Oncologic Drugs Advisory Committee; Notice of Meeting, 5520-5521 [2012-2462]
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5520
Federal Register / Vol. 77, No. 23 / Friday, February 3, 2012 / Notices
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC proposes to conduct a pilot study
to examine the feasibility of establishing
a national community-level surveillance
system on policy supports for healthful
eating and active living. Results of the
feasibility study will be used to assess
the feasibility of establishing a national
surveillance system and the best
methods for encouraging a high
response rate in a representative sample
of communities. The pilot study will be
conducted in two states with a
representative sample of 400
communities, 200 municipalities in
each state. The sample frame will be
generated from the U.S. Census of
Governments.
The proposed pilot study is designed
to address three key methodological
objectives. The first objective is to test
the feasibility of the proposed sampling
frame and to answer sample design
issues related to determining sampling
criteria for inclusion, as well as the
development of weights and estimates.
The second objective is to identify
and critically evaluate whether
respondents in diverse municipalities of
various sizes and organizational
structures are able to answer a selfadministered survey questionnaire. The
survey questionnaire includes 42 items
on the following topics: Communitywide planning efforts for healthy eating
and active living, the built environment
and policies that support physical
activity, and policies and practices that
support access to healthy food and
healthy eating. The estimated burden
per response is one hour. Issues to be
addressed include critical assessment of
the strengths and weaknesses of
methods for identifying the best
respondents for completing the survey
questionnaire; conducting a limited
process evaluation that identifies the
barriers and challenges respondents
may incur in providing reasonable and
current data for the questionnaire; and
arriving at a data collection instrument
with the lowest possible threshold for
respondent burden.
The third objective is to identify and
critically evaluate different methods of
study recruitment and non-response
follow-up. A split-sample approach will
be used to assign each target respondent
to one of two groups: a low-intensity
recruitment group or a moderateintensity recruitment group. All target
respondents in the study sample will
receive email reminders to encourage
participation in the survey. Target
respondents in the moderate-intensity
recruitment group will also receive up
to three telephone contacts to address
questions and serve as reminders. The
estimated burden per contact is five
minutes.
Respondents will be city/town
planners and managers, or individuals
with similar responsibilities. The
majority of survey responses will be
collected using a secure, web-based
survey data collection system.
Respondents who prefer to complete a
paper survey will be able to print the
survey from the web-based data
collection system, complete it, and
return it using instructions that will be
provided. OMB approval is requested
for one year. Participation is voluntary
and there are no costs to respondents
other than their time. The total
estimated burden hours are 450.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Form name
City/Town Manager-Planner ............
Survey of Community-Based Policy and Environmental Supports for Healthy Eating and Active Living
Telephone Non-Response Follow-up Contact Script
Kimberly S. Lane,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2012–2413 Filed 2–2–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
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
20:48 Feb 02, 2012
Jkt 226001
Number of
respondents
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 March 20, 2012, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 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.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
400
1
1
200
3
5/60
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: On March 20, 2012, during
the morning session, the committee will
discuss supplemental new drug
E:\FR\FM\03FEN1.SGM
03FEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 23 / Friday, February 3, 2012 / Notices
application (NDA) 022465/S–010,
VOTRIENT (pazopanib hydrochloride)
Tablets, application submitted by Glaxo
Wellcome Manufacturing Pte Ltd. doing
business as GlaxoSmithKline. The
proposed indication (use) for this
product is for the treatment of patients
with advanced soft tissue sarcoma (STS)
who have received prior chemotherapy.
The phase 3 STS trial population
excluded patients with adipocytic STS
or gastrointestinal stromal tumors.
During the afternoon session, the
committee will discuss NDA 022576,
with the proposed trade name
TALTORVIC (ridaforolimus) Tablets,
application submitted by Merck Sharp &
Dohme Corp. The proposed indication
(use) for this product is for the treatment
of adult and pediatric patients (aged 13
through 17 years with weight over 100
lb or 45.4 kg) with metastatic soft tissue
sarcoma or bone sarcoma as a
maintenance therapy for patients who
have completed at least 4 cycles of
chemotherapy without evidence of
disease progression.
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 March 6, 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 February 27, 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
VerDate Mar<15>2010
20:48 Feb 02, 2012
Jkt 226001
person will notify interested persons
regarding their request to speak by
February 28, 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: January 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–2462 Filed 2–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP–2012–0001]
Advisory Committee on Commercial
Operations of Customs and Border
Protection (COAC)
U.S. Customs and Border
Protection, Department of Homeland
Security (DHS).
ACTION: Committee Management; Notice
of Federal Advisory Committee Meeting.
AGENCY:
The Advisory Committee on
Commercial Operations of Customs and
Border Protection (COAC) will meet on
February 21, 2012, in Washington, DC.
The meeting will be open to the public.
As an alternative to on-site attendance,
U.S. Customs and Border Protection
(CBP) will also offer a live webcast of
the COAC meeting via the Internet.
DATED: COAC will meet on Tuesday,
February 21, 2012, from 10 a.m. to 4
p.m. Please note that the meeting may
close early if the committee has
completed its business.
REGISTRATION: If you plan on attending
via webcast, please register online at
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
5521
https://apps.cbp.gov/te_registration/
?w=73 by close-of-business on February
17, 2012. Please feel free to share this
information with interested members of
your organizations or associations. If
you plan on attending on-site, please
register either online at https://
apps.cbp.gov/te_registration/?w=72, or
by email to tradeevents@dhs.gov, or by
fax to (202) 325–4290 by close-ofbusiness on February 17, 2012.
If you have completed an online
webcast registration and wish to cancel
your registration, you may do so at
https://apps.cbp.gov/te_registration/
cancel.asp?w=73. If you have completed
an online on-site registration and wish
to cancel your registration, you may do
so at https://apps.cbp.gov/
te_registration/cancel.asp?w=72.
ADDRESSES: The meeting will be held at
U.S. Access Board Conference, 1331 F
Street NW., Suite 800 in Washington,
DC 20004. All visitors report to the
lobby in the building.
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact Ms. Wanda Tate, Office
of Trade Relations, U.S. Customs and
Border Protection at (202) 344–1661 as
soon as possible.
To facilitate public participation, we
are inviting public comment on the
issues to be considered by the
committee as listed in the ‘‘Agenda’’
section below.
Comments must be submitted in
writing no later than February 15, 2012,
and must be identified by USCBP–
2012–0001 and may be submitted by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Email: Tradeevents@dhs.gov.
Include the docket number in the
subject line of the message.
• Fax: (202) 325–4290.
• Mail: Ms. Wanda Tate, Office of
Trade Relations, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW., Room 5.2A, Washington,
DC 20229.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at https://www.regulations.gov,
including any personal information
provided.
Docket: For access to the docket to
read background documents or
comments received by the COAC, go to
https://www.regulations.gov.
There will be three public comment
periods held during the meeting on
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 77, Number 23 (Friday, February 3, 2012)]
[Notices]
[Pages 5520-5521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2462]
-----------------------------------------------------------------------
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 March 20, 2012, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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.
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), 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: On March 20, 2012, during the morning session, the
committee will discuss supplemental new drug
[[Page 5521]]
application (NDA) 022465/S-010, VOTRIENT (pazopanib hydrochloride)
Tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd.
doing business as GlaxoSmithKline. The proposed indication (use) for
this product is for the treatment of patients with advanced soft tissue
sarcoma (STS) who have received prior chemotherapy. The phase 3 STS
trial population excluded patients with adipocytic STS or
gastrointestinal stromal tumors.
During the afternoon session, the committee will discuss NDA
022576, with the proposed trade name TALTORVIC (ridaforolimus) Tablets,
application submitted by Merck Sharp & Dohme Corp. The proposed
indication (use) for this product is for the treatment of adult and
pediatric patients (aged 13 through 17 years with weight over 100 lb or
45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a
maintenance therapy for patients who have completed at least 4 cycles
of chemotherapy without evidence of disease progression.
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
March 6, 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
February 27, 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 February 28,
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: January 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-2462 Filed 2-2-12; 8:45 am]
BILLING CODE 4160-01-P
