Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH), 11731 [E9-5977]
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Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices
The public consultation draft report is
the result of work that began in 2004,
when SACGHS identified the effect of
gene patents and licensing practices on
patient and clinical access to genetic
tests as a high-priority issue that
warranted further study. SACGHS
activities in this area were deferred until
the completion of a National Academy
of Sciences (NAS) study on the granting
and licensing of intellectual property
rights to genetic and proteomic
discoveries and the effects of these
practices on research and innovation. In
the fall of 2005, NAS released that
study’s report, Reaping the Benefits of
Genomic and Proteomic Research:
Intellectual Property Rights, Innovation,
and Public Health. After reviewing the
report, SACGHS decided that more
information was needed regarding the
effects of gene patents and licenses on
patient and clinical access to genetic
tests. In 2006, a task force was formed
by SACGHS to guide its work in this
area. The task force commissioned case
studies, compiled relevant information
through a review of the literature, and
consulted with national and
international experts and stakeholders.
At the outset of its work, the task
force decided to limit the scope of its
inquiry to those genetic tests, whether
used for diagnostic, predictive, or other
clinical purposes, that rely on analysis
of nucleic acid molecules to determine
human genotype. As such, the kinds of
patent claims that the Committee
evaluated were nucleic acid-related
patent claims associated with genetic
tests for human genotype. This report
does not address protein-based genetic
tests or protein-related patent claims
associated with tests designed to infer
genotype.
The public consultation draft report
presents the Committee’s preliminary
findings. The draft report also includes
policy options. These options do not
necessarily correlate with any particular
preliminary finding, but rather provide
a framework within which to gather
public input. The Committee developed
these options to present a broad range
of possible actions, but has not yet
decided which, if any, of these policy
options to support.
Before SACGHS can develop specific
recommendations for the Secretary, the
Committee needs public input on
several issues, including whether
changes are needed in patenting and
licensing practices that affect genetic
testing, and the appropriateness,
feasibility, and implications of the
report’s policy options. Members of the
public are also invited to recommend
specific policy options not included in
the presented options and any needed
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modifications to existing options.
SACGHS also encourages the public to
provide any additional information and
data regarding the positive or negative
effects gene patenting or licensing
practices have had, are having, or may
have on patient and clinical access to
genetic tests.
The Committee will carefully
consider public input in finalizing its
report and developing any
recommendations to the Secretary.
Comments received by May 15, 2009,
will be considered by SACGHS in
preparing its final report. The public
comments and revised report will be
discussed during a future SACGHS
meeting.
Comments will be available for public
inspection at the NIH Office of
Biotechnology Activities Monday
through Friday between the hours of
8:30 a.m. and 5 p.m.
Dated: March 11, 2009.
Sarah Carr,
Executive Secretary, SACGHS.
[FR Doc. E9–5936 Filed 3–18–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), 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), CDC announces the
following meeting of the
aforementioned committee:
Time and Date: 11 a.m.–5 p.m., Thursday,
March 31, 2009.
Place: Audio Conference Call via FTS
Conferencing. The USA toll free dial in
number is 1–866–659–0537 with a pass code
of 9933701.
Status: Open to the public, but without a
public oral comment period.
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 which
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
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11731
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 the
CDC. NIOSH implements this responsibility
for CDC. The charter was issued on August
3, 2001, renewed at appropriate intervals,
most recently, August 3, 2007, and will
expire on August 3, 2009.
Purpose: This 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, advising 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.
Matters To Be Discussed: The agenda for
the conference call includes: Dose
Reconstruction Interview Scripts and
Procedures; Special Exposure Cohort Petition
Status Updates; Board Subcommittee and
Work Group Updates; Update on Board
Technical Support Contractor Activities;
Future Plans.
Due to administrative matters, this Federal
Register Notice is being published on less
than 15 calendar days notice to the public (41
CFR 102–3.150(b)).
The agenda is subject to change as
priorities dictate.
Because there is no public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
and should be submitted to the contact
person below in advance of the meeting.
Contact Person for More Information:
Theodore M. Katz, M.P.A., Executive
Secretary, NIOSH, CDC, 1600 Clifton Rd. NE.,
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: March 12, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–5977 Filed 3–18–09; 8:45 am]
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[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Notices]
[Page 11731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5977]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Advisory Board on Radiation and Worker Health (ABRWH or Advisory
Board), 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), CDC announces the following meeting of
the aforementioned committee:
Time and Date: 11 a.m.-5 p.m., Thursday, March 31, 2009.
Place: Audio Conference Call via FTS Conferencing. The USA toll
free dial in number is 1-866-659-0537 with a pass code of 9933701.
Status: Open to the public, but without a public oral comment
period.
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
which 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 the CDC. NIOSH implements
this responsibility for CDC. The charter was issued on August 3,
2001, renewed at appropriate intervals, most recently, August 3,
2007, and will expire on August 3, 2009.
Purpose: This 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, advising 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.
Matters To Be Discussed: The agenda for the conference call
includes: Dose Reconstruction Interview Scripts and Procedures;
Special Exposure Cohort Petition Status Updates; Board Subcommittee
and Work Group Updates; Update on Board Technical Support Contractor
Activities; Future Plans.
Due to administrative matters, this Federal Register Notice is
being published on less than 15 calendar days notice to the public
(41 CFR 102-3.150(b)).
The agenda is subject to change as priorities dictate.
Because there is no public comment period, written comments may
be submitted. Any written comments received will be included in the
official record of the meeting and should be submitted to the
contact person below in advance of the meeting.
Contact Person for More Information: Theodore M. Katz, M.P.A.,
Executive Secretary, NIOSH, CDC, 1600 Clifton Rd. NE., 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: March 12, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-5977 Filed 3-18-09; 8:45 am]
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