Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 24751 [2013-09874]
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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
VerDate Mar<15>2010
14:46 Apr 25, 2013
Jkt 229001
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.
BILLING CODE 4160–90–M
PO 00000
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
BILLING CODE 4163–18–P
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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[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Page 24751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09874]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
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]
BILLING CODE 4163-18-P
