41036 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 

• Information gathered will be used 

only internally for general service 

improvement and program management 

purposes and is not intended for release 

to the public; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 

and 

• Information gathered will yield 

qualitative information; the collections 

will not be designed or expected to 

yield statistically reliable results or used 

as though the results are generalizable to 

the population of study. 

Feedback collected under this generic 

clearance provides useful information, 

but it does not yield data that can be 

generalized to the overall population. 

This type of generic clearance for 

qualitative information will not be used 

for quantitative information collections 

that are designed to yield reliably 

actionable results, such as monitoring 

trends over time or documenting 

program performance. Such data uses 

require more rigorous designs that 

address: The target population to which 

generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior to 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

As a general matter, information 

collections submitted under this generic 

clearance will not result in any new 

system of records containing privacy 

information and will not ask questions 

of a sensitive nature, such as sexual 

behavior and attitudes, religious beliefs, 

and other matters that are commonly 

considered private. 

A Federal Register Notice with a 60- 

day comment period soliciting 

comments on this information 

collection was published on May 19, 

2021 (86 FR 27088). OGE did not 

receive any comments in response. 

OMB Number: 3209–0010. 

Type of Request: Extension. 

Affected Public: Individuals; Business 

or Other For-Profit Institutions; Not-ForProfit Institutions; State, Local, or Tribal 

Government. 

Projected average burden estimates 

for the next three years: 

Estimated Annual Number of 

Respondents: 91,425. 

Average Expected Annual Number of 

Activities: 39. 

Average Number of Respondents per 

Activity: 2,344. 

Responses per Respondent: 1. 

Annual Responses: 91,425. 

Average Minutes per Response: 3 

minutes. 

Annual Burden Hours: 3,900 hours. 

Frequency: On occasion. 

Request for Comments: Agency and 

public comment is invited specifically 

on the need for and practical utility of 

this information collection, the accuracy 

of OGE’s burden estimate, the 

enhancement of quality, utility and 

clarity of the information collected, and 

the minimization of burden (including 

the use of information technology). 

Comments will become a matter of 

public record. 

Approved: July 26, 2021. 

Emory Rounds, 

Director, U.S. Office of Government Ethics. 

[FR Doc. 2021–16221 Filed 7–29–21; 8:45 am] 

BILLING CODE 6345–03–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 (AHRQ), Health and Human 

Services (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) reapprove the proposed 

information collection project ‘‘Patient 

Safety Organization Certification for 

Initial Listing and Related Forms, 

Patient Safety Confidentiality 

Complaint Form, and Common 

Formats.’’ This proposed information 

collection was previously published in 

the Federal Register on May 12, 2021 

and allowed 60 days for public 

comment. AHRQ did not receive 

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 August 30, 2021. 

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 at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Patient Safety Organization 

Certification for Initial Listing and 

Related Forms, Patient Safety 

Confidentiality Complaint Form, and 

Common Formats’’ 

AHRQ invites the public to comment 

on this proposed information collection. 

The Patient Safety and Quality 

Improvement Act of 2005 (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 goal of the statute is to create a 

national learning system. By providing 

incentives of nation-wide 

confidentiality and legal privilege, the 

Patient Safety Act learning system 

improves patient safety and quality by 

providing an incentive for health care 

providers to work voluntarily with 

experts in patient safety to reduce risks 

and hazards to the safety and quality of 

patient care. 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) 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 


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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 41037 

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, Vol. 71, No. 95, May 17, 2006, 

p. 28701–2). Civil money penalties may 

be imposed for knowing or reckless 

impermissible disclosures of 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. 

Method of Collection 

With this submission, AHRQ is 

requesting approval of the following 

proposed administrative forms: 

1. PSO Certification for Initial Listing 

Form. This form, containing 

certifications of eligibility and a 

capacity and intention to comply with 

statutory criteria and regulatory 

requirements, is to be completed, in 

accordance with 42 U.S.C. 299b– 

24(a)(1), and the above-cited regulatory 

certification provisions, by an entity 

seeking to be listed by the Secretary as 

a PSO for an initial three-year period. 

2. PSO Certification for Continued 

Listing Form. In accordance with 42 

U.S.C. 299b–24(a)(2) and the abovecited regulatory certification provisions, 

this form is to be completed by a listed 

PSO seeking continued listing by the 

Secretary as a PSO for each successive 

three-year period. 

3. PSO Two Bona Fide Contracts 

Requirement Certification Form. To 

remain listed, a PSO must meet a 

statutory requirement in 42 U.S.C. 

299b–24(b)(1)(C) that it has contracts 

with more than one provider, within 

successive 24-month periods, beginning 

with the date of the PSO’s initial listing. 

This form is to be used by a PSO to 

certify whether it has met this statutory 

requirement and the corresponding 

regulatory provision. 

4. PSO Disclosure Statement Form. 

This form provides detailed instructions 

to a PSO regarding the disclosure 

statement it must submit and provides 

for the required certification by the PSO 

of the statement’s accuracy in 

accordance with the 42 U.S.C. 299b– 

24(b)(1)(E), when it (i) has a contract 

with a provider to carry out patient 

safety activities and (ii) it has financial, 

reporting, or contractual relationship(s) 

with that contracting provider or is not 

managed, controlled, and operated 

independently from that contracting 

provider. In accordance with the Patient 

Safety Act and the Patient Safety Rule, 

the Secretary is required to review each 

such report and make public findings as 

to whether a PSO can fairly and 

accurately carry out its responsibilities. 

5. PSO Profile Form. This form is 

designed to collect a minimum level of 

voluntary data necessary to develop 

aggregate statistics relating to PSOs, the 

types of providers they work with, and 

their general location in the US. The 

PSO Profile is intended to be completed 

annually by all PSOs that are ‘‘AHRQlisted’’ during any part of the previous 

calendar year. This information is 

collected by AHRQ’s PSO Privacy 

Protection Center (PSOPPC) and is used 

to populate the AHRQ PSO selection 

tool on the AHRQ PSO website, to 

generate slides presented at the PSO 

Annual Meeting, and to develop content 

for the annual report required by 42 

U.S.C. 299b–2(b)(2), the AHRQ National 

Healthcare Quality and Disparities 

Report. 

6. PSO Change of Listing Information 

Form. The Secretary is required under 

42 U.S.C. 299b–24(d) to maintain a 

publicly available list of PSOs. Under 

the Patient Safety Rule, that list 

includes, among other information, each 

PSO’s current contact information. The 

Patient Safety Rule, at 42 CFR 

3.102(a)(1)(vi), also requires that, during 

its period of listing, a PSO must 

promptly notify the Secretary of any 

changes in the accuracy of the 

information submitted for listing. 

7. PSO Voluntary Relinquishment 

Form. A PSO may voluntarily relinquish 

its status as a PSO for any reason. 

Pursuant to 42 CFR 3.108(c)(2), in order 

for the Secretary to accept a PSO’s 

notification of voluntary 

relinquishment, the notice must contain 

certain attestations and future contact 

information. This form provides an 

efficient manner for a PSO seeking 

voluntary relinquishment to provide all 

of the required information. 

OCR is requesting approval of the 

following administrative form: 

Patient Safety Confidentiality 

Complaint Form. The purpose of this 

collection is to allow OCR to collect the 

minimum information needed from 

individuals filing patient safety 

confidentiality complaints with OCR so 

that there is a basis for initial processing 

of those complaints. 

In addition, AHRQ is requesting 

approval for a set of common definitions 

and reporting formats (Common 

Formats). As authorized by 42 U.S.C. 

299b–23(b), AHRQ coordinates the 

development of the Common Formats 

that facilitate aggregation of comparable 

data at local, PSO, regional and national 

levels. The Common Formats allow 

PSOs and health care providers to 

voluntarily collect and submit 

standardized information regarding 

patient safety events to fulfill the 

national learning system envisioned by 

the Patient Safety Act. 

OMB previously approved the 

Common Formats and forms described 

above in 2008, 2011, 2014, and 2018. 

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. 

Use of the form is voluntary. It may help 

a complainant provide the essential 

information. Alternatively, a 

complainant may choose to submit a 

complaint in the form of a letter or 

electronically. An individual who needs 

help to submit a complaint in writing 

may call OCR for assistance. 


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41038 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 

Estimated Annual Respondent Burden 

The PSO information collection forms 

described below will be implemented at 

different times and frequencies due to 

the voluntary nature of seeking listing 

and remaining listed as a PSO, filing an 

OCR Patient Safety Confidentiality 

Complaint Form, and using the 

Common Formats. For the PSO forms, 

the burden estimates are based on the 

average of submissions received over 

the past three years. For the Common 

Formats, this estimate is based on the 

feedback that AHRQ has received 

during meetings and technical 

assistance calls from PSOs and other 

entities that have been utilizing the 

formats. 

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 

100,795.83 hours annually and the total 

cost burden is estimated to be 

$4,053,000.33 annually. 

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 10 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. After 

submitting a PSO Certification for Initial 

Listing Form, an entity may withdraw 

its form or submit a revised form, 

particularly after receiving technical 

assistance from AHRQ. In addition, 

AHRQ, on behalf of the Secretary, may 

deny listing if an entity does not meet 

the requirements of the Patient Safety 

Act and Patient Safety Rule. 

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 42 

responses annually. The PSO 

Certification for Continued Listing Form 

must be submitted by any interested 

PSO at least 75 days before the end of 

its current three-year listing period. 

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 51 

respondents per year and an estimated 

one hour per response. This collection 

of information takes place when the 

PSO notifies the Secretary that it has 

entered into two contracts with 

providers, which is required once every 

24 months. 

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 two respondents 

per year and estimated three hours per 

response. This information collection 

takes place when a PSO first reports 

having any of the specified types of 

additional relationships with a provider 

with which it has a contract to carry out 

patient safety activities. 

PSO Profile Form: The overall annual 

burden for the collection of information 

requested by the PSO Profile Form is 

based upon an estimate of 72 

respondents per year and an estimated 

three hours per response. The collection 

of information takes place annually with 

newly listed PSOs first eligible to 

submit the form in the calendar year 

after their initial listing by the Secretary. 

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 54 respondents per year and 

an estimated time of five minutes per 

response. This collection of information 

takes place on an ongoing basis as 

needed when there are changes to the 

PSO’s listing information. 

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. 

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. 

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. The use 

of the formats by PSOs and other 

entities is voluntary and is on an 

ongoing basis. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses 

per 

respondent 

Hours per 

response 

Total 

burden hours 

PSO Certification for Initial Listing Form ......................................................... 10 1 18 180 

PSO Certification for Continued Listing Form ................................................. 42 1 8 336 

PSO Two Bona Fide Contracts Requirement Form ........................................ 51 1 1 51 

PSO Disclosure Statement Form .................................................................... 2 1 3 6 

PSO Profile Form ............................................................................................ 72 1 3 216 

PSO Change of Listing Information ................................................................. 54 1 05/60 4.50 

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

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

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

Total .......................................................................................................... ........................ NA NA 100,795.83 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total 

burden hours 

Average 

hourly 

wage rate *

Total cost 

PSO Certification for Initial Listing Form ......................................................... 10 180 $40.21 $7,237.80 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 41039 

1https://www.whitehouse.gov/sites/ 

whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_

ICRs_5-28-2010.pdf. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form Number of 

respondents 

Total 

burden hours 

Average 

hourly 

wage rate *

Total cost 

PSO Certification for Continued Listing Form ................................................. 42 336 40.21 13,510.56 

PSO Two Bona Fide Contracts Requirement Form ........................................ 451 451 40.21 2,050.71 

PSO Disclosure Statement Form .................................................................... 2 6 40.21 241.26 

PSO Profile Form ............................................................................................ 72 216 40.21 8,685.36 

PSO Change of Listing Form .......................................................................... 54 4.50 40.21 180.95 

PSO Voluntary Relinquishment Form .............................................................. 4 2 40.21 80.42 

OCR Patient Safety Confidentiality Complaint Form ....................................... 1 .33 40.21 13.27 

Common Formats ............................................................................................ 1,000 100,000 40.21 4,021,000.00 

Total .......................................................................................................... ........................ ........................ ........................ 4,053,000.33 

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

Survey, May 2019, ‘‘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 

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: July 27, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–16326 Filed 7–29–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10398 #72] 

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 1 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 

CHIP State plan amendments, waivers, 

demonstrations, and reporting. This 

Federal Register notice seeks public 

comment on one or more of our 

collection of information requests that 

we believe are generic and fall within 

the scope of the umbrella. Interested 

persons are invited to submit comments 

regarding our burden estimates 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 must be received by 

August 13, 2021. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(see below) and the OMB control 

number (0938–1148). To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may access CMS’ 

website at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Following 

is a summary of the use and burden 

associated with the subject information 

collection(s). More detailed information 


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