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