Amended Notice, 17970 [E9-9037]
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17970
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices
rmajette on PRODPC74 with NOTICES
products. Such systems have been put
in place for drugs that are or are
suspected to be teratogenic, and the
programs are designed to ensure
patients are not pregnant and will not
become pregnant while taking the drug.
Such systems create burdens on patients
and the health care system. Is such a
system necessary for opioids? How
would such a program be implemented
given the number of patients,
prescribers, and other health care
providers involved in their use?
2. Should the REMS include controls
on distributors who distribute products
to pharmacies and other health care
providers? What controls are necessary,
and how can they be efficiently
provided without being unduly
burdensome on the health care system?
3. What existing systems (for example,
in pharmacies) already exist that could
be used to implement a REMS? For
example, could patient information be
provided through existing pharmacy
systems to patients? Are there systems
for providing education to prescribers
that could be used to provide the
educational component of a REMS?
4. FDAAA requires that innovator and
generic application holders use a single,
shared system to provide a REMS with
elements to assure safe use. What
obstacles need to be addressed before
such a system could be developed?
5. What metrics should be used to
assess the success of the REMS? Please
comment on the metrics that should be
applied to measure the success of each
of the components of the REMS (e.g.,
educational requirements) as well as
metrics to assess the impact of the
overall REMS on decreasing abuse and
misuse of long acting opioids and
extended release opioids while seeking
to ensure that they remain available for
patients who suffer daily from chronic
pain.
III. Attendance and Registration
Register via email to
OpioidREMS@fda.hhs.gov by providing
complete contact information for each
attendee (including name, title,
affiliation, address, email address, and
phone number(s)) by May 15, 2009.
Registration is free and will be on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. Please send no more
than two individuals from your
organization. Registration on the first
day of the meeting will be provided on
a space available basis beginning at 8
a.m.
If you wish to make an oral
presentation at the meeting, you must
indicate this at the time of registration.
FDA has included questions for
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comment in section II of this document.
You should also identify by number
each question you wish to address in
your presentation. FDA will do its best
to accommodate requests to speak.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. If you need special
accommodations because of disability,
please e-mail OpioidREMS@fda.hhs.gov
at least 7 days before the meeting.
IV. Comments
Regardless of attendance at the public
meeting, interested persons may submit
written or electronic comments to the
Division of Dockets Management (see
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. To ensure consideration,
submit comments by June 30, 2009.
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: April 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8992 Filed 4–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Amended Notice
The purpose of this notice is to inform
the public that the National Institutes of
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Health (NIH) is cancelling the May 5,
2009 meeting of the NIH Blue Ribbon
Panel to Advise on the Risk Assessment
of the National Emerging Infectious
Diseases Laboratories at Boston
University Medical Center. The
announcement for the May 5, 2009
meeting was previously published in
the Federal Register on April 3, 2009
(74 FR 15296).
The meeting will be rescheduled and
the new date for the meeting will be
announced and published in the
Federal Register.
Dated: April 14, 2009.
Kelly Fennington,
Special Assistant to the Acting Director,
Office of Science Policy, National Institutes
of Health.
[FR Doc. E9–9037 Filed 4–17–09; 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 Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Heart, Lung,
and Blood Advisory Council.
Date: June 10, 2009.
Open: 8 a.m. to 12 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C–Wing, Room
10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
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[Federal Register Volume 74, Number 74 (Monday, April 20, 2009)]
[Notices]
[Page 17970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9037]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Amended Notice
The purpose of this notice is to inform the public that the
National Institutes of Health (NIH) is cancelling the May 5, 2009
meeting of the NIH Blue Ribbon Panel to Advise on the Risk Assessment
of the National Emerging Infectious Diseases Laboratories at Boston
University Medical Center. The announcement for the May 5, 2009 meeting
was previously published in the Federal Register on April 3, 2009 (74
FR 15296).
The meeting will be rescheduled and the new date for the meeting
will be announced and published in the Federal Register.
Dated: April 14, 2009.
Kelly Fennington,
Special Assistant to the Acting Director, Office of Science Policy,
National Institutes of Health.
[FR Doc. E9-9037 Filed 4-17-09; 8:45 am]
BILLING CODE 4140-01-P
