Oncologic Drugs Advisory Committee; Notice of Meeting, 1181-1182 [2011-32]
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Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
center directors, the Chief Counsel, the
Associate Commissioner of Regulatory
Affairs, and the Chief Scientist. The
Task Force is charged with submitting a
written report to the Commissioner on
the Task Force’s findings and
recommendations.
The Task Force has held two public
meetings,1 launched an online blog
(https://fdatransparencyblog.fda.gov/),
and opened a docket. The online blog
and the docket received over 1,500
comments. The blog, which is ongoing,
has offered an opportunity for exchange
about specific ideas for transparency at
the Agency.
The Task Force is proceeding with the
Transparency Initiative in three phases:
• Phase I: FDA Basics.
• Phase II: Public Disclosure.
• Phase III: Transparency to
Regulated Industry.
Phase I is intended to provide the
public with basic information about
FDA and how the Agency does its work.
In early January 2010, FDA launched a
Web-based resource called FDA Basics
(https://www.fda.gov/fdabasics). The
resource now includes (1) 158 questions
and answers about FDA and the
products that the Agency regulates, (2)
9 short videos that explain various FDA
activities, and (3) 14 conversations with
FDA officials about the work of their
offices. Each month, senior officials
from FDA product centers and offices
host online sessions about a specific
topic and answer questions from the
public about that topic. FDA uses the
feedback provided by the public to
update this resource.
Phase II relates to FDA’s proactive
disclosure of information the Agency
has in its possession, and how to make
information about Agency activities and
decisionmaking more transparent,
useful, and understandable to the
public, while appropriately protecting
confidential information. On May 19,
2010, FDA released a report that
contains 21 draft proposals about
expanding the disclosure of information
by FDA while maintaining
confidentiality for trade secrets and
individually identifiable patient
information.
The Task Force solicited comment on
the content of the proposals, as well as
on which draft proposals should be
given priority, for 60 days. The Task
Force is reviewing the comments
received and will recommend specific
proposals to the Commissioner for
consideration. The Task Force’s
recommendations will consider
1 Transcripts and the webcast from both public
meetings are available on the FDA Web site, https://
www.fda.gov/transparency.
VerDate Mar<15>2010
15:30 Jan 06, 2011
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feasibility and priority, considering
other Agency priorities that require
resources. Not all of these proposals will
necessarily be implemented. Some may
require changes in law or regulation;
some may require a substantial amount
of resources.
Phase III is the subject of this
document and is described in more
detail in section II of this document.
II. Phase III: Transparency to Regulated
Industry
The third phase of the Transparency
Initiative addresses ways FDA can
become more transparent to regulated
industry to foster a more efficient and
cost-effective regulatory process.
Regulated industry provides the
public with food, drugs, medical
devices, cosmetics, and other widely
used and important consumer products.
FDA’s mission is to protect and promote
the public health through oversight of
these products.
In order to succeed, FDA must clearly
communicate standards and
expectations to industry.
Communicating requirements and
expectations to industry in a more
accessible manner promotes
understanding of, and compliance with,
rules set up to protect the supply of food
and medical products.
In response to a request for input from
FDA on this topic in March 2010 (75 FR
11893, March 12, 2010), regulated
companies requested additional
transparency about the standards to
which their products are held, the
process for soliciting guidance from the
Agency, and the progress of regulatory
efforts at the Agency. In the report, FDA
outlines 19 action items and 5 draft
proposals to improve transparency to
regulated industry.
The Task Force is soliciting comment
on the content of the five draft
proposals, as well as on which draft
proposals should be given priority, for
60 days. After considering public
comment on the draft proposals, the
Task Force will recommend specific
proposals to the Commissioner for
consideration. FDA will begin to
implement the action items in the report
in 2011.
III. Request for Comments
FDA is interested in receiving
comments from the public about the
content of the five draft proposals as
well as on which draft proposals should
be given priority. Interested persons
may submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
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1181
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Identify the draft proposal
which your comment addresses by the
number assigned to that proposal.
Received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–71 Filed 1–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
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, 2011, 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 ‘‘White Oak Conference Center
Parking and Transportation Information
for FDA Advisory Committee Meetings’’.
Please note that visitors to the White
Oak Campus must enter through
Building 1.
Contact Person: Nicole Vesely, 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: 301–847–8532, email:
nicole.vesely@fda.hhs.gov, or FDA
E:\FR\FM\07JAN1.SGM
07JAN1
jdjones on DSK8KYBLC1PROD with NOTICES
1182
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
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 hear
updates on new drug applications
(NDAs) and biologics license
applications (BLAs) approved under 21
CFR 314.500 and 601.40 (subpart H and
subpart E, respectively, accelerated
approval regulations) prior to January 1,
2009. These updates will provide
information related to the status of
phase IV clinical studies and to
difficulties associated with completion
of phase IV commitments. Phase IV
studies are postmarketing studies to
confirm clinical benefit of a drug after
it receives accelerated approval.
Specifically, the committee will
receive updates on the following
products: (1) BLA 125084, trade name
ERBITUX (cetuximab), application
submitted by Imclone Systems Inc.,
used in combination with the anticancer
agent irinotecan and indicated for the
treatment of epidermal growth factor
receptor (EGFR)-expressing colorectal
cancer that has metastasized (spread
beyond the colon or rectum) in patients
for whom chemotherapy using
irinotecan alone is ineffective or less
effective; (2) supplemental BLA (sBLA)
125011/24, trade name BEXXAR
(tositumomab and Iodine I 131
tositumomab), application submitted by
SmithKline Beecham Corp. doing
business as (d/b/a) GlaxoSmithKline,
indicated for the treatment of patients
with varieties of non-Hodgkin’s
lymphoma known as CD20 antigenexpressing relapsed or refractory, low
grade, follicular, or transformed nonHodgkin’s lymphoma, who have not
received the drug Rituximab; (3) NDA
21–673, tradename CLOLAR
(clofarabine) for intravenous infusion,
application submitted by Genzyme
Corp., indicated for the treatment of
pediatric patients 1 to 21 years old with
acute lymphoblastic leukemia (ALL)
whose disease has not responded to or
has relapsed following treatment with at
least two prior chemotherapy regimens;
(4) NDA 21–877, tradename ARRANON
(nelarabine) Injection, application
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
submitted by GlaxoSmithKline,
indicated for the treatment of patients
with types of leukemia or lymphoma
known as T-cell acute lymphoblastic
leukemia and T-cell lymphoblastic
lymphoma whose disease has not
responded to or has relapsed following
treatment with at least two
chemotherapy regimens; (5) BLA
125147, tradename VECTIBIX
(panitumumab), application submitted
by Amgen Inc., indicated for the
treatment of EGFR-expressing,
metastatic colorectal carcinoma with
disease progression on or following
fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy
regimens; and (6) sNDA 21–588/025,
tradename GLEEVEC (imatinib
mesylate) tablets, application submitted
by Novartis Pharmaceuticals Corp.,
indicated for the adjuvant (additional)
treatment of adult patients following
complete gross resection (removal) of a
form of cancer known as Kit (CD117)
positive gastrointestinal stromal tumors
(GIST).
Based on the updates provided, the
committee will have a general
discussion centering on possible ways
to improve the planning and conduct of
trials to confirm clinical benefit (post
marketing requirements). The overall
goal will be the optimization of the
accelerated approval process with a
focus on decreasing the amount of time
to confirm (or fail to confirm) clinical
benefit while continuing to provide
early availability of promising oncology
products.
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, 2011.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before January 14, 2011. 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, 2011.
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 Nicole
Vesely 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: January 3, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–32 Filed 1–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0633]
Determination of System Attributes for
the Tracking and Tracing of
Prescription Drugs; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled
‘‘Determination of System Attributes for
the Tracking and Tracing of Prescription
SUMMARY:
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1181-1182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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, 2011, 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 ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings''.
Please note that visitors to the White Oak Campus must enter through
Building 1.
Contact Person: Nicole Vesely, 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-
8532, email: nicole.vesely@fda.hhs.gov, or FDA
[[Page 1182]]
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 hear updates on new drug applications
(NDAs) and biologics license applications (BLAs) approved under 21 CFR
314.500 and 601.40 (subpart H and subpart E, respectively, accelerated
approval regulations) prior to January 1, 2009. These updates will
provide information related to the status of phase IV clinical studies
and to difficulties associated with completion of phase IV commitments.
Phase IV studies are postmarketing studies to confirm clinical benefit
of a drug after it receives accelerated approval.
Specifically, the committee will receive updates on the following
products: (1) BLA 125084, trade name ERBITUX (cetuximab), application
submitted by Imclone Systems Inc., used in combination with the
anticancer agent irinotecan and indicated for the treatment of
epidermal growth factor receptor (EGFR)-expressing colorectal cancer
that has metastasized (spread beyond the colon or rectum) in patients
for whom chemotherapy using irinotecan alone is ineffective or less
effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR
(tositumomab and Iodine I 131 tositumomab), application submitted by
SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline,
indicated for the treatment of patients with varieties of non-Hodgkin's
lymphoma known as CD20 antigen-expressing relapsed or refractory, low
grade, follicular, or transformed non-Hodgkin's lymphoma, who have not
received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR
(clofarabine) for intravenous infusion, application submitted by
Genzyme Corp., indicated for the treatment of pediatric patients 1 to
21 years old with acute lymphoblastic leukemia (ALL) whose disease has
not responded to or has relapsed following treatment with at least two
prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON
(nelarabine) Injection, application submitted by GlaxoSmithKline,
indicated for the treatment of patients with types of leukemia or
lymphoma known as T-cell acute lymphoblastic leukemia and T-cell
lymphoblastic lymphoma whose disease has not responded to or has
relapsed following treatment with at least two chemotherapy regimens;
(5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted
by Amgen Inc., indicated for the treatment of EGFR-expressing,
metastatic colorectal carcinoma with disease progression on or
following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC
(imatinib mesylate) tablets, application submitted by Novartis
Pharmaceuticals Corp., indicated for the adjuvant (additional)
treatment of adult patients following complete gross resection
(removal) of a form of cancer known as Kit (CD117) positive
gastrointestinal stromal tumors (GIST).
Based on the updates provided, the committee will have a general
discussion centering on possible ways to improve the planning and
conduct of trials to confirm clinical benefit (post marketing
requirements). The overall goal will be the optimization of the
accelerated approval process with a focus on decreasing the amount of
time to confirm (or fail to confirm) clinical benefit while continuing
to provide early availability of promising oncology products.
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, 2011. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 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 14, 2011.
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, 2011.
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 Nicole Vesely 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: January 3, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-32 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P
