47310 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage in or 

To Acquire Companies Engaged in 

Permissible Nonbanking Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors, 

Ann E. Misback, Secretary of the Board, 

20th Street and Constitution Avenue 

NW, Washington, DC 20551–0001, not 

later than September 8, 2021. 

A. Federal Reserve Bank of Atlanta 

(Erien O. Terry, Assistant Vice 

President) 1000 Peachtree Street NE, 

Atlanta, Georgia 30309. Comments can 

also be sent electronically to 

Applications.Comments@atl.frb.org: 

1. Peoples Bancshares, Inc., through 

its nonbank subsidiary, PB Community 

Impact Fund, LLC, both of Mendenhall, 

Mississippi; to engage de novo in 

community development activities 

pursuant to section 225.28(b)(12) of the 

Board’s Regulation Y. 

Board of Governors of the Federal Reserve 

System, August 19, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–18198 Filed 8–23–21; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Schedule of Visits and Use 

of Telemedicine for Routine Antenatal 

Care 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submissions. 

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 

Schedule of Visits and Use of 

Telemedicine for Routine Antenatal 

Care, 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 September 23, 2021. 

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: 

Jenae Benns, Telephone: 301–427–1496 

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 Schedule of Visits and Use 

of Telemedicine for Routine Antenatal 

Care. AHRQ is conducting this technical 

brief 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 Schedule of Visits and 

Use of Telemedicine for Routine 

Antenatal Care, including those that 

describe adverse events. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/schedule-visits-antenatal-care/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Schedule of Visits and 

Use of Telemedicine for Routine 

Antenatal Care helpful: 

D A list of completed studies that 

your organization has sponsored for this 

indication. 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: 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 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including 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 indication 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 indications 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: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 47311 

https://www.effectivehealthcare.ahrq.

gov/email-updates. 

The systematic 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 (KQs) 

KQ 1: What are the benefits and harms 

of different antenatal care schedules that 

vary by number or timing of visits for 

pregnancies requiring routine care and 

monitoring? 

KQ 2: What are the benefits and harms 

of telemedicine for providing routine 

antenatal care during pregnancy? 

KQ 3: What are patient, partner/ 

family, and provider perspectives, 

preferences, and experiences related to 

antenatal care visit schedules and use of 

telemedicine for routine antenatal care? 

PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING) 

Category Definition 

Population ....................................... KQ 1 & 2: 

• Pregnant individuals receiving routine/standard/basic/traditional antenatal care. 

• Allow studies of pregnant individuals at increased risk of poor outcomes (e.g., with gestational diabetes, 

gestational hypertension, fetal growth restriction, those receiving part of their antenatal care by maternalfetal medicine [MFM] or other specialists), as long as the study pertains to their routine antenatal care 

(i.e., not specifically to their enhanced care for their high-risk condition). 

KQ3: 

• Pregnant individuals. 

• Postpartum individuals. 

• Individuals considering or planning pregnancy. 

• Partners/family. 

• Providers of antenatal care (any profession or licensure). 

Allow studies that include high-risk patients, as long as the interventions being assessed pertain to routine 

care. 

Interventions .................................... KQ1: 

• Defined routine antenatal care schedules with focus on: 

D Total number of planned visits. 

D Overall schedule (timing, frequency, cadence). 

D Number of planned in-person visits. 

• Providers of routine antenatal visits include: Obstetricians/gynecologists, nurse practitioners, nurse midwives, nurses, physician assistants, family medicine clinicians. 

• Include interventions designed to evaluate different types of providers (e.g., a nurse instead of a doctor) 

if there is a concomitant comparison of different schedule of planned visits. 

• Include interventions designed to evaluate group visits if the group visits replace individual visits and 

there is a concomitant comparison of different schedule of planned visits. 

• Include interventions designed to evaluate home visits if the home visits replace in-clinic visits and there 

is a concomitant comparison of different schedule of planned visits. 

KQ2: 

• Antenatal care programs using telemedicine, including remote synchronous (real-time visits such as 

video calls) and asynchronous interactions (e.g., portal email discussions). 

Allow inclusion of devices designed to transmit information only if use of the devices are part of telemedicine interactions between patients and providers. 

KQ3: 

• Routine antenatal care, specific to interventions covered in KQ 1 and 2. 

Comparators ................................... KQ1: 

• Standard, routine, or alternative antenatal care schedule (as defined by the study). 

KQ2: 

• All in-person care, alternative telemedicine/remote care. 

• No (explicit) comparator. 

KQ3: 

• Not applicable. 

Outcomes (prioritized outcomes 

have an asterisk).

KQ1 & KQ2: 

• Pregnancy complications: 

D Maternal mortality. 

D Antenatal pregnancy complications. 

D Delivery-related complications. 

• Other maternal health outcomes: 

D Delivery outcomes. 

D Inappropriate weight gain. 

D Postpartum contraception—must be adjusted to account for patient preferences. 

• Maternal psychosocial, preferences, and related outcomes: 

D Quality of life measures.* 

D Psychosocial measures. 

D Mental health measures or diagnosis (e.g., anxiety, depression).* 

D Patient satisfaction with antenatal care.* 

D Patient preferences. 

D Resources. 

• Fetal/neonatal/infant outcomes: 

D Delivery timing. 

D Mortality. 

D Perinatal morbidity (e.g., birth trauma). 


lotter on DSK11XQN23PROD with NOTICES1
47312 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)—Continued 

Category Definition 

D Small for gestational age (e.g., birth weight <10% for similar age neonates),* low birth weight (e.g., 

<2.5 kg [5 lb, 8 oz]).* 

D Abnormal Apgar score (threshold, e.g. <7).* 

D Breastfeeding *—must be adjusted to account for patient preferences. 

D Need for social services. 

• Care utilization: 

D Attendance at planned antenatal visits (adherence/compliance). 

D Completion of ACOG recommended services.* 

D Number of unplanned visits.* 

D Number of referrals to other providers. 

D Unplanned hospital admissions. 

D Emergency room/triage visits. 

D Neonatal intensive care unit [NICU] admissions */length of stay. 

D Number of unplanned contacts (e.g., portal/phone messages). 

• Provider outcomes: 

D Provider satisfaction with antenatal care. 

• Harms: 

D Overdiagnosis (‘‘unnecessary’’ negative workups or misdiagnoses). 

D Delayed diagnoses (e.g., gestational diabetes).* 

D Harms to marginalized groups/equity outcomes. 

KQ3: 

• Perspectives and preferences related to interventions covered by KQ 1 and KQ 2. 

• Barriers and facilitators related to interventions covered by KQ 1 and KQ 2. 

Study Design ................................... KQ1 & KQ2: 

• Comparative studies (comparisons of different interventions), including parallel design, pre-post studies, 

and other comparisons. 

D Randomized or observational (nonrandomized). 

D Prospective or retrospective. 

• Surveys that compare interventions (specifically for patient preferences and satisfaction). 

• Registry (e.g., PRAMS [Pregnancy Risk Assessment Monitoring System], National family study) and 

other retrospective data sources may be eligible, but only if the comparison is between different numbers of planned or scheduled visits (KQ1) or if there is a specific evaluation of telemedicine (KQ2). 

• Single group studies (no direct comparison of interventions). 

D Preference and satisfaction outcomes only. 

• N ≥10 per intervention group. 

• (Existing systematic reviews and guidelines will be used as sources of otherwise missed eligible studies). 

KQ3: 

• Qualitative studies. 

• Interviews. 

• Focus groups. 

• Ethnographic studies. 

• Surveys with open-ended questions amenable to qualitative analysis. 

Timing ............................................. KQ1 & KQ2: 

• Interventions: During antenatal period (excluding labor and delivery). 

• Followup/Outcomes: Any (antenatal, peripartum, postpartum, or later). 

KQ3: 

• Any (as long as interventions of interest occurred during antenatal period). 

Setting ............................................. All KQs: 

• High income countries based on World Bank classifications. 

• Outpatient care. 

Dated: August 18, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–18125 Filed 8–23–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the renewal of 

the information collection project 

‘‘Medical Office Survey on Patient 

Safety Culture Database.’’ This proposed 

information collection was previously 

published in the Federal Register on 

May 3rd, 2021 and allowed 60 days for 

public comment. AHRQ did not receive 

any substantive comments from 

members of the public. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

DATES: Comments on this notice must be 

received by September 23, 2021. 


lotter on DSK11XQN23PROD with NOTICES1