Clinical Development Programs for Opioid Conversion; Public Workshop; Request for Comments, 31945-31946 [2013-12537]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31945-31946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0510]


Clinical Development Programs for Opioid Conversion; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Drug Evaluation 
and Research, is announcing a public scientific workshop to address 
public health concerns associated with the inclusion of equianalgesic 
opioid conversion tables in opioid product labels. Discussion will 
focus on the available data supporting the use of equianalgesic opioid 
conversion tables, problems associated with their use, and strategies 
used in clinical practice to convert patients from one opioid analgesic 
product to another. The goal of the workshop is to identify gaps in 
existing knowledge regarding equianalgesic opioid conversion in 
clinical practice, to develop a research agenda to address these gaps, 
and to identify mechanisms for communicating safe opioid analgesic 
conversion strategies to prescribers.
    Date and Time: The public workshop will be held on July 29, 2013, 
from 8 a.m. to 4:30 p.m.
    Location: The workshop 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 non-FDA employees is 
through Building 1 where routine security check procedures will be 
performed. For parking and security information, please visit https://www.fda.gov/AboutFDA/WorkingatFDA/Buildingsandfacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Elizabeth Giaquinto, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-3416, 
Elizabeth.Giaquinto@fda.hhs.gov, or Lisa Basham, Center for Drug 
Evaluation

[[Page 31946]]

and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-1175, Lisa.Basham@fda.hhs.gov.
    Registration to Attend the Workshop and Requests to Participate in 
Open Public Hearing: As part of the public workshop, an open public 
hearing will be held between 10: 15 a.m. and 11:15 a.m. on July 29, 
2013. If you wish to attend the public workshop or provide testimony 
for the open public hearing, please email your registration to: 
IssuesWithOpioids@fda.hhs.gov by July 15, 2013. Those without email 
access may register by contacting one of the persons listed in the 
Contact Persons section of the document. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email address, and telephone number.
    For those interested in providing testimony for the Open Public 
Hearing, please also provide a short abstract of your remarks by July 
15, 2013. We will try to accommodate all persons who wish to testify; 
however, the duration of each speaker's testimony during this open 
public hearing may be limited by time constraints.
    Registration for the public workshop is free and will be on a 
first-come, first-served basis. Early registration is recommended, 
because seating is limited. FDA may limit the number of participants 
from each organization as well as the total number of participants 
based on space limitations. Registrants will receive confirmation once 
they have been accepted for the workshop. Onsite registration on the 
day of the meeting will be based on space availability. If registration 
reaches maximum capacity, FDA will post a notice closing meeting 
registration for the workshop at: https://www.fda.gov/Drugs/NewsEvents/ucm340470.htm.
    Comments: Submit either electronic or written comments by August 
29, 2013. Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at https://www.regulations.gov.
    If you need special accommodations due to a disability, please 
contact Elizabeth Giaquinto or Lisa Basham (see Contact Persons) at 
least 7 days in advance of the public workshop.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing this workshop to address public health concerns 
associated with the inclusion of equianalgesic opioid conversion tables 
in opioid product labels. Use of these conversion tables, intended for 
safe conversion between opioid products, has resulted in prescribing 
errors, serious adverse events, and deaths. While FDA will be giving a 
brief presentation on the use of conversion tables in the current 
product labels, we are holding this scientific workshop to bring the 
academic experts together to achieve consensus on what does or does not 
need to be done to improve how opioids are converted in clinical 
practice.
    During the public workshop participants will do the following:
    1. Review the data available supporting the basis of equianalgesic 
opioid conversion tables.
    2. Review the problems associated with the use of equianalgesic 
opioid conversion tables, including prescribing errors and the 
occurrence of serious adverse events and deaths, with emphasis on the 
risks associated with extended-release opioids.
    3. Review clinical strategies used for converting patients from one 
opioid product to another opioid product and the data to support the 
safety of those strategies.
    4. Discuss gaps in the existing knowledge regarding equianalgesic 
opioid analgesic doses and opioid conversion in clinical practice.
    5. Develop a research agenda to address those gaps.
    6. Discuss the mechanisms for communicating about safe opioid 
analgesic conversion strategies to prescribers.
    FDA will post the agenda and additional workshop background 
material approximately 5 days before the workshop at: https://www.fda.gov/Drugs/NewsEvents/ucm340470.htm.

II. Transcripts

    Please be advised that approximately 30 days after the public 
workshop, a transcript will be available. It will be accessible at 
https://www.regulations.gov, and may be viewed at the Division of 
Dockets Management (see Comments). A transcript will also be available 
in either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12537 Filed 5-24-13; 8:45 am]
BILLING CODE 4160-01-P