Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2623 

quality and cost performance categories 

in a manner that applies the combined 

performance of all the MIPS eligible 

clinicians in the virtual group to each 

MIPS eligible clinician in the virtual 

group for the applicable performance 

period; and (2) be scored for the quality 

and cost performance categories based 

on such assessment. Form Number: 

CMS–10652 (OMB control number: 

0938–1343); Frequency: Yearly; 

Affected Public: Individuals and 

Households, Private Sector, Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

16; Total Annual Responses: 16; Total 

Annual Hours: 160 (For policy 

questions regarding this collection 

contact Renee O’Neill at 410–786–8821.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Quality 

Improvement Strategy Implementation 

Plan, Progress Report, and Modification 

Summary Supplement Forms. Use: 

Section 1311(c)(1)(E) of the Affordable 

Care Act requires qualified health plans 

(QHPs) offered through an Exchange 

must implement a quality improvement 

strategy (QIS) as described in section 

1311(g)(1). Section 1311(g)(3) of the 

Affordable Care Act specifies the 

guidelines under Section 1311(g)(2) 

shall require the periodic reporting to 

the applicable Exchange the activities 

that a qualified health plan has 

conducted to implement a strategy as 

described in section 1311(g)(1). CMS 

intends to have QHP issuers complete 

the appropriate QIS forms annually for 

implementation and progress reporting 

of their quality improvement strategies. 

The QIS forms will include topics to 

assess an issuer’s compliance in creating 

a payment structure that provides 

increased reimbursement or other 

incentives to improve the health 

outcomes of plan enrollees, prevent 

hospital readmissions, improve patient 

safety and reduce medical errors, 

promote wellness and health, and 

reduce health and health care 

disparities, as described in Section 

1311(g)(1) of the Affordable Care Act. 

The QIS forms will allow: (1) the 

Department of Health & Human Services 

(HHS) to evaluate the compliance and 

adequacy of QHP issuers’ quality 

improvement efforts, as required by 

Section 1311(c) of the Affordable Care 

Act, and (2) HHS will use the issuers’ 

validated information to evaluate the 

issuers’ quality improvement strategies 

for compliance with the requirements of 

Section 1311(g) of the Affordable Care 

Act. Form Number: CMS–10540 (OMB 

control number: 0938–1286); Frequency: 

Annually; Affected Public: Public sector 

(Individuals and Households), Private 

sector (Business or other for-profits and 

not-for-profit institutions); Number of 

Respondents: 250; Total Annual 

Responses: 250; Annual Hours: 4,933. 

(For policy questions regarding this 

collection, contact Preeti Hans at 301– 

492–1444). 

Dated: January 10, 2024. 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–00657 Filed 1–12–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Expedited Office of Management and 

Budget Review and Public Comment: 

Office of Community Services 

Affordable Housing and Supportive 

Services Demonstration Data 

Collection (New Collection) 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services 

ACTION: Request for public comments. 

SUMMARY: The Office of Community 

Services (OCS), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is requesting expedited 

review of an information collection 

request from the Office of Management 

and Budget (OMB) and inviting public 

comments on the proposed collection. 

The Affordable Housing and Supportive 

Services Demonstration was 

appropriated by the Departments of 

Labor, Health and Human Services, and 

Related Agencies Appropriations Bill, 

2023 through the Social Services 

Research Demonstration program 

(SSRD). The House report language 

directs ACF to provide a report on the 

findings of this demonstration within 1 

year after grants are awarded. ACF is 

soliciting public comment within the 

next 30 days and requesting expedited 

approval from OMB to collect 

information to study the 

implementation of this demonstration 

program to inform this report. Following 

initial approval, ACF will request an 

extension of approval within 6 months. 

This extension process will include 

additional commenting opportunities. 

DATES: Comments due within February 

15, 2024. 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: Copies of the proposed 

collection of information can be 

obtained and comments may be 

submitted by emailing infocollection@

acf.hhs.gov. Identify all by the title of 

the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF is requesting that 

OMB grant a 180-day approval for this 

request under procedures for expedited 

processing. A request for review under 

normal procedures will be submitted 

within 180 days of the approval for this 

request. Given the Congressional 

directive for a report on the Affordable 

Housing and Supportive Services 

Demonstration within 1 year, OCS has 

prepared data collection instruments to 

study the implementation of this 

demonstration program with the intent 

to produce a robust report to Congress. 

Under normal circumstances, OCS 

would submit the data collection 

instruments through a standard 

information collection request with 

OMB. However, the short timeframe 

attached to the Congressional directive 

make it reasonably likely that the use of 

normal clearance procedures to comply 

with the Paperwork Reduction Act 

would cause this Congressional 

deadline to be missed. If OCS were to 

proceed with the normal timeline for 

OMB review and approval, OCS would 

be unable to collect, clean, analyze, and 

consolidate program data such that it 

would be accessible for the report to 

Congress due within 1 year. Thus, OCS 

is requesting emergency OMB approval 

of this data collection to ensure we can 

accommodate the Congressional request 

for a report on the findings of this 

demonstration within 1 year. OCS is 

hoping to center the study around three 

main research categories— 

implementation of supportive services 

in affordable housing, changes in 

participant access to supportive services 

in affordable housing, and overall 

participant experience and outcomes 

along several variables of interest. 

Ultimately, OCS hopes to illustrate how 

supportive services are implemented in 

affordable housing spaces by program 

directors and caseworkers, and also 

demonstrate participant experiences 

accessing those services in the 

affordable housing setting, as well as 

which services and supports worked to 

improve resident well-being and overall 

self-sufficiency. To answer these 

research questions, OCS will engage in 

the following activities: 


ddrumheller on DSK120RN23PROD with NOTICES1
2624 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 

• Collecting program official, 

caseworker, and resident beneficiary 

level data from the Affordable Housing 

and Supportive Services Demonstration. 

• Conducting interviews with 

program officials and caseworkers that 

administer the supportive services to 

residents living in affordable housing 

units to better understand their program 

implementation efforts and responses to 

resident needs. 

• Conducting focus groups with 

beneficiary residents to understand their 

needs and experiences with the 

supportive services offered in their 

affordable housing residence. 

• Administering a self-sufficiency 

matrix to beneficiary residents to assess 

any change or improvement in 

beneficiary resident reporting of overall 

self-sufficiency and wellbeing, which is 

measured using several indicators, with 

the receipt of additional supportive 

services in the affordable housing 

setting. 

Respondents: There will be three 

types of respondents to the proposed 

instruments. First, the direct 

beneficiaries living in the residential 

housing communities will respond to 

instruments 1, 2, and 3. Second, the 

program directors/administrative staff 

will respond to instruments 4, 5, 6, and 

7. Finally, the caseworkers providing 

direct support to beneficiaries will 

respond to instrument 8. Caseworkers 

may also be asked to support the 

implementation and administration of 

instruments 1, 2, and 3. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total/ 

annual 

burden 

hours 

1—Self-Sufficiency Matrix ................................................................................................ 560 2 1.5 1,680 

2—Service Receipt Questionnaire .................................................................................. 560 2 .25 280 

3—Resident Focus Group ............................................................................................... 25 1 1.5 37.5 

4—Quarterly PPR Questions ........................................................................................... 9 4 2 72 

5—Semi-Annual Report MANDATORY ........................................................................... 9 2 3 54 

6—Semi-Annual Report OPTIONAL ............................................................................... 3 2 1 6 

7—Interviews of Program Directors ................................................................................ 18 1 1.5 27 

8—Interviews of Caseworkers ......................................................................................... 18 1 1 18 

Estimated Total Annual Burden Hours ..................................................................... .................... .................... .................... 2,174.5 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Comments will be considered and any 

necessary updates to materials made 

prior to, and responses provided in, the 

submission to OMB that will follow this 

public comment period. 

Authority: Sec. 1110, Social Security 

Act, 42 U.S.C. 1310. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–00648 Filed 1–12–24; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0065] 

Notice of Approval of Product Under 

Voucher: Material Threat Medical 

Countermeasure Priority Review 

Voucher; FABHALTA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

approval of a product redeeming a 

material threat medical countermeasure 

(MCM) priority review voucher. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

issuance of material threat MCM 

priority review vouchers as well as the 

approval of products redeeming a 

voucher. FDA has determined that 

FABHALTA (iptacopan) capsules, 

approved December 5, 2023, meets the 

redemption criteria. 

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: Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a) FDA will report the 

issuance of material threat MCM 

priority review vouchers and the 

approval of products for which a 

voucher was redeemed. FDA has 

determined that the application for 

FABHALTA (iptacopan) capsules, 

approved December 5, 2023, meets the 

redemption criteria. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For 

further information about FABHALTA 

(iptacopan) capsules go to the ‘‘Drugs@

FDA’’ website at http://www.accessdata.

fda.gov/scripts/cder/daf/. 

Dated: January 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00688 Filed 1–12–24; 8:45 am] 

BILLING CODE 4164–01–P 


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