Supplemental Evidence and Data Request on Disparities and Barriers for Pediatric Cancer Survivorship Care, 42855-42857 [2020-15190]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Disparities and Barriers for
Pediatric Cancer Survivorship Care
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Disparities and Barriers for Pediatric
Cancer Survivorship Care, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before 30 days after the date of
publication of this Notice.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Disparities and Barriers for
Pediatric Cancer Survivorship Care.
AHRQ is conducting this systematic
review pursuant to Section 903 of the
Public Health Service Act, 42 U.S.C.
299a–1.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
PO 00000
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42855
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Disparities and Barriers
for Pediatric Cancer Survivorship Care,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
pediatric-cancer-survivorship/protocol.
This is to notify the public that the
EPC Program would find the following
information on Disparities and Barriers
for Pediatric Cancer Survivorship Care
helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
E:\FR\FM\15JYN1.SGM
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42856
Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Guiding Questions (GQs)
The brief will be facilitated by guiding
questions, documenting research and
Key Informant input.
GQ1. What are the disparities in
survivorship care for pediatric cancer
survivors?
GQ2. What are the barriers to
survivorship care for pediatric cancer
survivors who experience disparities?
GQ3. What are proposed strategies for
addressing those barriers?
GQ4. What published and
unpublished studies have assessed these
strategies?
GQ5. What are future directions for
research in addressing barriers to
survivorship care for pediatric cancer
survivors?
Inclusion
Exclusion
All GQs:
• Childhood cancer survivors (CCS) of all ages.
We will accept the authors’ definition of CCS.
Mixed samples will be included where studies
include at least 50% CCS or report a subgroup analysis. In studies not self-identifying
as CCS research, we will apply the following
criteria: Diagnosed before age 21, received
primary acute treatment for cancer, currently in
remission, eligible to receive survivorship care
services, care plans, and/or models of followup care.
GQ1:
• Survivorship care. We will include studies addressing healthcare approaches aimed at the
health and wellbeing of cancer survivors.
All GQs:
• Studies that predominantly include other populations than CCS, that include patients diagnosed predominantly after the age of 20, that
had other conditions than cancer, or that are
currently undergoing treatment for cancer.
PICOTSS
(populations, interventions, comparators, outcomes,
timing, settings, study designs)
PICOTSS
Population .....................................................................
Independent variables and interventions .....................
Comparators .................................................................
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Outcomes .....................................................................
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GQ2:
• Barriers and facilitators of survivorship care for
CCS.
GQ3, GQ4, GQ5:
• Strategies to address barriers to survivorship
care and to reduce care disparities. We will include care initiatives, structured care programs, care plan, care models, and healthcare
interventions aiming to address barriers or disparities. Strategies may target CCS (e.g., providing patient information), healthcare providers (e.g., initiating training), or healthcare
systems (e.g., implementing health information
technologies such as telemedicine).
GQ1, GQ2:
• We will accept the authors’ choice of a participant characteristic comparator. Studies may
compare subgroups to the general population
of CCS or compare multiple participant subgroups defined by participant characteristics
(e.g., race/ethnicity, socioeconomic status,
gender, rural residence, educational attainment or patient or their parents, other disparate population).
GQ3:
• Strategies do not need to document alternative
care models in detail as long as the difference
of the proposed survivorship care strategy to
usual care is described.
GQ4, GQ5:
• Studies comparing participant subgroups as
defined in GQ1 and GQ2 and studies comparing to other care strategies (no intervention,
waitlist, usual care, other active strategies aiming to address barriers or disparities).
GQ1, GQ2:
• Disparities and barriers (causes of disparity)
in:
Æ Any patient outcomes related to utilization
of survivorship care services, care plans,
or models of care.
Æ Intermediate health outcomes and adverse events (short-term).
Æ Mortality (long-term, not related to cancer).
Æ Late effects and morbidity (including psychosocial).
Æ Quality of life and wellbeing and satisfaction with care.
Æ Cost and resource utilization.
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All GQs:
• Studies without reference to survivorship care
and studies not addressing care disparities,
barriers to care, or strategies outside of
healthcare.
All GQs:
• Studies not addressing patient characteristics
or intervention characteristics.
All GQs:
• Studies that do not relate to disparities or barriers to survivorship care for pediatric survivors.
E:\FR\FM\15JYN1.SGM
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Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices
PICOTSS
(populations, interventions, comparators, outcomes,
timing, settings, study designs)
PICOTSS
Timing ...........................................................................
Setting(s) ......................................................................
Study design and other limiters ....................................
Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
Exclusion
GQ3:
• Strategies will be documented regardless of
any information on outcome effects, but strategies need to aim to prevent, reduce, or mitigate disparities and barriers to survivorship
care.
GQ4:
• Changes (reduction) in disparities between
comparison groups for outcomes listed in GQ1
and GQ2.
GQ5:
• Ongoing and upcoming studies need to indicate that the study will report on outcomes eligible for GQ1, GQ2, or GQ4.
All GQs:
• No timing restriction apply. Studies may address CCS who recently or long in the past
experienced pediatric cancer and are now in
remission.
All GQs:
• All care settings applicable to US settings will
be eligible, including primary, secondary, and
tertiary care; inpatient and outpatient care; pediatric and adult care context.
All GQs:
• English-language publications.
GQ1, GQ2, GQ4, GQ5:
• Primary studies reporting empirical data (including both quantitative and qualitative data).
GQ1, GQ2:
• Studies may either report on distinct subgroups, e.g., dividing the sample by geographic characteristic and reporting data separately for rural and for urban participants or
studies may report associations with participant characteristics, e.g., reporting correlations
with a factor of interest such as gender differences.
GQ3:
• Strategies have to have been empirically tested in a research study reporting on the outcomes of interest or have been suggested by
an authoritative source such as a clinical practice guideline or relevant professional organization.
GQ 4:
• Studies with concurrent (e.g., randomized controlled trial) or historic comparator (e.g., organizational pre-post studies). Studies with results published in clinicaltrials.gov will be included regardless of whether a journal publication is available.
GQ5:
• Ongoing and upcoming studies have to have a
published protocol or are registered in a research registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–15190 Filed 7–14–20; 8:45 am]
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42857
All GQs:
• No exclusions apply.
All GQs:
• Studies in resource-limited settings such as
developing countries will be reviewed for comparability with US settings.
All GQs:
• Evaluations reported only in abbreviated format (e.g., in a conference abstract) with the
exception of trial records.
• Studies exclusively reported in non-English
publications.
• Systematic reviews will be retained for reference mining but are not eligible for inclusion.
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]]>Agencies
[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42855-42857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15190]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Disparities and
Barriers for Pediatric Cancer Survivorship Care
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Disparities and
Barriers for Pediatric Cancer Survivorship Care, which is currently
being conducted by the AHRQ's Evidence-based Practice Centers (EPC)
Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before 30 days after the date of
publication of this Notice.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Disparities and
Barriers for Pediatric Cancer Survivorship Care. AHRQ is conducting
this systematic review pursuant to Section 903 of the Public Health
Service Act, 42 U.S.C. 299a-1.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Disparities and Barriers for Pediatric Cancer
Survivorship Care, including those that describe adverse events. The
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/pediatric-cancer-survivorship/protocol.
This is to notify the public that the EPC Program would find the
following information on Disparities and Barriers for Pediatric Cancer
Survivorship Care helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://
[[Page 42856]]
www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Guiding Questions (GQs)
The brief will be facilitated by guiding questions, documenting
research and Key Informant input.
GQ1. What are the disparities in survivorship care for pediatric
cancer survivors?
GQ2. What are the barriers to survivorship care for pediatric
cancer survivors who experience disparities?
GQ3. What are proposed strategies for addressing those barriers?
GQ4. What published and unpublished studies have assessed these
strategies?
GQ5. What are future directions for research in addressing barriers
to survivorship care for pediatric cancer survivors?
----------------------------------------------------------------------------------------------------------------
PICOTSS (populations, interventions,
comparators, outcomes, timing, Inclusion Exclusion
settings, study designs) PICOTSS
----------------------------------------------------------------------------------------------------------------
Population........................... All GQs: All GQs:
Childhood cancer survivors Studies that
(CCS) of all ages. We will accept the predominantly include
authors' definition of CCS. Mixed other populations than
samples will be included where studies CCS, that include
include at least 50% CCS or report a patients diagnosed
subgroup analysis. In studies not self- predominantly after the
identifying as CCS research, we will age of 20, that had other
apply the following criteria: conditions than cancer,
Diagnosed before age 21, received or that are currently
primary acute treatment for cancer, undergoing treatment for
currently in remission, eligible to cancer.
receive survivorship care services,
care plans, and/or models of follow-up
care.
Independent variables and GQ1: All GQs:
interventions.
Survivorship care. We will Studies without
include studies addressing healthcare reference to survivorship
approaches aimed at the health and care and studies not
wellbeing of cancer survivors. addressing care
disparities, barriers to
care, or strategies
outside of healthcare.
GQ2:
Barriers and facilitators of
survivorship care for CCS.
GQ3, GQ4, GQ5:
Strategies to address barriers
to survivorship care and to reduce
care disparities. We will include care
initiatives, structured care programs,
care plan, care models, and healthcare
interventions aiming to address
barriers or disparities. Strategies
may target CCS (e.g., providing
patient information), healthcare
providers (e.g., initiating training),
or healthcare systems (e.g.,
implementing health information
technologies such as telemedicine).
Comparators.......................... GQ1, GQ2: All GQs:
We will accept the authors' Studies not
choice of a participant characteristic addressing patient
comparator. Studies may compare characteristics or
subgroups to the general population of intervention
CCS or compare multiple participant characteristics.
subgroups defined by participant
characteristics (e.g., race/ethnicity,
socioeconomic status, gender, rural
residence, educational attainment or
patient or their parents, other
disparate population).
GQ3:
Strategies do not need to
document alternative care models in
detail as long as the difference of
the proposed survivorship care
strategy to usual care is described.
GQ4, GQ5:
Studies comparing participant
subgroups as defined in GQ1 and GQ2
and studies comparing to other care
strategies (no intervention, waitlist,
usual care, other active strategies
aiming to address barriers or
disparities).
Outcomes............................. GQ1, GQ2: All GQs:
Disparities and barriers Studies that do
(causes of disparity) in: not relate to disparities
[cir] Any patient outcomes related to or barriers to
utilization of survivorship care survivorship care for
services, care plans, or models of care. pediatric survivors.
[cir] Intermediate health outcomes
and adverse events (short-term).
[cir] Mortality (long-term, not
related to cancer).
[cir] Late effects and morbidity
(including psychosocial).
[cir] Quality of life and wellbeing
and satisfaction with care.
[cir] Cost and resource utilization.
[[Page 42857]]
GQ3:
Strategies will be documented
regardless of any information on
outcome effects, but strategies need
to aim to prevent, reduce, or mitigate
disparities and barriers to
survivorship care.
GQ4:
Changes (reduction) in
disparities between comparison groups
for outcomes listed in GQ1 and GQ2.
GQ5:
Ongoing and upcoming studies
need to indicate that the study will
report on outcomes eligible for GQ1,
GQ2, or GQ4.
Timing............................... All GQs: All GQs:
No timing restriction apply. No exclusions
Studies may address CCS who recently apply.
or long in the past experienced
pediatric cancer and are now in
remission.
Setting(s)........................... All GQs: All GQs:
All care settings applicable Studies in
to US settings will be eligible, resource-limited settings
including primary, secondary, and such as developing
tertiary care; inpatient and countries will be
outpatient care; pediatric and adult reviewed for
care context. comparability with US
settings.
Study design and other limiters...... All GQs: All GQs:
English-language publications. Evaluations
GQ1, GQ2, GQ4, GQ5: reported only in
Primary studies reporting abbreviated format (e.g.,
empirical data (including both in a conference abstract)
quantitative and qualitative data). with the exception of
GQ1, GQ2: trial records.
Studies may either report on Studies exclusively
distinct subgroups, e.g., dividing the reported in non-English
sample by geographic characteristic and publications.
reporting data separately for rural and Systematic reviews
for urban participants or studies may will be retained for
report associations with participant reference mining but are not
characteristics, e.g., reporting eligible for inclusion.
correlations with a factor of interest
such as gender differences.
GQ3:
Strategies have to have been
empirically tested in a research study
reporting on the outcomes of interest
or have been suggested by an
authoritative source such as a
clinical practice guideline or
relevant professional organization.
GQ 4:
Studies with concurrent (e.g.,
randomized controlled trial) or
historic comparator (e.g.,
organizational pre-post studies).
Studies with results published in
clinicaltrials.gov will be included
regardless of whether a journal
publication is available.
GQ5:
Ongoing and upcoming studies
have to have a published protocol or
are registered in a research registry.
----------------------------------------------------------------------------------------------------------------
Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2020-15190 Filed 7-14-20; 8:45 am]
BILLING CODE 4160-90-P
