40848 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

of Information Collection: CLIA 

Collection of Information Requirements 

Related to SARS–CoV–2 Test Results 

Reporting; Use: In order to be in 

compliance with the new CLIA 

mandatory SARS–CoV–2 test results 

reporting requirements, laboratories will 

need to develop a mechanism to track, 

collect, and report test results as well as 

update policies and procedures. In 

addition, Accreditation Organizations 

(AOs) and Exempt States (ESs) will need 

to update laboratory standards to reflect 

the reporting requirements and update 

policies and procedures related to 

reporting laboratories that do not report 

test results as required. 

The CDC has an information 

collection request (OMB Control 

Number 0920–1299) in order to collect 

laboratory data related to the COVID–19 

Pandemic Response. The CMS package 

(ICR) is for laboratory implementation 

and CMS monitoring of compliance 

with the CMS–3401–IFC CLIA-certified 

laboratory reporting requirements. 

The information collected by the 

Centers for Medicare and Medicaid 

Services (CMS) or its designee, such as 

a CMS agent or CMS approved 

laboratory accreditation organization, 

when conducting inspections will be 

used to determine a laboratory’s 

compliance with the CLIA SARS–CoV– 

2 test result reporting requirements. 

During an on-site survey, the Conditionlevel laboratory requirement at 42 CFR 

493.41and 493.1100(a) are assessed for 

compliance. The information is used by 

CMS in determining appropriate Civil 

Money Penalties (CMPs) when 

laboratories fail to report as required. 

Form Number: CMS–10757 (OMB 

control number: 0938–1391); Frequency: 

Daily; Affected Public: Private Sector 

Not-for-profit institutions and State, 

Local and Tribal Governments; Number 

of Respondents: 77,033; Total Annual 

Responses: 308,114; Total Annual 

Hours: 1,386,873 (For policy questions 

regarding this collection contact Sarah 

Bennett at 410–786–3354.) 

Dated: July 26, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–16200 Filed 7–28–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

State Annual Long-Term Care 

Ombudsman Report-National 

Ombudsman Reporting System; OMB 

#0985–0005 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living is announcing that 

the proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under section 506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

This 30-Day notice collects comments 

on the information collection 

requirements related to the State Annual 

Long-Term Care Ombudsman ReportNational Ombudsman Reporting System 

[OMB #0985–0005]. 

DATES: Submit written comments on the 

collection of information by August 30, 

2021. 

ADDRESSES: Submit written comments 

and recommendations for the proposed 

information collection within 30 days of 

publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find the information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attn: OMB Desk 

Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Louise Ryan, Administration for 

Community Living, Washington, DC 

20201, (206) 615–2299 or by email: 

louise.ryan@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, ACL 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

The Administration for Community 

Living (ACL) is requesting approval to 

collect data for the State Annual LongTerm Care Ombudsman Report-National 

Ombudsman Reporting System [OMB 

#0985–0005]. This request covers minor 

changes and corrections to the current 

information collection, with a total of 

11,154 annual burden hours. The data 

collection tool will enhance ACL’s 

ability to understand and report on 

Long-Term Care Ombudsman (LTCO) 

program operations, experiences of 

long-term care facility residents and will 

reflect changes in LTCO program 

operations and long-term supports and 

services policies, research, and 

practices. States will continue to 

provide the following data and narrative 

information in the report: 

1. Numbers and descriptions of cases 

filed and complaints made on behalf of 

long-term care facility residents to the 

statewide ombudsman program; 

2. Major issues identified impacting 

on the quality of care and life of longterm care facility residents; 

3. Statewide program operations; 

4. Ombudsman activities in addition 

to complaint investigation; and 

5. Organizational conflict of interest 

reporting as required by 45 CFR part 

1324.21. 

Comments in Response to the 60-Day 

Federal Register Notice 

A notice was published in the Federal 

Register on March 10, 2021 (86 FR 

13720). There were four public 

comments received during the 60-day 

FRN. Please see ACLs response to 

comment listed below. 

Two of the four respondents 

(Maryland Ombudsman program and 

the National Association of State 

Ombudsman Programs (NASOP)) 

recommended adding a new complaint 

code ‘‘infection control.’’ 

Response: ACL agrees to add one 

complaint code ‘‘infection control’’ and 

corresponding definition, examples and 

reporting tips. The Iowa Ombudsman 

program recommended adding 

clarifying information to the Code I05 

(Housekeeping) to be inclusive of 

infection control, ACL will incorporate 

its suggestion into the new ‘‘Infection 

control’’ code. Two of the four 

respondents (Maryland Ombudsman 

program and NASOP) recommended 

changes to the ‘‘examples and reporting 

tips’’ under complaint code J01. 

Response: ACL agrees to modify the 

‘‘examples and reporting tips’’ on 

Complaint Code J01 ‘‘Administrative 

oversight’’ to incorporate problems with 

a facility planning and responding to an 

emergency. 

ACL received the following comments 

and did not accept them for inclusion in 

NORS. 

The Maryland Ombudsman proposed 

adding more detail and examples in the 

description fields in the following cells: 

S02, S06, S08, S09, S12.1, and S13 

stating that this would give the State 

Ombudsman more guidance on how to 

approach the narratives and to help 

ensure greater consistency across the 

country. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40849 

Response: ACL in coordination with 

ACL’s grantee, the National 

Ombudsman Resource Center (NORC) 

created in-depth training and training 

manuals on all aspects of NORS 

reporting, including examples of 

narratives for both complaint examples 

and systems issues and does not believe 

that additional guidance is necessary. 

See https://ltcombudsman.org/omb_

support/nors. 

The Maryland Ombudsman program 

also recommended the addition of a 

new complaint code in Facility Policies, 

Procedures and Practices (Code J) for 

emergency planning complaints. The 

Maryland Ombudsman program noted 

that there have been many instances of 

facilities needing to temporarily or 

permanently relocate residents for a 

variety of reasons from disasters to lack 

of appropriate staff in the building, 

facility closure, or the facility did not 

have an appropriate plan or did not 

have a plan at all. 

Response: ACL will not add a new 

complaint code, but will modify 

complaint code J01 ‘‘Administrative 

Oversight’’ to be inclusive of emergency 

planning. 

One recommendation was to include 

the addition of a county field (e.g., 

Federal Information Processing 

Standard code). The commenter noted 

that although looking at differences/ 

variation between states is important 

and valuable, having the ability to look 

at differences/variation within each 

state would be immensely beneficial for 

the conduct of ACL’s functions and 

would allow for analytics to be shared 

with state ombudsmen and other 

programs nationwide. 

Response: ACL does not accept this 

recommendation because of the level of 

burden necessary to gather and report 

this level of data. 

NASOP made recommendations to 

broaden the types of activities reported 

on systems issues work performed by 

the State Long-Term Ombudsman, the 

Office and local Ombudsman entities. 

NASOP asserts that this reporting 

element would provide needed depth 

and clarity about whether a State LongTerm Care Ombudsman has the 

necessary independence and resources 

to perform systems advocacy as required 

by the Older Americans Act. NASOP 

proposes that data collected as narrative 

examples of Systems Issues is 

insufficient and does not have practical 

utility without additional data 

collection to explain the scope of a 

state’s work on systems advocacy. ‘‘By 

only collecting two examples of a 

systems issue from each state, ACL has 

no objective means of determining a 

state’s compliance with the Act nor the 

independence of the Office. With our 

proposed addition data collection in 

Table 3, ACL will collect and provide 

the public with a more accurate picture 

of whether a state program is fulfilling 

the requirements of the Act.’’ 

Response: ACL does not agree with 

NASOP’s assessment of the current data 

collection on systems advocacy for 

several reasons. First, the FY 2020 data 

is not yet final and ACL has not been 

able to share systems advocacy data. 

Additionally, while NORS is one part of 

measuring program effectiveness it is 

not the only way that ACL determines 

compliance with the Older Americans 

Act. ACL provides continuous technical 

assistance on matters of compliance, 

conducted in-depth review of states 

compliance with the Ombudsman 

program regulation, and worked with 

states to develop compliance plans. ACL 

also has an on-going project to evaluate 

the effectiveness of the Ombudsman 

program and has gathered in-depth data 

on both state and local level 

Ombudsman program’s ability to 

conduct systemic advocacy. See https:// 

acl.gov/programs/program-evaluationsand-reports. In addition, the proposed 

data collection would be very 

burdensome on state and local programs 

to collect and report because the two 

recommended data elements include a 

sub-set of 10 possible elements to select 

and to keep track of the number of 

instances of each sub-set ultimately 

resulting in 20 new data elements. This 

type of data would not add meaningful 

information that would benefit ACL 

considering the level of effort required 

of states to train on this type of data 

collection, adapt software and report. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: Approximately 11,154 hours, 

with 52 state Ombudsman programs 

responding annually. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

Total ................................................................................................................. 52 1 214.5 11,154 

Dated: July 23, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–16132 Filed 7–28–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Notice of Federal Review of the 

Missouri Protection and Advocacy 

System (P&A) 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: Representatives of the 

Administration on Disabilities (AoD), 

Administration for Community Living 

(ACL), will be conducting a federal 

review of the Missouri Protection and 

Advocacy System (P&A) on September 

13–17, 2021. AoD is soliciting 

comments from interested parties on 

your experiences with the program, and 

strategies employed by P&A in meeting 

the needs of individuals with 

developmental disabilities and their 

families in Missouri. You are 

encouraged to share your experiences by 

way of email or telephone. 

DATES: Comments must be submitted 

electronically or via telephone by 

September 22, 2021, 11:59 p.m. (EST) in 

order to be included in the final report. 

Email: Katherine.Cargill-Willis@

acl.hhs.gov. 

Telephone: 202–795–7322. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Cargill-Willis, Administration 

for Community Living, Administration 

on Disabilities, 330 C Street SW, 1st 

Floor, Washington, DC 20201, 202–795– 

7322. 

Dated: July 23, 2021. 

Alison Barkoff, 

Acting Administrator & Assistant Secretary 

for Aging. 

[FR Doc. 2021–16131 Filed 7–28–21; 8:45 am] 

BILLING CODE 4154–01–P 


jbell on DSKJLSW7X2PROD with NOTICES