Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80247 

comments received from the public and 

other agencies. 

During the comment period for this 

proposal, a copy of the proposed PRA 

OMB submission, including the draft 

reporting form and instructions, 

supporting statement (which contains 

more detail about the information 

collection and burden estimates than 

this notice), and other documentation, 

will be made available on the Board’s 

public website at https://

www.federalreserve.gov/apps/ 

reportingforms/home/review or may be 

requested from the agency clearance 

officer, whose name appears above. On 

the page displayed at the link above, 

you can find the supporting information 

by referencing the collection identifier, 

FR 3052. Final versions of these 

documents will be made available at 

https://www.reginfo.gov/public/do/ 

PRAMain, if approved. 

Request for Comment on Information 

Collection Proposal 

The Board invites public comment on 

the following information collection, 

which is being reviewed under 

authority delegated by the OMB under 

the PRA. Comments are invited on the 

following: 

a. Whether the proposed collection of 

information is necessary for the proper 

performance of the Board’s functions, 

including whether the information has 

practical utility; 

b. The accuracy of the Board’s 

estimate of the burden of the proposed 

information collection, including the 

validity of the methodology and 

assumptions used; 

c. Ways to enhance the quality, 

utility, and clarity of the information to 

be collected; 

d. Ways to minimize the burden of 

information collection on respondents, 

including through the use of automated 

collection techniques or other forms of 

information technology; and 

e. Estimates of capital or startup costs 

and costs of operation, maintenance, 

and purchase of services to provide 

information. 

At the end of the comment period, the 

comments and recommendations 

received will be analyzed to determine 

the extent to which the Board should 

modify the proposal. 

Proposal Under OMB Delegated 

Authority To Extend for Three Years, 

Without Revision, the Following 

Information Collection 

Collection title: Supervisory and 

Regulatory Survey. 

Collection identifier: FR 3052. 

OMB control number: 7100–0322. 

General description of collection: This 

survey collects information from 

financial institutions specifically 

tailored to the Federal Reserve’s 

supervisory, regulatory, and operational 

responsibilities. The frequency and 

content of the questions may depend on 

economic, regulatory, supervisory, and 

legislative developments. The surveys 

are conducted on a voluntary basis. 

Frequency: On Occasion. 

Respondents: Respondents may 

include bank holding companies, state 

member banks, savings and loan 

holding companies, intermediate 

holding companies, U.S. branches and 

agencies of foreign banking 

organizations (FBOs), Edge Act and 

agreement corporations, non-bank 

financial companies that the Financial 

Stability Oversight Council has 

determined should be supervised by the 

Board, or the combined domestic 

operations of FBOs. 

Total estimated number of 

respondents: 5,000. 

Estimated average hours per response: 

0.5. 

Total estimated annual burden hours: 

60,000. 

Board of Governors of the Federal Reserve 

System, September 27, 2024. 

Benjamin W. McDonough, 

Deputy Secretary and Ombuds of the Board. 

[FR Doc. 2024–22634 Filed 10–1–24; 8:45 am] 

BILLING CODE 6210–01–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 extension of the 

currently approved information 

collection project: Medical Office 

Survey on Patient Safety Culture 

Database. This proposed information 

collection was previously published in 

the Federal Register on July 31, 2024 

and allowed 60 days for public 

comment. AHRQ received no 

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 November 1, 2024. 

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. 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 REPORTSCLEARANCEOFFICER@

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 Surveys on Patient Safety 

Culture® (SOPS®) Medical Office 

Survey 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 of 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 January 2009, 

on the AHRQ website. 

The AHRQ SOPS Medical Office 

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 SOPS Medical Office Database 

(OMB NO. 0935–0196, last approved on 

September 24, 2021) was developed by 

AHRQ in 2011 in response to requests 


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80248 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

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. 

The goal of the Medical Office Survey 

on Patient Safety Culture Database is to 

promote improvements in the quality 

and safety of healthcare 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. 

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. 

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 several 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) 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 

SOPS Medical Office Survey. 

(3) 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. 

(4) Data File(s) Submission—POCs 

upload their data file(s), using the 

medical office data file specifications, to 

ensure that users submit their data in a 

standardized way (e.g., variable names, 

order, coding, formatting). The number 

of submissions to the database is likely 

to vary from submission period to 

submission period 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 30 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. 

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 

All information collection for the 

SOPS Medical Office Database is done 

electronically, except the Data Use 

Agreement (DUA) that medical offices 

print, sign and return (either via fax, by 

scanning and emailing or uploading to 

a secure website, or by mailing back). 

Registration, submission of medical 

office information, and data upload is 

handled online through a secure 

website. Customized feedback reports 

are delivered electronically (the person 

submitting the data will enter a 

username and password for access to a 

secure website from which to download 

their reports). 

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 30 individual 

medical offices each, will complete the 

database submission steps and forms. 

Each POC will submit the following: 

1. Eligibility and Registration Form— 

Estimated to take 3 minutes to complete. 

2. Medical Office Site Information 

Form—Estimated to take 5 minutes to 

complete. 

3. Data Use Agreement—Estimated to 

take 3 minutes to complete. 

4. Survey Data File(s) Submission— 

Estimated to take 1 hour to complete. 

The total burden is estimated to be 

308 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 

$19,891 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses 

per POC 

Hours per 

response 

Total burden 

hours 

1. Eligibility/Registration Form ......................................................................... 85 1 3/60 5 

2. Medical Office Site Information Form .......................................................... 85 30 5/60 213 

3. Data Use Agreement ................................................................................... 85 1 3/60 5 

4. Data File(s) Submission .............................................................................. 85 1 1 85 

Total .......................................................................................................... NA NA NA 308 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

1. Eligibility/Registration Form ................................................................................................. 5 $64.58 $323 

2. Medical Office Site Information Form .................................................................................. 213 64.58 13,756 

3. Data Use Agreement ........................................................................................................... 5 64.58 323 


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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80249 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

4. Data File(s) Submission ...................................................................................................... 85 64.58 5,489 

Total .................................................................................................................................. 308 NA 19,891 

* Mean hourly wage rate of $64.58 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2023 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, 44 U.S.C. 3501–3520, 

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: September 26, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–22578 Filed 10–1–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10844 and CMS– 

10157] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: 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 

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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by November 1, 2024. 

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-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 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: Revision of a currently 

approved collection; Title of 

Information Collection: Small Biotech 

Exception and Biosimilar Delay 

Information Collection Request (ICR) for 

Initial Price Applicability Year 2027; 

Use: Under the authority in sections 

11001 and 11002 of the Inflation 

Reduction Act of 2022 (Pub. L. 117– 

169), the Centers for Medicare & 

Medicaid Services (CMS) is 

implementing the Medicare Drug Price 

Negotiation Program, codified in 

sections 1191 through 1198 of the Social 

Security Act (the Act). The Information 

Collection Request Forms for the Small 

Biotech Exception and Biosimilar Delay 

Information Collection Request for 

Initial Price Applicability Year 2027 

must be submitted to CMS before CMS 

establishes the selected drug list for 

initial price applicability year 2027. 

Small Biotech Exception: In 

accordance with section 1192(d)(2) of 

the Act, the term ‘‘negotiation-eligible 

drug’’ excludes, with respect to the 

initial price applicability years 2026, 

2027, and 2028, a qualifying single 

source drug that meets the requirements 

for the exception for small biotech drugs 

(the ‘‘Small Biotech Exception,’’ or 

‘‘SBE’’). 


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