Agency Forms Undergoing Paperwork Reduction Act Review, 49842-49843 [2022-17354]
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49842
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
Inclusion
Exclusion
Population .......................................
• Age 18 and above with symptomatic cervical degenerative disease (e.g., pain, radiculopathy, myelopathy) for all KQs except for KQ1, which includes asymptomatic patients.
Intervention ......................................
• Cervical spine surgery (e.g., discectomy, disc replacement, fusion, arthroplasty, laminectomy,
laminoplasty, corpectomy, cervical hybrid surgery,
foraminotomy).
• Non-surgical treatments (e.g., heat, exercise, acupuncture, drugs, radiofrequency ablation, steroid
injections, Botox® for neck pain, psychological
strategies [e.g., cognitive behavioral therapy], occupational therapy, multidisciplinary rehabilitation).
• Intraoperative neuromonitoring ..............................
• Imaging to identify symptomatic pseudarthrosis
after cervical fusion surgery.
• Preoperative MRI to predict neurologic recovery
in myelopathy.
• Any included intervention .......................................
• Placebo, waitlist, active control ..............................
• Pain, sensory function, motor function, gait, quality of life (e.g., VAS, NRS, NDI, SF–36, SF–12,
EQ–5Dm, mJOA score, Nurick score, MDI,
PROMIS–29, dysphagia scales, return to work).
• Fusion rate, reoperation rate .................................
• Harms (e.g., withdrawals due to adverse events,
serious adverse events, new symptomatic adjacent segment disease, postoperative infection,
device failure, ossification of the posterior ligament, development of kyphotic deformity).
• Sensitivity and specificity of imaging after cervical
fusion surgery.
• All time periods.
• Inpatient, outpatient, ambulatory surgical centers..
• RCTs, prospective trials and retrospective observational studies with a control group (study
N≥50), current systematic reviews for identification of additional studies.
• Younger than 18 years.
*• Effectiveness and harms of surgery based on
patient characteristics, disease characteristics and
radiographic characteristics (e.g., age, gender,
comorbidities [e.g., comorbid lumbar disease,
autoimmune disease, neurological disease, mental illness, Down’s syndrome], severity of cervical
degenerative disease, Frailty Index, sagittal
vertical aspect, degree of kyphosis, prior treatment [e.g., bracing, traction, medications, massage, acupuncture, injections, chiropractic care,
spinal manipulation], duration of pain, skill of surgeon).
• Patients without cervical degenerative disease.
• Nonhumans.
• Preoperative imaging using CT or plain films.
Comparators ....................................
Outcomes ........................................
Timing ..............................................
Setting .............................................
Study Design ...................................
• Nonoperative intervention versus nonoperative
intervention without surgical comparator.
• Nonvalidated instruments.
• Pre-post single-arm studies, case series, case reports, systematic reviews published prior to 2007.
CT = computed tomography; EQ–5D = EuroQol–5 dimension instrument; KQ = key question; MDI = myelopathy disability index; MRI = magnetic resonance imaging; mJOA = modified Japanese orthopedic association scale; NDI = neck disability index; NRS = numerical pain rating
scale; PROMIS–29 = patient reported outcome measurement information system; RCT = randomized controlled trial; QOL = quality of life; SF =
short form health survey (12 or 36 items); VAS = visual analogue scale for pain.
Dated: August 9, 2022.
Marquita Cullom,
Associate Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–17371 Filed 8–11–22; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4160–90–P
jspears on DSK121TN23PROD with NOTICES
[30Day–22–21IO]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Evaluation
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Reporting Template for National and
State Tobacco Control Program’’ to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on October 13, 2021 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
E:\FR\FM\12AUN1.SGM
12AUN1
49843
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary for the
proper performance of the functions of the
agency, including whether the information
will have practical utility;
(b) Evaluate the accuracy of the agencies
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and assumptions
used;
(c) Enhance the quality, utility, and clarity
of the information to be collected;
(d) Minimize the burden of the collection
of information on those who are to respond,
including, through the use of appropriate
automated, electronic, mechanical, or other
technological collection techniques or other
forms of information technology, e.g.,
permitting electronic submission of
responses; and
(e) Assess information collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Evaluation Reporting Template for
National and State Tobacco Control
Program—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC’s Office on Smoking and Health
(OSH) created the National and State
Tobacco Control Program (NTCP) in
1999 to encourage coordinated, national
efforts to reduce tobacco-related
diseases and deaths. The NTCP provides
funding and technical support to state
and territorial health departments.
NTCP funds 50 states, Washington DC,
Puerto Rico, and Guam. NTCP-funded
programs are working to eliminate
exposure to secondhand smoke,
promote quitting among adults and
youth, prevent initiation among youth
and young adults, and identify and
eliminate tobacco-related disparities. To
reach these goals, the programs
implement state and community
interventions, mass-reach health
communication interventions, tobacco
use and dependence treatment
interventions, and conduct surveillance
and evaluation.
This information collection project
supports the NTCP tobacco program
managers, administrators, and
evaluators by specifying which
information should be included in their
annual evaluation reports. Furthermore,
the information collected via this form
will allow OSH to monitor and evaluate
program performance, document
facilitators and barriers, lessons learned
and promising practices, establish
processes to support continuous
program improvement and
development, and assess the
effectiveness and outcomes of the
NTCP.
Information will be collected
electronically using an Excel
spreadsheet tool titled ‘‘Evaluation
Reporting Template for National and
State Tobacco Control Program’’ (ERT).
The collection of this information is part
of a federal reporting requirement for
funds received by NTCP recipients. The
information collection form will
consolidate information necessary for
evaluation of the NTCP.
The data collected through the
Evaluation Reporting Template for
National and State Tobacco Control
Program (ERT) was compared to all
other potential evaluation data sources
and designed not to duplicate any
information collected in other tools.
Although other NTCP data collection
tools are currently in use to collect data
for NTCP (Monitoring and Reporting
System for the National Tobacco Control
Program; OMB Control No. 0920–1097,
Exp. 04/30/2023), these existing data
collection tools are focused on financial
and programmatic management,
program implementation, and
performance measurement. By contrast,
the ERT will collect process and
outcome evaluation findings resulting
from individual evaluations designed by
each NTCP recipient. Findings will
include contextual factors, indicators,
lessons learned, and information about
health inequities and health disparities.
Recipients will use the ERT for
National and State Tobacco Control
Program to report information to CDC
about their Tobacco Control Program
evaluation findings. Each recipient will
submit an Evaluation Report template
annually. OMB approval is requested for
three years. Intended respondents
include 53 cooperative agreement
recipients. The estimated burden per
response is eight hours for each Annual
Evaluation Report. The total estimated
annualized burden is 424 hours.
jspears on DSK121TN23PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
State and Territorial Health Department Tobacco Control Program Staff.
Evaluation Reporting Template for National
and State Tobacco Control Program.
53
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–17354 Filed 8–11–22; 8:45 am]
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Number of
responses per
respondent
1
Average
burden per
response
(in hours)
8
Agencies
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49842-49843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17354]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-21IO]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Evaluation Reporting Template for National
and State Tobacco Control Program'' to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on October 13, 2021 to obtain comments from
the public and affected agencies. CDC did not receive comments related
to the previous notice. This notice serves to allow an additional 30
days for public and affected agency comments.
[[Page 49843]]
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information
to be collected;
(d) Minimize the burden of the collection of information on
those who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g.,
permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Evaluation Reporting Template for National and State Tobacco
Control Program--New--National Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC's Office on Smoking and Health (OSH) created the National and
State Tobacco Control Program (NTCP) in 1999 to encourage coordinated,
national efforts to reduce tobacco-related diseases and deaths. The
NTCP provides funding and technical support to state and territorial
health departments. NTCP funds 50 states, Washington DC, Puerto Rico,
and Guam. NTCP-funded programs are working to eliminate exposure to
secondhand smoke, promote quitting among adults and youth, prevent
initiation among youth and young adults, and identify and eliminate
tobacco-related disparities. To reach these goals, the programs
implement state and community interventions, mass-reach health
communication interventions, tobacco use and dependence treatment
interventions, and conduct surveillance and evaluation.
This information collection project supports the NTCP tobacco
program managers, administrators, and evaluators by specifying which
information should be included in their annual evaluation reports.
Furthermore, the information collected via this form will allow OSH to
monitor and evaluate program performance, document facilitators and
barriers, lessons learned and promising practices, establish processes
to support continuous program improvement and development, and assess
the effectiveness and outcomes of the NTCP.
Information will be collected electronically using an Excel
spreadsheet tool titled ``Evaluation Reporting Template for National
and State Tobacco Control Program'' (ERT). The collection of this
information is part of a federal reporting requirement for funds
received by NTCP recipients. The information collection form will
consolidate information necessary for evaluation of the NTCP.
The data collected through the Evaluation Reporting Template for
National and State Tobacco Control Program (ERT) was compared to all
other potential evaluation data sources and designed not to duplicate
any information collected in other tools. Although other NTCP data
collection tools are currently in use to collect data for NTCP
(Monitoring and Reporting System for the National Tobacco Control
Program; OMB Control No. 0920-1097, Exp. 04/30/2023), these existing
data collection tools are focused on financial and programmatic
management, program implementation, and performance measurement. By
contrast, the ERT will collect process and outcome evaluation findings
resulting from individual evaluations designed by each NTCP recipient.
Findings will include contextual factors, indicators, lessons learned,
and information about health inequities and health disparities.
Recipients will use the ERT for National and State Tobacco Control
Program to report information to CDC about their Tobacco Control
Program evaluation findings. Each recipient will submit an Evaluation
Report template annually. OMB approval is requested for three years.
Intended respondents include 53 cooperative agreement recipients. The
estimated burden per response is eight hours for each Annual Evaluation
Report. The total estimated annualized burden is 424 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
State and Territorial Health Evaluation Reporting 53 1 8
Department Tobacco Control Program Template for National
Staff. and State Tobacco
Control Program.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-17354 Filed 8-11-22; 8:45 am]
BILLING CODE 4163-18-P