Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 59986 [E9-27741]
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59986
Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Notices
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: November 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–27791 Filed 11–18–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
erowe on DSK5CLS3C1PROD 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: Endocrinologic and
Metabolic 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 January 12 and 13, 2010, 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: Paul Tran, 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:
paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512536. 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 January 12, 2010, the
committee will discuss new drug application
(NDA) 21–348, ZAVESCA (miglustat), 100
milligram (mg) capsules, by Actelion
Pharmaceuticals, Ltd., proposed for the
treatment of progressive neurological
manifestations (symptoms related to the
VerDate Nov<24>2008
15:22 Nov 18, 2009
Jkt 220001
nervous system) in patients with NiemannPick Disease (type C). On January 13, 2010,
the committee will discuss NDA 22–562,
CARBGLU (carglumic acid), 200 mg tablets,
by Orphan Europe SARL, proposed for the
treatment of hyperammonemia (elevated
levels of ammonia in the blood) in patients
with N acetyl glutamate synthetase (NAGS)
deficiency, an inherited disorder that causes
ammonia to accumulate in the blood.
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
December 28, 2009. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. on both
days. 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
December 17, 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 December 18, 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 Paul Tran
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/About
AdvisoryCommittees/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: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27741 Filed 11–18–09; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5281–N–96]
Recovery Act Reporting for the
Community Development Block Grant
Program for Indian Tribes and Alaska
Native Villages (ICDBG)
AGENCY: Office of the Chief Information
Officer, HUD.
ACTION: Notice.
SUMMARY: The proposed information
collection requirement described below
has been submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
The American Recovery and
Reinvestment Act of 2009 (Recovery
Act) provided a one-time Indian
Community Development Block Grant
funding to eligible Indian Tribes (or
Tribal organization on behalf of Indian
Tribes) for the development of decent
housing, environment, and economic
opportunities for low and moderateincome persons in Indian service areas.
DATES: Comments Due Date: December
21, 2009.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
approval Number (2577–0263) and
should be sent to: HUD Desk Officer,
Office of Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–5806.
FOR FURTHER INFORMATION CONTACT:
Lillian Deitzer, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 Seventh
Street, SW., Washington, DC 20410; email Lillian Deitzer at:
Lillian_L._Deitzer@HUD.gov or
telephone (202) 402–8048. This is not a
toll-free number. Copies of available
documents submitted to OMB may be
obtained from Ms. Deitzer.
SUPPLEMENTARY INFORMATION: This
notice informs the public that the
Department of Housing and Urban
Development has submitted to OMB a
request for approval of the Information
collection described below. This notice
is soliciting comments from members of
the public and affecting agencies
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) Evaluate the
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 74, Number 222 (Thursday, November 19, 2009)]
[Notices]
[Page 59986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Endocrinologic and Metabolic 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: Endocrinologic and Metabolic 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 January 12 and 13,
2010, 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: Paul Tran, 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:
paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512536. 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 January 12, 2010, the committee will discuss new drug
application (NDA) 21-348, ZAVESCA (miglustat), 100 milligram (mg)
capsules, by Actelion Pharmaceuticals, Ltd., proposed for the
treatment of progressive neurological manifestations (symptoms
related to the nervous system) in patients with Niemann-Pick Disease
(type C). On January 13, 2010, the committee will discuss NDA 22-
562, CARBGLU (carglumic acid), 200 mg tablets, by Orphan Europe
SARL, proposed for the treatment of hyperammonemia (elevated levels
of ammonia in the blood) in patients with N acetyl glutamate
synthetase (NAGS) deficiency, an inherited disorder that causes
ammonia to accumulate in the blood.
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
December 28, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. on both days.
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
December 17, 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
December 18, 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 Paul Tran 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: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27741 Filed 11-18-09; 8:45 am]
BILLING CODE 4160-01-S
