92940 Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 

Attention: Document Identifier/OMB 

Control Number: lll, 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 Collections 

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 

v1.20.1 beginning October 1, 2025 in 

order to meet the requirements of 

policies finalized in the Federal Fiscal 

Year (FY) 2025 Skilled Nursing Facility 

(SNF) Prospective Payment System 

(PPS) final rule (CMS–1802–F, RIN 

0938–AV30). Specifically, we finalized 

the collection of four new items as 

standardized patient assessment data 

elements, modified one item collected 

as a standardized patient assessment 

data element, and removed twenty-two 

items that are not needed for case-mix 

adjusting the SNF per diem payment for 

PDPM. 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 forprofit and not-for-profit institutions; 

Number of Respondents: 15,477; Total 

Annual Responses: 1,766,806; Total 

Annual Hours: 2,675,583. (For policy 

questions regarding this collection 

contact Heidi Magladry at 410–786– 

6034). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–27522 Filed 11–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10849] 

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 December 26, 2024. 

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, 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 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. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Negotiation Data 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices 92941 

Elements and Drug Price Negotiation 

Process for Initial Price Applicability 

Year 2027 under sections 11001 and 

11002 of the Inflation Reduction Act 

Information Collection Request (ICR) 

(CMS–10849, OMB 0938–1452); Use: 

Under the authority in sections 11001 

and 11002 of the Inflation Reduction 

Act of 2022 (Pub. L. 117–169), the 

Centers for Medicare & Medicaid 

Services (CMS) is implementing the 

Medicare Drug Price Negotiation 

Program, codified in sections 1191 

through 1198 of the Social Security Act 

(‘‘the Act’’). The Act establishes the 

Negotiation Program to negotiate 

maximum fair prices (‘‘MFPs’’), defined 

at 1191(c)(3) of the Act, for certain high 

expenditure, single source selected 

drugs covered under Medicare Part B 

and Part D. For the second year of the 

Negotiation Program, the Secretary of 

Health and Human Services (the 

‘‘Secretary’’) will select up to 15 high 

expenditure, single source drugs 

covered under Part D for negotiation. 

Negotiation Data Elements: The 

statute requires that CMS consider 

certain data from Primary 

Manufacturers as part of the negotiation 

process. To the extent that more than 

one entity meets the statutory definition 

of manufacturer (specified in section 

1193(a)(1) of the Act) for a selected drug 

for purposes of initial price applicability 

year 2027, CMS will designate the entity 

that holds the New Drug Application(s) 

(NDA(s))/Biologics License 

Application(s) (BLA(s)) for the selected 

drug to be ‘‘the manufacturer’’ of the 

selected drug (hereinafter the ‘‘Primary 

Manufacturer’’). The Primary 

Manufacturer’s data submissions 

include non-FAMP and related data for 

selected drugs for the purpose of 

establishing a ceiling price, as outlined 

in section 1193(a)(4)(A) of the Act, and 

the negotiation factors outlined in 

section 1194(e)(1) of the Act for the 

purpose of formulating offers and 

counteroffers process pursuant to 

section 1193(a)(4)(B) of the Act. Some of 

these data are held by the Primary 

Manufacturer and are not currently 

available to CMS. Data described in 

sections 1194(e)(1) and 1193(a)(4) of the 

Act must be submitted by the Primary 

Manufacturer. 

Section 1194(e)(2) of the Act requires 

CMS to consider certain data on 

selected drugs and their alternative 

treatments. Because the statute does not 

specify where these data come from, 

CMS will allow for optional submission 

from Primary Manufacturers and the 

public. CMS will additionally review 

existing literature, conduct internal 

analyses, and consult subject matter and 

clinical experts on the factors listed in 

section 1194(e)(2) of the Act. Primary 

Manufacturers may optionally submit 

this information as part of their 

Negotiation Data Elements Information 

Collection Request Form. The public 

may also optionally submit evidence 

about the selected drugs and their 

alternative treatments. 

Drug Price Negotiation Process: Any 

MFPs that are negotiated for the drugs 

selected for the second year of the 

Negotiation Program will apply 

beginning in initial price applicability 

year 2027. For initial price applicability 

year 2027, the negotiation period begins 

on the earlier of the date that the 

Primary Manufacturer enters into a 

Medicare Drug Price Negotiation 

Program Agreement or February 28, 

2025. 

Section 1194(b)(2)(C) of the Act 

provides that if the Primary 

Manufacturer does not accept CMS’ 

written initial offer, the Primary 

Manufacturer may submit an optional 

written counteroffer no later than 30 

days after the date of receipt of CMS’ 

written initial offer. If the Primary 

Manufacturer chooses to develop and 

submit a written counteroffer to CMS’ 

written initial offer during the drug 

price negotiation process for initial 

price applicability year 2027 in 

accordance with section 1194(b)(2)(C) of 

the Act, the Primary Manufacturer must 

submit the Statutory Written 

Counteroffer Form. Form Number: 

CMS–10849 (OMB control number: 

0938–1452); Frequency: Once; Affected 

Public: Private sector, Business or other 

for-profit; Number of Respondents: 340; 

Total Annual Responses: 340; Total 

Annual Hours: 23,764 (For policy 

questions regarding this collection 

contact Elisabeth Daniel at 667–290– 

8793.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–27490 Filed 11–22–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity: Services Provided to 

Unaccompanied Children (Office of 

Management and Budget #: 0970–0553) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Refugee 

Resettlement (ORR), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services, is inviting public comments 

on the proposed information collection, 

including proposed changes. The 

request consists of several forms that 

will allow the Unaccompanied Children 

(UC) Bureau to continue providing 

statutorily mandated services to 

unaccompanied children in ORR care. 

DATES: Comments due January 24, 2025. 

In compliance with the requirements of 

the Paperwork Reduction Act of 1995, 

ACF is soliciting public comment on the 

specific aspects of the information 

collection described in this notice. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ORR has undertaken a 

reorganization of its information 

collections to promote operational 

efficiency. The reorganization will 

result in more collections that contain 

fewer forms under a single Office of 

Management and Budget number. This 

information collection currently 

contains 22 unique forms (33 including 

alternative versions). Under the 

reorganization, ORR proposes to 

discontinue the use of six forms; 

transfer 10 forms to new information 

collections associated with Assessments 

and Home Studies/Post-Release 

Services; and revise five existing forms. 

The UC Bureau is requesting to 

discontinue the use of six forms created 

for the UC Path case management 

system, which was never implemented. 

Except where indicated below, the UC 

Path versions of these forms contain 

features and/or logic not replicated in 

the UC Portal, and have never been 

used, thus maintaining these forms is 

unnecessary. These forms include: 

• Long Term Foster Care Travel 

Request (Form S–14)—UC Path version 

only. UC Bureau plans to revise and 

continue using the UC Portal version. 

• Home Study/Post-Release Service 

(HS/PRS) Provider Entity (Form S–21A). 

• Home Study/Post-Release Service 

(HS/PRS) Subcontractor Entity (Form S– 

21B). 

• Home Study/Post-Release Service 

(HS/PRS) Primary Provider Profile 

(Form S–21C). 

• Home Study/Post-Release Service 

(HS/PRS) Subcontractor Profile (Form 

S–21D). 


khammond on DSK9W7S144PROD with NOTICES