Pediatric Advisory Committee; Notice of Meeting, 5343 [E6-1223]
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Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
during the regulatory review period by
July 31, 2006. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management (see ADDRESSES). Three
copies of any mailed information are to
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1313 Filed 2–1–06; 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.
cchase on PROD1PC60 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: 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 of
Health and Human Services 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 Wednesday, March 22, 2006,
from 8 a.m. to 6 p.m.
Location: Washington DC North/
Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen,
Office of Science and Health
Coordination, Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane, (for
VerDate Aug<31>2005
17:49 Jan 31, 2006
Jkt 208001
express delivery, rm. 14C–06) Rockville,
MD 20857, 301–827–6687, e-mail:
Jan.Johannessen@fda.hhs.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 Pediatric Advisory
Committee will hear and discuss a
report by the agency, as mandated in
Section 17 of the Best Pharmaceuticals
for Children Act (BPCA), on adverse
event reports possibly related to
clofarabine (CLOLAR), irbesartan
(AVAPRO), sibutramine (MERIDIA), and
the mixed salts amphetamine product
(ADDERALL). In continuation of a prior
committee discussion of adverse events
for the class of methylphenidate
products used to treat attention deficit
hyperactivity disorder (ADHD), the
committee will hear and discuss
neuropsychiatric adverse events
possibly related to other approved
ADHD medications. The presentations
will focus on neuropsychiatric adverse
event reports and clinical trial data from
approved ADHD medications. The
committee will also receive an update
on efforts to better understand
cardiovascular adverse events possibly
related to ADHD medications.
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 2006 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 March 8, 2006. Oral
presentations from the public will be
scheduled on March 22, 2006, between
approximately 1 p.m. and 2 p.m. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person by March 8, 2006, 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
PO 00000
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5343
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please notify Jan N.
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: January 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–1223 Filed 1–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic 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 of the Food and Drug
Administration (FDA). The meeting will
be open to the public.
Name of Committee:
Psychopharmacologic 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 23, 2006, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg,The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Cicely Reese, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, Fax: 301–
827–6776, e-mail:
ReeseCi@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm. Click on the year 2006 and
scroll down to the
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Page 5343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1223]
-----------------------------------------------------------------------
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 of Health and
Human Services 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 Wednesday, March 22,
2006, from 8 a.m. to 6 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination, 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, e-mail: Jan.Johannessen@fda.hhs.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 Pediatric Advisory Committee will hear and discuss a
report by the agency, as mandated in Section 17 of the Best
Pharmaceuticals for Children Act (BPCA), on adverse event reports
possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO),
sibutramine (MERIDIA), and the mixed salts amphetamine product
(ADDERALL). In continuation of a prior committee discussion of adverse
events for the class of methylphenidate products used to treat
attention deficit hyperactivity disorder (ADHD), the committee will
hear and discuss neuropsychiatric adverse events possibly related to
other approved ADHD medications. The presentations will focus on
neuropsychiatric adverse event reports and clinical trial data from
approved ADHD medications. The committee will also receive an update on
efforts to better understand cardiovascular adverse events possibly
related to ADHD medications.
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 2006 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 March 8, 2006.
Oral presentations from the public will be scheduled on March 22, 2006,
between approximately 1 p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person by March 8, 2006, 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 notify Jan N. 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: January 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1223 Filed 1-31-06; 8:45 am]
BILLING CODE 4160-01-S
