Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for Comments, 50429-50431 [2017-23535]
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Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices
50429
Dated: October 25, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–23669 Filed 10–30–17; 8:45 am]
[Docket No. FDA–2017–N–5897]
References
asabaliauskas on DSKBBXCHB2PROD with NOTICES
(6) How can CDC support state and
local health departments, traditional
healthcare providers, not for profit
health institutions, and professional
healthcare partner organizations to
ensure that evidence-based tobacco
cessation interventions are integrated
into primary and behavioral health care
settings on a consistent and sustainable
basis?
(7) How can the public health sector
most effectively maximize the impact of
public and private insurance coverage of
cessation treatments as part of efforts to
ensure that all tobacco users have
barrier-free access to these treatments?
Final Immediately Dangerous to Life or
Health (IDLH) Value Profiles
1. U.S. Department of Health and Human
Services. The Health Consequences of
Smoking—50 Years of Progress: A Report
of the Surgeon General. Atlanta: U.S.
Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Center for Chronic
Disease Prevention and Health
Promotion, Office on Smoking and
Health, 2014.
2. Xu X, Bishop EE, Kennedy SM, Simpson
SA, Pechacek TF. Annual Healthcare
Spending Attributable to Cigarette
Smoking: An Update. American Journal
of Preventive Medicine 2014;48(3):326–
33.
3. Babb S, Malarcher A, Schauer G, Asman
K, Jamal A. Quitting Smoking Among
Adults—United States, 2000–2015.
MMWR Morb Mortal Wkly Rep
2017;65:1457–1464.
4. Siu AL; US Preventive Services Task
Force. Behavioral and pharmacotherapy
interventions for tobacco smoking
cessation in adults, including pregnant
women: U.S. Preventive Services Task
Force recommendation statement. Ann
Intern Med 2015;163:622–34.
´
5. Fiore MC, Jaen CR, Baker TB, et al.
Treating Tobacco Use and Dependence:
2008 Update—Clinical Practice
Guidelines. Rockville (MD): U.S.
Department of Health and Human
Services, Public Health Service, Agency
for Healthcare Research and Quality,
2008.
6. Jamal A, King BA, Neff LJ, Whitmill J,
Babb SD, Graffunder CM. Current
Cigarette Smoking Among Adults—
United States, 2005–2015. MMWR Morb
Mortal Wkly Rep 2016;65:1205–1211.
7. Institute of Medicine. Ending the Tobacco
Problem: A Blueprint for the Nation.
Washington: The National Academies
Press, 2007.
8. Jha P, Ramasundarahettige C, Landsman V,
Rostron B, Thun M, Anderson RN,
McAfee T, Peto R. 21st-century hazards
of smoking and benefits of cessation in
the United States. New England Journal
of Medicine 2013;368(4):341–50.
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17:37 Oct 30, 2017
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Food and Drug Administration
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Packaging, Storage, and Disposal
Options To Enhance Opioid Safety—
Exploring the Path Forward; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
[CDC–2017–0048; Docket Number NIOSH–
156–C]
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
AGENCY:
ACTION:
Notice of availability.
NIOSH announces the
availability of the following four
Immediately Dangerous to Life or Health
(IDLH) Value Profile documents:
Acetonitrile [CAS No. 75–05–8],
Chloroacetonitrile [CAS No. 107–14–2],
Methacrylonitrile [CAS No. 126–98–7],
and Nitrogen dioxide [CAS No. 10102–
44–0].
SUMMARY:
The final IDLH Value Profile
documents were published on
September 29, 2017.
DATES:
These documents may be
obtained at the following link: https://
www.cdc.gov/niosh/idlh/default.html.
ADDRESSES:
R.
Todd Niemeier, MS, CIH, NIOSH,
Education and Information Division
(EID), Robert A. Taft Laboratories, 1090
Tusculum Ave., MS–C32, Cincinnati,
OH 45226, phone 513/533–8166 (not a
toll-free number), email: rbn4@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
On May 5,
2017, NIOSH published a request for
public review in the Federal Register
[82 FR 21239] on IDLH Value profiles.
We did not receive public comments,
but did receive peer and stakeholder
comments. These comments received
were reviewed and addressed where
appropriate.
SUPPLEMENTARY INFORMATION:
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2017–23665 Filed 10–30–17; 8:45 am]
BILLING CODE 4163–19–P
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The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Packaging, Storage,
and Disposal Options To Enhance
Opioid Safety—Exploring the Path
Forward.’’ The purpose of this 2-day
public workshop is to host a scientific
discussion with experts and seek input
from interested stakeholders regarding
the role of packaging, storage, and
disposal options within the larger
landscape of activities aimed at
addressing abuse, misuse, or
inappropriate access of prescription
opioid drug products (opioids); guiding
principles and considerations for the
design of packaging, storage, and
disposal options for opioids; integrating
packaging, storage, and disposal options
into existing health care and pharmacy
systems, including both open and
closed health care systems (e.g., a closed
system such as the U.S. Department of
Veterans Affairs); data needs and how to
address challenges in assessing the
impact of packaging, storage, and
disposal options in both the premarket
and postmarket settings; and ways in
which FDA could encourage the
development and assessment of
packaging, storage, and disposal options
for opioids that have the potential to
enhance opioid safety.
DATES: The public workshop will be
held on December 11 and 12, 2017, from
8:30 a.m. to 5 p.m. Submit either
electronic or written comments on this
public workshop by February 12, 2018.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
SUMMARY:
The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910. The hotel’s phone number is
301–589–0800.
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 February 12, 2018. The
ADDRESSES:
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Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of February 12, 2018. 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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–5897 for ‘‘Packaging, Storage,
and Disposal Options To Enhance
Opioid Safety—Exploring the Path
Forward.’’ 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
VerDate Sep<11>2014
17:37 Oct 30, 2017
Jkt 244001
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/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.
FOR FURTHER INFORMATION CONTACT:
Irene Z. Chan, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4420, Silver Spring,
MD 20993–0002, 301–796–3962,
Irene.Chan2@fda.hhs.gov; or Michelle
Eby, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22,
Rm. 4422, Silver Spring, MD 20993–
0002, 301–796–4714, Michelle.Eby@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is deeply concerned about the
widespread epidemic of opioid abuse,
dependence, and overdose in the United
States. FDA believes packaging, storage,
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and disposal options have the potential
to enhance the safety of legally
prescribed opioids. The development of
such options is an important component
of a multi-pronged approach to
addressing the current opioid epidemic.
FDA is exploring a scientific
framework that supports and encourages
the development of packaging, storage,
and disposal options that can reduce or
deter misuse, abuse, or inappropriate
access to opioids, while allowing for the
safe use of opioids by patients who need
them. FDA will need to define the
specific problems that packaging,
storage, and disposal options could
most effectively address; the guiding
scientific principles to consider for the
design and evaluation of these options;
and the types of data most useful for
evaluating them.
The Duke-Margolis Center for Health
Policy previously convened an expert
workshop on June 1, 2017, to begin
examining the potential role of
packaging, storage, and disposal options
in enhancing opioid safety and deterring
misuse, abuse, and inappropriate access.
This workshop provided a forum for
discussing (1) the role of packaging,
storage, and disposal options in
addressing factors that enable opioid
abuse and misuse or inappropriate
access; (2) the current range of existing
packaging, storage, and disposal
options; (3) approaches to evaluating the
impact of packaging, storage, and
disposal options on misuse and abuse or
inappropriate access of opioids; and (4)
considerations for integrating the use of
packaging, storage, and disposal options
into existing health care and pharmacy
systems. Following the June 1, 2017,
Duke-Margolis Center for Health Policy
expert workshop, an issues paper was
developed.1 While the expert workshop
and subsequent issues paper were
supported through a cooperative
agreement with FDA, the views
expressed in the accompanying
documents are those of the participants
in attendance of that expert workshop,
and do not necessarily reflect the
official positions and policies of the
Department of Health and Human
Services, or imply endorsements by the
U.S. Government or other organizations.
II. Topics for Discussion at the Public
Workshop
In this 2-day public workshop, FDA
plans to explore the appropriate path
forward by hosting a scientific
discussion with experts and seeking
input from interested stakeholders.
1 https://healthpolicy.duke.edu/events/exploringpackaging-storage-and-disposal-solutions-enhanceopioid-safety.
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Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices
fda.hhs.gov no later than December 4,
2017.
Public Participation in Scientific
Workshop: Time will be provided
during the discussion of each agenda
topic for audience participants to
provide comments if desired. Comments
should be specific to the discussion
topic, and the time provided will be at
the discretion of the session chair.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast. Additional information
will be made available regarding
accessing the webcast 2 days prior to the
public workshop at https://
www.fda.gov/Drugs/NewsEvents/
ucm571797.htm.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm571797.htm.
III. Participating in the Public
Workshop
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Further discussion is needed regarding
(1) the role of packaging, storage, and
disposal options within the larger
landscape of activities aimed at
addressing opioid abuse, misuse, or
inappropriate access; (2) guiding
principles and considerations for the
design of packaging, storage, and
disposal options for opioids; (3)
integrating packaging, storage, and
disposal options into existing health
care and pharmacy systems, including
both open and closed health care
systems (e.g., a closed system such as
the U.S. Department of Veterans
Affairs); (4) data needs and how to
address challenges in assessing the
impact of packaging, storage, and
disposal options in both the premarket
and postmarket settings; and (5) ways in
which FDA could encourage the
development and assessment of
packaging, storage, and disposal options
for opioids that have the potential to
enhance opioid safety.
Participants will include individuals
from a broad set of Federal, State, and
private and public stakeholders who are
working on the challenges of improving
pain management while addressing the
opioid abuse epidemic. Public
participation and comment is
encouraged.
BILLING CODE 4164–01–P
Registration: To register for the public
workshop, ‘‘Packaging, Storage, and
Disposal Options to Enhance Opioid
Safety—Exploring the Path Forward,’’
please visit the following Web site to
register: https://
nakamotoevents.wufoo.com/forms/
pads-task-force-public-meeting/. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by December 1, 2017, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 7:30 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact
Michelle Eby at Michelle.Eby@
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
17:37 Oct 30, 2017
Jkt 244001
Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23535 Filed 10–30–17; 8:45 am]
Food and Drug Administration
[Docket No FDA–2008–D–0610]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Medical Products
and Dietary Supplements During an
Influenza Pandemic
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the 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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
SUMMARY:
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50431
collection in the guidance on
‘‘Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 2, 2018.
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 January 2,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 2, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 82, Number 209 (Tuesday, October 31, 2017)]
[Notices]
[Pages 50429-50431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5897]
Packaging, Storage, and Disposal Options To Enhance Opioid
Safety--Exploring the Path Forward; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Packaging, Storage,
and Disposal Options To Enhance Opioid Safety--Exploring the Path
Forward.'' The purpose of this 2-day public workshop is to host a
scientific discussion with experts and seek input from interested
stakeholders regarding the role of packaging, storage, and disposal
options within the larger landscape of activities aimed at addressing
abuse, misuse, or inappropriate access of prescription opioid drug
products (opioids); guiding principles and considerations for the
design of packaging, storage, and disposal options for opioids;
integrating packaging, storage, and disposal options into existing
health care and pharmacy systems, including both open and closed health
care systems (e.g., a closed system such as the U.S. Department of
Veterans Affairs); data needs and how to address challenges in
assessing the impact of packaging, storage, and disposal options in
both the premarket and postmarket settings; and ways in which FDA could
encourage the development and assessment of packaging, storage, and
disposal options for opioids that have the potential to enhance opioid
safety.
DATES: The public workshop will be held on December 11 and 12, 2017,
from 8:30 a.m. to 5 p.m. Submit either electronic or written comments
on this public workshop by February 12, 2018. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's
phone number is 301-589-0800.
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 February 12, 2018. The
[[Page 50430]]
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of February 12, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-5897 for ``Packaging, Storage, and Disposal Options To
Enhance Opioid Safety--Exploring the Path Forward.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Irene Z. Chan, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver
Spring, MD 20993-0002, 301-796-3962, [email protected]; or
Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4422, Silver Spring, MD 20993-0002, 301-796-4714,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is deeply concerned about the widespread epidemic of opioid
abuse, dependence, and overdose in the United States. FDA believes
packaging, storage, and disposal options have the potential to enhance
the safety of legally prescribed opioids. The development of such
options is an important component of a multi-pronged approach to
addressing the current opioid epidemic.
FDA is exploring a scientific framework that supports and
encourages the development of packaging, storage, and disposal options
that can reduce or deter misuse, abuse, or inappropriate access to
opioids, while allowing for the safe use of opioids by patients who
need them. FDA will need to define the specific problems that
packaging, storage, and disposal options could most effectively
address; the guiding scientific principles to consider for the design
and evaluation of these options; and the types of data most useful for
evaluating them.
The Duke-Margolis Center for Health Policy previously convened an
expert workshop on June 1, 2017, to begin examining the potential role
of packaging, storage, and disposal options in enhancing opioid safety
and deterring misuse, abuse, and inappropriate access. This workshop
provided a forum for discussing (1) the role of packaging, storage, and
disposal options in addressing factors that enable opioid abuse and
misuse or inappropriate access; (2) the current range of existing
packaging, storage, and disposal options; (3) approaches to evaluating
the impact of packaging, storage, and disposal options on misuse and
abuse or inappropriate access of opioids; and (4) considerations for
integrating the use of packaging, storage, and disposal options into
existing health care and pharmacy systems. Following the June 1, 2017,
Duke-Margolis Center for Health Policy expert workshop, an issues paper
was developed.\1\ While the expert workshop and subsequent issues paper
were supported through a cooperative agreement with FDA, the views
expressed in the accompanying documents are those of the participants
in attendance of that expert workshop, and do not necessarily reflect
the official positions and policies of the Department of Health and
Human Services, or imply endorsements by the U.S. Government or other
organizations.
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\1\ https://healthpolicy.duke.edu/events/exploring-packaging-storage-and-disposal-solutions-enhance-opioid-safety.
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II. Topics for Discussion at the Public Workshop
In this 2-day public workshop, FDA plans to explore the appropriate
path forward by hosting a scientific discussion with experts and
seeking input from interested stakeholders.
[[Page 50431]]
Further discussion is needed regarding (1) the role of packaging,
storage, and disposal options within the larger landscape of activities
aimed at addressing opioid abuse, misuse, or inappropriate access; (2)
guiding principles and considerations for the design of packaging,
storage, and disposal options for opioids; (3) integrating packaging,
storage, and disposal options into existing health care and pharmacy
systems, including both open and closed health care systems (e.g., a
closed system such as the U.S. Department of Veterans Affairs); (4)
data needs and how to address challenges in assessing the impact of
packaging, storage, and disposal options in both the premarket and
postmarket settings; and (5) ways in which FDA could encourage the
development and assessment of packaging, storage, and disposal options
for opioids that have the potential to enhance opioid safety.
Participants will include individuals from a broad set of Federal,
State, and private and public stakeholders who are working on the
challenges of improving pain management while addressing the opioid
abuse epidemic. Public participation and comment is encouraged.
III. Participating in the Public Workshop
Registration: To register for the public workshop, ``Packaging,
Storage, and Disposal Options to Enhance Opioid Safety--Exploring the
Path Forward,'' please visit the following Web site to register:
https://nakamotoevents.wufoo.com/forms/pads-task-force-public-meeting/.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by December 1, 2017, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Michelle Eby at [email protected] no later than December
4, 2017.
Public Participation in Scientific Workshop: Time will be provided
during the discussion of each agenda topic for audience participants to
provide comments if desired. Comments should be specific to the
discussion topic, and the time provided will be at the discretion of
the session chair.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Additional information will be made available
regarding accessing the webcast 2 days prior to the public workshop at
https://www.fda.gov/Drugs/NewsEvents/ucm571797.htm.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm571797.htm.
Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23535 Filed 10-30-17; 8:45 am]
BILLING CODE 4164-01-P
