Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Notices 18021 

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 

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 

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 

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: 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 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 


lotter on DSK11XQN23PROD with NOTICES1
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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meetings 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of five AHRQ 

subcommittee meetings. 

SUMMARY: 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 

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 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: 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 


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