[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31945-31946]
From the Federal Register Online via the Government Publishing 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 http://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,
[email protected], 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, [email protected].
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:
[email protected] 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: http://www.fda.gov/Drugs/NewsEvents/ucm340470.htm.
Comments: Submit either electronic or written comments by August
29, 2013. Submit electronic comments to http://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 http://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: http://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
http://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