Peripheral and Central Nervous System Drugs Advisory Committee; Amendment of Notice, 9358 [E6-2541]
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rwilkins on PROD1PC63 with NOTICES
9358
Federal Register / Vol. 71, No. 36 / Thursday, February 23, 2006 / Notices
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, e-mail:
Cathy.Groupe@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On April 25, 2006, the
committee will meet between 8 a.m. to
5 p.m., to discuss new drug application
(NDA) 21–359 CELLEGESIC
(nitroglycerin [NTG] ointment), 0.4%
intra-anal, Cellegy Pharmaceuticals,
Inc., for the proposed indication of relief
of pain associated with anal fissures. On
April 26, 2006, the committee will meet
between 8 a.m. to 12 noon, to discuss
the agency’s draft recommendations for
relabeling of antihypertensive drugs for
outcome claims, as a followup to the
committee’s meeting on June 15, 2005,
where the committee discussed class
labeling of antihypertensive drugs based
on the proximity of their data to
outcome trials. Following this, from
approximately 1 p.m. to 5 p.m., the
committee will discuss the ‘‘Placebo in
Hypertension Adverse Reaction MetaAnalysis’’ Study, a meta-analysis of
more than 80,000 patients in placebocontrolled trials of antihypertensive
medications, which evaluated the risk of
irreversible harm in conducting
placebo-controlled trials in patients
with hypertension. 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/orhms/dockets/ac/
acmenu.htm under the heading
‘‘Cardiovascular and Renal Drugs
Advisory Committee.’’ (Click on the
year 2006 and scroll down to the above
named committee).
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 April 14, 2006. On April 25,
2006, oral presentations from the public
will be scheduled between
approximately 8:15 a.m. to 8:45 a.m. On
April 26, 2006, oral presentations from
the public will be scheduled between
approximately 8:15 a.m. to 8:45 a.m.
and 1 p.m. to 1:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before April 14, 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
VerDate Aug<31>2005
16:15 Feb 22, 2006
Jkt 205001
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 John
Lauttman at least 7 days in advance of
the meeting at 301–827–7001.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 15, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–2542 Filed 2–22–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the
Federal Register of January 27, 2006,
FDA announced that a meeting of the
Peripheral and Central Nervous System
Drugs Advisory Committee would be
held on March 7, 2006, from 8 a.m. to
5 p.m., and the open public hearing
portion scheduled between
approximately 1 p.m. and 2 p.m. On
page 4593, in the third column, the Date
and Time portion of the document is
amended to read as follows:
Date and Time: The meeting will be
held on March 7 and 8, 2006, from 8
a.m. to 5 p.m.
On page 4594, in the first column, in
the Procedure portion of the document,
the third sentence is amended to read as
follows:
Procedure: Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 5 p.m. on
March 7, 2006.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
Peripheral and Central Nervous
System Drugs Advisory Committee;
Amendment of Notice
Dated: February 15, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–2541 Filed 2–22–06; 8:45 am]
BILLING CODE 4160–01–S
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
National Institutes of Health
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Peripheral
and Central Nervous System Drugs
Advisory Committee. This meeting was
announced in the Federal Register of
January 27, 2006 (71 FR 4593). The
amendment is being made to reflect a
change in Date and Time and Procedure
portions of the document. An additional
day is being added to this meeting and
the length of time allotted for the open
public hearing portion is being
extended. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Sohail Mosaddegh, 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:
sohail.mosaddegh@fda.hhs.gov, or the
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington DC area), code
3014512543. Please call the Information
Line for up-to-date information on this
meeting.
PO 00000
Frm 00051
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
National Institute of Environmental
Health Sciences; Proposed Collection;
Comment Request; The Sister Study: A
Prospective Study of the Genetic and
Environmental Risk Factors for Breast
Cancer
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: The Sister
Study: A Prospective Study of the
Genetic and Environmental Risk Factors
for Breast Cancer. Type of Information
Collection Request: Revision of OMB
No. 0925–0522 and expiration date 31
July 2006. Need and Use of Information
Collection: The purpose of the Sister
Study is to study genetic and
environmental risk factors for the
E:\FR\FM\23FEN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 36 (Thursday, February 23, 2006)]
[Notices]
[Page 9358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System Drugs Advisory Committee;
Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Peripheral and Central Nervous System
Drugs Advisory Committee. This meeting was announced in the Federal
Register of January 27, 2006 (71 FR 4593). The amendment is being made
to reflect a change in Date and Time and Procedure portions of the
document. An additional day is being added to this meeting and the
length of time allotted for the open public hearing portion is being
extended. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Sohail Mosaddegh, 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:
sohail.mosaddegh@fda.hhs.gov, or the FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code
3014512543. Please call the Information Line for up-to-date information
on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 27, 2006,
FDA announced that a meeting of the Peripheral and Central Nervous
System Drugs Advisory Committee would be held on March 7, 2006, from 8
a.m. to 5 p.m., and the open public hearing portion scheduled between
approximately 1 p.m. and 2 p.m. On page 4593, in the third column, the
Date and Time portion of the document is amended to read as follows:
Date and Time: The meeting will be held on March 7 and 8, 2006,
from 8 a.m. to 5 p.m.
On page 4594, in the first column, in the Procedure portion of the
document, the third sentence is amended to read as follows:
Procedure: Oral presentations from the public will be scheduled
between approximately 1 p.m. and 5 p.m. on March 7, 2006.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: February 15, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-2541 Filed 2-22-06; 8:45 am]
BILLING CODE 4160-01-S
