Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 49384 [E9-23292]
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49384
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6116
Executive Boulevard, 8041, Rockville, MD
20852. (Telephone Conference Call).
Contact Person: Bratin K. Saha, PhD,
Scientific Review Officer, Program
Coordination and Referral Branch, Division
of Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Boulevard,
Room 8041, Bethesda, MD 20892. (301) 402–
0371. sahab@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel. NCI Cancer
Prevention Research II.
Date: October 30, 2009.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6116
Executive Boulevard, Room # 210, Rockville,
MD 20852. (Telephone Conference Call).
Contact Person: Irina Gordienko, PhD,
Scientific Review Officer, Scientific Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Rm. 7073, Bethesda,
MD 20892. 301–594–1566.
gordienkoiv@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel.
Community Clinical Oncology Programs.
Date: December 1–2, 2009.
Time: 7 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Courtyard Gaithersburg
Washingtonian Ctr, 204 Boardwalk Place,
Gaithersburg, MD 20878.
Contact Person: Gerald G. Lovinger, PhD,
Scientific Review Administrator, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Blvd., Room 8101,
Bethesda, MD 20892–8329. 301/496–7987.
lovingeg@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23269 Filed 9–25–09; 8:45 am]
BILLING CODE 4140–01–P
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16:33 Sep 25, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pulmonary-Allergy 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: Pulmonary-Allergy
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 November 18, 2009, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver
Spring, The Ballrooms, 8727 Colesville Rd.,
Silver Spring, MD. The hotel phone number
is 301–589–5200.
Contact Person: Kristine T. Khuc, 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:
Kristine.Khuc@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512545. 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: The committee will discuss
biologics license application (BLA) 103976,
supplement 5149, for XOLAIR (omalizumab),
manufactured by Genentech USA, Inc. and
Novartis Pharmaceuticals Corp. The
proposed indication for this product is to
treat moderate to severe persistent asthma in
patients between 6 and 11 years of age whose
symptoms are inadequately controlled with
inhaled steroid medications and have: (1) A
positive reaction to skin testing with
common substances that can cause allergies
and asthma, such as pollen or (2) in vitro
reactivity, which is measured with a blood
test that confirms the presence of specific
proteins consistent with allergies and
asthma.
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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
November 3, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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 October 26, 2009.
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 October 27, 2009.
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 Kristine T.
Khuc 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/AboutAdvisory
Committees/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: September 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23292 Filed 9–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\28SEN1.SGM
Notice.
28SEN1
]]>Agencies
[Federal Register Volume 74, Number 186 (Monday, September 28, 2009)]
[Notices]
[Page 49384]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23292]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Pulmonary-Allergy 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: Pulmonary-Allergy 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 November 18, 2009,
from 8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms,
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is
301-589-5200.
Contact Person: Kristine T. Khuc, 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:
Kristine.Khuc@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512545. 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: The committee will discuss biologics license application
(BLA) 103976, supplement 5149, for XOLAIR (omalizumab), manufactured
by Genentech USA, Inc. and Novartis Pharmaceuticals Corp. The
proposed indication for this product is to treat moderate to severe
persistent asthma in patients between 6 and 11 years of age whose
symptoms are inadequately controlled with inhaled steroid
medications and have: (1) A positive reaction to skin testing with
common substances that can cause allergies and asthma, such as
pollen or (2) in vitro reactivity, which is measured with a blood
test that confirms the presence of specific proteins consistent with
allergies and asthma.
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
November 3, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. 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 October 26, 2009. 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 October 27, 2009.
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 Kristine T. Khuc
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: September 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23292 Filed 9-25-09; 8:45 am]
BILLING CODE 4160-01-S
