Supplemental Evidence and Data Request on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies, 99265-99267 [2024-28933]
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Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
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[FR Doc. 2024–28926 Filed 12–9–24; 8:45 am]
BILLING CODE 6210–01–P
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99265
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Recurrent Nephrolithiasis
in Adults and Children: Comparative
Effectiveness of Preventive Medical
Strategies
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
Recurrent Nephrolithiasis in Adults and
Children: Comparative Effectiveness of
Preventive Medical Strategies, 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published and unpublished pertinent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 January 9, 2025.
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.
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
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Recurrent Nephrolithiasis
in Adults and Children: Comparative
Effectiveness of Preventive Medical
Strategies. 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
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
99266
Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
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 Recurrent Nephrolithiasis
in Adults and Children: Comparative
Effectiveness of Preventive Medical
Strategies. The entire research protocol
is available online at: https://
effectivehealthcare.ahrq.gov/products/
kidney-stones/protocol.
This is to notify the public that the
EPC Program would find the following
information on Recurrent
Nephrolithiasis in Adults and Children:
Comparative Effectiveness of Preventive
Medical Strategies 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
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.
urine chemistry, or genetic testing
performed prior to treatment?
b. Does effectiveness vary by blood or
urine chemistry or genetic testing
performed as followup after treatment is
initiated?
KQ 2: What are the comparative
harms of preventive treatment with diet
or pharmacologic agents in nonpregnant
children and adults with history of
nephrolithiasis?
a. Do harms vary by stone
composition, diet assessment, blood or
urine chemistry, or genetic testing
performed prior to treatment?
b. Do harms vary by blood or urine
chemistry or genetic testing performed
as followup after treatment is initiated?
KQ 3: What is the comparative
effectiveness of surveillance imaging
strategies in nonpregnant children and
adults with history of nephrolithiasis?
a. Does effectiveness vary with
preventive treatment?
b. Does effectiveness vary by timing of
imaging?
KQ 4: What are the comparative
harms of surveillance imaging strategies
in nonpregnant children and adults
with history of nephrolithiasis?
a. Do harms vary with preventive
treatment?
b. Do harms vary by timing of
imaging?
Key Questions (KQ)
KQ 1: What is the comparative
effectiveness of preventive treatment
with diet or pharmacologic agents in
nonpregnant children and adults with
history of nephrolithiasis?
a. Does effectiveness vary by stone
composition, diet assessment, blood or
Contextual Question (CQ)
CQ 1: What is the natural history of
kidney stone recurrence in children and
adults?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing, and
Setting)
khammond on DSK9W7S144PROD with NOTICES
DETAILED INCLUSION AND EXCLUSION CRITERIA FOR SYSTEMATIC REVIEW
Category
Include
Exclude
Populations ...............
All KQs: Nonpregnant children and adults with a history of
nephrolithiasis.
Interventions .............
KQ 1, 1a, 1b, 2, 2a, 2b: Dietary and/or pharmacological
treatment, including dietary supplements and FDA-approved prescription or OTC drugs (Appendix A).
KQ 1a, 2a: Eligible interventions along with evaluation of
stone composition, dietary intake, genetic testing, or
blood or urine chemistries before treatment is started.
KQ 1b, 2b: Eligible interventions along with evaluation of
genetic testing or blood and urine chemistries after treatment initiation.
KQ 3, 3a, 3b, 4, 4a, 4b: Followup imaging when used for
routine surveillance (CT scan, renal ultrasound, abdominal radiograph) to detect radiographic stone recurrence,
size, composition, location, or shape.
KQ 1, 1a, 1b, 2, 2a, 2b: Placebo, usual diet, no preventive
treatment (for effectiveness); other eligible intervention
(for comparative effectiveness).
All KQs: Children and adults without a history of
nephrolithiasis; pregnant persons; persons receiving
treatment for acute renal colic or for stone removal or
expulsion.
KQs 1, 2: Nondietary and nonpharmacological interventions, including behavioral interventions aimed to improve treatment adherence; interventions for the acute
treatment of kidney stones (e.g., surgery, lithotripsy,
medical expulsion therapy). Prescriptions drugs and OTC
medications that are not FDA-approved or available in
the United States.
KQ 3, 4: Imaging not used specifically for surveillance of
kidney stones.
Comparators .............
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All KQs: No comparator (single arm study).
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Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices
99267
DETAILED INCLUSION AND EXCLUSION CRITERIA FOR SYSTEMATIC REVIEW—Continued
Category
Outcomes .................
Timing .......................
Setting ......................
Study Designs, Publication Types, and
Language.
Include
Exclude
KQ 3, 3a, 3b, 4, 4a, 4b: Eligible followup imaging for routine surveillance of kidney stones, no followup imaging.
All KQs: Patient-centered health outcomes: Incident symptomatic stones, urinary tract obstruction with acute renal
impairment, end-stage renal disease, urinary tract infection, stone-removal procedures/surgery, procedure-related morbidity, emergency department visits and hospitalizations, quality of life, missed school or work, preventive treatment-related adverse events, imaging-related adverse events, serious adverse events,
discontinuations due to adverse events.
Intermediate outcomes: Growth of existing stones, incident
radiographic stones, radiation exposure, incidental imaging findings.
KQ 1, 3: Studies that measure outcomes at least 12
months after baseline.
KQ 2, 4: Followup not limited.
Outpatient clinical settings including primary care, urology,
nephrology, or other specialty stone clinics; countries
with HDI12 of very high (Appendix B).
All KQs: Published in peer-reviewed literature, unpublished
studies with enough information about methods to determine risk of bias; English language. RCTs; for comparisons lacking sufficient RCT evidence, NRSIs with concurrent comparator group and primary study aim/outcome to assess a dietary or pharmacologic intervention
or surveillance imaging approach are eligible.
KQ 1, 1a, 1b, 3, 3a, 3b: Blood or urine chemistry measures, urine supersaturation measures, acute pain.
KQ 1, 3: Studies of less than 12-months duration.
Inpatient settings; Countries with HDI other than very high.
All KQs: Interrupted time series, case series, narrative reviews, editorials, and commentaries are not eligible; systematic reviews are not eligible but will be reviewed to
determine whether any included studies are eligible.
Studies with fewer than 30 participants at baseline per
study arm. Studies published in languages other than
English.
KQ 2: Studies designed to report epidemiologic associations between dietary factors and stone incidence.
CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme Human Development
Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-counter; RCT = randomized controlled trial.
Dated: December 4, 2024.
Marquita Cullom,
Associate Director.
SUPPLEMENTARY INFORMATION:
Royalty-Free Starting Material (MVAclone 1) for the Clinical Development,
Evaluation, and Commercialization of a
Viable Mpox Vaccine
[FR Doc. 2024–28933 Filed 12–9–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Materials;
Availability for Access
National Institute of Allergy
and Infectious Diseases, National
Institutes of Health, HHS.
ACTION: Notice.
AGENCY:
The material listed below is
owned by an agency of the U.S.
Government and is available for transfer
to achieve expeditious use and/or
commercialization of results of federally
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FOR FURTHER INFORMATION CONTACT:
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Transfer and Intellectual Property
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Benjamin Hurley at 240–669–5092 or
benjamin.hurley@nih.gov.
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SUMMARY:
VerDate Sep<11>2014
17:28 Dec 09, 2024
Jkt 265001
Worldwide, leading health authorities
have cited the growing need for a
commitment to equitable vaccine access
and its role in curtailing future
epidemics—a vision that cannot be
realized without significant
improvements in the speed, scale, and
access of vaccine manufacturing and
deployment in historically underserved
regions. For at-risk populations and
those with contraindications to
commonly deployed vaccines, such
initiatives are even more vital.
Modified vaccinia virus Ankara
(MVA), developed more than 30 years
ago as a highly attenuated candidate
smallpox vaccine, was recloned at the
U.S. National Institute of Allergy and
Infectious Diseases (NIAID) (referred to
here as ‘‘MVA clone-1’’) from a 1974originating passage and evaluated for
safety and immunogenicity in both
normal and partially immune-deficient
animals. Subsequent studies verified the
protective ability of this attenuated
vaccine against mpox in non-human
primates, and clinical efforts since have
resulted in FDA approval and
PO 00000
Frm 00056
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availability of a two-dose MVA vaccine
in the U.S.
In support of the global humanitarian
effort to achieve equitable vaccine
access and in light of the current public
health emergency of international
concern (PHEIC) declared by the World
Health Organization in 2024—which
has resulted in more than 500 deaths in
the Democratic Republic of the Congo
since the beginning of this year—the
National Institute of Allergy and
Infectious Diseases (NIAID) is seeking
inquiries from parties interested in
independent R&D and/or collaborative
research to further develop, evaluate,
and commercialize a viable mpox
vaccine for distribution (particularly in
developing nations/regions currently
having minimal access to mpox
vaccines) using NIH-provided starting
material (MVA clone-1). While
traditional licensing opportunities
related to mpox detection are also
available (e.g., antibodies, neutralization
assays), NIAID will transfer the MVA
clone-1 material in question on a
royalty-free basis to qualified partners in
an effort to combat the current PHEIC.
In the event that NIAID has limited
ability to distribute material, or if
supply approaches exhaustion, priority
will be given to collaborators with a
proposed plan demonstrating, in
E:\FR\FM\10DEN1.SGM
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Agencies
[Federal Register Volume 89, Number 237 (Tuesday, December 10, 2024)]
[Notices]
[Pages 99265-99267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28933]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies
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 Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies, 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 January 9, 2025.
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 Recurrent
Nephrolithiasis in Adults and Children: Comparative Effectiveness of
Preventive Medical Strategies. 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
[[Page 99266]]
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 Recurrent Nephrolithiasis in
Adults and Children: Comparative Effectiveness of Preventive Medical
Strategies. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/kidney-stones/protocol.
This is to notify the public that the EPC Program would find the
following information on Recurrent Nephrolithiasis in Adults and
Children: Comparative Effectiveness of Preventive Medical Strategies
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
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 comparative effectiveness of preventive treatment
with diet or pharmacologic agents in nonpregnant children and adults
with history of nephrolithiasis?
a. Does effectiveness vary by stone composition, diet assessment,
blood or urine chemistry, or genetic testing performed prior to
treatment?
b. Does effectiveness vary by blood or urine chemistry or genetic
testing performed as followup after treatment is initiated?
KQ 2: What are the comparative harms of preventive treatment with
diet or pharmacologic agents in nonpregnant children and adults with
history of nephrolithiasis?
a. Do harms vary by stone composition, diet assessment, blood or
urine chemistry, or genetic testing performed prior to treatment?
b. Do harms vary by blood or urine chemistry or genetic testing
performed as followup after treatment is initiated?
KQ 3: What is the comparative effectiveness of surveillance imaging
strategies in nonpregnant children and adults with history of
nephrolithiasis?
a. Does effectiveness vary with preventive treatment?
b. Does effectiveness vary by timing of imaging?
KQ 4: What are the comparative harms of surveillance imaging
strategies in nonpregnant children and adults with history of
nephrolithiasis?
a. Do harms vary with preventive treatment?
b. Do harms vary by timing of imaging?
Contextual Question (CQ)
CQ 1: What is the natural history of kidney stone recurrence in
children and adults?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Detailed Inclusion and Exclusion Criteria for Systematic Review
----------------------------------------------------------------------------------------------------------------
Category Include Exclude
----------------------------------------------------------------------------------------------------------------
Populations........................ All KQs: Nonpregnant children and All KQs: Children and adults without
adults with a history of a history of nephrolithiasis;
nephrolithiasis. pregnant persons; persons receiving
treatment for acute renal colic or
for stone removal or expulsion.
Interventions...................... KQ 1, 1a, 1b, 2, 2a, 2b: Dietary and/ KQs 1, 2: Nondietary and
or pharmacological treatment, nonpharmacological interventions,
including dietary supplements and including behavioral interventions
FDA-approved prescription or OTC aimed to improve treatment
drugs (Appendix A). adherence; interventions for the
KQ 1a, 2a: Eligible interventions acute treatment of kidney stones
along with evaluation of stone (e.g., surgery, lithotripsy,
composition, dietary intake, genetic medical expulsion therapy).
testing, or blood or urine Prescriptions drugs and OTC
chemistries before treatment is medications that are not FDA-
started. approved or available in the United
KQ 1b, 2b: Eligible interventions States.
along with evaluation of genetic KQ 3, 4: Imaging not used
testing or blood and urine specifically for surveillance of
chemistries after treatment kidney stones.
initiation.
KQ 3, 3a, 3b, 4, 4a, 4b: Followup
imaging when used for routine
surveillance (CT scan, renal
ultrasound, abdominal radiograph) to
detect radiographic stone
recurrence, size, composition,
location, or shape.
Comparators........................ KQ 1, 1a, 1b, 2, 2a, 2b: Placebo, All KQs: No comparator (single arm
usual diet, no preventive treatment study).
(for effectiveness); other eligible
intervention (for comparative
effectiveness).
[[Page 99267]]
KQ 3, 3a, 3b, 4, 4a, 4b: Eligible
followup imaging for routine
surveillance of kidney stones, no
followup imaging.
Outcomes........................... All KQs: Patient-centered health KQ 1, 1a, 1b, 3, 3a, 3b: Blood or
outcomes: Incident symptomatic urine chemistry measures, urine
stones, urinary tract obstruction supersaturation measures, acute
with acute renal impairment, end- pain.
stage renal disease, urinary tract
infection, stone-removal procedures/
surgery, procedure-related
morbidity, emergency department
visits and hospitalizations, quality
of life, missed school or work,
preventive treatment-related adverse
events, imaging-related adverse
events, serious adverse events,
discontinuations due to adverse
events.
Intermediate outcomes: Growth of
existing stones, incident
radiographic stones, radiation
exposure, incidental imaging
findings.
Timing............................. KQ 1, 3: Studies that measure KQ 1, 3: Studies of less than 12-
outcomes at least 12 months after months duration.
baseline.
KQ 2, 4: Followup not limited........
Setting............................ Outpatient clinical settings Inpatient settings; Countries with
including primary care, urology, HDI other than very high.
nephrology, or other specialty stone
clinics; countries with HDI\12\ of
very high (Appendix B).
Study Designs, Publication Types, All KQs: Published in peer-reviewed All KQs: Interrupted time series,
and Language. literature, unpublished studies with case series, narrative reviews,
enough information about methods to editorials, and commentaries are
determine risk of bias; English not eligible; systematic reviews
language. RCTs; for comparisons are not eligible but will be
lacking sufficient RCT evidence, reviewed to determine whether any
NRSIs with concurrent comparator included studies are eligible.
group and primary study aim/outcome Studies with fewer than 30
to assess a dietary or pharmacologic participants at baseline per study
intervention or surveillance imaging arm. Studies published in languages
approach are eligible. other than English.
KQ 2: Studies designed to report
epidemiologic associations between
dietary factors and stone
incidence.
----------------------------------------------------------------------------------------------------------------
CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme
Human Development Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-
counter; RCT = randomized controlled trial.
Dated: December 4, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-28933 Filed 12-9-24; 8:45 am]
BILLING CODE 4160-90-P