Supplemental Evidence and Data Request on Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer, 75326-75327 [2020-26041]
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
C. Annual Burden
Respondents: 10,275.
Recordkeepers: 8,391.
Total Annual Responses: 342,019.
Total Burden Hours: 627,162 (123,702
reporting hours + 503,460 recordkeeping
hours).
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GSARegSec@gsa.gov.
Please cite OMB Control No. 9000–
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Part 3: Improper Business Practices and
Personal Conflicts of Interest.
William F. Clark,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2020–26096 Filed 11–24–20; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Models of Care That
Include Primary Care for Adult
Survivors of Childhood Cancer
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
Models of Care that Include Primary
Care for Adult Survivors of Childhood
Cancer, which is currently being
conducted by the AHRQ’s Evidencebased 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Access to published and unpublished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 December 28, 2020.
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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:27 Nov 24, 2020
Jkt 253001
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: 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 Models of Care that Include
Primary Care for Adult Survivors of
Childhood Cancer. AHRQ is conducting
this systematic review pursuant to
Section 902 of the Public Health Service
Act, 42 U.S.C. 299a.
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 Models of Care that
Include Primary Care for Adult
Survivors of Childhood Cancer,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
pediatric-adolescent-cancersurvivorship/protocol.
This is to notify the public that the
EPC Program would find the following
information on Models of Care that
Include Primary Care for Adult
Survivors of Childhood Cancer 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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://
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.
Contextual and Key Questions
We have developed contextual
questions to guide our preliminary
discussions with the stakeholders, as
well as the specific review questions (or
key questions) to be addressed.
Contextual Questions (CQ)
CQ1. How is effectiveness defined
and measured for survivorship care
models for adult survivors of childhood
cancer?
CQ2. What are the models of
survivorship care for adult survivors of
childhood cancer?
a. Which of these models include
primary care?
i. What is the evidence of
effectiveness of the different models that
include primary care?
CQ3. What survivorship care
resources are available for adult
survivors of childhood cancer and their
families?
a. What are the intended outcomes of
the different resources available for
adult survivors of childhood cancer and
their families?
b. What is the evidence of
effectiveness of the different resources
available for adult survivors of
childhood cancer and their families?
c. What are the monetary costs to
access these resources?
E:\FR\FM\25NON1.SGM
25NON1
Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
CQ4. What survivorship care
resources are available to providers who
care for adult survivors of childhood
cancer?
a. What are the intended outcomes of
the different resources available to care
providers?
b. What is the evidence of
effectiveness of the different resources
available to care providers?
c. What are the monetary costs to
access these resources?
Key Questions (KQs) for the Realist
Review
KQ1. For whom and under what
circumstances could different
survivorship care models for adult
survivors of childhood cancer that
include primary care be effective?
a. What are the key mechanisms by
which these models could be effective?
b. What are important contexts that
determine whether different
mechanisms could be effective?
KQ2. For whom and under what
circumstances could different
survivorship care resources for adult
survivors of childhood cancer be
effective in achieving their intended
outcomes?
a. For survivors and their families
i. What are the key mechanisms by
which these resources could lead to
their intended outcome?
ii. What are important contexts that
determine whether different
mechanisms could lead to outcomes?
b. For care providers
i. What are the key mechanisms by
which these resources could lead to
their intended outcome?
ii. What are important contexts that
determine whether different
mechanisms could lead to outcomes?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Interventions
• Models of childhood cancer
survivorship care for use in adult
survivors
Æ Models of childhood cancer
survivorship care for use in adult
survivors that include primary care
• Survivorship resources available to
adult survivors of childhood cancer
and their families
• Survivorship resources available to
care providers of adult survivors of
childhood cancer
Comparators
• Optional (will not require a
comparison)
Outcomes
List of outcomes will be informed by
contextual questions but may include:
• Intermediate patient health outcomes
• Morbidity
• Mortality
• Relapse
• Quality of life
• Psychosocial outcomes
• Mental health outcomes
• Caregiver burden
• Satisfaction with care
• Educational attainment
• Adherence with care
• Cost and resource utilization
• Unintended consequences
• Additional burdens
• Late effects—new cancers, cardiac or
respiratory issues, etc. from original
treatment
Timing
• After the transition from childhood
cancer care
Settings
• All care settings
Dated: November 19, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020–26041 Filed 11–24–20; 8:45 am]
BILLING CODE 4160–90–P
We will adapt the PICOTS framework
(populations, interventions,
comparators, outcomes, timing, and
setting) to inform our realist review. The
PICOTS include but are not limited to
the following.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
jbell on DSKJLSW7X2PROD with NOTICES
Population(s)
• Adult survivors of childhood cancer
(cancer diagnosed prior to age 21years
old) with no evidence of clinical
disease; and their families
• Care providers of adult survivors of
childhood cancer
VerDate Sep<11>2014
16:27 Nov 24, 2020
Jkt 253001
Submission for OMB Review; ORR
Serious Medical Procedure Request
(SMR) Form (New Collection)
ACTION:
Request for public comment.
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to collect
data for a new data collection, the
Serious Medical Procedure Request
(SMR) Form.
SUMMARY:
Comments due within 30 days of
publication. OMB must make a decision
about 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.
DATES:
Written 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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: Children with complex
medical/dental conditions may require
surgical intervention or procedures in
order to maintain and promote their
health while in ORR custody.
Procedures requiring general anesthesia,
surgeries, and invasive diagnostic
procedures (e.g., cardiac catheterization,
invasive biopsy, amniocentesis) require
advance ORR approval. Before a
decision can be rendered by ORR, data
on clinical indications, risks and
benefits of the surgery/procedure,
potential adverse outcomes if services
are not rendered, timeframe for
recovery, follow-up care, and points of
contact must be collected and submitted
to ORR. The form is not required for
emergency procedures, procedures
performed during hospitalization, or
procedures resulting from complication
of a previously approved procedure.
Respondents: Healthcare providers,
ORR grantee staff.
Annual Burden Estimates:
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
AGENCY:
PO 00000
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Fmt 4703
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75327
E:\FR\FM\25NON1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75326-75327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26041]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Models of Care That
Include Primary Care for Adult Survivors of Childhood Cancer
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 Models of Care
that Include Primary Care for Adult Survivors of Childhood Cancer,
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 December 28, 2020.
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 Models of Care that
Include Primary Care for Adult Survivors of Childhood Cancer. AHRQ is
conducting this systematic review pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
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 Models of Care that Include Primary Care for Adult
Survivors of Childhood Cancer, including those that describe adverse
events. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/pediatric-adolescent-cancer-survivorship/protocol.
This is to notify the public that the EPC Program would find the
following information on Models of Care that Include Primary Care for
Adult Survivors of Childhood Cancer 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://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.
Contextual and Key Questions
We have developed contextual questions to guide our preliminary
discussions with the stakeholders, as well as the specific review
questions (or key questions) to be addressed.
Contextual Questions (CQ)
CQ1. How is effectiveness defined and measured for survivorship
care models for adult survivors of childhood cancer?
CQ2. What are the models of survivorship care for adult survivors
of childhood cancer?
a. Which of these models include primary care?
i. What is the evidence of effectiveness of the different models
that include primary care?
CQ3. What survivorship care resources are available for adult
survivors of childhood cancer and their families?
a. What are the intended outcomes of the different resources
available for adult survivors of childhood cancer and their families?
b. What is the evidence of effectiveness of the different resources
available for adult survivors of childhood cancer and their families?
c. What are the monetary costs to access these resources?
[[Page 75327]]
CQ4. What survivorship care resources are available to providers
who care for adult survivors of childhood cancer?
a. What are the intended outcomes of the different resources
available to care providers?
b. What is the evidence of effectiveness of the different resources
available to care providers?
c. What are the monetary costs to access these resources?
Key Questions (KQs) for the Realist Review
KQ1. For whom and under what circumstances could different
survivorship care models for adult survivors of childhood cancer that
include primary care be effective?
a. What are the key mechanisms by which these models could be
effective?
b. What are important contexts that determine whether different
mechanisms could be effective?
KQ2. For whom and under what circumstances could different
survivorship care resources for adult survivors of childhood cancer be
effective in achieving their intended outcomes?
a. For survivors and their families
i. What are the key mechanisms by which these resources could lead
to their intended outcome?
ii. What are important contexts that determine whether different
mechanisms could lead to outcomes?
b. For care providers
i. What are the key mechanisms by which these resources could lead
to their intended outcome?
ii. What are important contexts that determine whether different
mechanisms could lead to outcomes?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
We will adapt the PICOTS framework (populations, interventions,
comparators, outcomes, timing, and setting) to inform our realist
review. The PICOTS include but are not limited to the following.
Population(s)
Adult survivors of childhood cancer (cancer diagnosed prior to
age 21years old) with no evidence of clinical disease; and their
families
Care providers of adult survivors of childhood cancer
Interventions
Models of childhood cancer survivorship care for use in adult
survivors
[cir] Models of childhood cancer survivorship care for use in adult
survivors that include primary care
Survivorship resources available to adult survivors of
childhood cancer and their families
Survivorship resources available to care providers of adult
survivors of childhood cancer
Comparators
Optional (will not require a comparison)
Outcomes
List of outcomes will be informed by contextual questions but may
include:
Intermediate patient health outcomes
Morbidity
Mortality
Relapse
Quality of life
Psychosocial outcomes
Mental health outcomes
Caregiver burden
Satisfaction with care
Educational attainment
Adherence with care
Cost and resource utilization
Unintended consequences
Additional burdens
Late effects--new cancers, cardiac or respiratory issues, etc.
from original treatment
Timing
After the transition from childhood cancer care
Settings
All care settings
Dated: November 19, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-26041 Filed 11-24-20; 8:45 am]
BILLING CODE 4160-90-P
