Submission for OMB Review: Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (New Collection), 49305-49306 [2019-20307]
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Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) three-dimensional conformal
radiotherapy
(ii) intensity-modulated radiation
therapy
(iii) proton beam therapy
(iv) stereotactic body radiation
therapy
(d) Radical prostatectomy
(i) open
(ii) laparoscopic
(1) without robotic assistance
(2) with robotic assistance
(6) Combination of above
KQ 2: How do patient characteristics
modify comparative effectiveness and
harms of CLPC therapies?
(1) Age
(2) Race/ethnicity
(3) Comorbidities
(4) Health status
KQ 3: How do tumor characteristics
modify comparative effectiveness and
harms of CLPC therapies?
(1) Baseline PSA
(2) Gleason score
(3) Tumor index scores (e.g., Cancer of
the Prostate Risk Assessment Score
[CAPRA], D’Amico Risk
Classification for Prostate Cancer,
etc.)
(4) Biomarker Status
(a) Decipher (Genomic Classifier)
(b) Oncotype Dx (Genomic Prostate
Score)
(c) Prolaris (Cell Cycle Progression)
KQ 4: How do provider/hospital
characteristics modify comparative
effectiveness of RP compared to other
therapies?
(1) Geographic region
(2) Hospital type
(3) Provider volume
(4) Institutional volume
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Interventions
KQ1 to 3
jbell on DSK3GLQ082PROD with NOTICES
(1) Radical prostatectomy (RP)
Comparators
KQ1 to KQ4
• Any other intervention of listed above
except certain within category
comparisons (e.g., nerve-sparing vs
non-nerve sparing prostatectomy;
different dosage/frequency/timing/
duration of same therapy)
(1) Watchful waiting (WW)
(2) Active surveillance (AS)
(3) Androgen deprivation therapy (ADT)
(4) Focal therapies
(a) Brachytherapy
(b) Cryotherapy
(c) High-intensity focused ultrasound
Jkt 247001
KQ1 to KQ3
• Overall survival/mortality
• Prostate cancer specific survival/
mortality
• Metastatic-progression free survival
• Metastases (lymph nodes/distant)
• Health status
• Quality of life (measured with
validated instruments)
• Prostate-cancer related quality of life
(measured with validated
instruments)
KQ4
• Overall survival/mortality
• Prostate cancer specific survival/
mortality
• Metastatic free survival/metastases
(lymph nodes/distant)
Common and serious treatment side
effects:
• Bowel, bladder, and sexual/erectile
dysfunction
• Serious adverse effects associated
with ADT such as cognitive
impairment, MACE, fractures
Timing
KQ1 to KQ3
Follow up from treatment initiation:
PO 00000
Frm 00061
• Mortality/survival outcomes/
metastases: 5 years or more
• Health status, quality of life and
harms: 1 year or more
KQ4
Follow up from treatment initiation:
• Mortality/survival outcomes/
metastases: 5 years or more
Setting
KQ1 to KQ4
• All settings
Study Design
KQ1 to KQ4
(1) RCTs
(2) Non-RCT if:
(a) Comparative
(b) Concurrent
(c) Multicenter (enrolling patients
treated at multiple locations)
(d) ≥500 patients
(e) Some method to control for
selection bias (propensity scores,
instrumental variables, multivariate
regression)
(f) Prospective data collection
Dated: September 16, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–20303 Filed 9–18–19; 8:45 am]
BILLING CODE 4160–90–P
Outcomes
KQ1 to KQ3
• Treatment naı¨ve men with CLPC
(stages T1 to T3)
17:30 Sep 18, 2019
KQ4
Harms
Population(s)
VerDate Sep<11>2014
(HIFU)
(d) Laser ablation
(e) Photodynamic therapy
(f) Irreversible electroporation
(5) Whole gland therapies
(a) Brachytherapy
(b) Cryotherapy
(c) External beam radiation therapy
(i) Three-dimensional conformal
radiotherapy
(ii) Intensity-modulated radiation
therapy
(iii) Proton beam therapy
(iv) Stereotactic body radiation
therapy
(d) Radical prostatectomy
(i) Open
(ii) Laparoscopic
(1) Without robotic assistance
(2) With robotic assistance
(6) Combination of above
49305
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review:
Assessing Models of Coordinated
Services for Low-Income Children and
Their Families (AMCS) (New
Collection)
Office of Planning, Research,
and Evaluation; ACF; HHS
ACTION: Request for public comment.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing to collect data for a new
study, Assessing Models of Coordinated
Services for Low-Income Children and
Their Families (AMCS).
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
E:\FR\FM\19SEN1.SGM
19SEN1
49306
Federal Register / Vol. 84, No. 182 / Thursday, September 19, 2019 / Notices
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Description: Through AMCS, ACF
seeks to learn more about how states
and communities coordinate early care
and education, family economic
security, and/or other health and human
services to most efficiently and
effectively serve the needs of lowincome children and their families. ACF
aims to understand strategies used to
support partnerships, including the
federal barriers to agency collaboration.
ADDRESSES:
In support of achieving these goals, the
study team will conduct site visits to six
programs that offer coordinated
services. The study team will gather
information through interviews with
program staff members, such as agency
leaders or frontline staff, and focus
groups with parents.
Data collection activities will include
up to six program site visits. Programs
will be identified through a scan of
publicly available information about
programs, recommendations from
stakeholders, and proposed telephone
interviews (the information collection
request for these interviews will be
submitted under the generic clearance:
Formative Data Collections for ACF
Research, OMB #0970–0356)). Once
potential programs are identified,
agency leaders will be invited to
participate in the site visit. Site visits
will include semi-structured interviews
with up to 30 total staff at each site.
Staff invited will include lead program
and partner staff to include agency
leaders (including program directors,
executive directors, or CEOs), directors
of programs within the site, frontline
staff (including service navigators or
coordinators), and focus groups with 8–
10 parents at each site. Semi-structured
interviews with program and partner
staff will obtain in-depth information
about the goals and objectives of
programs, the services provided, how
the coordinated services are
implemented, how staffing is managed,
data use, and any facilitators and
barriers to coordination. Focus groups
with parents participating in the
program will provide the opportunity to
learn about how parents perceive the
program, how it meets their needs, what
benefits they gain from the program, and
how they enroll, participate, and
progress through the program.
Respondents: Lead program and
partner program staff members working
in six programs across the United States
that coordinate early care and education
services with family economic security
services and/or other health and human
services, as well as parents receiving
services from these programs. Staff
respondents will be selected with the
goal of having staff represent each level
of the organization. Parents who have
participated in the program for at least
six months and who received early
childhood services and at least one
other program service will be invited to
participate in focus groups.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Master Interview Protocol ................................................................................
Parent Focus-Group Protocol ..........................................................................
Estimated Total Annual Burden
Hours: 420.
Authority: 42 U.S.C. 9858(a)(5).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–20307 Filed 9–18–19; 8:45 am]
BILLING CODE 4184–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSK3GLQ082PROD with NOTICES
[Docket No. FDA–2019–D–4048]
Safer Technologies Program for
Medical Devices; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:30 Sep 18, 2019
Jkt 247001
180
60
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Safer Technologies
Program for Medical Devices.’’ This
draft guidance describes a new,
voluntary program for certain medical
devices and device-led combination
products that are reasonably expected to
significantly improve the safety of
currently available treatments or
diagnostics that target an underlying
disease or condition associated with
morbidities and mortalities less serious
than those eligible for the Breakthrough
Devices Program. Devices and deviceled combination products are eligible
for this program if they are subject to
review under a premarket approval
application (PMA), De Novo
classification request (‘‘De Novo
request’’), or premarket notification
(510(k)). Consistent with the Agency’s
statutory mission to protect and
promote public health, FDA believes
SUMMARY:
PO 00000
Frm 00062
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Number of
responses per
respondent
Average
burden
hours per
response
1
1
Annual burden
hours
2
1
360
60
that this ‘‘Safer Technologies Program’’
or ‘‘STeP’’ will help patients have more
timely access to these medical devices
and device-led combination products by
expediting their development,
assessment, and review, while
preserving the statutory standards for
premarket approval, De Novo marketing
authorization, and 510(k) clearance.
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by November 18, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\19SEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49305-49306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review: Assessing Models of Coordinated
Services for Low-Income Children and Their Families (AMCS) (New
Collection)
AGENCY: Office of Planning, Research, and Evaluation; ACF; HHS
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE),
Administration for Children and Families (ACF), U.S. Department of
Health and Human Services (HHS), is proposing to collect data for a new
study, Assessing Models of Coordinated Services for Low-Income Children
and Their Families (AMCS).
DATES: Comments due within 30 days of publication. OMB is required to
make a decision concerning the collection of information between 30 and
60 days after publication of this document in the Federal Register.
Therefore, a comment is best assured of having its full effect if OMB
receives it within 30 days of publication.
[[Page 49306]]
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
[email protected], Attn: Desk Officer for the Administration
for Children and Families.
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
[email protected].
SUPPLEMENTARY INFORMATION:
Description: Through AMCS, ACF seeks to learn more about how states
and communities coordinate early care and education, family economic
security, and/or other health and human services to most efficiently
and effectively serve the needs of low-income children and their
families. ACF aims to understand strategies used to support
partnerships, including the federal barriers to agency collaboration.
In support of achieving these goals, the study team will conduct site
visits to six programs that offer coordinated services. The study team
will gather information through interviews with program staff members,
such as agency leaders or frontline staff, and focus groups with
parents.
Data collection activities will include up to six program site
visits. Programs will be identified through a scan of publicly
available information about programs, recommendations from
stakeholders, and proposed telephone interviews (the information
collection request for these interviews will be submitted under the
generic clearance: Formative Data Collections for ACF Research, OMB
#0970-0356)). Once potential programs are identified, agency leaders
will be invited to participate in the site visit. Site visits will
include semi-structured interviews with up to 30 total staff at each
site. Staff invited will include lead program and partner staff to
include agency leaders (including program directors, executive
directors, or CEOs), directors of programs within the site, frontline
staff (including service navigators or coordinators), and focus groups
with 8-10 parents at each site. Semi-structured interviews with program
and partner staff will obtain in-depth information about the goals and
objectives of programs, the services provided, how the coordinated
services are implemented, how staffing is managed, data use, and any
facilitators and barriers to coordination. Focus groups with parents
participating in the program will provide the opportunity to learn
about how parents perceive the program, how it meets their needs, what
benefits they gain from the program, and how they enroll, participate,
and progress through the program.
Respondents: Lead program and partner program staff members working
in six programs across the United States that coordinate early care and
education services with family economic security services and/or other
health and human services, as well as parents receiving services from
these programs. Staff respondents will be selected with the goal of
having staff represent each level of the organization. Parents who have
participated in the program for at least six months and who received
early childhood services and at least one other program service will be
invited to participate in focus groups.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total/annual Number of Average
Instrument number of responses per burden hours Annual burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Master Interview Protocol....................... 180 1 2 360
Parent Focus-Group Protocol..................... 60 1 1 60
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 420.
Authority: 42 U.S.C. 9858(a)(5).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-20307 Filed 9-18-19; 8:45 am]
BILLING CODE 4184-23-P
