National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 44596 [2011-18860]
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44596
Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Peripheral and
Central Nervous System 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 October 17, 2011, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Diem-Kieu Ngo,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, e-mail:
PCNS@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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: On October 17, 2011, the
committee will discuss supplemental
new drug application (sNDA) 21641
(013) for AZILECT (rasagiline mesylate)
Tablets, manufactured by Teva
Neuroscience, Inc., for the following
proposed indication: Treatment of
patients with idiopathic (of unknown
cause) Parkinson’s disease to slow
clinical progression and treat the signs
and symptoms of Parkinson’s disease as
initial monotherapy (the single drug
used to treat) and as adjunct (additional)
therapy to levodopa.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
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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 September 30, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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
September 22, 2011. 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 September 23, 2011.
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 Diem-Kieu
Ngo 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).
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Dated: July 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–18875 Filed 7–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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
Alcohol Abuse and Alcoholism Special
Emphasis Panel, Institutional Training Grant
Review.
Date: October 11, 2011.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: Legacy Hotel, 1775 Rockville Pike,
Rockville, MD 20852.
Contact Person: Beata Buzas, PhD,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, RM
2081, Rockville, MD 20852, 301–443–0800,
bbuzas@mail.nih.gov.
Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: July 20, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–18860 Filed 7–25–11; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Page 44596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; 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 Alcohol Abuse and
Alcoholism Special Emphasis Panel, Institutional Training Grant
Review.
Date: October 11, 2011.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant applications.
Place: Legacy Hotel, 1775 Rockville Pike, Rockville, MD 20852.
Contact Person: Beata Buzas, PhD, Scientific Review Officer,
National Institute on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, RM 2081, Rockville, MD
20852, 301-443-0800, bbuzas@mail.nih.gov.
Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards, National Institutes of Health,
HHS)
Dated: July 20, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-18860 Filed 7-25-11; 8:45 am]
BILLING CODE 4140-01-P
