Meeting of the National Advisory Council for Healthcare Research and Quality, 18021-18022 [2022-06527]
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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Notices
Modifiers/Subgroups of Interest
• Race, ethnicity
• Maternal age, parity, singleton/
multiple pregnancy, mode of delivery
(e.g., cesarean versus vaginal delivery,
preterm versus term)
• Co-occurring disorders (e.g., obesity,
diabetes)
• Subgroups defined by potential
indicators of social determinants of
health (e.g., insurance coverage,
English proficiency, income,
educational attainment)
• Timing of MgSO4 administration or
onset of preeclampsia with severe
features with respect to delivery
Æ Antepartum
Æ Intrapartum
Æ Postpartum
• Individuals with reduced kidney
function
•
•
•
Interventions
• Peripartum MgSO4 administration
Æ Any dose, route (except oral),
timing, duration of treatment,
concomitant treatment, or regimen
• Exclude: Oral magnesium
supplementation
lotter on DSK11XQN23PROD with NOTICES1
Comparators
• Alternative MgSO4 regimens
Æ Different criteria for initiation of
treatment
Æ Different criteria for stopping (or
continuing) treatment
Æ Different criteria for altering dosing
during treatment
Æ Different loading dose
Æ Different planned total dose
Æ Different route
Æ Different planned duration of
treatment
Æ Tailored interventions based on
pharmacokinetic monitoring (i.e.,
based on serum Mg levels)
Æ Combined treatment with
antihypertensive medications
(including regimens with
alternative antihypertensive
medications)
Æ Other variations in regimens
• Exclude: No MgSO4 treatment (either
placebo, no treatment, or non-MgSO4
comparators)
Æ Except retain RCTs with placebo,
no treatment, or non-MgSO4
comparators and NRCSs comparing
MgSO4 with no MgSO4 for
postpartum preeclampsia with
severe features These may be
included in network meta-analyses
to indirectly compare alternative
MgSO4 regimens.
Outcomes (prioritized outcomes have an
asterisk and are in bold font)
• Severe maternal health outcomes
Æ Maternal mortality, including
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•
•
pregnancy-related mortality *
Æ Severe maternal morbidity * (e.g.,
eclampsia *, stroke)
Newborn/child outcomes
Æ Infant morbidities * (e.g.,
respiratory depression, Apgar score)
Æ Breastfeeding outcomes * (e.g.,
initiation, success, duration)
Æ Fetal/neonatal mortality
Æ Cognitive function
Healthcare utilization and functional
status
Æ Length of postpartum hospital stay
Æ Time to ambulation
Patient reported outcomes
Æ Patient reported experience
measures (PREMs), for example
D Satisfaction with care *
D Quality of communication
D Support to manage preeclampsia
treatment
Æ Patient reported outcome measures
(PROMs), for example
D Global Quality of life *, e.g., SF–36
D Specific to postpartum
population*, e.g., Mother-Generated
Index, Functional Status After
Childbirth scales
D Psychosocial distress
• Anxiety *, e.g., State-Trait Anxiety
Inventory (STAI)
• Depression *, e.g., Edinburgh
Postnatal Depression Score (EPDS)
• Stress *, e.g., Impact of Event Scale
D Maternal-neonatal bonding *, e.g.,
Postpartum Bonding Questionnaire
Reduction of health disparities *
(increase in disparities included
under Harms)
Maternal harms/adverse events
Æ Magnesium-related toxicity *
(respiratory depression, loss of
reflexes, reduced urine output, need
for calcium infusion) *
Æ Other clinically important adverse
events* (e.g., hypotension,
neuromuscular blockade)
Æ Adverse drug interactions * (e.g.,
with antihypertensive medications)
Æ Generation or exacerbation of
health disparities *
Æ Other serious (e.g., severe flushing)
Study Design
• Comparative studies (comparisons of
different interventions)
Æ Randomized controlled trials N ≥10
per group
D Comparisons between MgSO4 and
placebo/no treatment or non-MgSO4
treatments must be randomized (for
potential network meta-analyses)
Æ Nonrandomized comparative
studies (prospective or
retrospective) that use statistical
techniques (e.g., regression
adjustment, propensity score
matching, inverse probability
weighting) to reduce bias due to
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18021
confounding
• Any publication language (unless
cannot be translated)
• Exclude
Æ Single group (noncomparative)
studies
Æ Case-control studies
Æ Claims database analyses
Æ Feasibility studies
Æ Qualitative studies
Æ Conference abstracts prior to 2020
(without subsequent, eligible peerreviewed publication)
Timing
• Intervention: Peripartum (antenatal,
during delivery hospitalization,
postpartum)
• Outcomes: Any
Setting
• Inpatient management
• Any publication date
• Any country
Dated: March 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–06532 Filed 3–28–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ).
ACTION: Notice of public meeting.
AGENCY:
This notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality.
SUMMARY:
The meeting will be held on
Thursday, May 12, 2022, from 10:00
a.m. to 3:00 p.m.
ADDRESSES: The meeting will be held
virtually.
DATES:
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Designated
Management Official, at the Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Mail Stop 06E37A,
Rockville, Maryland 20857, (301) 427–
1456. For press-related information,
please contact Bruce Seeman at (301)
427–1998 or Bruce.Seeman@
AHRQ.hhs.gov.
Closed captioning will be provided
during the meeting. If another
reasonable accommodation for a
disability is needed, please contact the
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18022
Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Notices
Food and Drug Administration (FDA)
Office of Equal Employment
Opportunity and Diversity Management
on (301) 827–4840, no later than
Monday, May 2, 2022. The agenda,
roster, and minutes will be available
from Ms. Heather Phelps, Committee
Management Officer, Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Rockville, Maryland
20857. Ms. Phelps’ phone number is
(301) 427–1128.
SUPPLEMENTARY INFORMATION:
I. Purpose
In accordance with section 10(a) of
the Federal Advisory Committee Act, 5
U.S.C. app., this notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality (the Council). The Council is
authorized by Section 941 of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director of AHRQ on
matters related to AHRQ’s conduct of its
mission including providing guidance
on (A) priorities for health care research,
(B) the field of health care research
including training needs and
information dissemination on health
care quality and (C) the role of the
Agency in light of private sector activity
and opportunities for public private
partnerships. The Council is composed
of members of the public, appointed by
the Secretary, and Federal ex-officio
members specified in the authorizing
legislation.
lotter on DSK11XQN23PROD with NOTICES1
II. Agenda
On Thursday, May 12, 2022, the
Council meeting will convene at 10:00
a.m., with the call to order by the
Council Chair and approval of previous
Council summary notes. The meeting
will begin with an introduction of NAC
members, an update on AHRQ
activities, and a discussion about new
opportunities with AHRQ’s new
Director. The agenda will also include
discussions about AHRQ and the
Patient-Centered Outcomes Research
(PCOR) Trust Fund and AHRQ’s role in
conducting and supporting health
services research, analysis and
evaluations focused on understanding
the effects of healthcare financing
policies. The meeting will adjourn at
3:00 p.m. The meeting is open to the
public. For information regarding how
to access the meeting as well as other
meeting details, including information
on how to make a public comment,
please go to https://www.ahrq.gov/news/
events/nac/. The final agenda will be
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available on the AHRQ website no later
than Thursday, May 5, 2022.
Dated: March 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–06527 Filed 3–28–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meetings
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of five AHRQ
subcommittee meetings.
AGENCY:
The subcommittees listed
below are part of AHRQ’s Health
Services Research Initial Review Group
Committee. Grant applications are to be
reviewed and discussed at these
meetings. Each subcommittee meeting
will be closed to the public.
DATES: See below for dates of meetings:
1. Healthcare Research Training (HCRT)
Dates: May 19–20, 23, 2022
July 15, 2022
2. Healthcare Effectiveness and
Outcomes Research (HEOR)
Date: June 8–9, 2022
3. Healthcare Information Technology
Research (HITR)
Date: June 9–10, 2022
4. Healthcare Safety and Quality
Improvement Research (HSQR)
Date: June 15–16, 2022
5. Health System and Value Research
(HSVR)
Date: June 16–17, 2022
ADDRESSES: Agency for Healthcare
Research and Quality (Virtual Review),
5600 Fishers Lane, Rockville, Maryland
20857.
FOR FURTHER INFORMATION CONTACT: (To
obtain a roster of members, agenda or
minutes of the non-confidential portions
of the meetings.)
Jenny Griffith, Committee
Management Officer, Office of
Extramural Research Education and
Priority Populations, Agency for
Healthcare Research and Quality
(AHRQ), 5600 Fishers Lane, Rockville,
Maryland 20857, Telephone (301) 427–
1557.
SUPPLEMENTARY INFORMATION: In
accordance with section 10(a)(2) of the
Federal Advisory Committee Act (5
U.S.C. app. 2), AHRQ announces
meetings of the above-listed scientific
peer review groups, which are
subcommittees of AHRQ’s Health
SUMMARY:
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Services Research Initial Review Group
Committee. The subcommittee meetings
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. app. 2 section 10(d), 5 U.S.C.
552b(c)(4), and 5 U.S.C. 552b(c)(6). The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.
Dated: March 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–06525 Filed 3–28–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10398 #74 and
#76]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
notices. The scope of the April 2021
umbrella accounts for Medicaid and
SUMMARY:
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Agencies
[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Notices]
[Pages 18021-18022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Meeting of the National Advisory Council for Healthcare Research
and Quality
AGENCY: Agency for Healthcare Research and Quality (AHRQ).
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a meeting of the National Advisory
Council for Healthcare Research and Quality.
DATES: The meeting will be held on Thursday, May 12, 2022, from 10:00
a.m. to 3:00 p.m.
ADDRESSES: The meeting will be held virtually.
FOR FURTHER INFORMATION CONTACT: Jaime Zimmerman, Designated Management
Official, at the Agency for Healthcare Research and Quality, 5600
Fishers Lane, Mail Stop 06E37A, Rockville, Maryland 20857, (301) 427-
1456. For press-related information, please contact Bruce Seeman at
(301) 427-1998 or [email protected].
Closed captioning will be provided during the meeting. If another
reasonable accommodation for a disability is needed, please contact the
[[Page 18022]]
Food and Drug Administration (FDA) Office of Equal Employment
Opportunity and Diversity Management on (301) 827-4840, no later than
Monday, May 2, 2022. The agenda, roster, and minutes will be available
from Ms. Heather Phelps, Committee Management Officer, Agency for
Healthcare Research and Quality, 5600 Fishers Lane, Rockville, Maryland
20857. Ms. Phelps' phone number is (301) 427-1128.
SUPPLEMENTARY INFORMATION:
I. Purpose
In accordance with section 10(a) of the Federal Advisory Committee
Act, 5 U.S.C. app., this notice announces a meeting of the National
Advisory Council for Healthcare Research and Quality (the Council). The
Council is authorized by Section 941 of the Public Health Service Act,
42 U.S.C. 299c. In accordance with its statutory mandate, the Council
is to advise the Secretary of the Department of Health and Human
Services and the Director of AHRQ on matters related to AHRQ's conduct
of its mission including providing guidance on (A) priorities for
health care research, (B) the field of health care research including
training needs and information dissemination on health care quality and
(C) the role of the Agency in light of private sector activity and
opportunities for public private partnerships. The Council is composed
of members of the public, appointed by the Secretary, and Federal ex-
officio members specified in the authorizing legislation.
II. Agenda
On Thursday, May 12, 2022, the Council meeting will convene at
10:00 a.m., with the call to order by the Council Chair and approval of
previous Council summary notes. The meeting will begin with an
introduction of NAC members, an update on AHRQ activities, and a
discussion about new opportunities with AHRQ's new Director. The agenda
will also include discussions about AHRQ and the Patient-Centered
Outcomes Research (PCOR) Trust Fund and AHRQ's role in conducting and
supporting health services research, analysis and evaluations focused
on understanding the effects of healthcare financing policies. The
meeting will adjourn at 3:00 p.m. The meeting is open to the public.
For information regarding how to access the meeting as well as other
meeting details, including information on how to make a public comment,
please go to https://www.ahrq.gov/news/events/nac/. The final agenda
will be available on the AHRQ website no later than Thursday, May 5,
2022.
Dated: March 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-06527 Filed 3-28-22; 8:45 am]
BILLING CODE 4160-90-P