Oncologic Drugs Advisory Committee; Notice of Meeting, 65670-65671 [2014-26237]
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Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
12. On page 47646, in the first
column, in the Response to Comment
21, in the first sentence of the response,
delete ‘‘from the coverage of part 114’’
and, at the end of the first sentence of
the response, insert ‘‘or that do not
otherwise meet the definitions of
acidified food.’’
13. On page 47646, in the first
column, in the Response to Comment
22, replace the response with the
following: ‘‘FDA does not agree that the
‘Food Product Group’ categories in any
way indicates FDA’s thinking as to
whether all fruit and vegetable juices are
acidified foods and are therefore subject
to the acidified foods regulations in
parts 108 and 114. Rather, the ‘Food
Product Group’ categories are designed
to help FDA understand the nature of
products. For more information on what
constitutes an acidified food, we
recommend manufacturers consult the
definition of acidified foods in
§ 114.3(b).’’
14. On page 47646, in the second
column, in the Response to Comment
24, replace the second paragraph of the
response with the following: ‘‘When
optional information about the ‘Food
Product Group’ category is provided, we
will use it to help us understand the
nature of the products and to help us
prioritize which facilities to inspect.’’
Dated: October 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26238 Filed 11–4–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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 December 11, 2014, from 8 a.m.
to 3:30 p.m.
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17:42 Nov 04, 2014
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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, 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: Information will be
presented to gauge investigator interest
in exploring potential pediatric
development plans for three products in
various stages of development for adult
cancer indications. The subcommittee
will consider and discuss issues
concerning diseases to be studied,
patient populations to be included, and
possible study designs in the
development of these products for
pediatric use. The discussion will also
provide information to the Agency
pertinent to the formulation of written
requests for pediatric studies, if
appropriate. The products under
consideration are: (1) GANETESPIB,
application submitted by Synta
Pharmaceuticals Corp. (2) Etirinotecan,
application submitted by Nektar
Therapeutics, and (3) RO5503781,
application submitted by Hoffmann-La
Roche, Inc.
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
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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 December 3, 2014.
Oral presentations from the public will
be scheduled between approximately
8:55 a.m. to 9:15 a.m., 11:10 a.m. to
11:30 a.m., and 2:10 p.m. to 2:30 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 25, 2014. 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 26, 2014.
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).
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Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices
Dated: October 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[FR Doc. 2014–26237 Filed 11–4–14; 8:45 am]
BILLING CODE 4164–01–P
Organization, Functions, and
Delegations of Authority
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Part G
Health Resources and Services
Administration
Centers for Disease Control and
Prevention (CDC)/Health Resources
and Services Administration (HRSA)
Advisory Committee on HIV, Viral
Hepatitis, and Sexually Transmitted
Disease (STD) Prevention and
Treatment
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
ACTION:
Notice; correction.
The Health Resources and
Services Administration published a
notice in the Federal Register, FR 2014–
25199 (October 23, 2014), announcing
the meeting for the Centers for Disease
Control and Prevention (CDC)/Health
Resources and Services Administration
(HRSA) Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and
Treatment. The action is to provide
correction to the virtual meeting audio
access code.
Correction: In the Federal Register,
FR 2014–25199 (October 23, 2014),
please make the following corrections:
Join the meeting by:
1. (Audio Portion) Calling the Toll free
Phone Number 1–888–942–8515 and
providing the Participant Pass Code
9582370, and
2. (Visual Portion) Connecting to the
Advisory Committee Adobe Connect Pro
Meeting using the following URL:
https://hrsa.connectsolutions.com/
cdchrsa_advcmt/.
SUMMARY:
Dated: October 29, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–26225 Filed 11–4–14; 8:45 am]
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17:42 Nov 04, 2014
Jkt 235001
Indian Health Service
Part G, of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (HHS), as amended at 70 FR
60350, October 17, 2005, and most
recently as amended at 75 FR 38112,
July 1, 2010 is hereby amended to
establish an Office of Human Resources
(OHR) and transfer the functions and
staff from the Program Integrity and
Ethics Staff (renamed as Division of
Personnel Security and Ethics), Division
of Commissioned Personnel Support,
and Division of Human Resources, from
the Office of Management Services and
the Division of Health Professions
Support, from the Office of Public
Health Support to the Office of Human
Resources within the IHS Headquarters
(HQ) organizational structure. The OHR
will ensure a competent work force
appropriately assigned to carry out the
IHS mission. The changes will relocate
major human resources (HR)
components within a single
organization that reports to the Director,
IHS. The Office will provide leadership
and accountability of Agency personnel
requirements, recruitment and
retention, management, and training
and development objectives and
activities to support the Agency’s
mission.
Office of Human Resources (OHR)
(GAN)
(1) Advises the Director, IRS, on HR
goals, objectives, policies, and priorities
of the Agency and the HR profession; (2)
provides leadership, direction, and
oversight of Agency-wide HR activities
that support the IHS organization and
programs; (3) develops and maintains
strategic and operational HR plans to
ensure a current and future work force
for management, program delivery, and
administrative support systems; (4)
furthers the Agency’s Indian Preference
by ensuring compliance with Indian
Preference statutory and policy
requirements; (5) develops,
promulgates, and administers Agency
HR guidelines, and instructions in
accordance with Office of Personnel
Management (OPM), HHS, Public
Health Service policies and the Indian
Health Care Improvement Act (IHCIA),
as amended; (6) ensures consistency in
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recruitment, training, and development
applications, approaches, and outcomes
by administering an Agency-wide HR
system of functional responsibility,
authority, and accountability; (7) issues
standards to monitor and evaluate all
IRS training and development activities
and ensures that expenditures for
recruitment, training, and development
support the Agency’s mission and goals;
(8) provides Agency-wide policy
guidance, consultation, and technical
assistance on all IHS HR management,
recruitment, and retention activities; (9)
manages Agency work force information
and conducts analyses, including trends
analysis and forecasting necessary for
Agency HR planning, management, and
evaluation; (10) administers an Agencywide information clearinghouse on HR
recruitment, training, and development
that serves all IHS organizations and
Tribal health programs; (11) directs the
Agency-wide scholarship, loan
repayment, professional recruitment
and retention, training, and
development systems; (12) administers
personnel management operations and
services for HQ organizational units;
(13) ensures a safe, healthy, and
productive work environment for IHS
personnel to carry out their assigned
duties and responsibilities, and that HR
factors are part of the Agency’s decision
making processes; (14) establishes and
maintains liaison and coordination with
a variety of public and private
organizations to provide the IHS with
up-to-date HR recruitment,
management, training, retention and
development technologies; (15) ensures
that organization and program changes
involve assessments of appropriate HR
requirements, including work design,
knowledge, skills, abilities, and work
load; (16) prepares reports and studies
reflecting IHS HR activities in response
to the Congress, other Federal agencies,
and Tribal Governments; and (17)
participates in cross-cutting issues and
processes, including, but not limited to
emergency preparedness/security,
budget formulation, self-determination
issues, Tribal shares computations and
resolution of audit findings as may be
needed and appropriate.
Division of Personnel Security and
Ethics (DPSE) (GANA)
(1) Advises the IHS Director and IHS
management and supervisors of
appropriate corrective and remedial
actions to address or correct
improprieties by Agency employees; (2)
directs and provides leadership in the
formulation of plans, guidance and
evaluation of the IHS Personnel Security
and Drug Testing Programs; (3) manages
and directs the IHS ‘‘Ethics Program’’,
E:\FR\FM\05NON1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65670-65671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-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: 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 December 11, 2014, from
8 a.m. to 3:30 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, 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: Information will be presented to gauge investigator
interest in exploring potential pediatric development plans for three
products in various stages of development for adult cancer indications.
The subcommittee will consider and discuss issues concerning diseases
to be studied, patient populations to be included, and possible study
designs in the development of these products for pediatric use. The
discussion will also provide information to the Agency pertinent to the
formulation of written requests for pediatric studies, if appropriate.
The products under consideration are: (1) GANETESPIB, application
submitted by Synta Pharmaceuticals Corp. (2) Etirinotecan, application
submitted by Nektar Therapeutics, and (3) RO5503781, application
submitted by Hoffmann-La Roche, Inc.
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
December 3, 2014. Oral presentations from the public will be scheduled
between approximately 8:55 a.m. to 9:15 a.m., 11:10 a.m. to 11:30 a.m.,
and 2:10 p.m. to 2:30 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 25, 2014. 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 26, 2014.
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).
[[Page 65671]]
Dated: October 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26237 Filed 11-4-14; 8:45 am]
BILLING CODE 4164-01-P
