Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting, 61713-61714 [2011-25684]
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Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Seldon received the proposal on May
27, 2011, and failed to respond within
the timeframe prescribed by regulation.
She therefore has waived her
opportunity for a hearing and any
contentions concerning her debarment
(21 CFR part 12).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 6, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–25680 Filed 10–4–11; 8:45 am]
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II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(B) of the
FD&C Act (21 U.S.C. 335a(a)(2)(B)),
under authority delegated to him (Staff
Manual Guide 1410.35), finds that
Deborah Martinez Seldon has been
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
As a result of the foregoing finding,
Ms. Seldon is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES), (see section 306(c)(1)(B),
(c)(2)(A)(ii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii),
and 321(dd))). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Ms.
Seldon in any capacity during Ms.
Seldon’s debarment, will be subject to
civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Ms. Seldon provides services in any
capacity to a person with an approved
or pending drug product application
during her period of debarment she will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act) (21
U.S.C. 335b(a)(7)). In addition, FDA will
not accept or review any abbreviated
new drug applications submitted by or
with the assistance of Deborah Martinez
Seldon during her period of debarment
(section 306(c)(1)(A) of the FD&C Act
(21 U.S.C. 335a(c)(1)(A)).
Any application by Deborah Martinez
Seldon for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4))
should be identified with Docket No.
FDA–2011–N–0165 and sent to the
Division of Dockets Management (see
ADDRESSES). All such submissions are to
be filed in four copies. The public
availability of information in these
submissions is governed by 21 CFR
10.20(j).
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Oncology Subcommittee of
the 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: Pediatric
Oncology Subcommittee of the
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 1, 2011, from 8 a.m.
to 5:30 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.
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, e-mail:
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
PO 00000
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61713
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 November 1, 2011,
information will be presented regarding
pediatric development plans for four
products that were either recently
approved by FDA, are in late stage
development for an adult oncology
indication, or in late stage development
in pediatric patients with cancer. The
subcommittee will consider and discuss
issues relating to the development of
each product for pediatric use and
provide guidance to facilitate the
formulation of Written Requests for
pediatric studies, if appropriate. The
four products under consideration are:
(1) Sodium thiosulfate injection,
application submitted by Adherex
Technologies, Inc.; (2) vismodegib
(GDC–0449), application submitted by
Genentech, Inc.; (3) pazopanib,
application submitted by Glaxo
Wellcome Manufacturing Pte Ltd.,
Singapore doing business as
GlaxoSmithKline; and (4) Medi-573
(fully human antibody to IGF–I and
IGF–II), application submitted by
MedImmune, LLC.
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 October 18, 2011.
Oral presentations from the public will
be scheduled between approximately
9:15 a.m. to 9:30 a.m., 11:15 a.m. to
11:30 a.m., 2:05 p.m. to 2:20 p.m., and
4:10 p.m. to 4:25 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
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61714
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
participants, and an indication of the
approximate time requested to make
their presentation on or before October
7, 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 October 11, 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 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 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25684 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; STAR METRICS (Science and
Technology for America’s
Reinvestment: Measuring the EffecTs
of Research on Innovation,
Competitiveness and Science)
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
Office of the Director of 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: STAR
METRICS (Science and Technology for
America’s Reinvestment: Measuring the
EffecTs of Research on Innovation,
SUMMARY:
Competitiveness and Science). Type of
Information Collection Request:
Reinstatement of OMB number 0925–
0616, expiration date 01/31/2011. Need
and Use of Information Collection: The
aim of STAR METRICS is twofold. The
goal of STAR METRICS is to continue
to provide mechanisms that will allow
participating universities and Federal
agencies with a reliable and consistent
means to account for the number of
scientists and staff that are on research
institution payrolls, supported by
Federal funds. In subsequent
generations of the program, it is hoped
that STAR METRICS will allow for
measurement of science impact on
economic outcomes (such as job
creation), on knowledge generation
(such as citations and patents) as well
as on social and health outcomes.
Frequency of Response: Quarterly.
Affected Public: Universities and other
research institutions. Type of
Respondents: University administrators.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 100. Estimated Number of
Responses per Respondent: 4. Average
Burden Hours per Response: 2.5.
Estimated Total Annual Burden Hours
Requested: 1,315. The annualized cost
to respondents is estimated to be
$65,750. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
A.12–1 ESTIMATES ANNUAL BURDEN HOURS
Number of
respondents
Form
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
7
100
1
4
45
2.5
315
1000
Total ..........................................................................................................
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Stage 1: One time data input ..........................................................................
Stage 2: Ongoing quarterly data input ............................................................
........................
........................
........................
1,315
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
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mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Julia Lane,
e-mail: julia.lane@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Dated: September 27, 2011.
Stefano Bertuzzi,
Office of the Director, Office of Science Policy
Analysis, Office of Science Policy, National
Institutes of Health.
[FR Doc. 2011–25732 Filed 10–4–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS
ACTION: Notice.
AGENCY:
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]]>Agencies
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61713-61714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Pediatric Oncology Subcommittee of the 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: Pediatric Oncology Subcommittee of the 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 1, 2011, from 8
a.m. to 5:30 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.
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, e-mail: 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 November 1, 2011, information will be presented
regarding pediatric development plans for four products that were
either recently approved by FDA, are in late stage development for an
adult oncology indication, or in late stage development in pediatric
patients with cancer. The subcommittee will consider and discuss issues
relating to the development of each product for pediatric use and
provide guidance to facilitate the formulation of Written Requests for
pediatric studies, if appropriate. The four products under
consideration are: (1) Sodium thiosulfate injection, application
submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC-0449),
application submitted by Genentech, Inc.; (3) pazopanib, application
submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing
business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to
IGF-I and IGF-II), application submitted by MedImmune, LLC.
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
October 18, 2011. Oral presentations from the public will be scheduled
between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m.,
2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 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
[[Page 61714]]
participants, and an indication of the approximate time requested to
make their presentation on or before October 7, 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 October 11, 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 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 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25684 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P
