Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 6567 [2012-2760]
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Federal Register / Vol. 77, No. 26 / Wednesday, February 8, 2012 / Notices
In FR Doc.
2011–33555, appearing on page 82300
in the Federal Register of Friday,
December 30, 2011 (76 FR 82300), the
following corrections are made:
1. On page 82300, in the third
column, in the DATES section, the
submission date for comments should
be corrected to ‘‘April 9, 2012’’. We are
extending the comment period from
February 28, 2012, to 60 days after this
correction notice publishes to allow the
public sufficient time to comment.
2. On page 82301, in the first column,
in the second full paragraph in the
SUPPLEMENTARY INFORMATION section, the
last sentence is corrected to read: ‘‘This
document solicits comments on certain
labeling requirements for blood and
blood components, including Source
Plasma, finalized as part of a rule FDA
published on January 3, 2012, entitled
‘Revisions to Labeling Requirements for
Blood and Blood Components,
Including Source Plasma.’’’ We are
making this change because the final
rule inadvertently did not publish on
December 30, 2011.
SUPPLEMENTARY INFORMATION:
Dated: February 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–2827 Filed 2–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 28 and 29, 2012 from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
VerDate Mar<15>2010
14:54 Feb 07, 2012
Jkt 226001
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, Fax: (301 ) 847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1 (800)
741–8138 (301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On both days, the committee
will discuss the role of cardiovascular
assessment in the preapproval and
postapproval settings for drugs and
biologics developed for the treatment of
obesity.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 14, 2012.
Oral presentations from the public will
be scheduled between approximately
8:30 a.m. and 10 a.m. on March 29,
2012. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
PO 00000
Frm 00037
Fmt 4703
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6567
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 6, 2012. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 7, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Paul Tran at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 2, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–2760 Filed 2–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0067]
Assessment of Analgesic Treatment of
Chronic Pain—A Public Workshop;
Request for Comments
Food and Drug Administration.
Notice of public workshop;
request for comments.
AGENCY:
ACTION:
The Food and Drug Administration
(FDA), Center for Drug Evaluation and
Research (CDER), is announcing a
public workshop to hear a discussion of
the available data on the efficacy of
analgesics in the treatment of chronic
non-cancer pain (CNCP). The focus of
the presentations and discussions by
scientific experts and other stakeholder
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Notices]
[Page 6567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 28 and 29, 2012
from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2417, Silver Spring, MD 20993-0002, (301) 796-9001, Fax: (301 ) 847-
8533, email: EMDAC@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1 (800) 741-8138 (301) 443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On both days, the committee will discuss the role of
cardiovascular assessment in the preapproval and postapproval settings
for drugs and biologics developed for the treatment of obesity.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 14, 2012. Oral presentations from the public will be scheduled
between approximately 8:30 a.m. and 10 a.m. on March 29, 2012. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 6, 2012. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by March 7, 2012.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Paul Tran at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 2, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-2760 Filed 2-7-12; 8:45 am]
BILLING CODE 4160-01-P
