Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 87375 

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 

December 31, 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: l, 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–10520 Marketplace Quality 

Standards 

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: Marketplace 

Quality Standards; Use: The Patient 

Protection and Affordable Care Act 

establishes requirements to support the 

delivery of quality health care coverage 

for health insurance issuers offering 

QHPs in Exchanges. Section 1311(c)(3) 

of the Patient Protection and Affordable 

Care Act directs the Secretary to 

develop a system to rate QHPs on the 

basis of quality and price and requires 

Exchanges to display this quality rating 

information on their respective 

websites. Section 1311(c)(4) of the 

Patient Protection and Affordable Care 

Act requires the Secretary to develop an 

enrollee satisfaction survey system to 

assess enrollee experience with each 

QHP (with more than 500 enrollees in 

the previous year) offered through an 

Exchange. Section 1311(h) requires 

QHPs to contract with certain hospitals 

that meet specific patient safety and 

health care quality standards beginning 

January 1, 2015. 

This collection of information is 

necessary to provide adequate and 

timely health care quality information 

for consumers, regulators, and 

Exchanges in the initial years of 

Exchange implementation. It is also 

necessary to collect information to 

appropriately monitor and provide a 

process for a survey vendor to appeal 

HHS’ decision to not approve a QHP 

Enrollee Survey vendor application. 

Form Number: CMS–10114 (OMB 

control number: 0938–1249); Frequency: 

Annually; Affected Public: Public sector 

(Individuals and Households), Private 

sector (Business or other for-profits and 

Not-for-profit institutions); Number of 

Respondents: 380; Total Annual 

Responses: 380; Total Annual Hours: 

138,112. (For policy questions regarding 

this collection contact Preeti Hands at 

301–492–5144.) 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25505 Filed 10–31–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10398 #86] 

Medicaid and Children’s Health 

Insurance Program (CHIP) Generic 

Information Collection Activities: 

Proposed Collection; Comment 

Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: On May 28, 2010, the Office 

of Management and Budget (OMB) 

issued Paperwork Reduction Act (PRA) 

guidance related to the ‘‘generic’’ 

clearance process. Generally, this is an 

expedited process by which agencies 

may obtain OMB’s approval of 

collection of information requests that 

are ‘‘usually voluntary, low-burden, and 

uncontroversial collections,’’ do not 

raise any substantive or policy issues, 

and do not require policy or 

methodological review. The process 

requires the submission of an 

overarching plan that defines the scope 

of the individual collections that would 

fall under its umbrella. This Federal 

Register notice seeks public comment 

on one or more of our collection of 

information requests that we believe are 

generic and fall within the scope of the 

umbrella. Interested persons are invited 

to submit 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 


khammond on DSKJM1Z7X2PROD with NOTICES
87376 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

November 15, 2024. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(CMS–10398 #86) and the OMB control 

number (0938–1148). 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: 

CMS–10398 #86/OMB control number: 

0938–1148, 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/ 

medicare/regulations-guidance/ 

legislation/paperwork-reduction-act1995/pra-listing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at 410–786–4669. 

SUPPLEMENTARY INFORMATION: 

Following is a summary of the use 

and burden associated with the subject 

information collection(s). More detailed 

information can be found in the 

collection’s supporting statement and 

associated materials (see ADDRESSES). 

Generic Information Collection 

1. Title of Information Collection: 

Section 1115 Reentry Demonstration 

Initiative; Type of Information 

Collection Request: New information 

collection request; Use: On April 17, 

2023, CMS released a State Medicaid 

Directors Letter (SMDL #23–003) 

announcing a demonstration 

opportunity to support community 

reentry and improve care transitions for 

individuals who are incarcerated and 

who are otherwise eligible for Medicaid 

to receive medical assistance under title 

XIX. The Section 1115 Reentry 

Demonstration Opportunity (hereinafter, 

‘‘the Reentry Demonstration Initiative’’) 

will allow states to offer coverage for 

certain pre-release services for up to 90 

days prior to the individual’s expected 

release date that could not otherwise be 

covered by Medicaid due to the 

Medicaid inmate exclusion policy. The 

provision is consistent with section 

5032 of the Substance Use Disorder 

Prevention that Promotes Opioid 

Recovery and Treatment for Patients 

and Communities Act (SUPPORT Act) 

(Pub. L. 115–271), ‘‘Promoting State 

Innovations to Ease Transitions 

Integration to the Community for 

Certain Individuals.’’ 

States applying for the Reentry 

Demonstration Initiative must provide a 

minimum set of pre-release services 

called the ‘‘pre-release benefit package.’’ 

The benefit package aims to improve 

transitions for individuals being 

released from jails or prisons and 

returning to their communities. The 

benefit package must include: (1) case 

management to assess and address 

physical and behavioral health needs 

and health-related social needs; and (2) 

medication-assisted treatment services 

for all types of substance use disorders 

as clinically appropriate, with 

accompanying counseling. Also 

required in the minimum set of services 

is a 30-day supply of all prescription 

medications that have been prescribed 

for the beneficiary. 

This collection of information request 

includes three templates that are 

intended to expedite CMS’s review of 

reentry demonstration initiative 

applications and to support state 

implementation planning and related 

transparency by standardizing the 

presentation of key information 

necessary for approvals, thereby 

reducing rounds of clarifying questions 

with state applicants. The three 

templates include the: (1) reentry 

demonstration initiative preprint, (2) 

reentry implementation plan template, 

and (3) reentry budget neutrality 

formulation workbook. The templates 

are strongly encouraged but optional 

and described in the following section. 

Form Number: CMS–10398 #86 (OMB 

control number: 0938–1148); Frequency: 

Annual and on occasion; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

10; Total Annual Responses: 30; Total 

Annual Hours: 300. (For policy 

questions regarding this collection 

contact: Raven Smith at 410–786–3731.) 

William N. Parham III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25503 Filed 10–31–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3575] 

Reauthorization of the Over-TheCounter Monograph Drug User Fee 

Program; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is hosting a public meeting to 

discuss proposed recommendations for 

the reauthorization of the Over-TheCounter [OTC] Monograph Drug User 

Fee Program (OMUFA) for fiscal years 

(FYs) 2026 through 2030. Under 

OMUFA, FDA collects user fees to 

support OTC monograph drug activities. 

The current legislative authority for 

OMUFA expires September 30, 2025. At 

that time, new legislation will be 

required to reauthorize OMUFA for 

future fiscal years. Following 

negotiations with the regulated industry 

and consultation with interested 

members of the public, the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) directs FDA to publish 

recommendations for the 

reauthorization of the OMUFA program 

in the Federal Register, provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations, and hold a meeting 

at which the public may present its 

views on such recommendations. FDA 

will then consider such public views 

and comments and revise such 

recommendations as necessary. 

DATES: The public meeting will be held 

on November 20, 2024, from 9 a.m. to 

12:30 p.m. Submit either electronic or 

written comments on this public 

meeting by December 20, 2024. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting is 

scheduled to be held at the FDA White 

Oak Campus, 10903 New Hampshire 

Ave., Bldg. 31 Conference Center, Rm. 

1503, Silver Spring, MD 20993. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 


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