46854 Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–17863 Filed 8–19–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10280, CMS– 

1557 and CMS–3070G–I] 

Agency Information Collection 

Activities: Proposed Collection; 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send 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 

October 19, 2021. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. 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. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address 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: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10280 Home Health Change of 

Care Notice 

CMS–1557 Survey Report Form for 

Clinical Laboratory Improvement 

Amendments (CLIA) and Supporting 

Regulations 

CMS–3070G–I ICF/IID Survey Report 

Form and Supporting Regulations 

Under the 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 

requires federal agencies to publish a 

60-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. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of the 

Information Collection: Home Health 

Change of Care Notice; Use: The 

purpose of the Home Health Change of 

Care Notice (HHCCN) is to notify 

original Medicare beneficiaries 

receiving home health care benefits of 

plan of care changes. Home health 

agencies (HHAs) are required to provide 

written notice to Original Medicare 

beneficiaries under various 

circumstances involving the reduction 

or termination of items and/or services 

consistent with Home Health Agencies 

Conditions of Participation (COPs). 

The home health COP requirements 

are set forth in § 1891[42 U.S.C. 

1395bbb] of the Social Security Act (the 

Act). The implementing regulations 

under 42 CFR 484.10(c) specify that 

Medicare patients receiving HHA 

services have rights. The patient has the 

right to be informed, in advance about 

the care to be furnished, and of any 

changes in the care to be furnished. The 

HHA must advise the patient in advance 

of the disciplines that will furnish care, 

and the frequency of visits proposed to 

be furnished. The HHA must advise the 

patient in advance of any change in the 

plan of care before the change is made.’’ 

Notification is required for covered 

and non-covered services listed in the 

plan of care (POC). The beneficiary will 

use the information provided to decide 

whether or not to pursue alternative 

options to continue receiving the care 

noted on the HHCCN. Form Number: 

CMS–10280 (OMB control number: 

0938–1196); Frequency: Yearly; Affected 

Public: Private Sector (Business or other 

for-profits, Not-for-Profit Institutions); 

Number of Respondents: 11,157; Total 

Annual Responses: 12,385,108; Total 

Annual Hours: 824,848. (For policy 

questions regarding this collection 

contact Jennifer McCormick at 410–786– 

2852.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations; Use: The form 

is used to report surveyor findings 

during a CLIA survey. For each type of 

survey conducted (i.e., initial 

certification, recertification, validation, 

complaint, addition/deletion of 

specialty/subspecialty, transfusion 

fatality investigation, or revisit 

inspections) the Survey Report Form 

incorporates the requirements specified 

in the CLIA regulations. Form Number: 

CMS–1557 (OMB control number: 

0938–0544); Frequency: Biennially; 

Affected Public: Private sector (Business 

or other for-profit and Not-for-profit 

institutions, State, Local or Tribal 

Governments and Federal Government); 

Number of Respondents: 15,975; Total 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 46855 

Annual Responses: 7,988; Total Annual 

Hours: 3,994. (For policy questions 

regarding this collection contact 

Kathleen Todd at 410–786–3385). 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: ICF/IID Survey 

Report Form and Supporting 

Regulations; Use: The information 

collected with forms 3070G, CMS– 

3070H and CMS–3070I is used by the 

surveyors from the State Survey 

Agencies (SAs) to determine the level of 

compliance with the ICF/IID Conditions 

of Participation (CoPs) necessary to 

participate in the Medicare/Medicaid 

program and to report any noncompliance with the ICF/IID CoPs to the 

Federal government. These forms 

summarize the survey team 

characteristics, facility characteristics, 

client population, and the special needs 

of clients. These forms are used in 

conjunction with the CMS regulation 

text and additional surveyor aids such 

as the CMS interpretive guidelines and 

probes. The CMS–3070G–I forms serves 

as coding worksheets, designed to 

facilitate data entry and retrieval into 

the Automated Survey Processing 

Environment Suite (ASPEN) in the State 

and at the CMS regional offices. Form 

Number: CMS–3070G–I (OMB control 

number: 0938–0062); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 5,758; Total Annual 

Responses: 5,758; Total Annual Hours: 

17,274. (For policy questions regarding 

this collection contact Caroline Gallaher 

at 410–786–8705.) 

Dated: August 17, 2021. 

William N. Parham, III 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–17908 Filed 8–19–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Updates to 

Uniform Standard for Waiver of the 

Ryan White HIV/AIDS Program Core 

Medical Services Expenditure 

Requirement, OMB No. 0906–XXXX– 

NEW 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, this 

notice announces that the Information 

Collection Request (ICR) is being 

forwarded by HRSA to the Office of 

Management and Budget (OMB) for 

review and approval. OMB will accept 

further comments from the public 

during the review and approval period. 

OMB may act on HRSA’s ICR only after 

the 30-day comment period for this 

Notice has closed. 

DATES: Comments on this ICR should be 

received no later than September 20, 

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 Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Updates to Uniform Standard for Waiver 

of the Ryan White HIV/AIDS Program 

Core Medical Services Expenditure 

Requirement, OMB No. 0906–XXXX– 

NEW. 

Abstract: In accordance with sections 

2604(c), 2612(b), and 2651(c) of the 

Public Health Service Act, Ryan White 

HIV/AIDS Program (RWHAP) recipients 

are required to spend not less than 75 

percent of grant funds on core medical 

services for individuals with HIV 

identified and eligible under the statute, 

after reserving statutory permissible 

amounts for administrative and clinical 

quality management costs. The RWHAP 

statute also grants the Secretary 

authority to waive this requirement for 

RWHAP Parts A, B, or C recipients if a 

number of requirements are met and a 

waiver request is submitted to HRSA for 

approval. RWHAP Part A, B, and C core 

medical services waiver requests—if 

approved—are effective for a 1-year 

budget period, and apply to funds 

awarded under the Minority AIDS 

Initiative. 

Currently, for a core medical services 

waiver request to be approved, (1) core 

medical services must be available and 

accessible to all individuals identified 

and eligible for the RWHAP in the 

recipient’s service area within 30 days, 

without regard to payer source; (2) there 

cannot be any AIDS Drug Assistance 

Program waiting lists in the recipient’s 

service area; and (3) a public process to 

obtain input on the waiver request from 

impacted communities, including 

clients and RWHAP-funded core 

medical services providers, on the 

availability of core medical services and 

the decision to request the waiver must 

have occurred. The public process may 

be a part of the same one used to seek 

input on community needs as part of the 

annual priority setting and resource 

allocation, comprehensive planning, 

statewide coordinated statement of 

need, public planning, and/or needs 

assessment processes. 

HRSA is proposing to simplify the 

waiver request process for RWHAP Parts 

A, B, and C recipients by revising Policy 

Number 13–07: Uniform Standard for 

Waiver of Core Medical Services 

Requirement for Grantees Under Part, A, 

B, and C. The proposed changes would 

reduce the administrative burden for 

recipients by lessening the 

documentation they must submit to 

HRSA when requesting a waiver. Under 

the proposed policy, recipients would 

be required to submit a one-page ‘‘HRSA 

RWHAP Core Medical Services Waiver 

Request Attestation Form’’ to HRSA in 

lieu of the multiple documents, 

including but not limited to a narrative 

of up to 10 pages currently required to 

submit a waiver request. Waiver request 

submission deadlines would also be 

revised. When finalized, the policy 

would replace HAB Policy Number 13– 

07 effective October 1, 2021, and would 

be named ‘‘Waiver of the Ryan White 

HIV/AIDS Program Core Medical 

Services Expenditure Requirement.’’ 


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