60 day FRN

3598

Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices
otolaryngology clinics, dermatology
clinics, pediatric surgical unit)

Newborns, infants, and children up to
18 years of age with known or suspected
infantile hemangiomas.

• Antiangiogenic agents
KQ4 Surgical interventions
Laser treatment
• Pulsed dye
• Fractionated laser
• Argon
• Carbon dioxide
• Neodymium (Nd): Yttrium
Aluminium Garnet YAG
• Erbium
Surgical treatment
• Cryotherapy
• Resection
• Embolization
• Radiofrequency ablation therapy

Intervention(s)

Comparator

[60Day–15–15LB]

Diagnostic imaging:
• Magnetic resonance imaging
• Computed tomography
• Magnetic resonance angiography
• Echocardiography
• Ultrasonography
• Endoscopy

KQ2, 3
• No treatment
• Other pharmacologic interventions
• Observation
• Complementary and alternative
medicine (CAM) (e.g., massage,
compression therapy, essential oils)
KQ4
• No treatment
• Other laser or surgical interventions
• Observation
• CAM (e.g., massage, compression
therapy, essential oils)

Proposed Data Collections Submitted
for Public Comment and
Recommendations

referred for surgical intervention, what
is the comparative effectiveness
(benefits/harms) of various types of
surgical interventions (including laser
and resection)?
PICOTS (Population, Intervention,
Comparator, Outcomes, Timing,
Setting)
KQ 1
Population

Comparator
• Other workup evaluation approaches
for treatment planning
• Other imaging modalities
Outcomes
• Ability to identify presence, number,
and extent of hemangiomas and
associated structural anomalies
(sensitivity and specificity)
• Harms including, but not limited to,
effects of sedation or imaging dye
Timing
• Immediate and short-term (≤3
months)
• Long-term (>3 months)
Setting
Inpatient and outpatient settings (e.g.,
pediatric radiology clinic,
otolaryngology clinics, dermatology
clinics, pediatric surgical unit)
KQs 2, 3, and 4
Population
Newborns, infants, and children up to
18 years of age with infantile
hemangiomas.

tkelley on DSK3SPTVN1PROD with NOTICES

Intervention(s)
KQ2 Pharmacologic interventions
• Systemic (e.g., propranolol) or topical
(e.g., timolol) beta-blockers
• Corticosteroids (topical, intralesional,
or systemic)
KQ3 Pharmacologic interventions
• Immunosuppressants (e.g., sirolimus)
• Immunomodulators (e.g., imiquimod,
interferon)
• Antineoplastics (e.g., intralesional
bleomycin, intravenous vincristine)
• Angiotensin-converting enzyme
inhibitors

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Outcomes
Intermediate outcomes (KQ2, 3, 4)
• Size/volume of hemangioma
• Impact on vision
• Aesthetic appearance as assessed by
clinician or parent
• Degree of ulceration
• Harms
• Quality of life
Final outcomes (KQ2, 3, 4)
• Marked improvement of
hemangiomas
• Prevention of disfigurement
• Resolution of airway obstruction
• Preservation of vision
• Preservation of organ function (e.g.,
thyroid function, cardiac function)
• Resolution of ulceration
• Psychological impact on the patient
• Harms including: pain, bleeding,
sequelae of scarring, skin atrophy,
venous prominence, disfigurement,
distortion of anatomic landmarks,
ulceration, infection,
hypopigmentation
Timing
KQ2, 3
• Immediate and short-term (≤2 years
of age)
• Long-term (>2 years of age)
KQ4
• Immediate and short-term (≤3
months)
• Long-term (>3 months)
Setting
Inpatient and outpatient settings (e.g.,
pediatric radiology clinic,

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Dated: December 30, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015–00766 Filed 1–22–15; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on:
(a) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology

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Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.

tkelley on DSK3SPTVN1PROD with NOTICES

Proposed Project
Enhancing Dialogue and Execution of
Dust Reduction Behaviors through
Workgroup Communication—New—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
NIOSH, under Public Law 91–596,
Sections 20 and 22 (Section 20–22,
Occupational Safety and Health Act of
1977) has the responsibility to conduct
research relating to innovative methods,
techniques, and approaches dealing
with occupational safety and health
problems.
This project focuses on mineworkers’
overexposure to respirable coal dust and
how using the Continuous Personal
Dust Monitor (CPDM), as an educational
tool, can help provide information to
mineworkers and their respective
workgroups, about ways to reduce
respirable coal dust exposure in their
work environment. NIOSH proposes a 3
year approval for a project that seeks to
understand what group communication
practices are important for mine worker
H&S and how those practices can be
developed, implemented, and
maintained over time. The following
questions guide this study:
What impact does a communication/
technology intervention model that was
designed and implemented have on:
(1) Workers’ health/safety behaviors,
including those that lower exposure to
dust; and (2) workers’ perceptions of
their organizations’ health and safety
values?
To answer the above questions,
NIOSH researchers developed an
intervention that focuses on workers’
communication about and subsequent
actions taken to reduce respirable dust
exposure over time, using information
provided by their Continuous Personal
Dust Monitor (CPDM). The intervention
will inform how workgroups
communicate with each other about
health and how this communication
impacts individual behavior such as
corrective dust actions taken by
workers.

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Coal Workers’ Pneumoconiosis (CWP)
or ‘‘Black Lung Disease’’ is caused by
miners’ exposure to respirable coal mine
dust and is the leading cause of death
due to occupational illness among US
coal miners—making this an issue
worth placing emphasis in mine health
research. X-rays provided from the US
National Coal Workers’ X-ray
Surveillance Program show that new
cases of CWP are occurring among
miners who have worked exclusively
under previous respirable coal mine
dust exposure limits. Previously, federal
law stated that respirable coal dust
levels must not exceed 2 mg/m3 for any
work shift [Code of Federal
Regulations]. However, under the new
respirable dust rule that passed May 1,
2014 (CFR part 70), the dust level may
not exceed 1.5 mg/m3. The new rule
also requires mine operators to use
CPDMs by February 1, 2016, for
designated occupations (DO). Although
CPDMs provide miners with near realtime feedback about their level of
respirable coal dust exposure, they do
not ensure that miners will use the
information to reduce their level of
exposure. Previous research indicates
that the use of information technology
can enhance lateral and horizontal
communication within organizations,
showing support for using the CPDM in
the current study (Hinds & Kiesler,
1995).
The intervention is designed to
involve workers in the interpretation of
CPDM feedback and discuss, with their
coworkers/workgroups, potential
changes to work practices that can
decrease exposure to respirable coal
mine dust. Data is collected during three
time points throughout a six-week
intervention to assess the ongoing
communication using CPDM feedback
and effects of the workgroup
communication on behavior. Data
collection and analysis will occur via a
pre/post survey with workers and focus
groups with workers and mine site
leaders. Safety circles are used to
communicate and encourage specific
behavior changes. A typical circle
includes a facilitator or leader (who
directs the meetings), 7–10 members,
and one-hour weekly meetings that take
place during the workday. During the
meetings, members review data relevant
to the problem and brainstorm possible
solutions. Industries have successfully
used ‘‘safety circles’’ to generate lists of
safety concerns that circle members
would like to analyze and solve.
Edwards [1983] documented that one
surface coal mine was able to decrease
the number of accidents on circle
members’ shifts by 27%. If underground

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3599

coal miners are able to actively
participate in the discussion of
respirable coal mine dust exposure
levels and what can be done to limit
future exposure, they may be more
inclined to behave in ways that limit
their exposure.
With the stricter regulations that just
passed the opportunity to proactively
improve communication around the
CPDM and identify appropriate
corrective actions, as required by the
Mine Health and Safety Administration,
is favorable. NIOSH proposes this
intervention design at three coal mine
sites. Coal mine sites will be recruited
who have inquired interest in learning
how to improve utility of the CPDM on
their site and/or interest in improving
their employees’ communication efforts.
Only a small sample of workers will
participate at each mine site because of
the time required for completion and to
ensure the longitudinal data can be
adequately collected over the six weeks.
In other words, we would rather collect
data multiple times with the same
worker and have fewer participants than
collect data from more workers but not
have the ability to appropriately followup during the subsequent two visits.
Data collection will take place with
no more than 150 mine workers and
nine mine site leaders over three years.
The respondents targeted for this study
include any active mine worker and any
active site leader at a coal mine site. It
is estimated that a sample of up to 150
mine workers will participate, which
includes participating in three focus
groups (in the form of workgroup
meetings) that will take approximately
60 minutes. The focus groups will
debrief general CPDM data so
participants can dialogue about ways to
lower their exposure levels. In addition,
workers will be asked to complete a pre
and post-test survey (∼15 minutes). It
also is estimated that a sample of up to
nine mine site leaders will participate in
the form of interviews/focus groups
about HSMS practices at the same
mining operations which have agreed to
participate. The interviews/focus groups
also will occur three times during each
of the NIOSH field visits and will take
no more than 30 minutes each.
All participants will be between the
ages of 18 and 75, currently employed,
and living in the United States.
Participation will require no more than
3.5 hours of workers’ time over the sixweek intervention and no more than 1.5
hours of site leaders’ time over the sixweek intervention period.
There is no cost to respondents other
than their time.

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3600

Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
hours

Form name

Mine Site Leaders/Managers.

Mine Recruitment Script ......................................

3

1

5/60

1

Initial/Mid/Post HSMS interview or focus group ..
Individual Miner Recruitment Script ....................
Pre/Post Org Perceptions Survey .......................
Pre/Mid/Post Behavior Focus Groups .................

3
50
50
50

3
1
2
3

30/60
5/60
15/60
1

5
4
25
150

..............................................................................

........................

........................

........................

185

Mine Worker ..................

Total ........................

Leroy A. 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. 2015–01094 Filed 1–22–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15ZK]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

tkelley on DSK3SPTVN1PROD with NOTICES

Number of
responses
per
respondent

Number of
respondents

Type of respondent

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the

VerDate Sep<11>2014

18:05 Jan 22, 2015

Jkt 235001

information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Research on the Efficacy and
Feasibility of Essentials for Parenting
Toddlers and Preschoolers—New—
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
It is estimated that 1 in 58 U.S.
children had been maltreated in a 1-year
period (i.e., victims of physical, sexual,
and emotional abuse or neglect). Parent
training is arguably the single most
effective prevention initiative
recognized to date. The Centers for
Disease Control and Prevention has
developed ‘‘Essentials for Parenting
Toddlers and Preschoolers’’ (EFP). This
web-based resource uses a
psychoeducational approach
incorporating modeling (through its
videos) and practice (through its

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activities). Thus, EFP is likely to
improve parenting (e.g., discipline
practices), reduce child behavior
problems, and may ultimately reduce
child maltreatment. Moreover, it is free
for parents and can be accessed through
any device that can use the Internet,
including computers, tablets, and smart
phones. If it proves to be effective, it
may ultimately be less expensive to
develop, evaluate, and disseminate EFP.
CDC is proposing an information
collection to OMB for a period of one
year. The purpose of this data collection
request is to determine whether a webbased platform for delivery of positive
parenting information yields changes in
parent and child behaviors that are
consistent with those observed in the
clinic setting. If EFP is successful at
increasing positive parenting and safe,
stable, nurturing relationships and
environments for children, then CDC
has a resource that can be easily and
freely disseminated to communities that
can potentially impact rates of child
maltreatment.
We will conduct a two-arm study of
200 parents of 2- to 4-year-old children.
In one arm, parents will be guided in
how and when they use specific
intervention modules. In the other arm,
parents will have access to the same
EFP content but will use as much or as
little of the intervention as they wish
and on whatever time line they wish.
Parents in both arms will complete
assessments of child externalizing
behavior, parenting behaviors (e.g., use
of praise and time outs), parenting
thoughts (e.g., perceived parenting
competence and burden), and parent
psychological adjustment (e.g.,
depression and anxiety), as well as
knowledge and perceived usefulness of
EFP intervention content. The impact of
this data collection on participants’
privacy is low.
The survey data will be housed in a
database on encrypted, password
protected electronic storage files. All
information shared will be in an
aggregate form for the scientific

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