Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Notices 38411 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–10680, CMS– 

10692 and CMS–10788] 

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 July 28, 2022. 

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, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/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. Title of Information Collection: 

Electronic Visit Verification Compliance 

Survey; Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Use: The 

web-based survey will allow states to 

self-report their progress in 

implementing electronic visit 

verification (EVV) for personal care 

services (PCS) and home health care 

services (HHCS), as required by section 

1903(l) of the Social Security Act. CMS 

will use the survey data to assess states’ 

compliance with section 1903(l) of the 

Act and levy Federal Medical 

Assistance Percentage (FMAP) 

reductions where necessary as required 

by 1903(l) of the Act. 

The survey will be disseminated to all 

51 state Medicaid agencies (including 

the District of Columbia) and the 

Medicaid agencies of five U.S. 

territories. States will be required to 

complete the survey in order to 

demonstrate that they are complaint 

with Section 1903(l) of the Act by 

reporting on their EVV implementation 

status for PCS provided under sections 

1905(a)(24), 1915(c), 1915(i), 1915(j), 

1915(k), and Section 1115 of the Act; 

and HHCS provided under 1905(a)(7) of 

the Act or under a demonstration 

project or waiver (e.g., 1915(c) or 1115 

of the Act). 

The survey will be a live form, 

meaning states will have the ability to 

update their 1903(l) compliance status 

on a continuous basis. As FMAP 

reductions are assigned quarterly per 

1903(l) of the Act, states who are not in 

compliance will be asked to review their 

survey information on a quarterly basis 

to ensure it is up-to-date and to update 

their survey responses as needed until 

they come into compliance. Form 

Number: CMS–10680 (OMB control 

number: 0938–1360); Frequency: On 

occasion; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 56; Number of Responses: 

336; Total Annual Hours: 504. (For 

questions regarding this collection 

contact Ryan Shannahan at 410–786– 

0295.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Home and 

Community Based Services (HCBS) 

Incident Management Survey; Use: The 

Survey will be disseminated to all 51 

state Medicaid agencies (including the 

District of Columbia) to assess incident 

management systems in 1915(c) 

waivers. States will be surveyed to 

identify methods and promising 

practices for identifying, reporting, 

tracking, and resolving incidents of 

abuse, neglect, and exploitation. The 

survey results will also be used to 

review the strengths and weaknesses of 

each state’s incident management 

system and will inform guidance to help 

ensure compliance with sections 

1902(a)(30(A) and 1915(c)(2)(A) of the 

Social Security Act. Form Number: 

CMS–10692 (OMB control number: 

0938–1362); Frequency: Once and on 

occasion; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 51; Total Annual 

Responses: 102; Total Annual Hours: 

153. (For policy questions regarding this 

collection contact Ryan Shannahan at 

410–786–0295.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Prescription 

Drug and Health Care Spending; Use: 

On December 27, 2020, the 

Consolidated Appropriations Act, 2021 

(CAA) was signed into law. Section 204 

of Title II of Division BB of the CAA 

added parallel provisions at section 

9825 of the Internal Revenue Code (the 

Code), section 725 of the Employee 

Retirement Income Security Act 

(ERISA), and section 2799A–10 of the 

Public Health Service Act (PHS Act) 

that require group health plans and 


khammond on DSKJM1Z7X2PROD with NOTICES
38412 Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Notices 

health insurance issuers offering group 

or individual health insurance coverage 

to annually report to the Department of 

the Treasury, the Department of Labor 

(DOL), and the Department of Health 

and Human Services (HHS) 

(collectively, ‘‘the Departments’’) certain 

information about prescription drug and 

health care spending, premiums, and 

enrollment under the plan or coverage. 

This information will support the 

development of public reports that will 

be published by the Departments on 

prescription drug reimbursements for 

plans and coverage, prescription drug 

pricing trends, and the role of 

prescription drug costs in contributing 

to premium increases or decreases 

under the plans or coverage. The 2021 

interim final rules, ‘‘Prescription Drug 

and Health Care Spending’’ issued by 

the Departments and the Office of 

Personnel Management (OPM) 

implement the provisions of section 

9825 of the Code, section 725 of ERISA, 

and section 2799A–10 of the PHS Act, 

as enacted by section 204 of Title II of 

Division BB of the CAA. OPM joined the 

Departments in issuing the 2021 interim 

final rules, requiring Federal Employees 

Health Benefits (FEHB) carriers to report 

information about prescription drug and 

health care spending, premiums, and 

plan enrollment in the same manner as 

a group health plan or health insurance 

issuer offering group or individual 

health insurance coverage. Form 

Number: CMS–10788 (OMB control 

number: 0938–1405); Frequency: 

Annual; Affected Public: Private Sector; 

Number of Respondents: 356; Total 

Annual Responses: 356; Total Annual 

Hours: 1,684,080. (For policy questions 

regarding this collection, contact 

Christina Whitefield at 301–492–4172.) 

Dated: June 23, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–13769 Filed 6–27–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Administration on Disabilities, The 

President’s Committee for People with 

Intellectual Disabilities 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The President’s Committee 

for People with Intellectual Disabilities 

(PCPID) will host a virtual meeting for 

its members to identify emerging topics 

to examine in the Committee’s Report to 

the President. All the PCPID meetings, 

in any format, are open to the public. 

This virtual meeting will be conducted 

in a presentation and discussion format. 

DATES: Thursday, July 28, 2022 from 

12:00 p.m. to 4:00 p.m. (EST). 

AGENDA: The Committee will discuss 

survey responses, collectively discuss 

emerging issues facing people with 

intellectual disabilities, and the 

preparation of the PCPID Report to the 

President, including its proposed 

content and format, and related data 

collection and analysis required to 

complete the writing of the Report. 

ADDITIONAL INFORMATION: For further 

information, please contact Mr. David 

Jones, Director, Office of Intellectual 

Developmental Disabilities, 330 C Street 

SW, Switzer Building, Room 1126, 

Washington, DC 20201. Telephone: 

202–795–7367. Fax: 202–795–7334. 

Email: David.Jones@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Stakeholder input is very important to 

the PCPID. Comments and suggestions 

especially from people with intellectual 

and developmental disabilities, are 

welcomed. If there are comments or 

feedback you would like to share with 

the PCPID as it begins to prioritize its 

work, please share them through the 

following ACL.gov link: https://acl.gov/ 

form/pcpid?j=1555178&sfmc_sub=

191090082&l=6707_HTML&u=

34777761&mid=515008575&jb=0. 

Comments received by June 30, 2022 

will be shared with the PCPID at the 

July 28th meeting. Comments received 

after June 30, 2022 will be compiled and 

shared with the PCPID quarterly. 

Webinar/Conference Call: The virtual 

meeting is scheduled for Thursday, July 

28, 2022 from 12:00 p.m. to 4:00 p.m. 

(EST) and may end early if discussions 

are finished. The meeting will be held 

through a zoom meeting platform. In 

order to participate, you must register in 

advanced of the meeting at the 

following link: https://

www.zoomgov.com/meeting/register/

vJIsdeCpqzgsEiNHISQhI6VBwpr

CzIlu8BU. 

BACKGROUND INFORMATION ON THE

COMMITTEE: The PCPID acts in an 

advisory capacity to the President and 

the Secretary of Health and Human 

Services on a broad range of topics 

relating to programs, services and 

support for individuals with intellectual 

disabilities. The PCPID Charter 

stipulates that the Committee shall: (1) 

provide such advice concerning 

intellectual disabilities as the President 

or the Secretary of Health and Human 

Services may request; and (2) provide 

advice to the President and the 

Secretary of Health and Human Services 

to promote full participation of people 

with intellectual disabilities in their 

communities, such as: (A) expanding 

educational opportunities; (B) 

promoting housing opportunities; (C) 

expanding opportunities for competitive 

integrated employment; (D) improving 

accessible transportation options; (E) 

protecting rights and preventing abuse; 

and (F) increasing access to assistive 

and universally designed technologies; 

and (3) provide advice to the President 

and the Secretary of Health and Human 

Services to help advance racial equity 

and support for people with intellectual 

disabilities within underserved 

communities. 

Dated: June 22, 2022. 

Jill Jacobs, 

Commissioner, Administration on 

Disabilities. 

[FR Doc. 2022–13699 Filed 6–27–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1496] 

Renal Cell Carcinoma: Developing 

Drugs and Biologics for Adjuvant 

Treatment; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Renal 

Cell Carcinoma: Developing Drugs and 

Biologics for Adjuvant Treatment.’’ This 

guidance is intended to facilitate the 

development of drugs and biologics for 

the adjuvant treatment of renal cell 

carcinoma and provides 

recommendations for the sponsor on 

this topic. The guidance includes 

recommendations regarding eligibility 

criteria, choice of comparator, followup 

imaging assessments, determination of 

disease recurrence, analyses of diseasefree survival, and interpretation of trial 

results. This guidance finalizes the draft 

guidance of the same title issued on 

October 2, 2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 28, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 


khammond on DSKJM1Z7X2PROD with NOTICES