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
Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 47313 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Medical Office Survey on Patient Safety 

Culture Database 

In 1999, the Institute of Medicine 

called for health care organizations to 

develop a ‘‘culture of safety’’ such that 

their workforce and processes focus on 

improving the reliability and safety of 

care for patients (IOM, 1999; To Err is 

Human: Building a Safer Health 

System). To respond to the need for 

tools to assess patient safety culture in 

health care, AHRQ developed and pilot 

tested the Medical Office Survey on 

Patient Safety Culture with OMB 

approval (OMB No. 0935–0131; 

Approved July 5, 2007). 

The survey is designed to enable 

medical offices to assess provider and 

staff perspectives about patient safety 

issues, medical error, and error 

reporting. The survey includes 38 items 

that measure 10 composites of patient 

safety culture. In addition to the 

composite items, 14 items measure staff 

perceptions how often medical offices 

have problems exchanging information 

with other settings as well as other 

patient safety and quality issues. AHRQ 

made the survey publicly available 

along with a Survey User’s Guide and 

other toolkit materials in December 

2008 on the AHRQ website. 

The AHRQ Medical Office SOPS 

Database consists of data from the 

AHRQ Medical Office Survey on Patient 

Safety Culture and may include 

reportable, non-required supplemental 

items. Medical offices in the U.S. can 

voluntarily submit data from the survey 

to AHRQ, through its contractor, Westat. 

The Medical Office SOPS Database 

(OMB No. 0935–0196, last approved on 

September 10, 2018) was developed by 

AHRQ in 2011 in response to requests 

from medical offices interested in 

tracking their own survey results. Those 

organizations submitting data receive a 

feedback report, as well as a report of 

the aggregated, de-identified findings of 

the other medical offices submitting 

data. These reports are used to assist 

medical office staff in their efforts to 

improve patient safety culture in their 

organizations. 

Rationale for the information 

collection. The Medical Office SOPS 

and the Medical Office SOPS Database 

support AHRQ’s goals of promoting 

improvements in the quality and safety 

of health care in medical office settings. 

The survey, toolkit materials, and 

database results are all made publicly 

available on AHRQ’s website. Technical 

assistance is provided by AHRQ through 

its contractor at no charge to medical 

offices, to facilitate the use of these 

materials for medical office patient 

safety and quality improvement. 

Request for information collection 

approval. AHRQ requests that OMB 

reapprove, under the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ’s collection of information for 

the AHRQ Medical Office SOPS 

Database; OMB No. 0935–0196, last 

approved on September 10, 2018. 

This database: 

(1) Presents results from medical 

offices that voluntarily submit their 

data, 

(2) Provides data to medical offices to 

facilitate internal assessment and 

learning in the patient safety 

improvement process, and 

(3) Provides supplemental 

information to help medical offices 

identify their strengths and areas with 

potential for improvement in patient 

safety culture. 

This study is being conducted by 

AHRQ through its contractor, Westat, 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

healthcare and on systems for the 

delivery of such care, including 

activities with respect to: The quality, 

effectiveness, efficiency, 

appropriateness and value of healthcare 

services; quality measurement and 

improvement; and database 

development. 42 U.S.C. 299a(a)(1), (2), 

and (8). 

Method of Collection 

To achieve the goal of this project the 

following activities and data collections 

will be implemented: 

(1) Eligibility and Registration Form— 

The medical office point-of-contact 

(POC) completes a number of data 

submission steps and forms, beginning 

with the completion of an online 

Eligibility and Registration Form. The 

purpose of this form is to collect basic 

demographic information about the 

medical office and initiate the 

registration process. 

(2) Data Use Agreement—The purpose 

of the data use agreement, completed by 

the medical office POC, is to state how 

data submitted by medical offices will 

be used and provides privacy 

assurances. 

(3) Medical Office Site Information 

Form—The purpose of the site 

information form also completed by the 

medical office POC, is to collect 

background characteristics of the 

medical office. This information will be 

used to analyze data collected with 

Medical Office SOPS survey. 

(4) Data Files Submission—POCs 

upload their data file(s), using the 

medical office data file specifications, to 

ensure that users submit standardized 

and consistent data in the way variables 

are named, coded, and formatted. The 

number of submissions to the database 

is likely to vary each year because 

medical offices do not administer the 

survey and submit data every year. Data 

submission is typically handled by one 

POC who is either an office manager or 

a survey vendor who contracts with a 

medical office to collect their data. 

POCs submit data on behalf of 20 

medical offices, on average, because 

many medical offices are part of a health 

system that includes many medical 

office sites, or the POC is a vendor that 

is submitting data for multiple medical 

offices. 

Survey data from the AHRQ Medical 

Office Survey on Patient Safety Culture 

are used to produce three types of 

products: 

(1) A Medical Office SOPS Database 

Report that is made publicly available 

on the AHRQ website; and 

(2) Individual Medical Office Survey 

Feedback Reports that are customized 

for each medical office that submits data 

to the database; and 

(3) Research data sets of individuallevel and medical office-level deidentified data to enable researchers to 

conduct analyses. All data released in a 

data set are de-identified at the 

individual-level and the medical officelevel. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in the 

database. An estimated 85 POCs, each 

representing an average of 20 individual 

medical offices each, will complete the 

database submission steps and forms. 

Each POC will submit the following: 

• Eligibility and registration form 

(completion is estimated to take about 3 

minutes). 

• Data Use Agreement (completion is 

estimated to take about 3 minutes). 

• Medical Office Information Form 

(completion is estimated to take about 5 

minutes). 

• Survey data submission will take an 

average of one hour. 


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47314 Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices 

The total burden is estimated to be 

235.5 hours. 

Exhibit 2 shows the estimated 

annualized cost burden based on the 

respondents’ time to submit their data. 

The cost burden is estimated to be 

$12,312 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

Number of 

respondents/ 

POCs 

Number of 

responses 

per POC 

Hours per 

response 

Total burden 

hours 

Eligibility/Registration Form ............................................................................. 85 1 3/60 4.25 

Data Use Agreement ....................................................................................... 85 1 3/60 4.25 

Medical Office Information Form ..................................................................... 85 20 5/60 142 

Data Files Submission ..................................................................................... 85 1 1 85 

Total .......................................................................................................... NA NA NA 235.5 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Registration Form ............................................................................................ 85 4.25 $52.28 $222 

Data Use Agreement ....................................................................................... 85 4.25 52.28 222 

Medical Office Information Form ..................................................................... 85 142 52.28 7,424 

Data Files Submission ..................................................................................... 85 85 52.28 4,444 

Total .......................................................................................................... NA 235.5 NA 12,312 

* Mean hourly wage rate of $52.28 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2019 National 

Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/oes/current/naics4_621100.htm. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ’s health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 18, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–18126 Filed 8–23–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0856] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Vaccines and Related Biological 

Products Advisory Committee 

(VRBPAC). The general function of the 

committee is to provide advice and 

recommendations to FDA on regulatory 

issues. Members will participate via 

teleconference. At least one portion of 

the meeting will be closed to the public. 

FDA is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

September 30, 2021, from 8:30 a.m. to 

3:40 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

VeknygU5MKM. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0856. 

The docket will close on September 29, 

2021. Submit either electronic or 

written comments on this public 

meeting by September 29, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 29, 2021. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

September 29, 2021. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

September 23, 2021, will be provided to 

the committee. Comments received after 

September 23, 2021, and by September 

29, 2021, will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 


lotter on DSK11XQN23PROD with NOTICES1