Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice, 13348-13349 [2013-04535]
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13348
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
Dated: February 22, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04543 Filed 2–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK2VPTVN1PROD 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: 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 May 2, 2013, 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: 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). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
VerDate Mar<15>2010
15:18 Feb 26, 2013
Jkt 229001
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: During the morning session,
the committee will discuss new drug
application (NDA) 204408, with the
established name tivozanib capsules,
submitted by AVEO Pharmaceuticals,
Inc. The proposed indication (use) for
this product is for the treatment of
advanced renal (kidney) cell carcinoma.
During the afternoon session, the
committee will discuss NDA 201848, a
drug/device combination product with
the proposed trade name Melblez Kit
(Melblez (melphalan) for Injection for
use with the Delcath Hepatic Delivery
System), submitted by Delcath Systems,
Inc. The proposed indication (use) for
this product is for the treatment of
patients with unresectable ocular
melanoma that is metastatic to the liver.
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 meeting
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 April 18, 2013. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m., and 3:30 p.m. to 4 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 April 10, 2013. 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 April 11, 2013.
PO 00000
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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: February 22, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04542 Filed 2–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Science Board to the Food and Drug
Administration Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Science
Board to the Food and Drug
Administration. This meeting was
announced in the Federal Register of
January 30, 2013 (78 FR 6332). The
amendment is being made to reflect
changes in the Date and Time, Agenda,
and Procedures portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Martha Monser, Office of the Chief
Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4286, Silver Spring,
MD 20993, 301–796–4627, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area). Please call the
Information Line for up-to-date
information on this meeting.
E:\FR\FM\27FEN1.SGM
27FEN1
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
In the
Federal Register of January 30, 2013,
FDA announced that a meeting of the
Science Board to the Food and Drug
Administration would be held on
February 27, 2013.
1. On page 6332, in the third column,
the Date and Time portion of the
document is changed to read as follows:
Date and Time: The meeting will be
held on Wednesday, February 27, 2013,
from approximately 8:30 a.m. to 3:45
p.m.
2. On page 6333, in the first column,
the Agenda portion of the document is
changed to read as follows:
Agenda: On February 27, 2013, the
Science Board will be provided with
updates and/or a draft report from the
Center for Devices and Radiological
Health Research Review subcommittee
and the Global Health subcommittee.
Progress updates will be presented
regarding the Global Health
subcommittee and the recently
established Center for Biologics
Evaluation and Research Review
Postmarketing Safety Review
subcommittee. Overviews of genomics
activities at the Centers for Food Safety
and Applied Nutrition and Veterinary
Medicine will be presented, along with
plans for an Agencywide working group
to address crosscutting genomics
activities. Finally, recipients of the
fiscal year 2012 Scientific Achievement
Awards (selected by the Science Board)
will provide overviews of the activities
for which the awards were given.
3. On page 6333, in the second
column, in the Procedures section, the
third sentence is changed to read as
follows:
Procedures: Oral presentations from
the public will be scheduled between
approximately 3 p.m. and 3:30 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04535 Filed 2–26–13; 8:45 am]
BILLING CODE 4160–01–P
erowe on DSK2VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
15:18 Feb 26, 2013
Jkt 229001
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:
Psychopharmacologic 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 March 21, 2013, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 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: Minh Doan, 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,
PDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On March 21, 2013, the
committee will discuss new drug
application (NDA) 204442,
PROBUPHINE (buprenorphine
hydrochloride and ethylene vinyl
acetate) subdermal implant, submitted
by Titan Pharmaceuticals, Inc., and its
safety and efficacy for the proposed
indication of maintenance treatment of
opioid dependence.
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
13349
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 meeting
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 March 14, 2013.
Oral presentations from the public will
be scheduled between approximately
1:45 p.m. and 2:45 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 March 6, 2013. 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 March 7, 2013.
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 Minh Doan
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).
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13348-13349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Science Board to the Food and Drug Administration Advisory
Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Science Board to the Food and Drug
Administration. This meeting was announced in the Federal Register of
January 30, 2013 (78 FR 6332). The amendment is being made to reflect
changes in the Date and Time, Agenda, and Procedures portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-4627, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington DC area). Please call the Information Line for up-to-
date information on this meeting.
[[Page 13349]]
SUPPLEMENTARY INFORMATION: In the Federal Register of January 30,
2013, FDA announced that a meeting of the Science Board to the Food and
Drug Administration would be held on February 27, 2013.
1. On page 6332, in the third column, the Date and Time portion of
the document is changed to read as follows:
Date and Time: The meeting will be held on Wednesday, February 27,
2013, from approximately 8:30 a.m. to 3:45 p.m.
2. On page 6333, in the first column, the Agenda portion of the
document is changed to read as follows:
Agenda: On February 27, 2013, the Science Board will be provided
with updates and/or a draft report from the Center for Devices and
Radiological Health Research Review subcommittee and the Global Health
subcommittee. Progress updates will be presented regarding the Global
Health subcommittee and the recently established Center for Biologics
Evaluation and Research Review Postmarketing Safety Review
subcommittee. Overviews of genomics activities at the Centers for Food
Safety and Applied Nutrition and Veterinary Medicine will be presented,
along with plans for an Agencywide working group to address
crosscutting genomics activities. Finally, recipients of the fiscal
year 2012 Scientific Achievement Awards (selected by the Science Board)
will provide overviews of the activities for which the awards were
given.
3. On page 6333, in the second column, in the Procedures section,
the third sentence is changed to read as follows:
Procedures: Oral presentations from the public will be scheduled
between approximately 3 p.m. and 3:30 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04535 Filed 2-26-13; 8:45 am]
BILLING CODE 4160-01-P
