Agency Forms Undergoing Paperwork Reduction Act Review, 14047-14048 [2014-05273]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices
Key Question 2
What is the comparative effectiveness
of 3DRT, IMRT, SBRT, and PBRT
regarding tumor control and patient
survival?
Key Question 3
Are there differences in comparative
effectiveness of 3DRT, IMRT, SBRT, and
PBRT for specific patient and tumor
characteristics?
Key Question 4
Is there variation in comparative
effectiveness of 3DRT, IMRT, SBRT, and
PBRT because of differences in user
experience, treatment planning,
treatment delivery, and target volume
delineation?
PICOTS (Population, Intervention,
Comparator(s), Outcomes, Timing,
Setting)
Identify for each key question:
tkelley on DSK3SPTVN1PROD with NOTICES
Population(s)
KQs 1–4: Populations of interest
include patients with head and neck
cancer. To define what constitutes head
and neck cancer, we consulted clinical
resources such as the National Cancer
Institute’s Physician Data Query (PDQ)
Cancer Information Summary and the
National Comprehensive Cancer
Network. The consensus definition of
head and neck cancer includes tumors
of:
1. larynx
2. pharynx (hypopharynx, oropharyx
and nasopharynx)
3. lip and oral cavity
4. paranasal sinus and nasal cavity
5. salivary gland
6. occult primary of the head and neck
The following tumors are excluded:
1. brain tumors
2. skull base tumors
3. uveal/choroidal melanoma, other
ocular and eyelid tumors
4. otologic tumors
5. cutaneous tumors of the head and
neck (including melanoma)
6. thyroid cancer
7. parathyroid cancer
8. esophageal cancer
9. trachea tumors
All therapeutic strategies will be
included. Radiotherapy (RT) can be
delivered as primary (curative) intent
therapy or as an adjunct to surgery.
Chemotherapy can also be given as an
adjunct to radiation therapy,
particularly in patients with more
advanced cancer (i.e., stages III or IV).
We will seek direct evidence for one
intervention compared to another, with
or without chemotherapy or surgery.
VerDate Mar<15>2010
17:51 Mar 11, 2014
Jkt 232001
Interventions
The primary interventions of interest
in all therapeutic settings are:
1. 3 dimensional conformal
radiotherapy (3DRT): Defined as
any treatment plan where CT-based
forward treatment planning is used
to delineate radiation beams and
target volumes in three dimensions
2. intensity modulated radiotherapy
(IMRT): Defined as any treatment
plan where intensity-modulated
radiation beams and computerized
inverse treatment planning is used
3. stereotactic body radiation therapy
(SBRT): Defined as conformal RT
(forward or reverse-planned)
delivered in 3 to 5 relatively larger
doses of ionizing radiation than
typically delivered in a standard
conformal schedule of 25–35 doses
4. proton beam radiotherapy (PBRT):
Defined as any treatment plan
where proton beam radiation is
used
Interventions may occur as part of a
multimodal treatment strategy if the
comparisons only differ with respect to
the radiation therapy given.
Comparators
All therapies will be compared to
each other as part of a continuum of
treatment for patients with head and
neck cancer. Thus, we will include
studies in which a RT method was
compared to a different method, for
example with or without chemotherapy
or surgery. We will include all studies
from which we can be reasonably
certain additional treatments are
contemporary and similar, leaving the
major comparison that between RT
modalities; those that we cannot
ascertain from the publication will be
excluded. To ensure chemotherapy or
other treatments are similar and
contemporary, we will consult accepted
guidelines such as those from the
National Comprehensive Cancer
Network (NCCN) or National Cancer
Institute (NCI). We will not extract
details on chemotherapy dosages or
schedules, but rather will ascertain their
degree of general similarity and the
proportions of patients who receive and
complete such regimens. We will
categorize and synthesize evidence
according to overall treatment, for
example concurrent chemoradiotherapy,
or adjuvant radiotherapy, not mixing
these in the strength of evidence
synthesis.
Outcomes
KQ 1, 3 & 4:
1. Final outcomes: quality of life
(QoL) and adverse events including;
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
14047
radiation induced toxicities, xerostomia,
mucositis, taste changes, dental
problems, and dysphagia.
2. Intermediate outcomes: Salivary
flow, probability of completing
treatment according to protocol.
We will search for evidence related to
user experience, treatment planning,
and target volume delineation within
the context of KQ4. In the absence of an
evidence-base on these measures, these
issues will be addressed as appropriate
in both the future research needs and
discussion sections of the report.
Based on input received from the
TEP, any outcomes not adequately
addressed in the literature will be stated
as evidence gaps for primary research in
the future research needs section of the
report.
KQ 2, 3 & 4:
1. Final outcomes: Overall survival
and cancer specific survival.
2. Intermediate outcomes: Local
control, and time to recurrence.
Timing
All durations of follow-up will be
considered.
Settings
Inpatient and outpatient.
Dated: March 6, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–05389 Filed 3–11–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day 14–0787]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Personal Flotation Devices (PFDs) and
Commercial Fishermen: Preconceptions
and Evaluation in Actual Use—
Reinstatement with Change (0920–0787,
E:\FR\FM\12MRN1.SGM
12MRN1
14048
Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices
expiration date 8/31/2010)—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
NIOSH has the responsibility under
Public Law 91–596 section 20
(Occupational Safety and Health Act of
1970) to conduct research relating to
innovative methods, techniques, and
approaches for dealing with
occupational safety and health
problems.
Commercial fishing is one of the most
dangerous occupations in the United
States, with a fatality rate 30 times
higher than the national average. Most
fishermen who die on the job drown
subsequent to a vessel sinking (52%) or
fall overboard (31%). Because drowning
is the leading cause of death for
commercial fishermen, its prevention is
one of the highest priorities for those
who work to make the industry safer.
The risk of drowning for commercial
fisherman is high, yet most fishermen
do not wear Personal Flotation Devices
(PFDs) while on deck. Of the 182
fishermen who died from falls
overboard between 2000 and 2011 none
operating in Alaska fisheries. This
questionnaire will contain questions
that measure fishermen’s risk
perceptions, safety attitudes, and beliefs
about PFDs, as well as recognition and
influence of NIOSH risk communication
activities. The questionnaire will take
approximately 20 minutes to complete.
Consistent with the previous OMBapproved data collection protocol, the
sample size was determined to be 400
total respondents to achieve a 95%
confidence level. Two hundred
independent respondents will be
sampled just prior to the 2014 season
and an additional two hundred will be
sampled just prior to the 2015 season.
This study has the potential to greatly
benefit the fishing industry. As a result
of previous research, NIOSH has gained
a baseline understanding of fishermen’s
reasons for not wearing PFDs. With this
empirical data at hand, an intensive risk
communication intervention has been
developed to address fishermen’s
concerns and remove the barriers that
are currently in place.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are 134.
of them were wearing a personal
flotation device (PFD). Many were
within minutes of being rescued when
they lost their strength and disappeared
under the surface of the water.
NIOSH recently conducted a study to
establish a baseline understanding of
Alaska fishermen’s perceptions of risk,
safety attitudes, and beliefs about PFDs;
and to evaluate a variety of modern
PFDs with commercial fishermen to
discover the features and qualities that
they like and dislike. Based upon these
results, NIOSH developed an intensive
risk communication strategy to raise
awareness to newer (potentially more
satisfactory) PFD models, to address
barriers, and to encourage increased
PFD use among fishermen working in
Alaska.
The purpose of this study is to first,
determine if fishermen’s perception of
risk, safety attitudes, and beliefs about
PFDs has shifted or remained the same
since the implementation of the initial
survey (2008–2009); and second, to
evaluate the effectiveness of the NIOSH
intensive risk communication
intervention.
NIOSH is requesting OMB approval to
administer a survey to fishermen
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Fishermen .........................................
2014 Fishing Season: Fishing for
Facts: A survey of fishermen’s
opinions about the risk of falls
overboard and PFDs.
2015 Fishing Season: Fishing for
Facts: A survey of fishermen’s
opinions about the risk of falls
overboard and PFDs.
Fishermen .........................................
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–05273 Filed 3–11–14; 8:45 am]
BILLING CODE 4163–18–P
tkelley on DSK3SPTVN1PROD with NOTICES
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 Cooperative Research
VerDate Mar<15>2010
17:51 Mar 11, 2014
Jkt 232001
Frm 00072
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hrs)
Total
burden
(in hrs)
200
1
20/60
67
200
1
20/60
67
Agreements to the World Trade Center
Health Program (U01) PAR 12–126,
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 meeting:
Times and Dates:
8:00 a.m.–5:00 p.m., April 1, 2014
(Closed);
8:00 a.m.–12:00 p.m., April 2, 2014
(Closed).
Place: Atlanta Marriott Century
Center, 2000 Century Boulevard NE.,
Atlanta, Georgia 30345, Telephone (404)
325–0000.
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
PO 00000
Number of
responses per
respondent
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Cooperative Research Agreements
Related to the World Trade Center
Health Program (U01) PAR 12–126.’’
Contact Person for More Information:
Nina Turner, Ph.D., Scientific Review
Officer, CDC/NIOSH, 1095 Willowdale
Road, Mailstop G905, Morgantown,
West Virginia 26505, Telephone: (304)
285–5975.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14047-14048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day 14-0787]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Personal Flotation Devices (PFDs) and Commercial Fishermen:
Preconceptions and Evaluation in Actual Use--Reinstatement with Change
(0920-0787,
[[Page 14048]]
expiration date 8/31/2010)--National Institute for Occupational Safety
and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
NIOSH has the responsibility under Public Law 91-596 section 20
(Occupational Safety and Health Act of 1970) to conduct research
relating to innovative methods, techniques, and approaches for dealing
with occupational safety and health problems.
Commercial fishing is one of the most dangerous occupations in the
United States, with a fatality rate 30 times higher than the national
average. Most fishermen who die on the job drown subsequent to a vessel
sinking (52%) or fall overboard (31%). Because drowning is the leading
cause of death for commercial fishermen, its prevention is one of the
highest priorities for those who work to make the industry safer.
The risk of drowning for commercial fisherman is high, yet most
fishermen do not wear Personal Flotation Devices (PFDs) while on deck.
Of the 182 fishermen who died from falls overboard between 2000 and
2011 none of them were wearing a personal flotation device (PFD). Many
were within minutes of being rescued when they lost their strength and
disappeared under the surface of the water.
NIOSH recently conducted a study to establish a baseline
understanding of Alaska fishermen's perceptions of risk, safety
attitudes, and beliefs about PFDs; and to evaluate a variety of modern
PFDs with commercial fishermen to discover the features and qualities
that they like and dislike. Based upon these results, NIOSH developed
an intensive risk communication strategy to raise awareness to newer
(potentially more satisfactory) PFD models, to address barriers, and to
encourage increased PFD use among fishermen working in Alaska.
The purpose of this study is to first, determine if fishermen's
perception of risk, safety attitudes, and beliefs about PFDs has
shifted or remained the same since the implementation of the initial
survey (2008-2009); and second, to evaluate the effectiveness of the
NIOSH intensive risk communication intervention.
NIOSH is requesting OMB approval to administer a survey to
fishermen operating in Alaska fisheries. This questionnaire will
contain questions that measure fishermen's risk perceptions, safety
attitudes, and beliefs about PFDs, as well as recognition and influence
of NIOSH risk communication activities. The questionnaire will take
approximately 20 minutes to complete. Consistent with the previous OMB-
approved data collection protocol, the sample size was determined to be
400 total respondents to achieve a 95% confidence level. Two hundred
independent respondents will be sampled just prior to the 2014 season
and an additional two hundred will be sampled just prior to the 2015
season.
This study has the potential to greatly benefit the fishing
industry. As a result of previous research, NIOSH has gained a baseline
understanding of fishermen's reasons for not wearing PFDs. With this
empirical data at hand, an intensive risk communication intervention
has been developed to address fishermen's concerns and remove the
barriers that are currently in place.
There are no costs to respondents other than their time. The total
estimated annual burden hours are 134.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hrs) (in hrs)
----------------------------------------------------------------------------------------------------------------
Fishermen..................... 2014 Fishing 200 1 20/60 67
Season: Fishing
for Facts: A
survey of
fishermen's
opinions about
the risk of
falls overboard
and PFDs.
Fishermen..................... 2015 Fishing 200 1 20/60 67
Season: Fishing
for Facts: A
survey of
fishermen's
opinions about
the risk of
falls overboard
and PFDs.
----------------------------------------------------------------------------------------------------------------
Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-05273 Filed 3-11-14; 8:45 am]
BILLING CODE 4163-18-P
