Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH), 51566-51567 [2015-21001]
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51566
Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / 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 or the
Advisory Board), National Institute for
Occupational Safety and Health
(NIOSH)
asabaliauskas on DSK5VPTVN1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting for the
aforementioned subcommittee:
Time and Date: 10:30 a.m.–5:00 p.m., EDT,
September 24, 2015.
Place: Audio Conference Call via FTS
Conferencing.
Status: Open to the public. The public is
welcome to submit written comments in
advance of the meeting, to the contact person
below. Written comments received in
advance of the meeting will be included in
the official record of the meeting. The public
is also welcome to listen to the meeting by
joining the teleconference at the USA tollfree, dial-in number at 1–866–659–0537 and
the pass code is 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, 2017.
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
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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 for Discussion: The agenda for the
Subcommittee meeting includes the
following dose reconstruction program
quality management and assurance activities:
Current findings from NIOSH and Advisory
Board dose reconstruction blind reviews;
dose reconstruction cases under review from
Sets 14–18, including the Oak Ridge sites (Y–
12, K–25, Oak Ridge National Laboratory),
and Savannah River Site; preparation of the
Advisory Board’s next report to the Secretary,
HHS, summarizing the results of completed
dose reconstruction reviews.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information:
Theodore Katz, Designated Federal Officer,
NIOSH, CDC, 1600 Clifton Road, Mailstop E–
20, Atlanta, Georgia 30333, Telephone (513)
533–6800, Toll Free 1 (800) CDC–INFO,
Email 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 the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21002 Filed 8–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH or the
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), and pursuant to the
requirements of 42 CFR 83.15(a), the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting of the
aforementioned committee:
Time and Date: 11:00 a.m.–2:00 p.m., EDT,
September 22, 2015.
Place: Audio Conference Call via FTS
Conferencing.
Status: Open to the public. The public is
welcome to submit written comments in
advance of the meeting, to the contact person
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
below. Written comments received in
advance of the meeting will be included in
the official record of the meeting. The public
is also welcome to listen to the meeting by
joining the teleconference at the USA tollfree, dial-in number, 1–866–659–0537 and
the passcode is 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, 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,
and will expire on August 3, 2017.
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 for Discussion: The agenda for the
conference call includes: Work Group and
Subcommittee Reports; SEC Petitions Update
for the November 2015 Advisory Board
Meeting; Plans for the November 2015
Advisory Board Meeting; and Advisory Board
Correspondence.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information:
Theodore M. Katz, M.P.A., Designated
Federal Officer, NIOSH, CDC, 1600 Clifton
Road NE., Mailstop: E–20, Atlanta, Georgia
30333, Telephone (513) 533–6800, Toll Free
1–800–CDC–INFO, Email 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 the Centers for Disease Control and
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Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21001 Filed 8–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Institute for Occupational
Safety and Health (BSC, NIOSH)
asabaliauskas on DSK5VPTVN1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:
Time and Date: 8:30 a.m.–3:00 p.m., EDT,
September 22, 2015.
Place: Patriots Plaza I, 395 E Street SW.,
Room 9000, Washington, DC 20201.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 33 people. The
meeting is also open to the public via
webcast. If you wish to attend in person or
by webcast, please see the NIOSH Web site
to register (https://www.cdc.gov/niosh/bsc/) or
call (404–498–2539) at least five business
days in advance of the meeting.
Teleconference is available toll-free; please
dial (888) 397–9578, Participant Pass Code
63257516. Members of the public who wish
to address the BSC, NIOSH are requested to
contact the Executive Secretary for
scheduling purposes (see contact information
below). Alternatively, written comments to
the BSC may be submitted via an on-line
form at the following Web site: https://
www.cdc.gov/niosh/bsc/contact.html.
Purpose: The Secretary, the Assistant
Secretary for Health, and by delegation the
Director, Centers for Disease Control and
Prevention, are authorized under Sections
301 and 308 of the Public Health Service Act
to conduct directly or by grants or contracts,
research, experiments, and demonstrations
relating to occupational safety and health and
to mine health. The Board of Scientific
Counselors provides guidance to the Director,
National Institute for Occupational Safety
and Health on research and prevention
programs. Specifically, the Board provides
guidance on the Institute’s research activities
related to developing and evaluating
hypotheses, systematically documenting
findings and disseminating results. The
Board evaluates the degree to which the
activities of the National Institute for
Occupational Safety and Health: (1) Conform
to appropriate scientific standards, (2)
address current, relevant needs, and (3)
produce intended results.
Matters for Discussion: NIOSH Director’s
update, Structuring Labor-Management
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Participation in Research, Systematic Review
(Grading Evidence and Recommendations),
Occupational Exposure Banding, and an
Update from the NIOSH Research Translation
Office.
Agenda items are subject to change as
priorities dictate. An agenda is also posted on
the NIOSH Web site (https://www.cdc.gov/
niosh/bsc/).
Contact Person for More Information: John
Decker, Executive Secretary, BSC, NIOSH,
CDC, 1600 Clifton Road NE., MS–E20,
Atlanta, GA 30329–4018, telephone (404)
498–2500, fax (404) 498–2526.
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 the CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–20999 Filed 8–24–15; 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: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Board on Radiation and
Worker Health, Department of Health
and Human Services, has been renewed
for a 2-year period through August 3,
2017.
For information, contact Mr.
Theodore Katz, Designated Federal
Officer, Advisory Board on Radiation
and Worker Health, Department of
Health and Human Services, 1600
Clifton Road, M/S E20, Atlanta, Georgia
30341, telephone 404/498–2533, or fax
404/498–2570.
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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21000 Filed 8–24–15; 8:45 am]
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51567
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2048]
Medical Device Epidemiology Network
Registry Task Force Report;
Availability, Web Site Location and
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of the report and Web site
location where the Agency has posted
the report entitled ‘‘Recommendations
for a National Medical Device
Evaluation System: Strategically
Coordinated Registry Networks to
Bridge the Clinical Care and Research,’’
developed by the Medical Device
Epidemiology Network’s Medical
Device Registry Task Force. In addition,
FDA has established a docket where
stakeholders may provide comments.
DATES: Submit either electronic or
written comments by October 26, 2015.
ADDRESSES: Submit electronic
comments on this document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4110,
Silver Spring, MD 20993–0002, 301–
796–6689, email: Danica.marinacdabic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA’s Center for Devices and
Radiological Health is responsible for
protecting the public health by assuring
the safety and effectiveness of medical
devices and radiation-emitting products.
A key part of this mission is to monitor
medical devices and radiological
products for continued safety and
effectiveness after they are in use and to
help the public get the accurate,
science-based information they need to
improve their health.
In September 2012, the FDA
published a report, ‘‘Strengthening Our
National System for Medical Device
Postmarket Surveillance,’’ that proposed
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Agencies
[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51566-51567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21001]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Board on Radiation and Worker Health (ABRWH or the
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), and pursuant to the requirements of 42
CFR 83.15(a), the Centers for Disease Control and Prevention (CDC),
announces the following meeting of the aforementioned committee:
Time and Date: 11:00 a.m.-2:00 p.m., EDT, September 22, 2015.
Place: Audio Conference Call via FTS Conferencing.
Status: Open to the public. The public is welcome to submit
written comments in advance of the meeting, to the contact person
below. Written comments received in advance of the meeting will be
included in the official record of the meeting. The public is also
welcome to listen to the meeting by joining the teleconference at
the USA toll-free, dial-in number, 1-866-659-0537 and the passcode
is 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,
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, and will expire on August 3,
2017.
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 for Discussion: The agenda for the conference call
includes: Work Group and Subcommittee Reports; SEC Petitions Update
for the November 2015 Advisory Board Meeting; Plans for the November
2015 Advisory Board Meeting; and Advisory Board Correspondence.
The agenda is subject to change as priorities dictate.
Contact Person for More Information: Theodore M. Katz, M.P.A.,
Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road NE.,
Mailstop: E-20, Atlanta, Georgia 30333, Telephone (513) 533-6800,
Toll Free 1-800-CDC-INFO, Email 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 the Centers for Disease Control and
[[Page 51567]]
Prevention and the Agency for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2015-21001 Filed 8-24-15; 8:45 am]
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