Supplemental Evidence and Data Request on Blood-Based Tests for Multiple Cancer Screening: A Systematic Review, 62746-62748 [2024-16973]
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Federal Register / Vol. 89, No. 148 / Thursday, August 1, 2024 / Notices
GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0080]
[Docket No. 2024–0001; Sequence No. 4]
Submission for OMB Review; General
Services Administration Acquisition
Regulation; Release of Claims for
Construction and Building Service
Contracts
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Notice.
[FR Doc. 2024–16981 Filed 7–31–24; 8:45 am]
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
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final payment under construction and
building services contracts.
DATES: Submit comments on or before:
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ADDRESSES: Written comments and
recommendations for this information
collection should be sent within 30 days
of publication of this notice to
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Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function.
FOR FURTHER INFORMATION CONTACT: Mr.
Bryon Boyer, Procurement Analyst, at
gsarpolicy@gsa.gov or 817–850–5580.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
SUMMARY:
A. Purpose
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their contract requirements and for work
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ddrumheller on DSK120RN23PROD with NOTICES1
the Regulatory Secretariat Division
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Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Blood-Based Tests for
Multiple Cancer Screening: A
Systematic Review
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submission.
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
Blood-based Tests for Multiple Cancer
Screening: A Systematic Review, 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 September 3, 2024.
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:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
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Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Blood-based Tests for
Multiple Cancer Screening: A
Systematic Review. AHRQ is conducting
this 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 Blood-based Tests for
Multiple Cancer Screening: A
Systematic Review. The entire research
protocol is available online at: https://
effectivehealthcare.ahrq.gov/products/
cell-free-dna/protocol.
This is to notify the public that the
EPC Program would find the following
information on Blood-based Tests for
Multiple Cancer Screening: A
Systematic Review helpful:
D A list of completed studies that
your organization has sponsored for this
topic. 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, if relevant: 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
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, 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 topic 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
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Federal Register / Vol. 89, No. 148 / Thursday, August 1, 2024 / Notices
types not included in the review; or
information on topics 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://effectivehealthcare.ahrq.gov/
email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Key Questions (KQ)
KQ 1: What is the effectiveness of
screening with blood-based multicancer
screening tests (MCST) on cancerspecific mortality and all-cause
mortality?
KQ 2a: What is the effectiveness of
screening with MCSTs on the
cumulative detection of cancer overall
and by cancer type?
62747
KQ 2b: What is the effectiveness of
screening with MCSTs on the
cumulative detection of late-stage
cancer (i.e., stage shift) overall and by
cancer type?
KQ 3: What is the accuracy of MCSTs
for detection of cancer and does
accuracy vary by cancer type or stage?
KQ 4: What are the harms of screening
with MCSTs?
KQ 5: What are the harms of the
evaluation and additional testing
following a positive MCST or with
surveillance following a negative
evaluation after a positive MCST?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
[Detailed inclusion and exclusion criteria for systematic review on blood-based tests for multiple cancer screening]
Inclusion criteria
Exclusion criteria
Population
KQs 1, 2, 4, 5 ...........................................................................................
Asymptomatic people 18 years of age or older .......................................
KQ 3: People 18 years of age or older with either (1) biopsy-confirmed
cancer or (2) who are asymptomatic without suspicion for cancer
(i.e., ‘‘healthy’’ individuals).
All KQ: People younger than 18 years of age; other than human populations (e.g., animal or in vitro laboratory studies).
KQs 1, 2, 4, 5: Adults with active cancer; adults undergoing evaluation
for suspected cancer or cancer recurrence; adults with a history of
invasive or hematologic cancer (other than nonmelanoma skin cancer) within the previous 3 years or a history of untreated cancer.
KQ 3: Adults undergoing diagnostic evaluation for possible cancer or
cancer recurrence.
Intervention
KQs 1, 2, 3, 4 ...........................................................................................
• Blood tests used for the screening of at least 2 different types of
cancer; tests using any analytes with any technology are eligible.
• Tests that were designed for cancer prognosis or surveillance in
those with cancer or who have completed cancer treatment (i.e.,
evaluation for minimal residual disease) are eligible as long as they
are being evaluated in an eligible population as defined above.
• Blood tests used in combination with other tests such as imaging are
eligible.
• MCSTs used instead of or in addition to usual care screening are eligible. We define usual care screening as follows: mammography
(breast), direct visualization such as colonoscopy or stool-based
tests (colorectal), low-dose computed tomography (lung), cytology,
human papilloma virus testing (cervical), and prostate specific antigen (prostate).
KQ 5: Tests or procedures (imaging, tissue biopsy, blood, urine, or cerebrospinal fluid) to evaluate positive signal(s) resulting from an
MCST or procedures used to surveil patients who have a negative
evaluation after a positive MCST signal.
KQs 1, 2, 3, 4: Tests that are not blood based (e.g., tissue, saliva,
urine, or other bodily fluids).
KQ 5: Tests or interventions not performed as a result of a positive
MCST.
Comparator
ddrumheller on DSK120RN23PROD with NOTICES1
KQs 1, 2, 4 ...............................................................................................
• No screening test ..................................................................................
• Usual care cancer screening as defined above ...................................
KQ 3: Tissue evaluation for confirmation of cancer; healthy asymptomatic status for controls.
KQ 5: No comparator required .................................................................
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KQs 1, 2, 4: No comparator group.
KQ 3: No reference standard for comparison.
KQ 5: Studies without a comparator group will not be excluded.
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Federal Register / Vol. 89, No. 148 / Thursday, August 1, 2024 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
[Detailed inclusion and exclusion criteria for systematic review on blood-based tests for multiple cancer screening]
Inclusion criteria
Exclusion criteria
Outcomes
KQ 1: Cancer mortality overall and by cancer type, all-cause mortality,
quality of life, functional status.
KQ 2a: Cumulative detection of cancer overall and by cancer type .......
KQ 2b: Cumulative detection of late-stage cancer overall and by cancer
type (i.e., Stage III or IV or organ-specific definition of late stage);
distribution of cancer stage at diagnosis (i.e., stage shift).
KQ 3: Accuracy (sensitivity, false negatives, specificity, false positives,
predictive value) by cancer type and by cancer stage.
KQ 4: Psychosocial and emotional distress including anxiety and worry,
false reassurance resulting in decrease in receipt of usual care
screening or change in health behaviors associated with cancer (alcohol, tobacco, drug use, diet, physical activity), overdiagnosis, outof-pocket patient costs, patient financial toxicity, and impact on insurability.
KQ 5: Radiation exposure from imaging, harms from invasive procedures, other adverse effects from evaluation that occur after a positive MCST, or out-of-pocket patient costs, patient financial toxicity,
and impact on insurability.
Outcomes not specifically indicated as included.
Composite measures composed of both included and excluded outcomes will be included but considered only in sensitivity analyses.
Timing
KQ 1: At least 5 years of followup ...........................................................
KQs 2, 4, 5: any timing ............................................................................
KQ 3: At least 1 year of followup for prediagnostic performance designs.a For diagnostic performance designs, controls must be considered cancer free at the time of the sample.
KQ 1: Studies with less than 5 years of followup.
Setting
• Recruitment from outpatient clinical settings, including primary care
or specialty care, community-based or public health settings, electoral rolls, or other population-based registries.
• Countries with a United Nations Human Development Index of high
or very high (Appendix A).
• Acute care settings, inpatient care settings.
• Countries with a United Nations Human Development Index of less
than high.
Study Design
KQs 1, 2, 4, 5: Randomized controlled trials; controlled trials ................
KQs 1, 2: Registered NRSIs with 1 or more eligible benefit outcomes
listed on study registration b.
KQs 4, 5: Unregistered NRSIs are also eligible ......................................
KQ 3: Studies that provide data related to test accuracy; both
prediagnostic test performance and diagnostic test performance designs are eligible. However, only diagnostic performance designs
conducted in external validation cohorts are eligible. Further, if results for multiple variations of the test are reported by authors, only
results from the test version selected for future commercial use or for
evaluation in future intervention studies will be eligible.
For all KQ: Modeling studies, case series, case reports, in vitro lab
studies, studies designed to assess analytic validity, narrative reviews, systematic reviews (reviews will not be included but will be
manually reviewed to identify primary research studies that the
search may have missed).
KQs 1, 2: Cohort studies that have not been registered or that report
eligible outcomes that were not included in the study’s registration b
studies designed with a sample size that was not based on outcomes related to cancer detection or mortality.
KQ 3: Accuracy results derived from discovery, development, internal
validation, or split sample cohorts are not eligible because multiple
analytes, technologies, or AI classifiers are being evaluated to develop the test and these results do not reflect the final state of the
test that would be used in routine practice.
Language
English ......................................................................................................
Languages other than English.
ddrumheller on DSK120RN23PROD with NOTICES1
a KQ
3 prediagnostic accuracy performance studies that use disease-free longitudinal followup as a reference standard should have a minimum of 1-year followup.
b Refers to study registration in ClinicalTrials.gov database, or another study registry such as those included in the World Health Organization
International Clinical Trials Registry Platform.
KQ = key question; MCST = multiple cancer screening test; NRSI = non-randomized study of interventions.
Dated: July 25, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–16973 Filed 7–31–24; 8:45 am]
BILLING CODE 4160–90–P
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]]>Agencies
[Federal Register Volume 89, Number 148 (Thursday, August 1, 2024)]
[Notices]
[Pages 62746-62748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16973]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Blood-Based Tests for
Multiple Cancer Screening: A Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
-----------------------------------------------------------------------
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 Blood-based
Tests for Multiple Cancer Screening: A Systematic Review, 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 September 3, 2024.
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: Kelly Carper, Telephone: 301-427-1656
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 Blood-based Tests for
Multiple Cancer Screening: A Systematic Review. AHRQ is conducting this
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 Blood-based Tests for Multiple Cancer Screening: A
Systematic Review. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/cell-free-dna/protocol.
This is to notify the public that the EPC Program would find the
following information on Blood-based Tests for Multiple Cancer
Screening: A Systematic Review helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, if
relevant: 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 topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, 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 topic 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
[[Page 62747]]
types not included in the review; or information on topics 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://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1: What is the effectiveness of screening with blood-based
multicancer screening tests (MCST) on cancer-specific mortality and
all-cause mortality?
KQ 2a: What is the effectiveness of screening with MCSTs on the
cumulative detection of cancer overall and by cancer type?
KQ 2b: What is the effectiveness of screening with MCSTs on the
cumulative detection of late-stage cancer (i.e., stage shift) overall
and by cancer type?
KQ 3: What is the accuracy of MCSTs for detection of cancer and
does accuracy vary by cancer type or stage?
KQ 4: What are the harms of screening with MCSTs?
KQ 5: What are the harms of the evaluation and additional testing
following a positive MCST or with surveillance following a negative
evaluation after a positive MCST?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
[Detailed inclusion and exclusion criteria for systematic review on
blood-based tests for multiple cancer screening]
------------------------------------------------------------------------
Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population
------------------------------------------------------------------------
KQs 1, 2, 4, 5......................... All KQ: People younger than 18
Asymptomatic people 18 years of age or years of age; other than human
older. populations (e.g., animal or
KQ 3: People 18 years of age or older in vitro laboratory studies).
with either (1) biopsy-confirmed KQs 1, 2, 4, 5: Adults with
cancer or (2) who are asymptomatic active cancer; adults
without suspicion for cancer (i.e., undergoing evaluation for
``healthy'' individuals). suspected cancer or cancer
recurrence; adults with a
history of invasive or
hematologic cancer (other than
nonmelanoma skin cancer)
within the previous 3 years or
a history of untreated cancer.
KQ 3: Adults undergoing
diagnostic evaluation for
possible cancer or cancer
recurrence.
------------------------------------------------------------------------
Intervention
------------------------------------------------------------------------
KQs 1, 2, 3, 4......................... KQs 1, 2, 3, 4: Tests that are
Blood tests used for the not blood based (e.g., tissue,
screening of at least 2 different saliva, urine, or other bodily
types of cancer; tests using any fluids).
analytes with any technology are KQ 5: Tests or interventions
eligible. not performed as a result of a
Tests that were designed for positive MCST.
cancer prognosis or surveillance in
those with cancer or who have
completed cancer treatment (i.e.,
evaluation for minimal residual
disease) are eligible as long as they
are being evaluated in an eligible
population as defined above.
Blood tests used in
combination with other tests such as
imaging are eligible.
MCSTs used instead of or in
addition to usual care screening are
eligible. We define usual care
screening as follows: mammography
(breast), direct visualization such as
colonoscopy or stool-based tests
(colorectal), low-dose computed
tomography (lung), cytology, human
papilloma virus testing (cervical),
and prostate specific antigen
(prostate).
KQ 5: Tests or procedures (imaging,
tissue biopsy, blood, urine, or
cerebrospinal fluid) to evaluate
positive signal(s) resulting from an
MCST or procedures used to surveil
patients who have a negative
evaluation after a positive MCST
signal.
------------------------------------------------------------------------
Comparator
------------------------------------------------------------------------
KQs 1, 2, 4............................ KQs 1, 2, 4: No comparator
No screening test............. group.
Usual care cancer screening as KQ 3: No reference standard for
defined above. comparison.
KQ 3: Tissue evaluation for KQ 5: Studies without a
confirmation of cancer; healthy comparator group will not be
asymptomatic status for controls. excluded.
KQ 5: No comparator required...........
------------------------------------------------------------------------
[[Page 62748]]
Outcomes
------------------------------------------------------------------------
KQ 1: Cancer mortality overall and by Outcomes not specifically
cancer type, all-cause mortality, indicated as included.
quality of life, functional status. Composite measures composed of
KQ 2a: Cumulative detection of cancer both included and excluded
overall and by cancer type. outcomes will be included but
KQ 2b: Cumulative detection of late- considered only in sensitivity
stage cancer overall and by cancer analyses.
type (i.e., Stage III or IV or organ-
specific definition of late stage);
distribution of cancer stage at
diagnosis (i.e., stage shift).
KQ 3: Accuracy (sensitivity, false
negatives, specificity, false
positives, predictive value) by cancer
type and by cancer stage.
KQ 4: Psychosocial and emotional
distress including anxiety and worry,
false reassurance resulting in
decrease in receipt of usual care
screening or change in health
behaviors associated with cancer
(alcohol, tobacco, drug use, diet,
physical activity), overdiagnosis, out-
of-pocket patient costs, patient
financial toxicity, and impact on
insurability.
KQ 5: Radiation exposure from imaging,
harms from invasive procedures, other
adverse effects from evaluation that
occur after a positive MCST, or out-of-
pocket patient costs, patient
financial toxicity, and impact on
insurability.
------------------------------------------------------------------------
Timing
------------------------------------------------------------------------
KQ 1: At least 5 years of followup..... KQ 1: Studies with less than 5
KQs 2, 4, 5: any timing................ years of followup.
KQ 3: At least 1 year of followup for
prediagnostic performance designs.\a\
For diagnostic performance designs,
controls must be considered cancer
free at the time of the sample.
------------------------------------------------------------------------
Setting
------------------------------------------------------------------------
Recruitment from outpatient Acute care settings,
clinical settings, including primary inpatient care settings.
care or specialty care, community- Countries with a
based or public health settings, United Nations Human
electoral rolls, or other population- Development Index of less than
based registries. high.
Countries with a United
Nations Human Development Index of
high or very high (Appendix A).
------------------------------------------------------------------------
Study Design
------------------------------------------------------------------------
KQs 1, 2, 4, 5: Randomized controlled For all KQ: Modeling studies,
trials; controlled trials. case series, case reports, in
KQs 1, 2: Registered NRSIs with 1 or vitro lab studies, studies
more eligible benefit outcomes listed designed to assess analytic
on study registration \b\. validity, narrative reviews,
KQs 4, 5: Unregistered NRSIs are also systematic reviews (reviews
eligible. will not be included but will
KQ 3: Studies that provide data related be manually reviewed to
to test accuracy; both prediagnostic identify primary research
test performance and diagnostic test studies that the search may
performance designs are eligible. have missed).
However, only diagnostic performance KQs 1, 2: Cohort studies that
designs conducted in external have not been registered or
validation cohorts are eligible. that report eligible outcomes
Further, if results for multiple that were not included in the
variations of the test are reported by study's registration \b\
authors, only results from the test studies designed with a sample
version selected for future commercial size that was not based on
use or for evaluation in future outcomes related to cancer
intervention studies will be eligible. detection or mortality.
KQ 3: Accuracy results derived
from discovery, development,
internal validation, or split
sample cohorts are not
eligible because multiple
analytes, technologies, or AI
classifiers are being
evaluated to develop the test
and these results do not
reflect the final state of the
test that would be used in
routine practice.
------------------------------------------------------------------------
Language
------------------------------------------------------------------------
English................................ Languages other than English.
------------------------------------------------------------------------
\a\ KQ 3 prediagnostic accuracy performance studies that use disease-
free longitudinal followup as a reference standard should have a
minimum of 1-year followup.
\b\ Refers to study registration in ClinicalTrials.gov database, or
another study registry such as those included in the World Health
Organization International Clinical Trials Registry Platform.
KQ = key question; MCST = multiple cancer screening test; NRSI = non-
randomized study of interventions.
Dated: July 25, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-16973 Filed 7-31-24; 8:45 am]
BILLING CODE 4160-90-P
