National Institute on Drug Abuse; Notice of Closed Meeting, 49385 [E9-23085]
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Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
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 20, 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 new
drug application (NDA) 22–368, for ARIDOL
(mannitol bronchial challenge test),
manufactured by Pharmaxis Ltd. The
proposed use of this product is to assess
bronchial hyperresponsiveness (airway
irritability in the lungs) to aid in diagnosing
patients 6 years of age or older who have
symptoms of asthma or symptoms that are
suggestive of 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 5, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. to 2 pm. 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
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presentation on or before October 28, 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 29, 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. E9–23270 Filed 9–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel
B/START Review.
Date: October 15, 2009.
Time: 9 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
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49385
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852,
(Virtual Meeting).
Contact Person: Gerald L. McLaughlin,
PhD, Scientific Review Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Blvd., Bethesda, MD
20892–8401, 301–402–6626,
gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: September 18, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23085 Filed 9–25–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflicts: Addiction, Learning, and Feeding.
Date: October 6–7, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Brian Hoshaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181,
MSC 7844, Bethesda, MD 20892. 301–435–
1033. hoshawb@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Motivated
Behavior.
Date: October 7, 2009.
Time: 1 p.m. to 2 p.m.
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28SEN1
Agencies
[Federal Register Volume 74, Number 186 (Monday, September 28, 2009)]
[Notices]
[Page 49385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23085]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel B/START Review.
Date: October 15, 2009.
Time: 9 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6101 Executive Boulevard,
Rockville, MD 20852, (Virtual Meeting).
Contact Person: Gerald L. McLaughlin, PhD, Scientific Review
Administrator, Office of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC 8401, 6101 Executive Blvd.,
Bethesda, MD 20892-8401, 301-402-6626, gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS).
Dated: September 18, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-23085 Filed 9-25-09; 8:45 am]
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