Supplemental Evidence and Data Request on Medical Care for Adults With Down Syndrome, 97618-97619 [2024-28830]
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Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices
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[FR Doc. 2024–28847 Filed 12–6–24; 8:45 am]
BILLING CODE 6732–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Medical Care for Adults
With Down Syndrome
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
Medical Care for Adults with Down
Syndrome, 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Access to published and unpublished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 January 8, 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
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SUMMARY:
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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 Medical Care for Adults
with Down Syndrome. 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 Medical Care for Adults
with Down Syndrome. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/care-adults-down-syndrome/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Medical Care for Adults
with Down Syndrome 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,
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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.
Key Questions (KQ)
1. What are the benefits, harms, and
considerations of screening and
diagnostic interventions, for cooccurring medical and behavioral health
conditions in adults with Down
syndrome?
2. What are the benefits and harms,
and considerations of interventions to
treat co-occurring medical and
behavioral health conditions
specifically in adults with Down
syndrome?
Contextual Questions (CQ)
1. What conditions occur at an
increased or decreased prevalence in
adults with Down syndrome compared
to the general adult population. How
does prevalence vary by age/decade of
age, gender, setting (rural), and race/
ethnicity?
2. How do clinical symptoms and the
presentation of common co-occurring
behavioral/mental health conditions
(e.g., anxiety and depression) differ
among adults with Down syndrome
compared to their presentation in the
general adult population?
E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices
97619
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
PICOTS
KQ1
KQ2
Population ............................
Adults 18+ years of age with Down syndrome.
Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic
status.
Screening/diagnostic tests for co-occurring medical
conditions in adults with Down syndrome.
Alternative test for screening/diagnosis or no screening.
Adults 18+ years of age with Down syndrome
Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic
status.
Treatment interventions for co-occurring medical conditions in adults with Down syndrome.
For all conditions, compared with usual care or alternative intervention for treatment.
Intermediate outcomes:
Treatment adherence.
Lab values.
Healthcare utilization.
Final outcomes:
Change in standardized symptom measures.
Morbidity/mortality.
Quality of life.
Functional outcomes (e.g., activities of daily living, assisted living/nursing home status).
Caregiver or family outcomes (including caregiver
health and quality of life).
Harm outcomes:
Adverse treatment effects.
All duration and follow up.
US and non-US settings.
All healthcare settings (e.g., primary care, specialty
care, specialized clinics, etc.).
Intervention ..........................
Comparator ..........................
Outcome ...............................
Benefits: accurate diagnosis, time to diagnosis or intervention/treatment.
Health and quality of life outcomes.
Harms: adverse events related to screening/diagnosis
(mortality, medical trauma, unnecessary testing, etc.).
Timing ..................................
Setting ..................................
All duration and follow up.
US and non-US settings.
All healthcare settings (e.g., primary care, specialty
care, specialized clinics, etc.)
Abbreviations: KQ = key question.
Dated: December 3, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–28830 Filed 12–6–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–319, CMS–2088–
17, CMS–224–14 and CMS–R–297/CMS–
L564]
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
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Comments on the collection(s) of
information must be received by the
OMB desk officer by January 8, 2025.
ADDRESSES: 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. To obtain copies of a
supporting statement and any related
forms for the proposed collection(s)
summarized in this notice, please access
the CMS PRA website by copying and
pasting the following web address into
your web browser: https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.
DATES:
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
SUMMARY:
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
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FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Use: Title XIX and title XXI State
agencies are required to submit the
MEQC pilot planning document in
accordance with § 431.814(b), and the
MEQC case level and CAP reports based
on pilot findings in accordance with
§§ 431.816 and 431.820, respectively.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09DEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Notices]
[Pages 97618-97619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28830]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Medical Care for Adults
With Down Syndrome
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 Medical Care for
Adults with Down Syndrome, 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 8, 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 Medical Care for
Adults with Down Syndrome. 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 Medical Care for Adults with Down Syndrome. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/care-adults-down-syndrome/protocol.
This is to notify the public that the EPC Program would find the
following information on Medical Care for Adults with Down Syndrome
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)
1. What are the benefits, harms, and considerations of screening
and diagnostic interventions, for co-occurring medical and behavioral
health conditions in adults with Down syndrome?
2. What are the benefits and harms, and considerations of
interventions to treat co-occurring medical and behavioral health
conditions specifically in adults with Down syndrome?
Contextual Questions (CQ)
1. What conditions occur at an increased or decreased prevalence in
adults with Down syndrome compared to the general adult population. How
does prevalence vary by age/decade of age, gender, setting (rural), and
race/ethnicity?
2. How do clinical symptoms and the presentation of common co-
occurring behavioral/mental health conditions (e.g., anxiety and
depression) differ among adults with Down syndrome compared to their
presentation in the general adult population?
[[Page 97619]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
PICOTS KQ1 KQ2
----------------------------------------------------------------------------------------------------------------
Population....................... Adults 18+ years of age with Down Adults 18+ years of age with Down
syndrome. syndrome
Subgroups: demographics (age, race, Subgroups: demographics (age, race,
ethnicity, gender), geography (rural ethnicity, gender), geography (rural
and urban), socioeconomic status. and urban), socioeconomic status.
Intervention..................... Screening/diagnostic tests for co- Treatment interventions for co-
occurring medical conditions in occurring medical conditions in
adults with Down syndrome. adults with Down syndrome.
Comparator....................... Alternative test for screening/ For all conditions, compared with
diagnosis or no screening. usual care or alternative
intervention for treatment.
Outcome.......................... Benefits: accurate diagnosis, time to Intermediate outcomes:
diagnosis or intervention/treatment. Treatment adherence.
Health and quality of life outcomes. Lab values.
Harms: adverse events related to Healthcare utilization.
screening/diagnosis (mortality, Final outcomes:
medical trauma, unnecessary testing, Change in standardized symptom
etc.). measures.
Morbidity/mortality.
Quality of life.
...................................... Functional outcomes (e.g., activities
of daily living, assisted living/
nursing home status).
Caregiver or family outcomes
(including caregiver health and
quality of life).
Harm outcomes:
Adverse treatment effects.
Timing........................... All duration and follow up. All duration and follow up.
Setting.......................... US and non-US settings. US and non-US settings.
All healthcare settings (e.g., primary All healthcare settings (e.g.,
care, specialty care, specialized primary care, specialty care,
clinics, etc.) specialized clinics, etc.).
----------------------------------------------------------------------------------------------------------------
Abbreviations: KQ = key question.
Dated: December 3, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-28830 Filed 12-6-24; 8:45 am]
BILLING CODE 4160-90-P
