85624 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

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, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

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–10387—Minimum Data Set 3.0 

Nursing Home and Swing Bed 

Prospective Payment System (PPS) 

For the collection of data related to 

the Patient Driven Payment Model 

and the Skilled Nursing Facility 

Quality Reporting Program (QRP) 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Minimum Data 

Set 3.0 Nursing Home and Swing Bed 

Prospective Payment System (PPS) For 

the collection of data related to the 

Patient Driven Payment Model and the 

Skilled Nursing Facility Quality 

Reporting Program (QRP); Use: We are 

requesting to implement the MDS 3.0 

v1.19.1 beginning October 1, 2024 in 

order to meet the requirements of 

policies finalized in the Federal Fiscal 

Year (FY) 2024 Skilled Nursing Facility 

(SNF) Prospective Payment System 

(PPS) final rule (CMS–1779–F, RIN 

0938–AV02). Specifically, CMS adopted 

two new measures and removed three 

measures from the SNF QRP. As a result 

of these changes, the total annual hour 

burden across facilities has decreased, 

and the annual cost burden across 

facilities has decreased. Form Number: 

CMS–10387 (OMB control number: 

0938–1140); Frequency: Yearly; Affected 

Public: Private Sector: Business or other 

for-profit and not-for-profit institutions; 

Number of Respondents: 15,471; Total 

Annual Responses: 3,469,183; Total 

Annual Hours: 2,861,351. (For policy 

questions regarding this collection 

contact Heidi Magladry at 410–786– 

6034). 

Dated: December 4, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–26927 Filed 12–7–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10219 and CMS– 

10593] 

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 

(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 

February 6, 2024. 

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: __, 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, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

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–10219 HEDIS Data Collection for 

Medicare Advantage 

CMS–10593 Establishment of an 

Exchange by a State and Qualified 

Health Plans 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85625 

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: Revision of a currently 

approved collection; Title of 

Information Collection: HEDIS Data 

Collection for Medicare Advantage; Use: 

Sections 422.152 and 422.516 of 

Volume 42 of the Code of Federal 

Regulations (CFR) specify that MAOs 

must submit quality performance 

measures as specified by the Secretary 

of the Department of Health and Human 

Services and by CMS. These quality 

performance measures include HEDIS®. 

HEDIS® data are used in the Medicare 

Part C Star Ratings which are used to 

determine Quality Bonus Payments to 

Medicare Advantage contracts. 

CMS requires MAOs, § 1876 cost 

contracts, and Medicare Medicaid Plans 

(MMPs or demonstrations) to submit 

HEDIS® data on an annual basis to (1) 

assess care that is provided to Medicare 

beneficiaries and (2) to provide 

information to Medicare beneficiaries to 

make more informed decisions when 

choosing a health plan. 

The HEDIS® data collection supports 

the CMS strategic goals of advancing 

health equity and improving health 

outcomes for Medicare beneficiaries. 

The HEDIS® measures are part of the 

Medicare Part C Star Ratings as 

described at §§ 422.160, 422.162, 

422.164, and 422.166. CMS publishes 

the Medicare Part C Star Ratings each 

year to: (1) incentivize quality 

improvement in Medicare Advantage 

(MA); and (2) assist beneficiaries in 

finding the best plan for them. The Star 

Ratings are used to determine MA 

Quality Bonus Payments. Form Number: 

CMS–10219 (OMB control number: 

0938–1028); Frequency: Yearly; Affected 

Public: Private Sector, Business or other 

for-profits and Not-for-profits 

institutions ; Number of Respondents: 

808; Total Annual Responses: 808; Total 

Annual Hours: 258,560. (For policy 

questions regarding this collection 

contact Lori Luria at Lori.Luria@

cms.hhs.gov). 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Establishment of 

an Exchange by a State and Qualified 

Health Plans; Use: Section 1311(d) of 

the Affordable Care Act requires an 

Exchange to be a governmental agency 

or nonprofit entity established by a 

State; requires an Exchange make 

Qualified Health Plans (QHPs) available 

to eligible individuals and employers; 

and identifies the minimum functions 

an Exchange must perform. CMS and 

other federal partners will use the data 

collected from states operating SBEs to 

determine Exchange compliance with 

federal standards for operating the 

Exchange. The data that health 

insurance issuers, Exchanges, and other 

entities that Exchanges contract within 

performing Exchange functions collect 

will help to inform CMS, Exchanges, 

and health insurance issuers on the 

participation of individuals, employers, 

and employees in the individual 

Exchange and SHOP. Form Number: 

CMS–10593 (OMB control number: 

0938–1312); Frequency: Annually; 

Affected Public: Private Sector, Business 

or other for-profits and Not-for-profits 

institutions; Number of Respondents: 

20; Total Annual Responses: 20; Total 

Annual Hours: 55,026. (For policy 

questions regarding this collection 

contact Tiffany Y. Animashaun at 

Tiffany.Animashaun@cms.hhs.gov). 

Dated: December 5, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–27035 Filed 12–7–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–2194, FDA– 

2022–E–2195, and FDA–2022–E–2196] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Tivdak 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Tivdak and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications to the Director of the U.S. 

Patent and Trademark Office (USPTO), 

Department of Commerce, for the 

extension of patents which claim that 

human biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by February 6, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 5, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 6, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 


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