Advisory Committee for Reproductive Health Drugs; Notice of Meeting, 29705 [E9-14638]
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Federal Register / Vol. 74, No. 119 / Tuesday, June 23, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Advisory Committee for Reproductive
Health Drugs; 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: Advisory
Committee for Reproductive Health
Drugs.
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 August 13, 2009, from 8 a.m. to
4:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact: Kalyani Bhatt, 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:
Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), code
3014512537. 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 biologics license applications
(BLAs) 125–320, 125–331, 125–332, and
125–333, proposed trade name PROLIA
(denosumab) subcutaneous injection, 60
milligrams (mg), Amgen Inc., for the
proposed indications of the treatment
and prevention of osteoporosis in
postmenopausal women, and the
treatment and prevention of bone loss in
patients undergoing hormone ablation
for prostate or breast cancer. Hormone
ablation is a term used to encompass
VerDate Nov<24>2008
16:15 Jun 22, 2009
Jkt 217001
therapies for hormone sensitive breast
or prostate cancer administered to
decrease sex hormone (estrogen or
testosterone) levels. These therapies can
result in increased bone loss.
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, click on the year 2009 and
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 July 30, 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 July 22, 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 July 23, 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 Kalyani
Bhatt 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
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Fmt 4703
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29705
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: June 11, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–14638 Filed 6–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
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
Deafness and Other Communication
Disorders Special Emphasis Panel; ARRA
P30 Faculty Recruitment.
Date: July 13, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Christine A. Livingston,
PhD, Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd., MSC
7180, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders; 93.701, ARRA Related Biomedical
Research and Research Support Awards,
National Institutes of Health, HHS)
Dated: June 16, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–14616 Filed 6–22–09; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 74, Number 119 (Tuesday, June 23, 2009)]
[Notices]
[Page 29705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14638]
[[Page 29705]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Advisory Committee for Reproductive Health Drugs; 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: Advisory Committee for Reproductive Health
Drugs.
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 August 13, 2009, from 8
a.m. to 4:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
Contact: Kalyani Bhatt, 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: Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in
Washington, DC area), code 3014512537. 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 biologics license
applications (BLAs) 125-320, 125-331, 125-332, and 125-333, proposed
trade name PROLIA (denosumab) subcutaneous injection, 60 milligrams
(mg), Amgen Inc., for the proposed indications of the treatment and
prevention of osteoporosis in postmenopausal women, and the treatment
and prevention of bone loss in patients undergoing hormone ablation for
prostate or breast cancer. Hormone ablation is a term used to encompass
therapies for hormone sensitive breast or prostate cancer administered
to decrease sex hormone (estrogen or testosterone) levels. These
therapies can result in increased bone loss.
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, click on the year 2009 and 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 July
30, 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 July 22, 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 July 23,
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 Kalyani Bhatt 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: June 11, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-14638 Filed 6-22-09; 8:45 am]
BILLING CODE 4160-01-S