Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting., 12762-12763 [2013-04141]
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Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
term ‘‘release agent’’ referred to an agent
used to facilitate the release of foods
from food contact surfaces, where the
agent has been applied directly to the
food contact surface, rather than
incorporated into the food. In that
guidance, we also stated our intention to
reconsider our enforcement priorities
with regard to the labeling of lecithin
derived from soy used as a component
of a release agent approximately 18
months after the issuance of the
guidance. Further, we stated our
expectation that, during the period in
which we considered the exercise of our
enforcement discretion, manufacturers
of foods that use lecithin derived from
soy as a component of a release agent
would revise as necessary the labels of
their relevant food products to comply
with FALCPA and begin to label their
products using the FALCPA-compliant
labels by the end of the enforcement
discretion period.
We believe that there has been
sufficient time for all manufacturers of
foods that use lecithin derived from soy
as a component of a release agent to
revise the labels for such foods to be
consistent with the requirements of
section 403(w) of the FD&C Act.
Therefore, we no longer believe it is
appropriate to consider the exercise of
our enforcement discretion with regard
to foods that use lecithin derived from
soy as a component of a release agent.
For these reasons, we are withdrawing
the April 2006 guidance entitled
‘‘Guidance on the Labeling of Certain
Uses of Lecithin Derived from Soy
Under Section 403(w) of the Federal
Food, Drug, and Cosmetic Act.’’
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04251 Filed 2–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
mstockstill on DSK4VPTVN1PROD with NOTICES
Joint Meeting of the Medical Imaging
Drugs Advisory Committee and the
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.
VerDate Mar<15>2010
17:22 Feb 22, 2013
Jkt 229001
Name of Committees: Medical
Imaging Drugs Advisory Committee and
the Oncologic Drugs Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 3, 2013, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., 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: Diane Goyette, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email: MIDAC@
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 May 3, 3013, the
committees will discuss the safety and
efficacy of currently approved leukocyte
growth factors (LGFs) as potential
treatments for radiation-induced
myelosuppression associated with a
radiological/nuclear incident.
(Myelosuppression is a reduction of
blood cell production, which can be
caused by radiation exposure.)
Currently approved LGFs are licensed
under biological license applications
(BLAs): 103353, NEUPOGEN (filgrastim,
Amgen, Inc.), 125031, NEULASTA
(pegfilgrastim, Amgen, Inc.), 103362,
LEUKINE, (sargramostim, Genzyme,
Inc.), and 125294, TBO–FILGRASTIM
(tbo-filgrastim, Sicor Biotech, UAB). The
National Institute of Allergy and
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Infectious Diseases (NIAID) has
submitted efficacy data for filgrastim,
based on treatment in an animal model
of radiation-induced myelosuppression.
Safety and other supportive information
are currently described in the labeling
for LGFs.
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 19, 2013. 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 April 11,
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 12, 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 Diane
Goyette 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
E:\FR\FM\25FEN1.SGM
25FEN1
Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
learn about possible modifications
before coming to the meeting.
Agenda: On Thursday, March 14,
2013, the Pediatric Advisory Committee
will meet to discuss pediatric-focused
safety reviews, as mandated by the Best
Pharmaceuticals for Children Act
(Public Law 107–109) and the for
Dated: February 19, 2013.
Pediatric Research Equity Act (Public
Jill Hartzler Warner,
Law 108–155) for: ACTEMRA
Acting Associate Commissioner for Special
(tocilizumab), ALIMTA (Pemetrexed
Medical Programs.
disodium), CREON (pancrelipase),
[FR Doc. 2013–04141 Filed 2–22–13; 8:45 am]
GADAVIST (gadobutrol), HIZENTRA
BILLING CODE 4160–01–P
[Immune Globulin Subcutaneous
(Human), 20% Liquid], INOMAX (nitric
oxide), INVEGA (paliperidone),
DEPARTMENT OF HEALTH AND
KEDBUMIN (albumin human), KYTRIL
HUMAN SERVICES
Injection (granisetron hydrochloride),
LAMICTAL XR (lamotrigine),
Food and Drug Administration
MENACTRA [Meningococcal (Groups
A, C, Y and W–135) Polysaccharide
[Docket No. FDA–2013–N–0001]
Diphtheria Toxoid Conjugate Vaccine],
Pediatric Advisory Committee; Notice
MOXEZA (moxifloxacin ophthalmic
of Meeting
solution 0.5%), NATROBA (spinosad),
NEXIUM (esomeprazole magnesium),
AGENCY: Food and Drug Administration,
NEXIUM IV (esomeprazole sodium),
HHS.
UROXATRAL (alfuzosin
ACTION: Notice.
hydrochloride), and ZENPEP
(pancrelipase). Also, there will be an
This notice announces a forthcoming
Informational Update on Codeine.
meeting of a public advisory committee
FDA intends to make background
of the Food and Drug Administration
material available to the public no later
(FDA). The meeting will be open to the
than 2 business days before the meeting.
public.
If FDA is unable to post the background
Name of Committee: Pediatric
material on its Web site prior to the
Advisory Committee.
meeting, the background material will
General Function of the Committee:
be made publicly available at the
To provide advice and
location of the advisory committee
recommendations to the Agency on
meeting, and the background material
FDA’s regulatory issues.
will be posted on FDA’s Web site after
Date and Time: The meeting will be
the meeting. Background material is
held on Thursday, March 14, 2013 from available at https://www.fda.gov/
8 a.m. to 5:30 p.m.
AdvisoryCommittees/Calendar/
Location: Sheraton Silver Spring
default.htm. Scroll down to the
Hotel, 8777 Georgia Ave., Silver Spring, appropriate advisory committee meeting
MD 20910, 301–589–0800 or visit the
link.
hotel’s Web site at https://
Procedure: Interested persons may
www.sheratonsilverspring.com/.
present data, information, or views,
Contact Person: Walter Ellenberg,
orally or in writing, on issues pending
Office of the Commissioner, Food and
before the committee. Written
Drug Administration, 10903 New
submissions may be made to the contact
Hampshire Ave., Bldg. 32, rm. 5154,
person on or before March 7, 2013. Oral
Silver Spring, MD 20993, 301–796–
presentations from the public will be
0885, email walter.ellenberg@
scheduled between approximately 11:30
fda.hhs.gov or FDA Advisory Committee a.m. and 12:30 p.m. Those individuals
Information Line, 1–800–741–8138
interested in making formal oral
(301–443–0572 in the Washington, DC
presentations should notify the contact
area). A notice in the Federal Register
person and submit a brief statement of
about last minute modifications that
the general nature of the evidence or
arguments they wish to present, the
impact a previously announced
names and addresses of proposed
advisory committee meeting cannot
participants, and an indication of the
always be published quickly enough to
approximate time requested to make
provide timely notice. Therefore, you
their presentation on or before February
should always check the Agency’s Web
27, 2013. Time allotted for each
site at https://www.fda.gov/
presentation may be limited. If the
AdvisoryCommittees/default.htm and
number of registrants requesting to
scroll down to the appropriate advisory
speak is greater than can be reasonably
committee meeting link, or call the
accommodated during the scheduled
advisory committee information line to
mstockstill on DSK4VPTVN1PROD with NOTICES
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).
VerDate Mar<15>2010
17:22 Feb 22, 2013
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12763
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 28, 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 Walter
Ellenberg at 301–796–0885, email
walter.ellenberg@fda.hhs.gov, 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 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04256 Filed 2–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Fecal Microbiota for Transplantation;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER), and the National
Institutes of Health, National Institute of
Allergy and Infectious Diseases (NIAID),
are announcing a public workshop
entitled ‘‘Fecal Microbiota for
Transplantation.’’ The purpose of the
public workshop is to exchange
information with the medical and
scientific community about the
regulatory and scientific issues
associated with fecal microbiota for
transplantation (FMT).
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12762-12763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Joint Meeting of the Medical Imaging Drugs Advisory Committee and
the 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 Committees: Medical Imaging Drugs Advisory Committee and
the Oncologic Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 3, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., 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: Diane Goyette, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533,
email: MIDAC@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 May 3, 3013, the committees will discuss the safety and
efficacy of currently approved leukocyte growth factors (LGFs) as
potential treatments for radiation-induced myelosuppression associated
with a radiological/nuclear incident. (Myelosuppression is a reduction
of blood cell production, which can be caused by radiation exposure.)
Currently approved LGFs are licensed under biological license
applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.),
125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE,
(sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-
filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and
Infectious Diseases (NIAID) has submitted efficacy data for filgrastim,
based on treatment in an animal model of radiation-induced
myelosuppression. Safety and other supportive information are currently
described in the labeling for LGFs.
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 19, 2013. 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 April 11, 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 12, 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 Diane Goyette 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
[[Page 12763]]
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: February 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04141 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P
