Pediatric Advisory Committee; Notice of Meeting, 67179 [05-22014]
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Federal Register / Vol. 70, No. 213 / Friday, November 4, 2005 / Notices
In FR Doc.
03–4691, appearing on page 9690 in the
Federal Register of February 28, 2003,
the following corrections are made:
1. On page 9690, in the third column,
in the first complete paragraph, in the
third line, ‘‘2,810’’ is corrected to read
‘‘2,901’’; in the fourth line, ‘‘2,201’’ is
corrected to read ‘‘2,292’’.
2. On page 9690, in the third column,
in the second complete paragraph,
beginning in the fourth line, ‘‘December
12, 1993’’ is corrected to read
‘‘September 12, 1993’’; in line 10,
‘‘December 12, 1993’’ is corrected to
read ‘‘September 12, 1993’’.
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 05–22012 Filed 11–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric 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: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues. The committee
also advises and makes
recommendations to the Secretary under
45 CFR 46.407 on research involving
children as subjects that is conducted or
supported by the Department of Health
and Human Services, when that
research is also regulated by FDA.
Date and Time: The meeting will be
held on Friday, November 18, 2005,
from 8 a.m. to 2 p.m.
Location: Washington DC North/
Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen,
Office of Science and Health
Coordination of the Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, rm. 14C–06),
Rockville, MD 20857, 301–827–6687, or
by e-mail: jjohannessen@fda.gov or FDA
Advisory Committee Information Line,
VerDate Aug<31>2005
22:35 Nov 03, 2005
Jkt 208001
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
8732310001. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss a
report by the agency on Adverse Event
Reporting, as mandated in Section 17 of
the Best Pharmaceuticals for Children
Act, for AGRYLIN (anagrelide),
PARAPLATIN (carboplatin), DIFLUCAN
(fluconazole), CAMPTOSAR
(irinotecan), TAMIFLU (oseltamivir),
VIOXX (rofecoxib), FERRLECIT (sodium
ferric gluconate complex), and IMITREX
(sumatriptan).
The background material will become
available no later than the day before
the meeting and will be posted under
the Pediatric Advisory Committee
Docket site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm. (Click
on the year 2005 and scroll down to
Pediatric Advisory Committee
meetings.)
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 by November 10, 2005. Oral
presentations from the public will be
scheduled on Friday, November 18,
2005, between approximately 8:30 a.m.
and 9:30 a.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by November 10, 2005, 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.
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 Jan
Johannessen at least 7 days in advance
of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 31, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–22014 Filed 11–3–05; 8:45 am]
BILLING CODE 4160–01–S
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67179
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committee on Special
Studies Relating to the Possible LongTerm Health Effects of Phenoxy
Herbicides and Contaminants (Ranch
Hand 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: Advisory
Committee on Special Studies Relating
to the Possible Long-Term Health Effects
of Phenoxy Herbicides and
Contaminants (Ranch Hand Advisory
Committee).
General Function of the Committee:
To advise the Secretary of Health and
Human Services (the Secretary) and the
Assistant Secretary for Health
concerning its oversight of the conduct
of the Ranch Hand study by the U.S. Air
Force and provide scientific oversight of
the Department of Veterans Affairs
Army Chemical Corps Vietnam Veterans
Health Study, and other studies in
which the Secretary or the Assistant
Secretary for Health believes
involvement by the committee is
desirable.
Date and Time: The meeting will be
held on November 18, 2005, from 8:30
a.m. to 4 p.m.
Location: Food and Drug
Administration, 5630 Fishers Lane, rm.
1066, Rockville, MD 20857.
Contact Person: Leonard Schechtman,
National Center for Toxicological
Research (HFT–10), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–6696, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512560. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss
the following items: (1) Updates and
interactions with the Institute of
Medicine’s Air Force Health Study
(AFHS) Disposition Study Committee;
(2) AFHS closure preparations; (3)
updates from the Air Force on the AFHS
history, program management, and the
Comprehensive Study Report; (4)
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 70, Number 213 (Friday, November 4, 2005)]
[Notices]
[Page 67179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22014]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric 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: Pediatric Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues. The committee
also advises and makes recommendations to the Secretary under 45 CFR
46.407 on research involving children as subjects that is conducted or
supported by the Department of Health and Human Services, when that
research is also regulated by FDA.
Date and Time: The meeting will be held on Friday, November 18,
2005, from 8 a.m. to 2 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination of the Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14C-06),
Rockville, MD 20857, 301-827-6687, or by e-mail: jjohannessen@fda.gov
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 8732310001. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss a report by the agency on
Adverse Event Reporting, as mandated in Section 17 of the Best
Pharmaceuticals for Children Act, for AGRYLIN (anagrelide), PARAPLATIN
(carboplatin), DIFLUCAN (fluconazole), CAMPTOSAR (irinotecan), TAMIFLU
(oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate
complex), and IMITREX (sumatriptan).
The background material will become available no later than the day
before the meeting and will be posted under the Pediatric Advisory
Committee Docket site at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm. (Click on the year 2005 and scroll down to Pediatric
Advisory Committee meetings.)
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 by November 10,
2005. Oral presentations from the public will be scheduled on Friday,
November 18, 2005, between approximately 8:30 a.m. and 9:30 a.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person by November
10, 2005, 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.
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 Jan Johannessen at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 31, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-22014 Filed 11-3-05; 8:45 am]
BILLING CODE 4160-01-S
