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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