Oncologic Drugs Advisory Committee; Notice of Meeting, 58399-58400 [2012-23186]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
Fiscal Year 2012. Program expansion
supplemental award funds will support
T/TA efforts by the ICI in serving the
two additional two grantees.
Statutory Authority: The statutory
authority is the Developmental Disabilities
Assistance and Bill of Rights Act of 2000,
Section 161.
Jamie Kendall,
Deputy Commissioner, Administration on
Intellectual and Developmental Disabilities.
[FR Doc. 2012–23244 Filed 9–19–12; 8:45 am]
BILLING CODE 4184–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369; (Formerly
Docket No. 2007D–0168)]
Draft Guidance for Industry on
Bioequivalence Recommendations for
Pentosan Polysulfate Sodium Capsule;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Pentosan
Polysulfate Sodium.’’ The
recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for pentosan polysulfate
sodium capsule.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 19,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:11 Sep 19, 2012
Jkt 226001
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Wu, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9326.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311; FDA–2007–D–0433),
FDA announced the availability of a
guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products’’ that explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. This notice
announces the availability of draft BE
recommendations for pentosan
polysulfate sodium capsule.
New drug application 020193 for
Elmiron (pentosan polysulfate sodium)
capsule was initially approved by FDA
in September 1996. There are no
approved ANDAs for this product. FDA
is now issuing a draft guidance for
industry on BE recommendations for
generic pentosan polysulfate sodium
capsule (Draft Pentosan Polysulfate
Sodium Capsule BE Recommendations).
In March 2012, Janssen
Pharmaceuticals, Inc. (Janssen),
manufacturer of the reference listed
drug (RLD), Elmiron, submitted
(through its attorneys) a citizen petition
requesting that FDA require that any
ANDA referencing Elmiron meet certain
conditions, including conditions related
to demonstrating BE (Docket No. FDA–
2012–P–0295). FDA is reviewing the
issues raised in the petition. FDA will
consider any comments on the Draft
Pentosan Polysulfate Sodium Capsule
BE Recommendations before responding
to Janssen’s citizen petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for pentosan polysulfate sodium
capsule. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
58399
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23177 Filed 9–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–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 November 8, 2012, 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,
E:\FR\FM\20SEN1.SGM
20SEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
58400
Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
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
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) 204026, with the
established name pomalidomide,
application submitted by Celgene
Corporation. The proposed indication
(use) for this product is in combination
with dexamethasone for patients with
relapsed and refractory multiple
myeloma who have received at least 2
prior regimens of established benefit,
including both lenalidomide and
bortezomib and have demonstrated
disease progression on the last therapy.
During the afternoon session, the
committee will discuss supplemental
new drug application (sNDA) 021882/
015, with the trade name EXJADE
(deferasirox) tablets for oral suspension,
application submitted by Novartis
Pharmaceutical Corporation. The
proposed indication (use) for this
product is for the treatment of chronic
iron overload in patients with nontransfusion-dependent thalassemia
syndromes (beta-thalassemia
intermedia, HbE beta-thalassemia, and
alpha-thalassemia) aged 10 years and
older.
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
VerDate Mar<15>2010
16:11 Sep 19, 2012
Jkt 226001
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 October 25, 2012.
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 October 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
October 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).
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Dated: September 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23186 Filed 9–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Anti-Infective 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: Anti-Infective
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 November 29, 2012, from 8 a.m.
to 5 p.m.
Location: DoubleTree by Hilton Hotel
Washington DC-Silver Spring, The
Ballroom, 8727 Colesville Rd., Silver
Spring, MD 20910. The hotel’s phone
number is 301–589–5200.
Contact Person: Diane Goyette, 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:
AIDAC@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: The committee will discuss
new drug application (NDA) 22407,
VIBATIV (telavancin hydrochloride)
sterile powder for injection, submitted
by Theravance, Inc., for the requested
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58399-58400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-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 November 8, 2012, 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,
[[Page 58400]]
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 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) 204026, with the established name pomalidomide,
application submitted by Celgene Corporation. The proposed indication
(use) for this product is in combination with dexamethasone for
patients with relapsed and refractory multiple myeloma who have
received at least 2 prior regimens of established benefit, including
both lenalidomide and bortezomib and have demonstrated disease
progression on the last therapy.
During the afternoon session, the committee will discuss
supplemental new drug application (sNDA) 021882/015, with the trade
name EXJADE (deferasirox) tablets for oral suspension, application
submitted by Novartis Pharmaceutical Corporation. The proposed
indication (use) for this product is for the treatment of chronic iron
overload in patients with non-transfusion-dependent thalassemia
syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and
alpha-thalassemia) aged 10 years and older.
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
October 25, 2012. 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
October 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 October 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: September 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-23186 Filed 9-19-12; 8:45 am]
BILLING CODE 4160-01-P
