Anti-Infective Drugs Advisory Committee; Notice of Meeting, 58400-58401 [2012-23185]
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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
58401
Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
indication of nosocomial pneumonia
(pneumonia contracted by hospitalized
patients), including ventilatorassociated pneumonia, caused by
susceptible isolates of the following
Gram-positive bacteria: Staphylococcus
aureus (including methicillinsusceptible and -resistant isolates) or
Streptococcus pneumoniae (penicillin
susceptible strains).
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 November 13, 2012.
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
November 2, 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 November 5, 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 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/
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).
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI) (OMB No.
0925–0613). Type of Information
Collection Request: Revision. Need and
Use of Information Collection: The U.S.
Food and Drug Administration (FDA)
holds the National Cancer Institute
(NCI) responsible, as a sponsor of
investigational drug trials, for the
collection of information about the
clinical investigators who participate in
these trials and to assure the FDA that
systems for accountability are being
maintained by investigators in its
clinical trials program. The information
collected is used to identify qualified
investigators and to facilitate the
submission and distribution of
important information relative to the
investigational drug and the response of
the patient to that drug. Investigators are
physicians who specialize in the
treatment of patients with cancer. Data
obtained from the Drug Accountability
Record is used to track the dispensing
of investigational anticancer agents from
receipt from the NCI to dispensing or
administration to patients. NCI and/or
its auditors use this information for
compliance purposes. Frequency of
Response: Up to 16 times per year.
Affected Public: Private sector including
businesses, other for-profit
organizations, and non-profit
institutions. Type of Respondents:
Investigators, pharmacists, nurses,
pharmacy technicians, and data
managers. The annualized respondents’
burden for record keeping is estimated
to require 14,223 hours (see Table 1).
There are no capital costs, operating
costs, or maintenance costs.
Dated: September 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23185 Filed 9–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment
Request: Drug Accountability Report
Form and Investigator Registration
Procedure in the Conduct of
Investigational Trials for the Treatment
of Cancer (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
SUMMARY:
TABLE 1—ESTIMATES OF ANNUAL BURDEN
Investigators and Designee for Investigator Registration and DARF.
mstockstill on DSK4VPTVN1PROD with NOTICES
Form
Statement of Investigator .................
20,112
1
15/60
5,028
Supplemental Investigator ................
Financial Disclosure .........................
Drug Accountability Record Form
(DARF and DARF-Oral).
20,112
20,112
3,907
1
1
16
10/60
5/60
4/60
3,352
1,676
4,167
...........................................................
........................
........................
........................
14,223
Totals .........................................
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16:11 Sep 19, 2012
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PO 00000
Frm 00048
Number of
respondents
Fmt 4703
Sfmt 4703
Frequency of
response
Average time
per response
(hours)
Type of
respondents
E:\FR\FM\20SEN1.SGM
20SEN1
Total hour
burden
]]>Agencies
[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58400-58401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23185]
-----------------------------------------------------------------------
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
[[Page 58401]]
indication of nosocomial pneumonia (pneumonia contracted by
hospitalized patients), including ventilator-associated pneumonia,
caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus (including methicillin-susceptible and -resistant
isolates) or Streptococcus pneumoniae (penicillin susceptible strains).
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
November 13, 2012. 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 November 2, 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 November 5, 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 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/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. 2012-23185 Filed 9-19-12; 8:45 am]
BILLING CODE 4160-01-P
