Psychopharmacologic Drugs Advisory Committee; Notice of Meeting, 41220 [E6-11537]
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41220
Federal Register / Vol. 71, No. 139 / Thursday, July 20, 2006 / Notices
Federal agencies, state and local
governments, schools of public health,
colleges and universities, private
industry, nonprofit foundations,
professional associations, clinicians,
researchers, administrators, and health
planners. There are no costs to the
respondents other than their time. The
total estimated annualized burden hours
are 8,645.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Office-based physicians (eligible):
Physician Induction Interview ...............................................................................................
Patient Record form .............................................................................................................
Pulling and re-filing Patient Record form .............................................................................
CCSS ....................................................................................................................................
Office-based physicians (ineligible):
Patient Induction Interview ...................................................................................................
Community Health Center Directors:
Community Health Center Induction Interview .....................................................................
CHC Providers:
Physician Induction Interview ...............................................................................................
Patient Record Form ............................................................................................................
Pulling and re-filing Patient Record form .............................................................................
CCSS ....................................................................................................................................
Dated: July 11, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–11521 Filed 7–19–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES_1
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:
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 September 7 and 8, 2006, from
8 a.m. to 5 p.m.
Location: Hilton Hotel,The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD
20877.
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:
VerDate Aug<31>2005
19:44 Jul 19, 2006
Jkt 208001
Cicely.Reese@fda.hhs.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 under the heading
‘‘Psychopharmacologic Drugs Advisory
Committee (PDAC).’’ (Click on the year
2006 and scroll down to PDAC
meetings.)
Agenda: On September 7, 2006, the
committee will discuss new drug
application (NDA) 21–999, paliperidone
extended-release (ER) tablets, Janssen,
L.P./Johnson & Johnson Pharmaceutical
Research and Development, L.L.C.,
proposed indication for treatment of
schizophrenia. On September 8, 2006,
the committee will discuss NDA 21–
992, desvenlafaxine succinate (DVS
233), ER tablets, Wyeth
Pharmaceuticals, proposed indication
for treatment of major depressive
disorder.
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 August 23, 2006.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on both days. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person and submit a brief
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Number of
responses/respondent
Avg. burden
per response
(in hrs)
2,662
2,263
399
712
1
30
30
1
35/60
5/60
1/60
15/60
888
1
5/60
104
1
20/60
312
265
47
312
1
30
30
1
35/60
5/60
1/60
15/60
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 August 23, 2006.
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 Cicely Reese
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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–11537 Filed 7–19–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committee for Reproductive
Health Drugs; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20JYN1.SGM
Notice.
20JYN1
]]>Agencies
[Federal Register Volume 71, Number 139 (Thursday, July 20, 2006)]
[Notices]
[Page 41220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11537]
-----------------------------------------------------------------------
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 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 September 7 and 8, 2006,
from 8 a.m. to 5 p.m.
Location: Hilton Hotel,The Ballrooms, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
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: Cicely.Reese@fda.hhs.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 under the heading ``Psychopharmacologic
Drugs Advisory Committee (PDAC).'' (Click on the year 2006 and scroll
down to PDAC meetings.)
Agenda: On September 7, 2006, the committee will discuss new drug
application (NDA) 21-999, paliperidone extended-release (ER) tablets,
Janssen, L.P./Johnson & Johnson Pharmaceutical Research and
Development, L.L.C., proposed indication for treatment of
schizophrenia. On September 8, 2006, the committee will discuss NDA 21-
992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth
Pharmaceuticals, proposed indication for treatment of major depressive
disorder.
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
August 23, 2006. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on both days. Time allotted for
each presentation may be limited. Those desiring to make 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 August 23, 2006.
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 Cicely Reese 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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11537 Filed 7-19-06; 8:45 am]
BILLING CODE 4160-01-S
