Oncologic Drugs Advisory Committee; Notice of Meeting, 31025-31026 [2012-12588]
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31025
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
200
100
20,000
5
100,000
Total ..............................................................................
........................
........................
........................
........................
100,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Therefore, the estimated annual
reporting burden for this information is
25,000 hours and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12589 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
srobinson on DSK4SPTVN1PROD with NOTICES
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: Risk Communication
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 June 29, 2012, from 8 a.m. to 3 p.m.
Location: FDA White Oak Campus,
Building 31 Conference Center, Great Room,
10903 New Hampshire Ave., Silver Spring,
MD 20993. 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: Lee L. Zwanziger, Risk
Communication Staff, Office of Planning,
Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3278, Silver
Spring, MD 20993, 301–796–9151, FAX: 301–
847–8611, email: RCAC@fda.hhs.gov, or FDA
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 upto-date information on this meeting. A notice
VerDate Mar<15>2010
16:31 May 23, 2012
Jkt 226001
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: On June 29, 2011, the Committee
will discuss recent research on
communicating and understanding
uncertainty, and risk perception and
information seeking when facing multiple
risks.
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, 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 June
21, 2012. Oral presentations from the public
will be scheduled between approximately 1
p.m. and 2 p.m. on June 29, 2012. 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 June
18, 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 June 19, 2012. Interested
persons can also log on to https://
collaboration.fda.gov/rcac/ to hear and see
the proceedings.
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
PO 00000
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persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Lee L.
Zwanziger 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: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12587 Filed 5–23–12; 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 July 25, 2012, from 8 a.m. to 12:30 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.
E:\FR\FM\24MYN1.SGM
24MYN1
srobinson on DSK4SPTVN1PROD with NOTICES
31026
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
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, email: ODAC@fda.hhs.gov, or FDA
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 upto-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 discuss and
provide general advice on the extent to
which, if any, the pre-surgical identification
of clear cell carcinoma of the kidney using
an imaging test provides useful clinical
information.
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 July
10, 2012. Oral presentations from the public
will be scheduled between approximately
10:30 a.m. and 11:30 a.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 June
29, 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 July 2, 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 Minh Doan
at least 7 days in advance of the meeting.
VerDate Mar<15>2010
16:31 May 23, 2012
Jkt 226001
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: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Use of Computer Simulation of the
United States Blood Supply in Support
of Planning for Emergency
Preparedness and Medical
Countermeasures; Public Workshop
[FR Doc. 2012–12588 Filed 5–23–12; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Requirements for Importing Food and
Drug Administration Regulated
Products Into the United States
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: ‘‘Requirements for
Importing Food and Drug
Administration Regulated Products Into
the United States.’’ The topics to be
discussed are FDA regulations with
respect to importing pharmaceutical
products, medical devices, food
products, as well as technology which
applies to brokers and forwarders.
Date and Time: The meeting will be
held on July 18, 2012, from 8:30 a.m. to
5 p.m. in Des Plaines, IL.
Location: The meeting will be held at
the Illinois Department of
Transportation Building, 9511 West
Harrison St., Des Plaines, IL, 60016.
Contact: Lisa Misevicz, Food and
Drug Administration, 550 West Jackson
Blvd., suite 1500, Chicago, IL 60661;
312–596–4217; email:
lisa.misevicz@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) to the contact person by July 2,
2012.
If you need special accommodations
due to a disability, please contact Lisa
Misevicz at least 7 days in advance.
SUMMARY:
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12592 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
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Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Use of Computer Simulation
of the United States Blood Supply in
Support of Planning for Emergency
Preparedness and Medical
Countermeasures.’’ The purpose of this
public workshop is to provide
stakeholders a forum for discussion of
data needs and to obtain feedback on
possible modeling scenarios to explore
emergency supply situations should a
pandemic or epidemic disease or other
events that could adversely impact the
blood supply in the United States occur.
The public workshop will include
presentations and panel discussions
with experts from academia, regulated
industry, government, and other
stakeholders.
Date and Time: The public workshop
will be held on July 24, 2012, from 8:30
a.m. to 5 p.m.
Location: The public workshop will
be held at the Hyatt Regency Bethesda,
One Bethesda Metro Center, 7400
Wisconsin Ave., Bethesda, MD 20814,
301–657–1234.
Contact Person: Mark Walderhaug,
Center for Biologics Evaluation and
Research (HFM–210), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6028, email:
Mark.Walderhaug@fda.hhs.gov.
Registration: Mail or email your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Mark
Walderhaug (see Contact Person) by July
17, 2012. There is no registration fee for
the public workshop. Early registration
is recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 8 a.m.
If you need special accommodations
due to a disability, please contact Mark
Walderhaug (see Contact Person) at least
7 days in advance.
SUPPLEMENTARY INFORMATION: The
public workshop presentations and
panel discussions will: (1) Discuss
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31025-31026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12588]
-----------------------------------------------------------------------
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 July 25, 2012, from 8
a.m. to 12:30 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.
[[Page 31026]]
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, email: ODAC@fda.hhs.gov, or FDA 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 discuss and provide general advice on
the extent to which, if any, the pre-surgical identification of
clear cell carcinoma of the kidney using an imaging test provides
useful clinical information.
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
July 10, 2012. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11:30 a.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
June 29, 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 July
2, 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 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).
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12588 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P
