Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH), 66986 [E9-29976]
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Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Subcommittee for Dose
Reconstruction Reviews (SDRR),
Advisory Board on Radiation and
Worker Health (ABRWH), National
Institute for Occupational Safety and
Health (NIOSH)
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention, announces the
following meeting for the
aforementioned subcommittee:
Time and Date: 9:30 a.m.–5 p.m., January
7, 2010.
Place: Cincinnati Airport Marriott, 2395
Progress Drive, Hebron, Kentucky 41018.
Telephone (859) 334–4611, Fax (859) 334–
4619.
Status: Open to the public, but without a
public comment period. To access by
conference call dial the following
information at 1 (866) 659–0537, Participant
Pass Code 9933701.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that have
been promulgated by the Department of
Health and Human Services (HHS) as a final
rule; advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule; advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program; and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC.
NIOSH implements this responsibility for
CDC. The charter was issued on August 3,
2001, renewed at appropriate intervals, and
will expire on August 3, 2011.
Purpose: The Advisory Board is charged
with (a) Providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
VerDate Nov<24>2008
13:19 Dec 16, 2009
Jkt 220001
endangered the health of members of this
class. The Subcommittee for Dose
Reconstruction Reviews was established to
aid the Advisory Board in carrying out its
duty to advise the Secretary, HHS, on dose
reconstruction.
Matters To Be Discussed: The agenda for
the Subcommittee meeting includes:
discussion of dose reconstruction cases
under review (sets 6–9); OCAS dose
reconstruction quality management and
assurance activities.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot attend,
written comments may be submitted. Any
written comments received will be provided
at the meeting and should be submitted to
the contact person below well in advance of
the meeting.
Contact Person for More Information:
Theodore Katz, Designated Federal Officer,
NIOSH, CDC, 1600 Clifton Road, Mailstop E–
20, Atlanta GA 30333, Telephone (513) 533–
6800, Toll Free 1 (800) CDC–INFO, E-mail
ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: December 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–29976 Filed 12–16–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 February 10, 2010, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD. The
hotel phone number is 301–977–8900.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Contact Person: Nicole Vesely,
Pharm.D., Center for Drug Evaluation
and Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, 5630 Fishers Lane, rm.
1093) Rockville, MD 20857, 301–827–
6793, FAX: 301–827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. 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 February 10, 2010, during
the morning session, the committee will
discuss new drug application (NDA)
022–481, proposed trade name PIXUVRI
(pixantrone dimaleate) injection,
manufactured by Cell Therapeutics, Inc.
The proposed indication (use) for this
product is as a single agent treatment for
patients with recurring or refractory
(difficult to treat), aggressive nonHodgkin’s lymphoma (NHL) who have
received two or more prior lines of
therapy.
During the afternoon session, the
committee will discuss NDA 022–374,
proposed trade name OMAPRO
(omacetaxine mepesuccinate) for
injection, manufactured by ChemGenex
Pharmaceuticals. The proposed
indication (use) for this product is for
the treatment of adults with chronic
myeloid leukemia (CML) bearing a
genetic alteration known as the Bcr-Abl
T315I mutation, and who have failed
prior therapy with the drug IMATINIB.
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
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Notices]
[Page 66986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29976]
[[Page 66986]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory
Board on Radiation and Worker Health (ABRWH), National Institute for
Occupational Safety and Health (NIOSH)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention, announces the following meeting for the aforementioned
subcommittee:
Time and Date: 9:30 a.m.-5 p.m., January 7, 2010.
Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron,
Kentucky 41018. Telephone (859) 334-4611, Fax (859) 334-4619.
Status: Open to the public, but without a public comment period.
To access by conference call dial the following information at 1
(866) 659-0537, Participant Pass Code 9933701.
Background: The Advisory Board was established under the Energy
Employees Occupational Illness Compensation Program Act of 2000 to
advise the President on a variety of policy and technical functions
required to implement and effectively manage the new compensation
program. Key functions of the Advisory Board include providing
advice on the development of probability of causation guidelines
that have been promulgated by the Department of Health and Human
Services (HHS) as a final rule; advice on methods of dose
reconstruction which have also been promulgated by HHS as a final
rule; advice on the scientific validity and quality of dose
estimation and reconstruction efforts being performed for purposes
of the compensation program; and advice on petitions to add classes
of workers to the Special Exposure Cohort (SEC).
In December 2000, the President delegated responsibility for
funding, staffing, and operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC. NIOSH implements this
responsibility for CDC. The charter was issued on August 3, 2001,
renewed at appropriate intervals, and will expire on August 3, 2011.
Purpose: The Advisory Board is charged with (a) Providing advice
to the Secretary, HHS, on the development of guidelines under
Executive Order 13179; (b) providing advice to the Secretary, HHS,
on the scientific validity and quality of dose reconstruction
efforts performed for this program; and (c) upon request by the
Secretary, HHS, advise the Secretary on whether there is a class of
employees at any Department of Energy facility who were exposed to
radiation but for whom it is not feasible to estimate their
radiation dose, and on whether there is reasonable likelihood that
such radiation doses may have endangered the health of members of
this class. The Subcommittee for Dose Reconstruction Reviews was
established to aid the Advisory Board in carrying out its duty to
advise the Secretary, HHS, on dose reconstruction.
Matters To Be Discussed: The agenda for the Subcommittee meeting
includes: discussion of dose reconstruction cases under review (sets
6-9); OCAS dose reconstruction quality management and assurance
activities.
The agenda is subject to change as priorities dictate.
In the event an individual cannot attend, written comments may
be submitted. Any written comments received will be provided at the
meeting and should be submitted to the contact person below well in
advance of the meeting.
Contact Person for More Information: Theodore Katz, Designated
Federal Officer, NIOSH, CDC, 1600 Clifton Road, Mailstop E-20,
Atlanta GA 30333, Telephone (513) 533-6800, Toll Free 1 (800) CDC-
INFO, E-mail ocas@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: December 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-29976 Filed 12-16-09; 8:45 am]
BILLING CODE 4163-18-P
