Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations, 6562-6565 [2020-02236]
Download as PDF
<![CDATA[
6562
Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Patroula Smpokou, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5328,
Silver Spring, MD 20993, 240–402–
9651; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Mucopolysaccharidosis Type III
(Sanfilippo Syndrome): Developing
Drugs for Treatment.’’ This draft
guidance provides the Agency’s
recommendations regarding the
structure of clinical development
programs for investigational drugs
intended to treat mucopolysaccharidosis
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
type III. This draft guidance is intended
to facilitate greater consistency in
approaches among development
programs and to ensure that sponsors
receive clear and specific guidance to
foster greater efficiency of drug
development in this rare disease. The
draft guidance describes specific
considerations relating to eligibility
criteria and trial design and discusses
the Agency’s current recommendations
for efficacy endpoints to support
approval of drugs for
mucopolysaccharidosis type III.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Mucopolysaccharidosis Type III
(Sanfilippo Syndrome): Developing
Drugs for Treatment.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
part 312 (Investigational New Drug
Application) have been approved under
OMB control number 0910–0014, and
the collections of information in 21 CFR
part 314 (Applications for FDA
Approval to Market a New Drug) have
been approved under OMB control
number 0910–0001, including 21 CFR
312.30, 314.50(d)(5), and 314.126(b)(6).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: January 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02220 Filed 2–4–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5973]
Agency Information Collection
Activities; Proposed Collection;
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 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 research entitled
‘‘Health Care Providers’ Understanding
of Opioid Analgesic Abuse Deterrent
Formulations.’’ This research consists of
a survey examining the health care
providers’ current perceptions,
understanding, and behaviors related to
opioid analgesic abuse deterrent
formulations (ADFs) and a study
exploring the effectiveness of different
terminology and descriptions for these
products.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 6, 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 April 6, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 6, 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.
DATES:
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://
E:\FR\FM\05FEN1.SGM
05FEN1
Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–5973 for ‘‘Agency Information
on Collection Activities; Proposed
Collection; Comment Request; Health
Care Providers’ Understanding of
Opioid Analgesic Abuse Deterrent
Formulations.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
For copies of the questionnaire
contact: Office of Communications
(OCOMM) Research Team,
CDEROCOMMResearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
6563
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 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 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
E:\FR\FM\05FEN1.SGM
05FEN1
6564
Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
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
White House 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 consists 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
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 one
description of an abuse deterrent
formulation prescription drug product
and then complete a questionnaire that
assesses their comprehension and
perceptions of the information,
including terminology. We will test up
to four variations in wording, including
the description of ADF included in
FDA’s guidance ‘‘Abuse Deterrent
Opioids—Evaluation and Labeling’’
(Ref. 2).
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
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 4
Number of
respondents 3
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Phase 2
Pretest screener ..........................................................
Pretest .........................................................................
Survey screener ..........................................................
Survey ..........................................................................
470
235
2,120
1,060
1
1
1
1
470
235
2,120
1,060
0.17
0.33
0.17
0.33
(10
(20
(10
(20
minutes)
minutes)
minutes)
minutes)
...
...
...
..
79.90
77.55
360.40
349.80
0.17
0.33
0.17
0.33
(10
(20
(10
(20
minutes)
minutes)
minutes)
minutes)
...
...
...
...
124.44
120.78
360.40
349.80
................................
1,823.07
jbell on DSKJLSW7X2PROD with NOTICES
Phase 3
Pretests screener ........................................................
Pretests ........................................................................
Main study screener ....................................................
Main study ...................................................................
732
366
2,120
1,060
1
1
1
1
732
366
2,120
1,060
Total ......................................................................
........................
........................
........................
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.
2 Includes
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\05FEN1.SGM
05FEN1
Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
6565
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. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. 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.
2. * FDA (2015). ‘‘Abuse Deterrent
Opioids—Evaluation and Labeling: Guidance
for Industry.’’ Available from https://
www.fda.gov/downloads/Drugs/Guidances/
UCM334743.pdf.
Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02236 Filed 2–4–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0418]
Nonprescription Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Nonprescription Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
a docket for public comment on this
document.
DATES: The meeting will be held on
March 11, 2020, from 8 a.m. to 5 p.m.
ADDRESSES: The meeting will be held at
FDA White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503),
Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For security information,
please refer to https://www.fda.gov/
about-fda/white-oak-campusinformation/public-meetings-fda-whiteoak-campus. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–0418.
The docket will close on March 10,
2020. Submit either electronic or
written comments on this public
meeting by March 10, 2020. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before March
10, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 10, 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.
Comments received on or before
March 3, 2020, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–0418 for ‘‘Nonprescription
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
E:\FR\FM\05FEN1.SGM
05FEN1
]]>Agencies
[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6562-6565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5973]
Agency Information Collection Activities; Proposed Collection;
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 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 research entitled ``Health Care Providers'
Understanding of Opioid Analgesic Abuse Deterrent Formulations.'' This
research consists of a survey examining the health care providers'
current perceptions, understanding, and behaviors related to opioid
analgesic abuse deterrent formulations (ADFs) and a study exploring the
effectiveness of different terminology and descriptions for these
products.
DATES: Submit either electronic or written comments on the collection
of information by April 6, 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 April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 6, 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://
[[Page 6563]]
www.regulations.gov will be posted to the docket unchanged. Because
your comment will be made public, you are solely responsible for
ensuring that your comment does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-5973 for ``Agency Information on Collection Activities;
Proposed Collection; Comment Request; Health Care Providers'
Understanding of Opioid Analgesic Abuse Deterrent Formulations.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
For copies of the questionnaire contact: Office of Communications
(OCOMM) Research Team, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 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
[[Page 6564]]
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 White House 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 consists 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 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 one
description of an abuse deterrent formulation prescription drug product
and then complete a questionnaire that assesses their comprehension and
perceptions of the information, including terminology. We will test up
to four variations in wording, including the description of ADF
included in FDA's guidance ``Abuse Deterrent Opioids--Evaluation and
Labeling'' (Ref. 2).
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
Activity respondents responses per Total annual Average burden per response Total hours
\3\ respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest screener............................. 470 1 470 0.17 (10 minutes)........................ 79.90
Pretest...................................... 235 1 235 0.33 (20 minutes)........................ 77.55
Survey screener.............................. 2,120 1 2,120 0.17 (10 minutes)........................ 360.40
Survey....................................... 1,060 1 1,060 0.33 (20 minutes)........................ 349.80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretests screener............................ 732 1 732 0.17 (10 minutes)........................ 124.44
Pretests..................................... 366 1 366 0.33 (20 minutes)........................ 120.78
Main study screener.......................... 2,120 1 2,120 0.17 (10 minutes)........................ 360.40
Main study................................... 1,060 1 1,060 0.33 (20 minutes)........................ 349.80
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 1,823.07
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
[[Page 6565]]
\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. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. 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.
2. * FDA (2015). ``Abuse Deterrent Opioids--Evaluation and
Labeling: Guidance for Industry.'' Available from https://www.fda.gov/downloads/Drugs/Guidances/UCM334743.pdf.
Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02236 Filed 2-4-20; 8:45 am]
BILLING CODE 4164-01-P
