Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute), 24751-24752 [2013-09873]
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Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
original report, we presented them for
discussion with a newly convened TEP
for this update and made changes as
necessary. This update will summarize
the more recent evidence comparing the
relative effectiveness and safety of
treatment options for clinically
localized prostate cancer. The key
questions we will address are as
follows:
Key Question 1
What are the comparative risks and
benefits of the following therapies for
clinically localized prostate cancer?
a. Radical prostatectomy, including
open (retropubic and perineal) and
laparoscopic (with or without robotic
assistance) approaches.
b. External Beam Radiotherapy,
including standard therapy and
therapies designed to decrease exposure
to normal tissues such as 3D conformal
radiation therapy, intensity-modulated
radiation therapy, proton beam therapy,
and stereotactic body radiation therapy.
c. Interstitial brachytherapy.
d. Cryosurgery.
e. Watchful waiting.
f. Active surveillance.
g. Hormonal therapy as primary
therapy, adjuvant, or neoadjuvant to
other therapies.
h. High-intensity focused ultrasound.
Key Question 2
How do specific patient
characteristics (e.g., age, race/ethnicity,
presence or absence of comorbid illness,
preferences such as trade-off of
treatment-related adverse effects vs.
potential for disease progression) affect
the outcomes of these therapies overall
and differentially?
Key Question 3
How do provider/hospital
characteristics affect outcomes of these
therapies overall and differentially (e.g.,
geographic region, case volume,
learning curve)?
Key Question 4
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How do tumor characteristics (e.g.,
Gleason score, tumor volume, screendetected vs. clinically detected tumors,
and PSA levels) affect the outcomes of
these therapies overall and
differentially?
Population, Interventions,
Comparators, Outcomes, Timing,
Settings Criteria Population
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were enrolled and outcomes were not
stratified by stage.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Interventions
Centers for Disease Control and
Prevention
• For Key Questions 1, 2, 3, and 4, we
will include treatment options for men
with clinically localized prostate cancer:
radical prostatectomy (including
retropubic, perineal, laparoscopic,
robotic-assisted), watchful waiting,
active surveillance, External Beam
Radiotherapy (including conventional
radiation, Intensity Modulated
Radiotherapy, 3D conformal radiation,
proton beam, and stereotactic body
radiation therapy), brachytherapy,
androgen deprivation therapy, highintensity focused ultrasound, and
cryotherapy.
Comparators
• Any of the interventions of interest
above or watchful waiting.
Outcomes
• The primary outcome is overall
mortality or survival. Additional
outcomes include prostate-cancerspecific mortality or survival,
biochemical (PSA) progression,
metastatic and/or clinical progressionfree survival, health status, and quality
of life. We will focus primarily on
common and severe adverse events of
treatment including bowel, bladder, and
sexual dysfunction, as well as harms
from biopsy such as bleeding and
nosocomial infections.
• For Key Question 3, we plan to
examine outcomes after radical
prostatectomy, the most common
treatment for localized prostate cancer,
in association with provider location,
case volume, and affiliation with
academic centers.
Timing
• Duration of follow-up will be
appropriate for the outcome under
consideration.
• No restrictions by setting.
The meeting announced below
concerns Continuing Prospective Birth
Cohort Study Involving Environmental
Uranium Exposure in the Navajo
Nation, Funding Opportunity
Announcement (FOA) TS13–001, Initial
Review.
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 aforementioned SEP:
Time and Date: 12:00 p.m.–3:30 p.m., June
13, 2013 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Continuing Prospective Birth
Cohort Study Involving Environmental
Uranium Exposure in the Navajo Nation,
FOA TS13–001.’’
Contact Person for More Information: Jane
Suen, Dr.P.H, M.S., M.P.H., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F63, Atlanta, Georgia 30341,
Telephone: (770) 488–4281.
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. 2013–09874 Filed 4–25–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 15, 2013.
Carolyn M. Clancy,
AHRQ, Director.
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Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
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Settings
[FR Doc. 2013–09739 Filed 4–25–13; 8:45 am]
• Key Questions 1, 2, 3, and 4: Men
considered to have clinically localized
prostate cancer (T1 to T2, N0 to X, M0
to X) regardless of age, histologic grade,
or PSA level. Articles will be excluded
if men with disease stage higher than T2
24751
Centers for Disease Control and
Prevention
Safety and Occupational Health Study
Section (SOHSS), National Institute for
Occupational Safety and Health
(NIOSH or Institute)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
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24752
Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
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Times and Dates:
8:00 a.m.–5:00 p.m., June 13, 2013 (Closed)
8:00 a.m.–5:00 p.m., June 14, 2013 (Closed)
Place: Embassy Suites, 1900 Diagonal
Road, Alexandria, Virginia 22314,
Telephone: (703) 684–5900, Fax: (703) 684–
0653.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Purpose: The Safety and Occupational
Health Study Section will review, discuss,
and evaluate grant application(s) received in
response to the Institute’s standard grants
review and funding cycles pertaining to
research issues in occupational safety and
health, and allied areas.
It is the intent of NIOSH to support broadbased research endeavors in keeping with the
Institute’s program goals. This will lead to
improved understanding and appreciation for
the magnitude of the aggregate health burden
associated with occupational injuries and
illnesses, as well as to support more focused
research projects, which will lead to
improvements in the delivery of occupational
safety and health services, and the
prevention of work-related injury and illness.
It is anticipated that research funded will
promote these program goals.
Matters To Be Discussed: The meeting will
convene to address matters related to the
conduct of Study Section business and for
the study section to consider safety and
occupational health-related grant
applications. These portions of the meeting
will be closed to the public in accordance
with provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and the
Determination of the Director, Management
Analysis and Services Office, Centers for
Disease Control and Prevention, pursuant to
Section 10(d) Public Law 92–463.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Price
Connor, Ph.D., NIOSH Health Scientist, CDC,
2400 Executive Parkway, Mailstop E–20,
Atlanta, Georgia 30345, Telephone: (404)
498–2511, Fax: (404) 498–2571.
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. 2013–09873 Filed 4–25–13; 8:45 am]
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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 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), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting for the
aforementioned subcommittee:
Time and Date: 9:00 a.m.–5:00 p.m.
Eastern Time, May 21, 2013.
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 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, 2013.
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
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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: dose
reconstruction program quality management
and assurance activities, including: current
findings from NIOSH internal dose
reconstruction blind reviews; and discussion
of dose reconstruction cases under review
(sets 8–9, and Savannah River Site, Rocky
Flats Plant, and Los Alamos National
Laboratory cases from sets 10–13).
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 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
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. 2013–09877 Filed 4–25–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–685, CMS–
10436, CMS–10452, CMS–10180 and CMS–
R–199]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
AGENCY:
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Agencies
[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24751-24752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09873]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Safety and Occupational Health Study Section (SOHSS), National
Institute for Occupational Safety and Health (NIOSH or Institute)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act
[[Page 24752]]
(Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC)
announces the following meeting of the aforementioned committee:
Times and Dates:
8:00 a.m.-5:00 p.m., June 13, 2013 (Closed)
8:00 a.m.-5:00 p.m., June 14, 2013 (Closed)
Place: Embassy Suites, 1900 Diagonal Road, Alexandria, Virginia
22314, Telephone: (703) 684-5900, Fax: (703) 684-0653.
Status: The meeting will be closed to the public in accordance
with provisions set forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Purpose: The Safety and Occupational Health Study Section will
review, discuss, and evaluate grant application(s) received in
response to the Institute's standard grants review and funding
cycles pertaining to research issues in occupational safety and
health, and allied areas.
It is the intent of NIOSH to support broad-based research
endeavors in keeping with the Institute's program goals. This will
lead to improved understanding and appreciation for the magnitude of
the aggregate health burden associated with occupational injuries
and illnesses, as well as to support more focused research projects,
which will lead to improvements in the delivery of occupational
safety and health services, and the prevention of work-related
injury and illness. It is anticipated that research funded will
promote these program goals.
Matters To Be Discussed: The meeting will convene to address
matters related to the conduct of Study Section business and for the
study section to consider safety and occupational health-related
grant applications. These portions of the meeting will be closed to
the public in accordance with provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the
Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention, pursuant to Section 10(d) Public Law
92-463.
Agenda items are subject to change as priorities dictate.
Contact Person for More Information: Price Connor, Ph.D., NIOSH
Health Scientist, CDC, 2400 Executive Parkway, Mailstop E-20,
Atlanta, Georgia 30345, Telephone: (404) 498-2511, Fax: (404) 498-
2571.
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. 2013-09873 Filed 4-25-13; 8:45 am]
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