Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83015 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Associate Secretary of the Board. 

[FR Doc. 2024–23784 Filed 10–11–24; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RETIREMENT THRIFT 

INVESTMENT BOARD 

Notice of Board Meeting 

DATES: October 22, 2024 at 10 a.m. 

eastern daylight time (EDT). 

ADDRESSES: Telephonic. Dial-in (listen 

only) information: Number: 1–202–599– 

1426, Code: 828 801 968 #; or via web: 

https://www.frtib.gov/. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Weaver, Director, Office of 

External Affairs, (202) 942–1640. 

SUPPLEMENTARY INFORMATION: BOARD

MEETING AGENDA. 

Open Session 

1. Approval of the September 24, 2024, 

Board Meeting Minutes 

2. Monthly Reports 

(a) Participant Report 

(b) Legislative Report 

3. Quarterly Reports 

(c) Investment Review 

(d) Audit Status 

(e) Budget Review 

4. Internal Audit Update 

5. OEA Annual Presentation 

6. Social Science Update 

Closed Session 

7. Information covered under 5 U.S.C. 

552b(c)(6), (c)(9)(B), and (c)(10). 

Authority: 5 U.S.C. 552b(e)(1). 

Dated: October 9, 2024. 

Dharmesh Vashee, 

General Counsel, Federal Retirement Thrift 

Investment Board. 

[FR Doc. 2024–23779 Filed 10–11–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–855B, CMS–R– 

48 and CMS–10239] 

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 November 14, 

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: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare 

Enrollment Application for Clinics/ 

Group Practices and Other Suppliers; 

Use: Various sections of the Act, the 

United States Code (U.S.C.), Internal 

Revenue Service (IRS) Code, and the 

CFR require providers and suppliers to 

furnish information concerning the 

amounts due and the identification of 

individuals or entities that furnish 

medical services to beneficiaries before 

payment can be made. The Form CMS– 

855B application is submitted when the 

applicant first requests Medicare 

enrollment. The application is used by 

the MACs to collect data to ensure the 

applicant has the necessary credentials 

to provide the health care services for 

which they intend to bill Medicare; this 

includes data that allows the Medicare 

contractor to correctly price, process, 

and pay the applicant’s claims. It also 

gathers information that enables MACs 

to ensure that the supplier is neither 

excluded from the Medicare program 

nor debarred, suspended, or excluded 

from any other Federal agency or 

program. The application is also used by 

enrolled suppliers when they are 

reporting a change in their ownership, 

a change in their current Medicare 

enrollment information, or are 

revalidating or reactivating their 

Medicare enrollment. Form Number: 

CMS–855B (OMB control number: 

0938–1377); Frequency: Occasionally; 

Affected Public: Private Sector; Business 

or other for-profits, and Not-for Profits; 

Number of Respondents: 132,800; 

Number of Responses: 132,800; Total 

Annual Hours: 155,884. (For questions 

regarding this collection, contact Frank 

Whalen at 410–786–1302 or 

Frank.Whelan@cms.hhs.gov.) 

1. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Hospital 

Conditions of Participation (CoPs) and 

Supporting Regulations; Use: The 

purpose of this package is to request 

from the Office of Management and 

Budget (OMB) approval of the 


khammond on DSKJM1Z7X2PROD with NOTICES
83016 Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 

reinstatement with change of the 

information collection request 

associated with OMB control number: 

0938–0328. 

The information collection 

requirements described herein are 

needed to implement the Medicare and 

Medicaid Conditions of Participation 

(CoPs) for a total of 5,132 facilities that 

includes: 4,994 accredited and nonaccredited hospitals and 138 Critical 

Access Hospitals (CAHs) with Distinct 

Part Units (DPUs); specifically, 119 

CAHs with psychiatric DPUs and 19 

CAHs with rehabilitation DPUs. The 

information collection requirements for 

the 1,245 CAHs without DPUs (1,383 

total CAHs less 138 CAHs with DPUs) 

are covered under OMB control number: 

0938–1043 (CMS–10239). 

As previous stated, this notice is 

related to a reinstatement of the 

information collection request that 

expired on 11/30/2017. The previous 

iteration of this OMB control number 

0938–0328 (approved November 14, 

2014) had a burden of 14,424,655 

annual hours. For this requested 

reinstatement, with changes, the 

adjusted annual hourly burden for 

industry is 3,566,521 hours at an annual 

cost of $310,989,894. The decrease in 

burden hours is primarily due to the fact 

that many of the information collections 

that were previously required as CoPs 

by CMS are now customary and usual 

industry practice and would take place 

in the absence of the Medicare and 

Medicaid programs. In addition, where 

possible, CMS reduced the burden of 

CoPs with prior information collections. 

For example, the burden for individual 

hospitals that are part of a multihospital system was reduced by 

allowing a multi-hospital system, which 

represent approximately 70% of 

hospitals today, to develop a unified 

Quality Assessment and Performance 

Improvement (QAPI) program rather 

than requiring each hospital in the 

system to maintain separate programs 

and reporting requirements. 

This reinstatement also reflects a 

change in how the annual burden costs 

for information collection requirements 

for Hospital CoPs are calculated. In 

prior submissions, the fully loaded wage 

estimates applied only an additional 

33% to the hourly wage to account for 

fringe benefits. This reinstatement 

applies an additional 100% to the 

median hourly wage to reflect the costs 

more accurately to hospitals for 

compliance with the current CoPs. 

Additional changes reflected in this 

reinstatement are some of the 

information collections were placed on 

participating hospitals as CoPs during 

the recent COVID–19 Public Health 

Emergency (PHE), specifically regarding 

collecting and reporting data on 

incidents and hospital management of 

infection diseases. The burden of many 

of these information collections were 

accounted for in other OMB 

submissions, such as the ‘‘Unified 

Hospital Data Surveillance System (U.S. 

Healthcare COVID–19 Collection’’ (OMB 

control number 0990–0478), and some 

of these collections ended or were 

revised after HHS declared the end of 

the COVID–19 PHE in April 2024. As a 

result, this reinstatement does not 

include information collection 

requirements that have expired, and 

only includes the annual burden and 

costs to participating hospitals and 

CAHs with DPUs for information 

collections that have remained as CoPs 

after the COVID–19 PHE ended. In 

addition, in anticipation of an upcoming 

final rule titled ‘‘Medicare and Medicaid 

Programs and the Children’s Health 

Insurance Program; Hospital Inpatient 

Prospective Payment Systems for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Policy Changes and Fiscal Year 

2025 Rates; Quality Programs 

Requirements; and Other Policy 

Changes,’’ this package includes burden 

estimates for additional information 

collection requirements that CMS is 

adding as CoPs in the interest of public 

health and ensuring resiliency in the 

U.S. health care system. The 

aforementioned final rule, CMS–1808–F 

(RIN 0938–AV34), is currently on public 

display at the Office of the Federal 

Register and scheduled for publication 

on August 28, 2024. 

Finally, this reinstatement 

incorporates additional information 

collection requirements associated with 

a number of new CoPs for hospitals and 

CAHs regarding obstetrical services 

which are outlined in detail in the July 

2024 proposed rule titled ‘‘Medicare 

and Medicaid Programs: Hospital 

Outpatient Prospective Payment and 

Ambulatory Surgical Center Payment 

Systems; Quality Reporting Programs, 

Including the Hospital Inpatient Quality 

Reporting Program; Health and Safety 

Standards for Obstetrical Services in 

Hospitals and Critical Access Hospitals; 

Prior Authorization; Requests for 

Information; Medicaid and CHIP 

Continuous Eligibility; Medicaid Clinic 

Services Four Walls Exceptions; 

Individuals Currently or Formerly in 

Custody of Penal Authorities; Revision 

to Medicare Special Enrollment Period 

for Formerly Incarcerated Individuals; 

and All-Inclusive Rate Add-On Payment 

for High-Cost Drugs Provided by Indian 

Health Service and Tribal Facilities’’ (89 

FR 59186). Form Number: CMS–R–48 

(OMB control number: 0938–0328); 

Frequency: Yearly; Affected Public: 

Private Sector (Business or other forprofit); Number of Respondents: 4,664; 

Total Annual Responses: 2,647,647; 

Total Annual Hours: 3,566,521 (For 

policy questions regarding this 

collection contact Claudia Molinar at 

410–786–8445). 

3. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions of 

Participation for Critical Access 

Hospitals (CAH) and Supporting 

Regulations; Use: The purpose of this 

package is to request from the Office of 

Management and Budget (OMB) the 

approval to reinstate, with changes, the 

information collection request, 

associated with OMB Control Number 

0938–1043, titled ‘‘Critical Access 

Hospital (CAH) Conditions of 

Participation (CoPs) and Supporting 

Regulations.’’ 

Sections 1820 and 1861(mm) of the 

Social Security Act provide that CAHs 

participating Medicare meet certain 

specified requirements. The regulations 

containing the information collection 

requirements are located at 42 CFR part 

485, subpart F. These regulations 

implement sections 1102, 1138, 

1814(a)(8), 1820(a–f), 1861(mm), 1864, 

and 1871 of the Act. 

This is a reinstatement of the 

information collection request that 

expired on March 31, 2024. The 

previous iteration of this OMB No. 

0938–1043 (approved March 25, 2021) 

had a burden of 33,905 annual hours. 

For this requested reinstatement, with 

changes, the estimated total annual 

burden hours for the industry is 898,332 

hours and the estimated annual burden 

costs are $74,020,673. 

The increase in burden hours from the 

prior package is primarily due to new 

information collections associated with 

new CoPs for CAHs outlined in the two 

CMS rules referenced below. The new 

CoPs include multiple information 

collection requirements that are onetime burdens for developing new 

policies and protocols and ongoing 

reporting requirements, such as daily or 

biweekly reporting of respiratory 

illnesses as well as maternal deaths. The 

reasons for the increased information 

collections are discussed in more detail 

in the rules and are summarized in the 

information collection request. 

(1) Obstetrical services included in 

the proposed rule, Medicare and 

Medicaid Programs: Hospital Outpatient 

Prospective Payment and Ambulatory 

Surgical Center Payment Systems; 

Quality Reporting Programs, Including 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices 83017 

the Hospital Inpatient Quality Reporting 

Program; Health and Safety Standards 

for Obstetrical Services in Hospitals and 

Critical Access Hospitals; Prior 

Authorization; Requests for Information; 

Medicaid and CHIP Continuous 

Eligibility; Medicaid Clinic Services 

Four Walls Exceptions; Individuals 

Currently or Formerly in Custody of 

Penal Authorities; Revision to Medicare 

Special Enrollment Period for Formerly 

Incarcerated Individuals; and AllInclusive Rate Add-On Payment for 

High-Cost Drugs Provided by Indian 

Health Service and Tribal Facilities, 89 

FR 59186 (July 22, 2024) (hereinafter 

referred to as the ‘‘July 2024 Proposed 

Rule’’). 

(2) Reporting of acute respiratory 

illnesses in the interest of public health 

and ensuring resiliency in the U.S. 

health care system included in the Final 

rule: Medicare and Medicaid Programs 

and the Children’s Health Insurance 

Program; Hospital Inpatient Prospective 

Payment Systems for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Policy Changes and Fiscal Year 

2025 Rates; Quality Programs 

Requirements; and Other Policy 

Changes. The aforementioned final rule, 

CMS–1808–F (RIN 0938–AV34), is 

currently on display at the Office of the 

Federal Register and scheduled for 

publication on August 28, 2024 

(hereinafter referred to as the ‘‘August 

2024 Final Rule’’). 

The change in total burden hours is 

also due to prior information collection 

requests are exempt from the PRA 

because the requirements are customary 

and usual industry practice and would 

take place in the absence of the 

Medicare and Medicaid programs. Form 

Number: CMS–10239 (OMB control 

number: 0938–1043); Frequency: Yearly; 

Affected Public: Private Sector (Business 

or other for-profit); Number of 

Respondents: 1,245; Total Annual 

Responses: 9,145; Total Annual Hours: 

898,332 (For policy questions regarding 

this collection contact Claudia Molinar 

at 410–786–8445). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–23737 Filed 10–11–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher; KISQALI 

(ribociclib) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

supplemental application for KISQALI 

(ribociclib), approved September 17, 

2024, meets the criteria for redeeming a 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application (Supplement18) for KISQALI (ribociclib) meets the 

redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about KISQALI 

(ribociclib), go to the ‘‘Drugs@FDA’’ 

website at https://www.accessdata.

fda.gov/scripts/cder/daf/. 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23651 Filed 10–11–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4095] 

Using Relative Supersaturation To 

Support ‘Urinary Tract Health’ Claims 

for Adult Maintenance Cat Food; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry #284 entitled 

‘‘Using Relative Supersaturation To 

Support ‘Urinary Tract Health’ Claims 

for Adult Maintenance Cat Food.’’ 

FDA’s Center for Veterinary Medicine 

(CVM) has evaluated the use of relative 

supersaturation (RSS) methodology to 

support urinary tract health claims for 

certain adult maintenance cat food. RSS 

is a measurement that estimates the 

potential for crystal formation and 

bladder stone growth, which is a 

common affliction in cats. This 

guidance provides recommendations for 

how pet food manufacturers can use 

RSS methodology to substantiate 

general structure or function claims that 

an adult maintenance cat food supports 

urinary tract health by promoting a 

healthy mineral content in the urinary 

tract. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 15, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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, 


khammond on DSKJM1Z7X2PROD with NOTICES