National Institute for Occupational Safety and Health (NIOSH), Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), 45504-45505 [2016-16579]
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Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
iii. Hyaluronic acid (to be assessed for
review in next update)
C. Topical and transdermal agents (to
be assessed for review in next
update)
i. Capsaicin (to be assessed for review
in next update)
ii. NSAIDs (to be assessed for review
in next update)
II. Cell-based therapies
A. Platelet-rich plasma
B. Intraarticular or arthroscopic
administration of mesenchymal
stem-cells or chondrocytes or tissue
C. Exclusions:
i. Phase I or II trials will not be
included for efficacy, as the
interventions are generally not
FDA-approved for use.
III. Physical treatments and/or weight
loss
A. Physical therapy and exercise
programs
i. Manual therapy
ii. Land-based therapy and/or exercise
iii. Exercise programs (aerobic,
resistance)
iv. Aquatherapy
v. Balneotherapy, mud therapy
vi. Heat or cold
vii. Self-management programs
B. Weight loss
C. Braces or kinesiology taping
D. Orthotic shoe inserts and/or
wedges
E. Vibrating platform
F. Neuromuscular electrical
stimulation (e.g., Transcutaneous
electrical nerve stimulation)
IV. Acupuncture (to be assessed for
review in next update)
A. Needle acupuncture alone (to be
assessed for review in next update)
B. Moxibustion (to be assessed for
review in next update)
V. Combination interventions (to be
assessed for review in next update)
A. Sequential treatment algorithms (to
be assessed for review in next
update)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Comparators
I. Pharmacologic treatments: Placebocontrolled or head-to-head noninferiority only
II. Cell-based therapies: Placebo- or
sham-controlled only
III. Physical treatments and/or weight
loss: Placebo-controlled, usual carecontrolled, or wait list-controlled
only except for weight loss
IV. Neuromuscular electrical
stimulation: Sham stimulation
without current
V. Wait list
VI. Treatment as usual
VII. Studies that use the untreated knee
as a control will be excluded, based
on evidence indicating that
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individuals with OA in one knee
are likely to have some, but not
necessarily identically, reduced
function in the other knee and that
treatment of one knee only may
improve pain in that knee but may
not markedly improve function
VIII. Studies that use participants as
their own controls will be excluded,
unless no randomized controlled
trials are identified for a particular
intervention of interest, as quasiexperimental designs provide
weaker evidence.
IX. Exclusions:
A. Studies that use an active control
that has not been established to be
effective will be excluded. Efficacy
and effectiveness must be
established before examining
comparative effectiveness
questions.
Outcomes
I. Short-term clinical outcomes
A. Pain (e.g., VAS, WOMAC, KOOS,)
B. Joint stiffness (WOMAC)
C. Function (WOMAC, Lequesne,
others)
D. OARSI physical outcomes (e.g.,
timed up-and-go, 6-minute walk
test)
E. Patient Reported Outcome
Measurement System (PROMIS®)
and Osteoarthritis-Computer
Adaptive Test (OA–CAT)
F. Inflammation or effusion
G. Medication use
II. Long-term clinical outcomes
A. Any of the short-term clinical
outcomes
B. Instrumental activities of daily
living (IADLs)
C. Quality of life (e.g., SF–36,
EuroQuol EQ–5D, Arthritis SelfEfficacy scale, global assessment,
patient satisfaction)
D. Surgery (i.e., rate of undergoing
knee replacement)
III. Adverse effects of intervention(s)
IV. Outcome reporting
A. Only studies that report outcomes
for knee OA alone
B. Mean differences at followup or
percent of responders at followup
will be abstracted
Timing
Minimum 1 month follow-up from
initiation of treatment
Settings
Any setting
Andrew B. Bindman,
AHRQ Director.
[FR Doc. 2016–16632 Filed 7–13–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institute for Occupational
Safety and Health (NIOSH), Safety and
Occupational Health Study Section:
Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Safety
and Occupational Health Study Section,
Centers for Disease Control and
Prevention, Department of Health and
Human Services, has been renewed for
a 2-year period through June 30, 2018.
For more information contact: JoAnne
Fairbanks, Executive Secretary, Safety
and Occupational Health Study Section,
Department of Health and Human
Services, 1600 Clifton Road NE.,
Mailstop E74, Atlanta, Georgia 30333,
telephone 304/285–6143 or fax 304/
285–6147.
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.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–16583 Filed 7–13–16; 8:45 am]
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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
(ABRWH or Advisory Board)
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:
Times and Dates: 8:15 a.m.–5:00 p.m.,
Mountain Time, August 9, 2016; 8:15
a.m.–1:00 p.m., Mountain Time, August
10, 2016.
Public Comment Time and Date: 5:00
p.m.–6:00 p.m.*, Mountain Time,
August 9, 2016.
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Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
* Please note that the public comment
period may end before the time
indicated, following the last call for
comments. Members of the public who
wish to provide public comments
should plan to attend the public
comment session at the start time listed.
Place: Residence Inn by Marriott, 635
West Broadway, Idaho Falls, Idaho
83402; Phone: (208) 542–0000; Fax:
(208) 542–0021.
Status: Open to the public, limited
only by the space available. The meeting
space accommodates approximately 100
people. The public is also welcome to
listen to the meeting by joining the
teleconference at USA toll-free, dial-in
number, 1–866–659–0537 and the pass
code is 9933701.
Live Meeting Connection: https://
www.livemeeting.com/cc/cdc/join?id=
M3QDP7&role=attend&pw=ABRWH;
Meeting ID: M3QDP; Entry Code:
ABRWH.
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, rechartered on March 22, 2016
pursuant to Executive Order 13708, and
will expire on September 30, 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
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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 Advisory Board meeting includes:
NIOSH Program Update; Department of
Labor Program Update; Department of
Energy Program Update; Report by the
Dose Reconstruction Review Methods
Work Group; Dose Reconstruction
Report to the Secretary; SEC Petitions
Update; Site Profile review for: Pinellas
Plant (Clearwater, Florida), and United
Nuclear Co. (Hematite, Missouri); SEC
petitions for: Area IV of Santa Susana
Field Laboratory (1965; Ventura County,
California), Argonne National
Laboratory West (1951–1979; Scoville,
Idaho), Blockson Chemical Company
(1960–1991; Joliet, Illinois), Idaho
National Laboratory (1949–1970;
Scoville, Idaho), Savannah River Site
(1973–2007; Aiken, South Carolina),
and Westinghouse Electric Co. (1960–
2011; Bloomfield, New Jersey); and a
Board Work Session.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot
attend, written comments may be
submitted to the contact person below
well in advance of the meeting. Any
written comments received will be
provided at the meeting in accordance
with the redaction policy provided
below.
Policy on Redaction of Board Meeting
Transcripts (Public Comment):
(1) If a person making a comment
gives his or her personal information, no
attempt will be made to redact the
name; however, NIOSH will redact
other personally identifiable
information, such as contact
information, social security numbers,
case numbers, etc., of the commenter.
(2) If an individual in making a
statement reveals personal information
(e.g., medical or employment
information) about themselves that
information will not usually be
redacted. The NIOSH Freedom of
Information Act (FOIA) coordinator
will, however, review such revelations
in accordance with the Federal
Advisory Committee Act and if deemed
appropriate, will redact such
information.
(3) If a commenter reveals personal
information concerning a living third
party, that information will be reviewed
by the NIOSH FOIA coordinator, and
upon determination, if deemed
appropriate, such information will be
redacted, unless the disclosure is made
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45505
by the third party’s authorized
representative under the Energy
Employees Occupational Illness
Compensation Program Act (EEOICPA)
program.
(4) In general, information concerning
a deceased third party may be disclosed;
however, such information will be
redacted if (a) the disclosure is made by
an individual other than the survivor
claimant, a parent, spouse, or child, or
the authorized representative of the
deceased third party; (b) if it is unclear
whether the third party is living or
deceased; or (c) the information is
unrelated or irrelevant to the purpose of
the disclosure.
The Board will take reasonable steps
to ensure that individuals making
public comment are aware of the fact
that their comments (including their
name, if provided) will appear in a
transcript of the meeting posted on a
public Web site. Such reasonable steps
include: (a) A statement read at the start
of each public comment period stating
that transcripts will be posted and
names of speakers will not be redacted;
(b) A printed copy of the statement
mentioned in (a) above will be
displayed on the table where
individuals sign up to make public
comments; (c) A statement such as
outlined in (a) above will also appear
with the agenda for a Board Meeting
when it is posted on the NIOSH Web
site; (d) A statement such as in (a) above
will appear in the Federal Register
Notice that announces Board and
Subcommittee meetings.
Contact Person for More Information:
Theodore Katz, Designated Federal
Officer, NIOSH, CDC, 1600 Clifton Road
NE., MS E–20, Atlanta, Georgia 30333,
telephone: (513) 533–6800, toll free: 1–
800–CDC–INFO, email: dcas@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.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–16579 Filed 7–13–16; 8:45 am]
BILLING CODE 4163–18–P
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]]>Agencies
[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45504-45505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16579]
-----------------------------------------------------------------------
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 (ABRWH or Advisory Board)
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:
Times and Dates: 8:15 a.m.-5:00 p.m., Mountain Time, August 9,
2016; 8:15 a.m.-1:00 p.m., Mountain Time, August 10, 2016.
Public Comment Time and Date: 5:00 p.m.-6:00 p.m.*, Mountain Time,
August 9, 2016.
[[Page 45505]]
* Please note that the public comment period may end before the
time indicated, following the last call for comments. Members of the
public who wish to provide public comments should plan to attend the
public comment session at the start time listed.
Place: Residence Inn by Marriott, 635 West Broadway, Idaho Falls,
Idaho 83402; Phone: (208) 542-0000; Fax: (208) 542-0021.
Status: Open to the public, limited only by the space available.
The meeting space accommodates approximately 100 people. The public is
also welcome to listen to the meeting by joining the teleconference at
USA toll-free, dial-in number, 1-866-659-0537 and the pass code is
9933701.
Live Meeting Connection: https://www.livemeeting.com/cc/cdc/join?id=M3QDP7&role=attend&pw=ABRWH; Meeting ID: M3QDP; Entry Code:
ABRWH.
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, rechartered on March 22, 2016
pursuant to Executive Order 13708, and will expire on September 30,
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 Advisory Board meeting
includes: NIOSH Program Update; Department of Labor Program Update;
Department of Energy Program Update; Report by the Dose Reconstruction
Review Methods Work Group; Dose Reconstruction Report to the Secretary;
SEC Petitions Update; Site Profile review for: Pinellas Plant
(Clearwater, Florida), and United Nuclear Co. (Hematite, Missouri); SEC
petitions for: Area IV of Santa Susana Field Laboratory (1965; Ventura
County, California), Argonne National Laboratory West (1951-1979;
Scoville, Idaho), Blockson Chemical Company (1960-1991; Joliet,
Illinois), Idaho National Laboratory (1949-1970; Scoville, Idaho),
Savannah River Site (1973-2007; Aiken, South Carolina), and
Westinghouse Electric Co. (1960-2011; Bloomfield, New Jersey); and a
Board Work Session.
The agenda is subject to change as priorities dictate.
In the event an individual cannot attend, written comments may be
submitted to the contact person below well in advance of the meeting.
Any written comments received will be provided at the meeting in
accordance with the redaction policy provided below.
Policy on Redaction of Board Meeting Transcripts (Public Comment):
(1) If a person making a comment gives his or her personal
information, no attempt will be made to redact the name; however, NIOSH
will redact other personally identifiable information, such as contact
information, social security numbers, case numbers, etc., of the
commenter.
(2) If an individual in making a statement reveals personal
information (e.g., medical or employment information) about themselves
that information will not usually be redacted. The NIOSH Freedom of
Information Act (FOIA) coordinator will, however, review such
revelations in accordance with the Federal Advisory Committee Act and
if deemed appropriate, will redact such information.
(3) If a commenter reveals personal information concerning a living
third party, that information will be reviewed by the NIOSH FOIA
coordinator, and upon determination, if deemed appropriate, such
information will be redacted, unless the disclosure is made by the
third party's authorized representative under the Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) program.
(4) In general, information concerning a deceased third party may
be disclosed; however, such information will be redacted if (a) the
disclosure is made by an individual other than the survivor claimant, a
parent, spouse, or child, or the authorized representative of the
deceased third party; (b) if it is unclear whether the third party is
living or deceased; or (c) the information is unrelated or irrelevant
to the purpose of the disclosure.
The Board will take reasonable steps to ensure that individuals
making public comment are aware of the fact that their comments
(including their name, if provided) will appear in a transcript of the
meeting posted on a public Web site. Such reasonable steps include: (a)
A statement read at the start of each public comment period stating
that transcripts will be posted and names of speakers will not be
redacted; (b) A printed copy of the statement mentioned in (a) above
will be displayed on the table where individuals sign up to make public
comments; (c) A statement such as outlined in (a) above will also
appear with the agenda for a Board Meeting when it is posted on the
NIOSH Web site; (d) A statement such as in (a) above will appear in the
Federal Register Notice that announces Board and Subcommittee meetings.
Contact Person for More Information: Theodore Katz, Designated
Federal Officer, NIOSH, CDC, 1600 Clifton Road NE., MS E-20, Atlanta,
Georgia 30333, telephone: (513) 533-6800, toll free: 1-800-CDC-INFO,
email: dcas@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.
Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 2016-16579 Filed 7-13-16; 8:45 am]
BILLING CODE 4163-18-P
