to
optimize health outcomes for
individuals with SCD. The goals of the
SCDTDRCP are to improve health
outcomes in individuals with SCD;
reduce morbidity and mortality caused
by SCD; reduce the number of
individuals with SCD receiving care
only in emergency departments; and
improve the quality of coordinated and
comprehensive services to individuals
with SCD and their families. The
program funds five grantees to establish
regional networks to provide leadership
and support for regional and statewide
activities in SCD. The grantees develop
and establish systemic mechanisms to
improve the treatment of SCD, by: (1)
Increasing the number of providers
treating individuals with SCD using the
National Heart, Lung and Blood
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Agencies
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40663-40666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5973]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Health Care
Providers' Understanding of Opioid Analgesic Abuse Deterrent
Formulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).
DATES: Fax written comments on the collection of information by August
6, 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
Comments'' or by using the search function. The title of this
information collection is ``Health Care Providers' Understanding of
Opioid Analgesic Abuse Deterrent Formulations.'' 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.
Health Care Providers' Understanding of Opioid Analgesic Abuse
Deterrent Formulations
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.
Prescription opioids play a significant role in the opioid misuse
and abuse epidemic in the United States. Opioid analgesics with
properties designed to deter abuse, commonly known as abuse deterrent
formulations (ADFs), may play a role in helping to curb this epidemic.
Currently available ADFs have been demonstrated to deter some forms of
abuse (injection, snorting, or, in some cases, chewing and swallowing).
FDA's own research and other evidence suggests considerable variability
in health care providers' (HCPs) knowledge of and attitudes toward
prescription opioid products and practices (Ref. 1), including
understanding of ADFs. ADF prescription practices may present
opportunities for HCPs to reduce opioid abuse. Conducting a
comprehensive evaluation of opioid prescribers' knowledge, attitudes,
perceptions, experiences, and behaviors related to ADFs will help to
inform FDA's approaches to ADFs.
Given the significance and far-reaching nature of the opioid
crisis, along with FDA concerns about potential misunderstanding among
HCPs about ADF terminology and capabilities, FDA determined that
systematic research was necessary to provide the detailed and
comprehensive evidence on which to base the Agency's ADF-related
policy, regulatory, and communication decisions, including potential
alternative language that may be necessary to describe and explain
these products. This work aligns with Priority 1 of the FDA's Strategic
Policy Roadmap (https://www.fda.gov/about-fda/reports/healthy-innovation-safer-families-fdas-2018-strategic-policy-roadmap), and the
Department of Health and Human Services (HHS) and the Administration
have similarly placed high priorities on addressing the epidemic of
misuse and abuse of opioid drugs harming U.S. families.
The study's purpose is to explore and assess the ADF-related
knowledge, attitudes, and behaviors among opioid prescribers
(physicians, nurse practitioners and physician assistants) and
dispensers/pharmacists, including the related terms addiction and abuse
deterrence, and to explore possible alternative language for describing
these products. Phase 1 consisted of focus groups (OMB approval under
control number 0910-0695). The research described in this notice
represents Phases 2 and 3 of the overall project.
Phase 2 will consist of a survey based on the Phase 1 focus group
findings related to: (1) Health care provider understanding of
addiction, abuse, and abuse deterrent formulations; (2) attitudes
toward, perceptions about, and experiences with abuse-deterrent opioid
analgesics and abuse deterrence, including prescribing decisions and
practices, potential barriers to using ADFs, the quality and
understandability of the ADF nomenclature, and the underlying reasons
for these perceptions; and (3) HCPs' ideas for minimizing confusion
about ADFs, the kinds of ADF training needed, and suggested language/
terms they believe would best convey the concept of abuse deterrence to
HCPs. The objective of the survey will be to determine the prevalence
of HCP knowledge, attitudes, behaviors, and perceptions identified
through the qualitative discussion occurring in the Phase 1 focus
groups and to uncover any subgroup differences among opioid prescribers
and dispensers. We will conduct one pretest, averaging not longer than
20 minutes, to pilot the main survey
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procedures among the target HCP populations. The main survey will also
average 20 minutes.
Phase 3 will build on findings from the Phase 1 focus groups and
Phase 2 survey and will consist of an experimental study examining
variations in descriptive terminology for abuse deterrent formulation
products. We will conduct two pretests, each averaging not longer than
20 minutes, to test the experimental manipulations and pilot the main
study procedures. The main study procedure will also average 20 minutes
in length. Participants will be randomly assigned to read a description
of abuse deterrent formulation opioids that contains one of four terms
that could be used to refer to these products (ADF will function as the
control term) and then complete a questionnaire that assesses their
comprehension and perceptions of the information, including
terminology, as well as their attitudes, behavioral intentions, and
experience related to these types of opioid products.
For all phases of this research, we will recruit adult health care
professional volunteers 18 years of age or older. We will exclude
individuals who work for HHS or work in the health care, marketing, or
pharmaceutical industries. The sample will consist of 10 percent
pharmacists, at least half of whom dispense ADF opioids. The other 90
percent will be prescribers who, at the time they are recruited, spend
at least 50 percent of their time seeing patients and who have
prescribed opioids to at least five different patients in the last 30
days, with at least half of the opioids they prescribe being for
chronic non-cancer pain. The prescriber sample will be segmented to
include 70 percent primary care providers (i.e., those practicing in
family practice, or internal or general medicine) and 30 percent a mix
of specialists practicing in a variety of fields such as rheumatology,
neurology, anesthesiology, pain management, emergency medicine,
surgery, orthopedics, and physical medicine and rehabilitation. In each
of these groups, 60 to 70 percent will consist of physicians, 15
percent nurse practitioners, and 15 percent physician assistants. A
minimum of 30 percent must have experience prescribing an ADF opioid.
We will use soft quotas to ensure that our sample includes a
diversity of participants, including related to age, race/ethnicity,
gender, years and location of practice, and opioid prescribing levels.
We will also exclude pretest participants from the main studies, and
participants will not be able to participate in more than one phase of
the project. With the sample sizes described below, we will have
sufficient power to detect primarily small-sized effects for Phases 2
and 3.
In the Federal Register of February 5, 2020 (85 FR 6562), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three submissions that were
PRA-related. Within those submissions, FDA received multiple comments,
which the Agency has addressed below.
(Comment 1) I believe Phase 2 should include more pharmacists than
10 percent ratio.
(Response 1) We have carefully planned the sample for the study to
ensure sufficient numbers of prescribers, including primary care
providers and several types of specialists (including neurologists,
pain management specialists, rheumatologists, neurologists, surgeons,
orthopedists, physical medicine and rehabilitation specialists),
physician assistants and nurse practitioners, as well as including a
group of pharmacists for analysis. Expanding the sample further is
beyond the scope of what we have planned for the project. Our power
analysis suggests we will have sufficient power to ensure comparisons
between groups in the sample. In addition, in the earlier focus group
phase, pharmacists said they rarely talk with patients about ADFs and
never talk with health care professionals about them, suggesting the
feedback we would receive from them would likely be limited.
(Comment 2) Practitioners chosen should be based on greater
prescribing habits. Those practitioners who are the larger rate of
treating chronic non-cancer pain with ADF opioid should be the target
of information gathering.
(Response 2) One of our screening criteria is that at least half of
a provider's prescriptions must be for chronic, non-cancer pain. We
plan to include approximately equal numbers of low, medium, and high
prescribers across each prescriber type and field of practice so that
comparisons can be made between groups. In addition, in the earlier
focus group phase, current prescribers of ADFs were already aware of
and had significant knowledge about ADFs, so their feedback likely
would not provide the kind of insight needed about the misunderstanding
and confusion we previously observed among other prescribers.
(Comment 3) We support FDA's decision to conduct a comprehensive
evaluation of opioid prescribers' knowledge, attitudes, perceptions,
experiences, and behaviors related to ADFs and agree with the FDA that
new language is needed to better describe and explain ADFs.
(Response 3) Thank you for this comment.
(Comment 4) We strongly encourage testing the impact of terminology
that more accurately describes the product's abuse-deterrent
properties. For example, if a pill is formulated to be difficult to
crush, it should be labeled ``crush-resistant.''
(Response 4) The survey, in part, will provide HCPs an opportunity
to propose terms they think best describe these opioids and will test
both objectively and subjectively numerous alternative terms that were
commonly cited as appropriate by HCP participants in the earlier focus
group phase of this study. This includes terms that relate to physical
manipulation such as ``alteration-resistant opioids'' and ``tamper-
resistant opioids.''
(Comment 5) We support FDA's efforts to ensure the diversity of the
sample populations for the three proposed studies. It is important to
study health care providers with varying opioid prescribing levels, and
years and locations of practice. We particularly commend the efforts to
additionally account for diverse ages, ethnicities, and gender of the
health care providers, as all of these factors can affect knowledge,
attitudes, and the patients they serve.
(Response 5) Thank you for this comment.
(Comment 6) The proposed study plans to include a wide range of
health care providers, including primary care providers; specialists
from various fields such as rheumatology, neurology, anesthesiology,
pain management, emergency medicine, surgery, orthopedics, and physical
medicine and rehabilitation; nurse practitioners; physician assistants;
as well as dispensers/pharmacists. However, there is clear evidence
that dentists, periodontists, and oral surgeons should also be
included, since research has shown that they often overprescribe
opioids.
(Response 6) While the reviewers raises an important consideration,
the inclusion of dentists and oral surgeons is beyond the scope of the
current study. Dentists do not typically prescribe for long-term pain
and are therefore less likely to prescribe an abuse-deterrent
formulation opioid or ADF, which is the main focus of this study. For a
similar reason, based on what we heard in the earlier focus group phase
of this study, we chose to exclude emergency medicine physicians from
the sample survey populations.
(Comment 7) The proposed study should explore providers' knowledge
of
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how ADF opioids are used and abused once they are on the market.
Opioids considered to be abuse-deterrent are still widely abused
through the most common oral route.
(Response 7) Our survey questions will include items about provider
knowledge of ADFs, including specific questions to test whether they
are aware that ADFs can still be abused, as well as related to their
experiences with use, misuse, and abuse of opioids.
(Comment 8) We applaud the effort to gather information about HCPs'
understanding of these products. This effort is consistent with the
Agency's history of extensive and diverse efforts to balance the needs
of people seeking relief from severe acute and chronic pain and the
simultaneous need to avoid worsening of the abuse, addiction, and
diversion of opioid medications in these times of the opioid overdose
epidemic.
(Response 8) Thank you for this comment.
(Comment 9) We believe that the proposed sample design adequately
accounts for current ADF product prescribers for chronic non-cancer
pain. It is not clear, however, whether the proposed sample design
would adequately capture the second relevant population, i.e.
appropriate potential prescribers of ADF products for chronic non-
cancer pain. Commenter recommends that FDA focus on those HCPs who
specialize in chronic non-cancer pain management, because these
relatively few HCPs manage a disproportionate volume of patients with
chronic non-cancer pain and, therefore, manage a disproportionate
volume of current and appropriate potential prescriptions of ADF
products for chronic non-cancer pain.
Suggestions:
The proposed threshold of 5 patients treated with opioids
for chronic non-cancer pain in a typical month is too low. A low
threshold does not ensure that pain specialists will be included, and
evidence has shown that the treatment of chronic non-cancer pain with
opioids has consolidated under such pain specialists in recent years.
Study should focus on HCPs who specialize in chronic non-
cancer pain management. This small subset of HCPs manage a
disproportionate volume of patients with chronic non-cancer pain, and
therefore, they manage a disproportionate volume of current and
appropriate potential ADF prescriptions.
Study can capture both intended populations (current and
``appropriate potential'' prescribers) by recruiting only pain
specialists and imposing a threshold for experience prescribing ADF
products.
(Response 9) Pain management is one of the specialties included on
our recruitment screener (in addition to rheumatology, neurology,
anesthesiology, surgery, orthopedics, and physical medicine and
rehabilitation). Our screening criteria will ensure an approximately
equal number of low, medium, and high-volume prescribers across each
provider group. We also have included a requirement that at least 50
percent of prescriptions must be for chronic, non-cancer pain. A key
objective of this study is to gain insight into misunderstandings about
ADF opioids and the terminology and how to best address the confusion
and misunderstandings that we found in the earlier focus group phase of
the study as well as in prior research FDA conducted. These data
indicated pain management specialists already tend to have considerable
knowledge about and experience with ADFs, suggesting their feedback
would likely be of limited usefulness with respect to the study's key
objectives. This is similarly the case for ADF prescribers, which is
the reason the study populations were purposely inclusive of a broad
cross-section of opioid prescribers.
(Comment 10) Include a screening question with a list of ADF
products to account for respondents' lack of knowledge about which
products are and are not ADF.
(Response 10) Thank you for the suggestion. Our recruitment
screener includes such a question, which asks respondents to identify
which of 17 different listed opioids they have prescribed, including
six abuse-deterrent formulations that will not be identified as such.
The survey questionnaire itself also asks prescribers to specifically
cite in an open-ended question the ADF opioids they have prescribed,
which will be used, in part, to asses ADF knowledge.
(Comment 11) Set quotas to ensure recruitment of representative
sample sizes for both non-specialists and pain specialists.
(Response 11) Early in the protocol development we identified the
need for samples of prescribers working in primary care fields and
among those in specific specialties, which research has shown generally
prescribe the most opioids overall, and the sample populations included
in the study will reflect this necessary diversity.
(Comment 12) Lower Ns for Phase 2 and 3 to ensure timely
completion. In the company's experience, a survey of 200 HCPs takes 5
weeks to complete.
(Response 12) We identified current sample sizes based on power
calculations. Any reduction in sample size would reduce our power to
find effects. We have planned a timeline for the project to complete
both phases 2 and 3 based experience collecting data using these
methods but will be adjusting as necessary given the COVID-19 pandemic
and any other unforeseen factors. This project is an FDA priority, and
we will prioritize rigorous methodology that ensures representativeness
and robust data and evidence even if it means taking a little more
time.
(Comment 13) Implement appropriate honoraria to ensure feasibility
and timely results.
(Response 13) The financial incentive rates were based on going
rates for incentives in provider panel surveys and on recent research
on incentives for physician surveys. These will also comport with those
allowable by OMB. In addition, our experience has shown that the topic
of this study--opioids and the national crisis--and the fact that the
research is being undertaken by FDA, the Federal agency responsible for
regulating these products, are additional incentives for participation.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2 4
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Number of respondents Number of responses Total annual Average burden per
Activity \3\ per respondent responses response Total hours
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Phase 2:
Pretest screener............... 470................... 1..................... 470.................. 0.17................. 79.90
(10 minutes).........
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Pretest........................ 235................... 1..................... 235.................. 0.33................. 77.55
(20 minutes).........
Survey screener................ 2,120................. 1..................... 2,120................ 0.17................. 360.40
(10 minutes).........
Survey......................... 1,060................. 1..................... 1,060................ 0.33................. 349.80
(20 minutes).........
Phase 3:
Pretests screener.............. 732................... 1..................... 732.................. 0.17................. 124.44
(10 minutes).........
Pretests....................... 366................... 1..................... 366.................. 0.33................. 120.78
(20 minutes).........
Main study screener............ 2,120................. 1..................... 2,120................ 0.17................. 360.40
(10 minutes).........
Main study..................... 1,060................. 1..................... 1,060................ 0.33................. 349.80
(20 minutes).........
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Total...................... ...................... ...................... ..................... ..................... 1,823.07
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Includes total burden for project phases 2 and 3.
\3\ Includes 10 percent overage.
\4\ With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached. Those
participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in mind,
we have included an additional 10 percent over our target number of valid completes to account for some overage.
II. Reference
The following reference is on display with the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected.
1. Hwang, C.S., L.W. Turner, S.P. Kruszewski, et al. ``Primary
Care Physicians' Knowledge and Attitudes Regarding Prescription
Opioid Abuse and Diversion.'' The Clinical Journal of Pain, 32(4),
279-284, 2016.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14516 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P