Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 83499 

agencies. The FSCAC will provide 

advice and recommendations to the 

Administrator of GSA, the FedRAMP 

Board, and agencies on technical, 

financial, programmatic, and 

operational matters regarding the secure 

adoption of cloud computing products 

and services. The FSCAC will ensure 

effective and ongoing coordination of 

agency adoption, use, authorization, 

monitoring, acquisition, and security of 

cloud computing products and services 

to enable agency mission and 

administrative priorities. The purposes 

of the Committee are: 

• To examine the operations of 

FedRAMP and determine ways that 

authorization processes can 

continuously be improved, including 

the following: 

Æ Measures to increase agency reuse 

of FedRAMP authorizations. 

Æ Proposed actions that can be 

adopted to reduce the burden, 

confusion, and cost associated with 

FedRAMP authorizations for cloud 

service providers. 

Æ Measures to increase the number of 

FedRAMP authorizations for cloud 

computing products and services 

offered by small businesses concerns (as 

defined by section 3(a) of the Small 

Business Act (15 U.S.C. 632(a)). 

Æ Proposed actions that can be 

adopted to reduce the burden and cost 

of FedRAMP authorizations for 

agencies. 

• Collect information and feedback 

on agency compliance with, and 

implementation of, FedRAMP 

requirements. 

• Serve as a forum that facilitates 

communication and collaboration 

among the FedRAMP stakeholder 

community. 

The FSCAC will meet no fewer than 

three (3) times a calendar year. Meetings 

shall occur as frequently as needed, 

called, and approved by the DFO. 

Purpose of the Meeting and Agenda 

The November 14, 2024 public 

meeting will be dedicated to continued 

deliberations in order to develop an 

initial draft of recommendations to the 

GSA Administrator on their initial two 

(2) priority initiatives of (1) identifying 

and documenting top challenges and 

proposing solutions around the barrier 

to entry for Cloud Service Providers 

(CSPs) with a focus on small businesses, 

third party assessment organizations 

(3PAOs), and small & large agencies, 

and (2) identifying and documenting 

ways to expedite the authorization 

process for Cloud Service Offerings 

(CSOs), such as exploring agile 

authorizations and other potential cost 

reductions, both labor and financial, 

with a focus on small businesses. 

Members of the public will have the 

opportunity to provide oral public 

comments during this meeting, and may 

also submit public comments in writing 

prior to this meeting by completing the 

public comment form on our website, 

https://gsa.gov/fscac. The meeting 

agenda will be posted on https://

gsa.gov/fscac prior to the meeting and 

can be accessed by selecting the 

‘‘Federal Secure Cloud Advisory 

Committee meetings’’ tab on the left, 

and then selecting the ‘‘November 14, 

2024—Virtual’’ meeting accordion in 

order to view all meeting materials, 

agenda, and registration information. 

Meeting Attendance 

The virtual meeting is open to the 

public. The meeting materials, 

registration information, and agenda 

will be made available prior to the 

meeting online at https://gsa.gov/fscac, 

by selecting the ‘‘Federal Secure Cloud 

Advisory Committee meetings’’ tab on 

the left, and then selecting the 

‘‘November 14, 2024—Virtual’’ meeting 

accordion. Registration for attending the 

virtual meeting is highly encouraged by 

5:00 p.m. EST, on Monday, November 

11, 2024. After registration, individuals 

will receive instructions on how to 

attend the meeting via email. 

For information on services for 

individuals with disabilities, or to 

request accommodation for a disability, 

please email the FSCAC staff at 

FSCAC@gsa.gov at least 10 days prior to 

the meeting date. Live captioning may 

be provided virtually. 

Public Comment 

Members of the public attending will 

have the opportunity to provide oral 

public comment during the FSCAC 

meeting. Written public comments can 

be submitted at any time by completing 

the public comment form on our 

website, https://gsa.gov/fscac, located 

under the ‘‘Get Involved’’ section. All 

written public comments will be 

provided to FSCAC members in advance 

of the meeting if received by 

Wednesday, November 6, 2024. 

Margaret Dugan 

Service-Level Liaison, Federal Acquisition 

Service, General Services Administration. 

[FR Doc. 2024–23788 Filed 10–15–24; 8:45 am] 

BILLING CODE 6820–34–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: In compliance with the 

Paperwork Reduction Act of 1995, 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 reinstatement with 

change of the information collection 

project ‘‘Patient Safety Organization 

Certification for Initial Listing and 

Related Forms, Patient Safety 

Confidentiality Complaint Form, and 

Common Formats’’, OMB No. 0935– 

0143 for which approval expired on 

September 30, 2024. This information 

collection was previously published in 

the Federal Register on August 12th, 

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 15, 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. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

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

email REPORTSCLEARANCEOFFICER@

ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Title: Patient Safety Organization 

Certification for Initial Listing and 

Related Forms, Patient Safety 

Confidentiality Complaint Form, and 

Common Formats. 

OMB No.: 0935–0143. 

OMB Expiration Date: September 

30th, 2024. 

Type of Request: Reinstatement, with 

change, of previously approved 

collection for which approval has 

expired. 


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83500 Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 

The Patient Safety and Quality 

Improvement Act of 2005 (the Patient 

Safety Act), signed into law on July 29, 

2005, was enacted in response to 

growing concern about patient safety in 

the United States and the Institute of 

Medicine’s 1999 report, ‘‘To Err is 

Human: Building a Safer Health 

System’’. The Patient Safety Act 

signifies the Federal Government’s 

commitment to fostering a culture of 

patient safety among health care 

providers; it offers a mechanism for 

creating an environment in which the 

causes of risks and hazards to patient 

safety can be thoroughly and honestly 

examined and discussed without fear of 

penalties and liabilities. It provides for 

the voluntary formation of Patient 

Safety Organizations (PSOs) that can 

collect, aggregate, and analyze 

confidential information reported 

voluntarily by health care providers. By 

analyzing substantial amounts of patient 

safety event information across multiple 

institutions, PSOs are able to identify 

patterns of failures and propose 

measures to eliminate or reduce risks 

and hazards. 

In order to implement the Patient 

Safety Act, the Department of Health 

and Human Services (HHS) issued the 

Patient Safety and Quality Improvement 

Final Rule (Patient Safety Rule, 42 CFR 

part 3), which became effective on 

January 19, 2009. The Patient Safety 

Rule outlines the requirements that 

entities must meet to become and 

remain listed as PSOs, the process by 

which the Secretary of HHS (Secretary) 

will accept certifications and list PSOs, 

and provisions pertaining to the 

confidentiality and privilege protections 

for patient safety work product (PSWP). 

When specific statutory requirements 

are met, the information collected and 

the analyses and deliberations regarding 

the information receive confidentiality 

and privilege protections under this 

legislation. The Secretary delegated 

authority to the Director of the Office for 

Civil Rights (OCR) to interpret and 

enforce the confidentiality protections 

of the Patient Safety Act (Federal 

Register, 71 FR 28701–2, May 17, 2006). 

Civil money penalties may be imposed 

for knowing or reckless impermissible 

disclosures of identifiable PSWP. AHRQ 

implements and administers the rest of 

the statute’s provisions. 

Pursuant to the Patient Safety Rule 

(42 CFR 3.102), an entity that seeks to 

be listed as a PSO by the Secretary must 

certify that it meets certain requirements 

and, upon listing, would meet other 

criteria. To remain listed for renewable 

three-year periods, a PSO must re-certify 

that it meets these obligations and 

would continue to meet them while 

listed. The Patient Safety Act and 

Patient Safety Rule also impose other 

obligations discussed below that a PSO 

must meet to remain listed. In 

accordance with the requirements of the 

Patient Safety Rule (see, e.g., 42 CFR 

3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), 

and 3.112), the entities seeking to be 

listed and to remain listed must 

complete the proposed forms, in order 

to attest to compliance with statutory 

criteria and the corresponding 

regulatory requirements. 

Proposed Revisions 

The following forms have revisions 

for clarification which are described 

below: 

1. PSO Certification for Initial 

Listing—This form has been revised to 

include clarification on the role of the 

primary point of contact. 

2. PSO Certification for Continued 

Listing—This form has been revised to 

include clarifications on the role of the 

primary point of contact, more precise 

language about whether there are any 

changes to the parent organization or 

any additional parent organizations and 

an additional note to clarify how users 

should determine the response to the 

standardized way they collect patient 

safety work product (PSWP). 

3. PSO Profile form—The form has 

been revised to add a new clinical 

discipline, ‘‘Clinical Dialysis Services’’. 

4. PSO Change of Listing Form—This 

form has been revised to note 

clarifications for the parent and the 

point of contact sections. 

5. PSO Voluntary Relinquishment 

Form—This form has been revised to 

include a change from street to mailing 

address for future contacts with delisted 

PSOs. 

6. Patient Safety Confidentiality 

Complaint Form—The form has two 

parts, the complaint form and the 

consent form. The complaint form was 

updated (1) to conform the notice to 

individuals about confidentiality of 

identifying information submitted on 

the complaint form with the existing 

approved OCR HIPAA Rules complaint 

form and (2) to update OCR contact 

information. The consent form was 

updated (1) to conform notice to 

individuals about confidentiality of 

identifying information submitted on 

the consent form with the existing 

approved OCR HIPAA Rules consent 

form, (2) to more fully describe OCR 

authorities allowing collection of 

information in Privacy Act of 1974 

notices, and (3) to update OCR contact 

information. 

7. Common Formats—Since the last 

approval, AHRQ has released Common 

Formats Event Reporting for Diagnostic 

Safety, Version 1.0 (CFER–DS V1.0) and 

the Common Formats for SurveillanceHospital V1.0 (CFS–H V1.0), which is a 

revision/update from the last version 

(CFS- H V0.3 Beta). 

OMB previously approved the 

Common Formats and forms described 

above in 2008, 2011, 2014, 2018, and 

2021. AHRQ will use these forms, other 

than the Patient Safety Confidentiality 

Complaint Form, to obtain information 

necessary to carry out its authority to 

implement the Patient Safety Act and 

Patient Safety Rule. This includes 

obtaining initial and subsequent 

certifications from entities seeking to be 

or remain listed as PSOs and for making 

the statutorily required determinations 

prior to and during an entity’s period of 

listing as a PSO. The PSO Division, 

housed in AHRQ’s Center for Quality 

Improvement and Patient Safety, uses 

this information. OCR will use the 

Patient Safety Confidentiality Complaint 

Form to collect information for the 

initial assessment of an incoming 

complaint. The form is modeled on 

OCR’s form for complaints alleging 

violations of the privacy of protected 

health information. 

Method of Collection 

The PSO forms are available in a 

format that allows completion and 

submission of the information online. 

AHRQ has updated the electronic 

submission of all forms, except the 

Patient Safety Confidentiality Compliant 

For which is administered by OCR, 

including the capability of the system to 

auto populate certain fields based on 

prior submissions by the PSOs. In 

addition, paper forms can be 

downloaded, completed and submitted 

through electronic mail, to pso@

ahrq.hhs.gov, or via postal mail. The 

Common Formats, accompanying user 

guide, and technical specifications are 

available as printable electronic files on 

the PSOPPC website at 

www.PSOPPC.org. 

In addition to paper submission of 

complaints, OCR facilitates electronic 

submission of complaints. First, the 

Patient Safety Confidentiality Complaint 

Form is available on the OCR website at 

https://www.hhs.gov/hipaa/filing-acomplaint/patient-safetyconfidentiality/index.html. The form is 

available to be downloaded 

electronically to a user’s own computer 

in a form that allows a complainant to 

fill out the form electronically if they so 

choose. The Patient Safety 

Confidentiality Complaint Form can 

then be printed and submitted, or 

submitted electronically via electronic 

mail. Second, the form is available in a 


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Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 83501 

format that allows completion and 

submission of the information online. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondent to provide the requested 

information and Exhibit 2 shows the 

estimated annualized cost burden 

associated with the respondents’ time to 

provide the requested information. The 

total burden hours are estimated to be 

100,811.58 hours annually and the total 

cost burden is estimated to be 

$4,946,824.23 annually. 

1. PSO Certification for Initial Listing 

Form: The average annual burden for 

the collection of information requested 

by the certification forms for initial 

listing is based upon a total average 

estimate of 11 respondents per year and 

an estimated time of 18 hours per 

response. The estimated response 

number includes submissions by not 

only entities listed as PSOs, but also 

entities that submit initial listing forms 

that do not become PSOs. 

2. PSO Certification for Continued 

Listing Form: The average annual 

burden for the collection of information 

requested by the certification form for 

continued listing has an estimated time 

of eight hours per response and 40 

responses annually. 

3. PSO Two Bona Fide Contracts 

Requirement Certification Form: The 

average annual burden for the collection 

of information requested by the PSO 

Two Bona Fide Contract Certification 

Form is based upon an estimate of 56 

respondents per year and an estimated 

one hour per response. 

4. PSO Disclosure Statement Form: 

The overall annual burden for the 

collection of information requested by 

the PSO Disclosure Statement Form is 

based upon an estimate of 3 respondents 

per year and estimated 3 hours per 

response. 

5. PSO Profile Form: The overall 

annual burden for the collection of 

information requested by the PSO 

Profile Form is based upon an estimate 

of 74 respondents per year and an 

estimated three hours per response. 

6. PSO Change of Listing Information 

Form: The average annual burden for 

the collection of information requested 

by the PSO Change of Listing 

Information Form is based upon an 

estimate of 51 respondents per year and 

an estimated time of five minutes per 

response. 

7. PSO Voluntary Relinquishment 

Form: The average annual burden for 

the collection of information requested 

by the PSO Voluntary Relinquishment 

Form is based upon a total average 

estimate of four respondents per year 

and an estimated time of thirty minutes 

per response. 

8. OCR Patient Safety Confidentiality 

Complaint Form: The overall annual 

burden estimate of one hour for the 

collection of information requested by 

the form is based on an estimate of one 

respondent per year and an estimated 

twenty minutes per response. 

9. Common Formats: AHRQ estimates 

that 5% FTE of a patient safety manager 

at a facility will be spent to administer 

the Common Formats, which is 

approximately 100 hours a year. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses 

per respondent 

Hours per 

response 

Total burden 

Hours 

1. PSO Certification for Initial Listing Form ......................................................... 11 1 18 198 

2. PSO Certification for Continued Listing Form ................................................. 40 1 8 320 

3. PSO Two Bona Fide Contracts Requirement Form ........................................ 56 1 1 56 

4. PSO Disclosure Statement Form .................................................................... 3 1 3 9 

5. PSO Profile Form ............................................................................................ 74 1 3 222 

6. PSO Change of Listing Information ................................................................ 51 1 05/60 4.25 

7. PSO Voluntary Relinquishment Form ............................................................. 4 1 30/60 2 

8. OCR Patient Safety Confidentiality Complaint Form ...................................... 1 1 20/60 .33 

9. Common Formats ............................................................................................ 1,000 1 100 100,000 

Total .............................................................................................................. ...................... NA NA 100,811.58 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Total 

burden hours 

Average hourly 

wage rate * Total cost 

1. PSO Certification for Initial Listing Form ............................................................................. 198 $49.07 $9,715.86 

2. PSO Certification for Continued Listing Form ..................................................................... 320 49.07 15,702.40 

3. PSO Two Bona Fide Contracts Requirement Form ........................................................... 56 49.07 2,747.92 

4. PSO Disclosure Statement Form ........................................................................................ 9 49.07 441.63 

5. PSO Profile Form ................................................................................................................ 222 49.07 10,893.54 

6. PSO Change of Listing Form .............................................................................................. 4.25 49.07 208.55 

7. PSO Voluntary Relinquishment Form ................................................................................. 2 49.07 98.14 

8. OCR Patient Safety Confidentiality Complaint Form .......................................................... .33 49.07 15.35 

9. Common Formats ................................................................................................................ 100,000 49.07 4,907,000 

Total .................................................................................................................................. ........................ ............................ 4,946,824.23 

* Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29–0000, National Compensation 

Survey, May 2023, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ https://www.bls.gov/oes/current/oes290000.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 


lotter on DSK11XQN23PROD with NOTICES1
83502 Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 

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: October 3, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–23708 Filed 10–15–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–25–0572] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘CDC and 

ATSDR Health Message Testing System 

(HMTS)’’ to the Office of Management 

and Budget (OMB) for review and 

approval. CDC previously published a 

‘‘Proposed Data Collection Submitted 

for Public Comment and 

Recommendations’’ notice on June 4, 

2024 to obtain comments from the 

public and affected agencies. CDC 

received one non-substantive comment. 

This notice serves to allow an additional 

30 days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

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. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

CDC and ATSDR Health Message 

Testing System (HMTS) (OMB Control 

No. 0920–0572, Exp. 10/31/2024)— 

Extension—Office of Communications 

(OC), Centers for Disease Control and 

Prevention (CDC) 

Background and Brief Description 

Before CDC disseminates a health 

message to the public, the message 

always undergoes scientific review. 

However, even though the message is 

based on sound scientific content, there 

is no guarantee that the public will 

understand a health message or that the 

message will move people to take 

recommended action. Communication 

theorists and researchers agree that for 

health messages to be as clear and 

influential as possible, target audience 

members or representatives must be 

involved in developing the messages 

and provisional versions of the 

messages must be tested with members 

of the target audience. Increasingly, 

there are circumstances when CDC must 

move swiftly to protect life, prevent 

disease, or calm public anxiety. Health 

message testing is even more important 

in these instances, because of the 

critical nature of the information need. 

In the interest of timely health 

message dissemination, many programs 

forgo the important step of testing 

messages on dimensions such as clarity, 

salience, appeal, and persuasiveness 

(i.e., the ability to influence behavioral 

intention). Skipping this step avoids the 

delay involved in the standard OMB 

review process, but at a high potential 

cost. Untested messages can waste 

communication resources and 

opportunities because the messages can 

be perceived as unclear or irrelevant. 

Untested messages can also have 

unintended consequences, such as 

jeopardizing the credibility of federal 

health officials. 

The CDC/ATSDR Health Message 

Testing System (HMTS), a Generic 

information collection, enables 

programs across CDC and ATSDR to 

collect the information they require in a 

timely manner to: 

• Ensure quality and prevent waste in 

the dissemination of health information 

by CDC to the public; 

• Refine message concepts and test 

draft materials for clarity, salience, 

appeal, and persuasiveness to target 

audiences; 

• Guide the action of health 

communication officials who are 

responding to health emergencies, 

Congressionally-mandated campaigns 

with short timeframes, media-generated 

public concern, time-limited 

communication opportunities, trends, 

and the need to refresh materials or 

dissemination strategies in an ongoing 

campaign. 

Each testing instrument will be based 

on specific health issues or topics. 

Although it is not possible to develop 

one instrument for use in all instances, 

the same kinds of questions are asked in 

most message testing. This package 

includes generic questions and formats 

that can be used to develop health 

message testing data collection 

instruments. These include a list of 

screening questions, comprised of 

demographic and introductory 

questions, along with other questions 

that can be used to create a mix of 

relevant questions for each proposed 

message testing data collection method. 

However, programs may request to use 

additional questions if needed. Message 

testing questions will focus on issues 

such as comprehension, impressions, 

personal relevance, content and 

wording, efficacy of response, channels, 

and spokesperson/sponsor. Such 

information will enable message 

developers to enhance the effectiveness 

of messages for intended audiences. 

Data collection methods proposed for 


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