Oncologic Drugs Advisory Committee; Notice of Meeting, 82310-82311 [2011-33548]
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Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
Dated: December 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33552 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
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: Cardiovascular
and Renal 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 February 23, 2012, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910.
The hotel’s telephone number is (301)
589–5200.
Contact Person: Kristina Toliver,
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, email:
CRDAC@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: The committee will discuss
new drug application (NDA) 203202,
proposed trade name NORTHERA
(droxidopa capsules), submitted by
Chelsea Therapeutics, Inc., for the
VerDate Mar<15>2010
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Jkt 226001
treatment of symptomatic neurogenic
orthostatic hypotension in patients with
primary autonomic failure (Parkinson’s
Disease, Multiple System Atrophy, and
Pure Autonomic Failure), Dopamine
Beta-Hydroxylase Deficiency, and NonDiabetic Autonomic Neuropathy.
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 February 8, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 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 January
31, 2012. 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 February 1, 2012.
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 Kristina
Toliver 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/Advisory
Committees/AboutAdvisoryCommittees/
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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: December 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33561 Filed 12–29–11; 8:45 am]
BILLING CODE 4130–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Oncologic 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: Oncologic 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 February 8, 2012, from 8 a.m.
to 12:30 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: Caleb Briggs, 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, email:
ODAC@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
E:\FR\FM\30DEN1.SGM
30DEN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
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
supplemental biologics license
application 125320/28 for XGEVA
(denosumab) injection, application
submitted by Amgen Inc. The proposed
indication (use) for this product is for
the treatment of men with castrateresistant prostate cancer at high risk of
developing bone metastases, or spread
of cancer to the bones.
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 January 25, 2012.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11:30 a.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 January 17, 2012. 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
January 18, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
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 Caleb Briggs
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/Advisory
Committees/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: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33548 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0247]
Food and Drug Administration
Transparency Initiative: Food and Drug
Administration Report on Good
Guidance Practices: Improving
Efficiency and Transparency;
Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments.
ACTION:
As part of the Transparency
Initiative, the Food and Drug
Administration (FDA or Agency) is
announcing the availability of a report
entitled ‘‘Food and Drug Administration
Report on Good Guidance Practices:
Improving Efficiency and
Transparency.’’ This report was
prepared in response to Action Item 11
in the Phase III Report (FDA
Transparency Initiative: Improving
Transparency to Regulated Industry,
dated January 2011). In that action item,
the Commissioner of Food and Drugs
(the Commissioner), Dr. Margaret A.
Hamburg, called for a cross-Agency
working group to prepare a report
identifying FDA’s ‘‘best practices’’ and
making recommendations to streamline
the development of guidance
documents, reduce the time between
issuing draft and final guidance
documents, and make it easier to find
guidance documents on FDA’s Web site.
SUMMARY:
PO 00000
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Fmt 4703
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82311
Submit either electronic or
written comments by February 28, 2012.
ADDRESSES: Submit electronic
comments to https://www.regulations.
gov. Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. All comments should be
identified with the docket number
found in brackets at the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Dwyer, Office of Policy, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4228, Silver Spring,
MD 20993, (301) 796–4820, FAX: (301)
847–8616, lisa.dwyer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
On January 21, 2009, President
Obama issued a memorandum urging
the heads of executive departments and
Agencies to create an ‘‘unprecedented
level of openness’’ to ‘‘strengthen our
democracy and promote efficiency and
effectiveness’’ (see Memorandum to
Heads of Executive Departments and
Agencies on Transparency and Open
Government, January 21, 2009, (74 FR
4685, January 26, 2009)). In response,
the following June FDA launched its
Transparency Initiative. Information on
the FDA Transparency Initiative is
available at https://www.fda.gov/
AboutFDA/Transparency/Transparency
Initiative/default.htm.
As part of this initiative, FDA issued
the Phase III Report (FDA Transparency
Initiative: Improving Transparency to
Regulated Industry, dated January 2011)
in January 2011. The Phase III Report
contained 19 action items and 5 draft
proposals to make FDA’s operations and
decisionmaking processes more
transparent and to foster more efficient
and cost-effective regulatory processes.
In Action Item 11 of the Phase III
Report, the Commissioner called for a
cross-Agency working group to prepare
a report identifying FDA’s ‘‘best
practices’’ and making
recommendations to: (1) Streamline the
development of guidance documents,
(2) reduce the time between issuing
draft and final guidance documents, and
(3) make it easier to find guidance
documents on FDA’s Web site.
In response to that action item, a
cross-Agency working group under the
leadership of the Office of Policy in the
Office of the Commissioner prepared a
report entitled ‘‘Food and Drug
Administration Report on Good
Guidance Practices: Improving
Efficiency and Transparency’’ (GGP
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82310-82311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Oncologic 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: Oncologic 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 February 8, 2012, from 8
a.m. to 12:30 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: Caleb Briggs, 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, email: ODAC@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
[[Page 82311]]
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 supplemental biologics license
application 125320/28 for XGEVA (denosumab) injection, application
submitted by Amgen Inc. The proposed indication (use) for this product
is for the treatment of men with castrate-resistant prostate cancer at
high risk of developing bone metastases, or spread of cancer to the
bones.
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
January 25, 2012. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11:30 a.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 January 17, 2012.
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 January 18, 2012.
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 Caleb Briggs 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: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33548 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
