Document ID: FDA-2017-N-2903-0002
Agency: fda
Document Type: Notice
Title: Data and Methods for Evaluating the Impact of Opioid Formulations With
Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments
Posted Date: 2017-06-14T04:00Z

[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27271-27273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12299]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2903]

Data and Methods for Evaluating the Impact of Opioid Formulations 
With Properties Designed To Deter Abuse in the Postmarket Setting: A 
Scientific Discussion of Present and Future Capabilities; Public 
Workshop; Issues Paper; 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 a public workshop entitled ``Data and Methods for Evaluating 
the Impact of Opioid Formulations with Properties Designed to Deter 
Abuse in the Postmarket Setting: A Scientific Discussion of Present and 
Future Capabilities.'' The purpose of the public workshop is to host a 
scientific discussion with expert panel members and interested 
stakeholders about the challenges in using the currently available data 
and methods for assessing the impact of opioid formulations with 
properties designed to deter abuse on opioid misuse, abuse, addiction, 
overdose, and death in the postmarket setting. The goal of this meeting 
is to discuss ways to improve the analysis and interpretation of 
existing data, as well as to discuss opportunities and challenges for 
collecting and/or linking additional data to improve national 
surveillance and research capabilities in this area. To assist in the 
workshop discussion, FDA is making available an issues paper that 
provides a brief overview of the currently available data resources 
used for evaluating the impact of opioid formulations with properties 
designed to deter abuse; summarizes some of the key methodological 
issues in this area; and outlines the issues that we would like to 
discuss during the upcoming workshop, including enhancing existing 
resources, applying new methodology, and creating new resources.

DATES: The public workshop will be held on July 10 and 11, 2017, from 
8:30 a.m. to 5 p.m. Submit either electronic or written comments on 
this public workshop by September 11, 2017. Late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before September 11, 2017. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of September 11, 2017. 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. 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:

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

[[Page 27272]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2093 for ``Data and Methods for Evaluating the Impact of 
Opioid Formulations with Properties Designed to Deter Abuse Properties 
in the Postmarket Setting: A Scientific Discussion of Present and 
Future Capabilities; Public Workshop; Issues Paper; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
DATES), will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cynthia Kornegay, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2456, Silver 
Spring, MD, 20993-0002, 301-796-0187, Cynthia.Kornegay@fda.hhs.gov; or 
Cherice Holloway, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 22, Rm. 4466, Silver Spring, MD, 20993-0002, 301-796-4909, 
Cherice.Holloway@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In this 2-day public workshop, FDA plans to host a scientific 
discussion with expert panel members and interested stakeholders about 
the challenges in using the currently available data and methods for 
assessing the impact of opioid formulations with properties designed to 
deter abuse on opioid misuse, abuse, addiction, overdose, and death in 
the postmarket setting. The goal of this meeting is to discuss ways to 
improve the analysis and interpretation of existing data, as well as to 
discuss opportunities and challenges for collecting and/or linking 
additional data to improve national surveillance and research 
capabilities in this area.

II. Topics for Discussion at the Public Workshop

    FDA has developed an issues paper entitled ``Data and Methods for 
Evaluating the Impact of Opioid Formulations with Properties Designed 
to Deter Abuse in the Postmarket Setting.'' This issues paper (1) 
provides a brief overview of the currently available data resources 
used for evaluating opioid formulations with properties designed to 
deter abuse; (2) summarizes some of the key methodological issues in 
this area; and (3) outlines the issues we would like to discuss during 
the upcoming workshop, including modifying existing resources, applying 
new methodology, and creating new resources. The issues paper can be 
found on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.

III. Participating in the Public Workshop

    Registration: To register to attend the public workshop, ``Data and 
Methods for Evaluating the Impact of Opioid Formulations with 
Properties Designed to Deter Abuse in the Postmarket Setting: A 
Scientific Discussion of Present and Future Capabilities,'' in person 
or virtually via Webcast, please contact Cherice Holloway at 
cherice.holloway@fda.hhs.gov by June 26, 2017. 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 June 26, 2017. 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 meeting/public workshop 
will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Cherice Holloway at cherice.holloway@fda.hhs.gov no later than 
Friday, June 30, 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

[[Page 27273]]

also be Webcast. Additional information about accessing the Webcast 
will be made available at least 2 days prior to the public workshop at: 
https://www.fda.gov/Drugs/NewsEvents/ucm540845.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 Division of Dockets 
Management (see ADDRESSES). A link to the transcript will also be 
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12299 Filed 6-13-17; 8:45 am]
BILLING CODE 4164-01-P