Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting, 59568-59569 [E9-27718]
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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
Patriots Plaza Building, Washington, DC
20201, telephone (202) 245–0655, fax (202)
245–0664.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: November 6, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–27623 Filed 11–17–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0143]
Risk Evaluation and Mitigation
Strategies for Certain Opioid Drugs;
Notice of Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is announcing a
meeting with sponsors of certain opioid
drug products regarding the
development of Risk Evaluation and
Mitigation Strategies (REMS) for these
products. Other members of the public
are invited to attend and observe. The
REMS is intended to ensure that the
benefits of these drugs continue to
outweigh certain risks. FDA has
encouraged affected sponsors to work
collectively to develop a proposed
REMS. The purpose of this meeting is to
hear from sponsors about the status of
the development of a proposed REMS
and their views regarding the specific
features of the REMS for these products.
To promote transparency of the REMS
development process, other members of
the public are invited to attend the
meeting as observers. Additional
opportunities for public input will be
provided before FDA finalizes the
elements of the REMS.
DATES: The meeting will be held on
December 4, 2009, from 9 a.m. to 1 p.m.
To ensure consideration at the meeting,
submit comments by November 27,
2009. Register to attend the meeting by
November 27, 2009. See section III of
this document for information on how
to register for the meeting.
ADDRESSES: The public meeting will be
held at the Holiday Inn WashingtonCollege Park, 10000 Baltimore Ave.,
College Park, MD 20740.
SUMMARY:
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061. Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
A live webcast of this meeting will be
viewable at https://ConnectLive.com/
events/fda120409 on the day of the
meeting. A video record of the meeting
will be available at the same Web
address for 1 year.
FOR FURTHER INFORMATION CONTACT:
Theresa (Terry) Martin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196,
Silver Spring, MD 20993, 301–796–
3448, FAX: 301–847–8753, or
Patrick Frey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6350,
Silver Spring, MD 20993, 301–796–
3844, FAX: 301–847–8443, e-mail:
OpioidREMS@fda.hhs.gov.
I. Background
On February 6, 2009, the Food and
Drug Administration (FDA) sent letters
to manufacturers of certain opioid drug
products, indicating that these drugs
will be required to have a Risk
Evaluation and Mitigation Strategy
(REMS) to ensure that the benefits of the
drugs continue to outweigh the risks. A
table of opioid products that will be
required to have REMS is available on
the agency’s Web site at https://
www.fda.gov/Drugs/DrugSafety/
InformationbyDrugClass/
ucm163654.htm. Copies of this
document may be requested from
Theresa (Terry) Martin (see FOR FURTHER
INFORMATION CONTACT). The affected
opioid drugs include brand name and
generic products and are formulated
with the active ingredients fentanyl,
hydromorphone, methadone, morphine,
oxycodone, and oxymorphone. The
REMS would be intended to ensure that
the benefits of these drugs continue to
outweigh the risks associated with: (1)
Use of high doses of long-acting opioids
and extended-release opioid products in
non-opioid-tolerant and inappropriately
selected individuals; (2) abuse; (3)
misuse; and (4) overdose, both
accidental and intentional. REMS for
these opioids would likely include
elements to assure safe use to ensure
that prescribers, dispensers, and
patients are aware of, and understand,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
the risks and how these products should
be used.
On March 3, 2009, FDA held a
meeting with affected sponsors to
discuss how the REMS could be
designed to manage the risks while also
minimizing burdens to the health care
system. FDA presented a high-level
overview, regulatory background, and
the proposed elements of the REMS
followed by questions and comments
from the sponsors. At this meeting, FDA
encouraged sponsors to work
collectively to develop a proposed
REMS. The FDA presentations and
minutes from this meeting are available
on the agency’s Web site at https://
www.fda.gov/Drugs/DrugSafety/
InformationbyDrugClass/
ucm163660.htm. In May, FDA held
meetings with other affected
stakeholders including health care
professionals, patient advocates, and
pharmacy groups. FDA then held a
public meeting on May 27 and 28, 2009,
where FDA heard from members of the
public on what the REMS should look
like for these products, how to minimize
the burden on the health care
community and patients, and how FDA
should evaluate the REMS to determine
whether it achieves its objectives.
Nearly 100 members of the public spoke
at the meeting, and many others have
submitted written comments to the
docket (Docket No. FDA–2009–N–0143).
For additional background information
about this issue see 74 FR 17967, April
20, 2009.
II. Purpose of Meeting
The purpose of this meeting is for
FDA to hear from sponsors of longacting opioids and extended-release
opioid products on the development of
the REMS for these products and their
views about the specific features of the
REMS. Other members of the public are
invited to attend the meeting as
observers. Because this is a meeting
between FDA staff and the sponsors,
only FDA staff will be permitted to
question the sponsors at the meeting.
However, interested persons who attend
the public meeting will be given an
opportunity to provide suggestions for
questions for FDA staff to ask the
sponsors, at FDA’s sole discretion.
Index cards will be provided for this
purpose. There will be additional
opportunities for public input before
FDA finalizes the elements of the REMS.
III. Attendance and Registration
Registration: Register by e-mail to
OpioidREMS@fda.hhs.gov. Provide
complete contact information for each
attendee, including name, title,
affiliation, address, e-mail, and phone
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
number. Registration requests should be
received by November 27, 2009.
Registration is free and will be on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability on
the day of the event starting at 8 a.m.
If you need special accommodations
because of disability, please contact
Theresa (Terry) Martin (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
In addition, a live webcast of this
meeting will be viewable at https://
ConnectLive.com/events/fda120409 on
the day of the meeting. A video record
of the meeting will be available at the
same Web address for 1 year.
IV. Comments
In addition, any person may submit
written or electronic comments to the
Division of Dockets Management (see
DATES and ADDRESSES). Submit a single
copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified 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.
V. Transcripts
mstockstill on DSKH9S0YB1PROD with NOTICES
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the
meeting. A transcript will also be made
available in either hard copy or on CD–
ROM, upon submission of a Freedom of
Information request. Written requests
are to be sent to Division of Freedom of
Information (HFI–35), Office of
Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
A—Cancer Centers.
Date: December 10–11, 2009.
Time: 8 a.m. to 12:10 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Gail J Bryant, MD,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Blvd., Room 8107,
MSC 8328, Bethesda, MD 20892–8328, (301)
402–0801, gb30t@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: November 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–27715 Filed 11–17–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27718 Filed 11–17–09; 8:45 am]
National Institutes of Health
BILLING CODE 4160–01–S
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
Center for Scientific Review; Notice of
Closed Meeting
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59569
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Addictions,
Drugs, and Violence.
Date: November 24, 2009.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Michael Micklin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3136,
MSC 7759, Bethesda, MD 20892, (301) 435–
1258, micklinm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–27704 Filed 11–17–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59568-59569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27718]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0143]
Risk Evaluation and Mitigation Strategies for Certain Opioid
Drugs; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting
with sponsors of certain opioid drug products regarding the development
of Risk Evaluation and Mitigation Strategies (REMS) for these products.
Other members of the public are invited to attend and observe. The REMS
is intended to ensure that the benefits of these drugs continue to
outweigh certain risks. FDA has encouraged affected sponsors to work
collectively to develop a proposed REMS. The purpose of this meeting is
to hear from sponsors about the status of the development of a proposed
REMS and their views regarding the specific features of the REMS for
these products. To promote transparency of the REMS development
process, other members of the public are invited to attend the meeting
as observers. Additional opportunities for public input will be
provided before FDA finalizes the elements of the REMS.
DATES: The meeting will be held on December 4, 2009, from 9 a.m. to 1
p.m. To ensure consideration at the meeting, submit comments by
November 27, 2009. Register to attend the meeting by November 27, 2009.
See section III of this document for information on how to register for
the meeting.
ADDRESSES: The public meeting will be held at the Holiday Inn
Washington-College Park, 10000 Baltimore Ave., College Park, MD 20740.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061.
Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document.
A live webcast of this meeting will be viewable at https://ConnectLive.com/events/fda120409 on the day of the meeting. A video
record of the meeting will be available at the same Web address for 1
year.
FOR FURTHER INFORMATION CONTACT: Theresa (Terry) Martin, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301-796-
3448, FAX: 301-847-8753, or
Patrick Frey, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6350,
Silver Spring, MD 20993, 301-796-3844, FAX: 301-847-8443, e-mail:
OpioidREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On February 6, 2009, the Food and Drug Administration (FDA) sent
letters to manufacturers of certain opioid drug products, indicating
that these drugs will be required to have a Risk Evaluation and
Mitigation Strategy (REMS) to ensure that the benefits of the drugs
continue to outweigh the risks. A table of opioid products that will be
required to have REMS is available on the agency's Web site at https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163654.htm.
Copies of this document may be requested from Theresa (Terry) Martin
(see FOR FURTHER INFORMATION CONTACT). The affected opioid drugs
include brand name and generic products and are formulated with the
active ingredients fentanyl, hydromorphone, methadone, morphine,
oxycodone, and oxymorphone. The REMS would be intended to ensure that
the benefits of these drugs continue to outweigh the risks associated
with: (1) Use of high doses of long-acting opioids and extended-release
opioid products in non-opioid-tolerant and inappropriately selected
individuals; (2) abuse; (3) misuse; and (4) overdose, both accidental
and intentional. REMS for these opioids would likely include elements
to assure safe use to ensure that prescribers, dispensers, and patients
are aware of, and understand, the risks and how these products should
be used.
On March 3, 2009, FDA held a meeting with affected sponsors to
discuss how the REMS could be designed to manage the risks while also
minimizing burdens to the health care system. FDA presented a high-
level overview, regulatory background, and the proposed elements of the
REMS followed by questions and comments from the sponsors. At this
meeting, FDA encouraged sponsors to work collectively to develop a
proposed REMS. The FDA presentations and minutes from this meeting are
available on the agency's Web site at https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163660.htm. In May, FDA held
meetings with other affected stakeholders including health care
professionals, patient advocates, and pharmacy groups. FDA then held a
public meeting on May 27 and 28, 2009, where FDA heard from members of
the public on what the REMS should look like for these products, how to
minimize the burden on the health care community and patients, and how
FDA should evaluate the REMS to determine whether it achieves its
objectives. Nearly 100 members of the public spoke at the meeting, and
many others have submitted written comments to the docket (Docket No.
FDA-2009-N-0143). For additional background information about this
issue see 74 FR 17967, April 20, 2009.
II. Purpose of Meeting
The purpose of this meeting is for FDA to hear from sponsors of
long-acting opioids and extended-release opioid products on the
development of the REMS for these products and their views about the
specific features of the REMS. Other members of the public are invited
to attend the meeting as observers. Because this is a meeting between
FDA staff and the sponsors, only FDA staff will be permitted to
question the sponsors at the meeting. However, interested persons who
attend the public meeting will be given an opportunity to provide
suggestions for questions for FDA staff to ask the sponsors, at FDA's
sole discretion. Index cards will be provided for this purpose. There
will be additional opportunities for public input before FDA finalizes
the elements of the REMS.
III. Attendance and Registration
Registration: Register by e-mail to OpioidREMS@fda.hhs.gov. Provide
complete contact information for each attendee, including name, title,
affiliation, address, e-mail, and phone
[[Page 59569]]
number. Registration requests should be received by November 27, 2009.
Registration 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 based on space
limitations. Registrants will receive confirmation once they have been
accepted. Onsite registration on the day of the meeting will be based
on space availability on the day of the event starting at 8 a.m.
If you need special accommodations because of disability, please
contact Theresa (Terry) Martin (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
In addition, a live webcast of this meeting will be viewable at
https://ConnectLive.com/events/fda120409 on the day of the meeting. A
video record of the meeting will be available at the same Web address
for 1 year.
IV. Comments
In addition, any person may submit written or electronic comments
to the Division of Dockets Management (see DATES and ADDRESSES). Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.
V. Transcripts
Transcripts of the meeting will be available for review at the
Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 30 days after the meeting. A
transcript will also be made available in either hard copy or on CD-
ROM, upon submission of a Freedom of Information request. Written
requests are to be sent to Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27718 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S
