Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting, 81618 [2010-32591]
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81618
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
mg, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to the
TRANDATE products listed in this
document. Additional ANDAs that refer
to these products may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32507 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
emcdonald on DSK2BSOYB1PROD with NOTICES
Anesthetic and Life Support 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.
VerDate Mar<15>2010
22:37 Dec 27, 2010
Jkt 223001
Name of Committee: Anesthetic and Life
Support 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 10, 2011, from 8 a.m. to 4:30 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Building 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 ‘‘White Oak Conference
Center Parking and Transportation
Information for FDA Advisory Committee
Meetings’’. Please note that visitors to the
White Oak Campus must enter through
Building 1.
Contact Person: Kalyani Bhatt, 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, e-mail: kalyani.bhatt@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 upto-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 March 10, 2011, the committee
will: (1) Receive updates regarding
neurodegenerative findings (findings related
to degeneration in the nervous system) in
juvenile animals exposed to anesthetic drugs,
as well as results from human
epidemiological studies using anesthesia in
children (information related to studies of
patterns and causes of disease); (2) discuss
the relevance of these findings to pediatric
patients and provide guidance for future
preclinical and clinical studies; and (3)
discuss the potential implications of these
data upon the practice of pediatric anesthesia
as well as the communication of the risk of
sedative/anesthetic agents to prescribers and
parents.
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
committee. Written submissions may be
made to the contact person on or before
February 24, 2011. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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
February 15, 2011. 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 February 16, 2011.
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 Kalyani
Bhatt 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: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–32591 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Request for Notification From
Consumer Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels and Request for Nominations
for Voting and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\28DEN1.SGM
Notice.
28DEN1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Page 81618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Anesthetic and Life Support 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: Anesthetic and Life Support 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 10, 2011, from
8 a.m. to 4:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave.,
Building 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 ``White Oak
Conference Center Parking and Transportation Information for FDA
Advisory Committee Meetings''. Please note that visitors to the
White Oak Campus must enter through Building 1.
Contact Person: Kalyani Bhatt, 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, e-mail: kalyani.bhatt@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 March 10, 2011, the committee will: (1) Receive
updates regarding neurodegenerative findings (findings related to
degeneration in the nervous system) in juvenile animals exposed to
anesthetic drugs, as well as results from human epidemiological
studies using anesthesia in children (information related to studies
of patterns and causes of disease); (2) discuss the relevance of
these findings to pediatric patients and provide guidance for future
preclinical and clinical studies; and (3) discuss the potential
implications of these data upon the practice of pediatric anesthesia
as well as the communication of the risk of sedative/anesthetic
agents to prescribers and parents.
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
February 24, 2011. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. 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
February 15, 2011. 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
February 16, 2011.
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 Kalyani Bhatt 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: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32591 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P
