National Institute for Occupational Safety and Health (NIOSH); Advisory Board on Radiation and Worker Health, 52798-52799 [E6-14787]
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52798
Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 06–7486 Filed 9–6–06; 8:45 am]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) gives notice of a
decision to designate a class of
employees at the Ames Laboratory, in
Ames, Iowa as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On August 8, 2006, the Secretary
of HHS designated the following class of
employees as an addition to the SEC:
SUMMARY:
Department of Energy (DOE) employees or
DOE contractor or subcontractor employees
who worked at the Ames Laboratory in one
or more of the following facilities/locations:
Chemistry Annex 1 (also known as ‘‘the old
women’s gymnasium’’ and ‘‘Little Ankeny’’),
Chemistry Annex 2, Chemistry Building (also
known as ‘‘Gilman Hall’’), Research Building,
or the Metallurgical Building (also known as
‘‘Harley Wilhelm Hall’’) from January 1, 1942
through December 31, 1954 for a number of
work days aggregating at least 250 work days,
or in combination with work days within the
parameters (excluding aggregate work day
requirements) established for one or more
classes of employees in the SEC, and who
were monitored or should have been
monitored.
rwilkins on PROD1PC63 with NOTICES
This designation will become
effective on September 7, 2006, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
requests can also be submitted by e-mail
to OCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 06–7485 Filed 9–6–06; 8:45 am]
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Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Department of Energy (DOE) employees or
DOE contractor or subcontractor employees
who were monitored or should have been
monitored for:
(1) Thorium exposures while working in
Building 9201–3, 9202, 9204–1, 9204–3,
9206, or 9212 at Y–12 for a number of work
days aggregating at least 250 work days from
January 1948 through December 1957 or in
combination with work days within the
parameters (excluding aggregate work day
requirements) established for one or more
classes of employees in the SEC; or
(2) Radionuclide exposures associated with
cyclotron operations in Building 9201–2 at
Y–12 for a number of work days aggregating
at least 250 work days from January 1948
through December 1957 or in combination
with work days within the parameters
(excluding aggregate work day requirements)
established for one or more classes of
employees in the SEC.
This designation will become
effective on September 7, 2006, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provisions by Congress regarding
the decision by HHS to add the class to
the SEC.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support;
National Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, MS C–46, Cincinnati, OH
45226, Telephone 513–533–6800 (this is
not a toll-free number). Information
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice.
SUMMARY: The Department of Health and
Human Services (HHS) gives notice of a
decision to designate a class of
employees at the Y–12 Plant, in Oak
Ridge, Tennessee as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On August 8, 2006, the Secretary
of HHS designated the following class of
employees an addition to the SEC:
PO 00000
BILLING CODE 4160–17–M
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National Institute for Occupational
Safety and Health (NIOSH); Advisory
Board on Radiation and Worker Health
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 committee meeting:
Name: Advisory Board on Radiation
and Worker Health (ABRWH), National
Institute for Occupational Safety and
Health and Subcommittee for Dose
Reconstruction and Site Profile Reviews
(SDRSPR).
Subcommittee Meeting Time and
Date: 9 a.m.–12 p.m., September 19,
2006.
Committee Meeting Times and Dates:
1 p.m.–4:45 p.m., September 19, 2006.
8:30 a.m.–5 p.m., September 20, 2006.
8:30 a.m.–5 p.m., September 21, 2006.
Public Comment Times and Dates:
5 p.m.–6 p.m., September 19, 2006.
7:30 p.m.–8:30 p.m., September 20,
2006.
Place: Westin Casuarina, 160 E.
Flamingo Road, Las Vegas, Nevada
89169. Phone 702.836.5900, Fax
702.836.5990.
Status: Open to the public, limited
only by the space available. The meeting
space accommodates approximately 75
to 100 people.
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
E:\FR\FM\07SEN1.SGM
07SEN1
rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices
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, and will expire on August 3,
2007.
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, 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.
Matters to be Discussed: The agenda
for the Subcommittee meeting includes
Individual Dose Reconstruction Reviews
and Procedures Reviews; Subcommittee
Operations and Future Plans. The
agenda for the Advisory Board meeting
includes Presentation of SEC Petitions
for Oak Ridge Institute of Nuclear
Studies (ORINS), Chapman Valve, S–50
Thermal, and Los Alamos National
Laboratory (LANL) (Radioactive
Lanthanum Exposure); Updates on SEC
Petitions for Nevada Test Site (NTS),
Pacific Proving Ground (PPG), Ames
Laboratory, and Rocky Flats Plant;
Working Group Reports on the
Savannah River Site (SRS) Profile, NTS
Site Profile, and SEC Petitions;
Individual Dose Reconstruction
Reviews; Procedures Review; NIOSH
Conflict of Interest Policy; Board
Conflict of Interest Policy; Status and
Future Funding of Sanford Cohen &
Associates (SC&A) Contract; Science
Issues Updates; Charter for New
Subcommittee; Working Group and
Subcommittee Assignments; NIOSH,
Office of Compensation Analysis and
Support (OCAS) and Department of
Labor (DOL) Status Reports; Board
Correspondence; Board Future Plans,
and Board Working Time. The agenda is
subject to change as priorities dictate.
In the event an individual cannot
attend, written comments may be
submitted. Any written comments
VerDate Aug<31>2005
18:11 Sep 06, 2006
Jkt 208001
should be submitted to the contact
person below well in advance of the
meeting, and the comments will be
provided at the meeting.
For Further Information Contact: Dr.
Lewis V. Wade, Executive Secretary,
NIOSH, CDC, 4676 Columbia Parkway,
Cincinnati, Ohio 45226, Telephone
513.533.6825, Fax 513.533.6826.
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: August 31, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–14787 Filed 9–6–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0336]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Commercially Distributed Analyte
Specific Reagents (ASRs): Frequently
Asked Questions; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Commercially Distributed
Analyte Specific Reagents (ASRs):
Frequently Asked Questions.’’ This
guidance document is intended to
clarify the regulations regarding ASRs
and the role and responsibilities of ASR
manufacturers.
DATES: Submit written or electronic
comments on this draft guidance by
December 6, 2006.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Commercially Distributed
Analyte Specific Reagents (ASRs):
Frequently Asked Questions’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
PO 00000
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52799
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Courtney C. Harper, Center for Devices
and Radiological Health (HFZ–440),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0490.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is providing this guidance in
order to eliminate confusion regarding
particular marketing practices among
ASR manufacturers. ASRs are the
building blocks of laboratory-developed
tests and are defined and classified in a
rule codified at § 864.4020 (21 CFR
864.4020). With this draft guidance
document, FDA seeks to advise ASR
manufacturers that it views certain
practices as being inconsistent with the
marketing of an ASR, as defined in
§ 864.4020. Some manufacturers have
believed that when they combine a
Class I ASR, which is exempt from
premarket notification requirements
under section 510(l) of the Federal
Food, Drug, and Cosmetic Act (the act),
(21 U.S.C. 360(l)), with other products,
or with instructions for use in a specific
test, the product remains exempt
because of the presence of an ASR.
However, as explained in this draft
guidance, when an ASR is marketed in
certain ways, FDA views the product as
no longer being an ASR within the
meaning of § 860.4020.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized will
represent the agency’s current thinking
on commercially distributed ASRs. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 173 (Thursday, September 7, 2006)]
[Notices]
[Pages 52798-52799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH);
Advisory Board on Radiation and Worker Health
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 committee meeting:
Name: Advisory Board on Radiation and Worker Health (ABRWH),
National Institute for Occupational Safety and Health and Subcommittee
for Dose Reconstruction and Site Profile Reviews (SDRSPR).
Subcommittee Meeting Time and Date: 9 a.m.-12 p.m., September 19,
2006.
Committee Meeting Times and Dates:
1 p.m.-4:45 p.m., September 19, 2006.
8:30 a.m.-5 p.m., September 20, 2006.
8:30 a.m.-5 p.m., September 21, 2006.
Public Comment Times and Dates:
5 p.m.-6 p.m., September 19, 2006.
7:30 p.m.-8:30 p.m., September 20, 2006.
Place: Westin Casuarina, 160 E. Flamingo Road, Las Vegas, Nevada
89169. Phone 702.836.5900, Fax 702.836.5990.
Status: Open to the public, limited only by the space available.
The meeting space accommodates approximately 75 to 100 people.
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
[[Page 52799]]
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, and will expire on August 3, 2007.
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,
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.
Matters to be Discussed: The agenda for the Subcommittee meeting
includes Individual Dose Reconstruction Reviews and Procedures Reviews;
Subcommittee Operations and Future Plans. The agenda for the Advisory
Board meeting includes Presentation of SEC Petitions for Oak Ridge
Institute of Nuclear Studies (ORINS), Chapman Valve, S-50 Thermal,
andLos Alamos National Laboratory (LANL) (RadioactiveLanthanum
Exposure); Updates on SEC Petitions for NevadaTest Site (NTS), Pacific
Proving Ground (PPG), Ames Laboratory, and Rocky Flats Plant; Working
Group Reports on the Savannah River Site (SRS) Profile, NTS Site
Profile, and SEC Petitions; Individual Dose Reconstruction Reviews;
Procedures Review; NIOSH Conflict of Interest Policy; Board Conflict of
Interest Policy; Status and Future Funding of Sanford Cohen &
Associates (SC&A) Contract; Science Issues Updates; Charter for New
Subcommittee; Working Group and Subcommittee Assignments; NIOSH, Office
of Compensation Analysis and Support (OCAS) and Department of Labor
(DOL) Status Reports; Board Correspondence; Board Future Plans, and
Board Working Time. The agenda is subject to change as priorities
dictate.
In the event an individual cannot attend, written comments may be
submitted. Any written comments should be submitted to the contact
person below well in advance of the meeting, and the comments will be
provided at the meeting.
For Further Information Contact: Dr. Lewis V. Wade, Executive
Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226,
Telephone 513.533.6825, Fax 513.533.6826.
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: August 31, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E6-14787 Filed 9-6-06; 8:45 am]
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