[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]


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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.

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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


