Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 90295 

completing the error rate reports, 

including their estimated burden hours 

for each report. All CCDF Lead Agencies 

required to submit the error rate reports 

were invited to participate, and 56 

percent (29 out of 52 Lead Agencies) 

responded. Lead Agency respondents 

represented a geographically diverse 

group of states with a range in size as 

defined by the numbers of children and 

families served by CCDF. There were 

expected variations in responses which 

may reflect differences in states’ 

administrative structures and 

complexity, staff capacity, reporting 

technology, interpretation of the survey 

questions, and other factors. However, 

even considering the range of responses 

and any outliers, OCC determined that 

the burden hours estimates should be 

lowered to reflect the survey results. In 

addition, to more accurately account for 

the work described by survey 

respondents, OCC further broke out the 

estimated burden hours for the RRW 

into the following two parts: (1) the 

estimated hours needed for states to 

customize the standard RRW template 

to reflect their state’s rules, policies, and 

procedures; and (2) the estimated hours 

needed for states to use the customized 

RRW to conduct each of the 276 case 

reviews. 

• Root Causes of Error: OCC proposes 

to standardize the root causes of error in 

Item 19 of the ACF–404 State Improper 

Payment Report by creating a dropdown list of error cause choices. 

Currently, Lead Agencies enter free text 

to describe the causes of errors in their 

Federal error rate reviews. While this 

approach allows flexibility at the 

individual reporting level, inconsistent 

terminology and descriptions across 

states and reporting cycles makes it 

difficult to analyze, report, and track 

national and state-level error trends over 

time. Further, the current approach can 

add additional burden to states during 

the report review and approval process 

because clarifications about error cause 

descriptions are often requested by 

Federal reviewers. We request comment 

on whether standardizing error causes 

in Item 19 would benefit Lead Agencies 

in their data analysis, ease of report 

preparation, and tracking of error trends 

over time. We also request comments on 

whether the proposed list of 

standardized error causes would meet 

Lead Agency reporting needs, and if not, 

what additional or different error causes 

should be included. 

Respondents: CCDF grantees from 

states, the District of Columbia, and 

Puerto Rico. 

Annual Burden Estimates: Burden 

estimates are shown based on the total 

burden over a 3-year period divided by 

three to show average annual burden 

estimates. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

Sampling Decisions, Assurances, and Fieldwork Preparation Plan ....... 52 1 35 1,820 607 

ACF–403 Record Review Worksheet: template ...................................... 52 1 63 3,276 1,092 

ACF–403 Record Review Worksheet: case record reviews ................... 52 276 3.0 43,056 14,352 

ACF–404 State Improper Payments Report ............................................ 52 1 66 3,432 1,144 

ACF–405 State Improper Payments Report Corrective Action Plan ...... 6 a 2 24 288 96 

Estimated Total Annual Burden Hours: ............................................ .................... ........................ ........................ ................ 17,291 

aThe total number of responses per respondent over 3 years ranges from 1–3, depending on how long it takes respondents to reduce the Improper Payment Rate to below the threshold. Respondents submit a Corrective Action Plan that covers a 1-year period; at the end of each year, 

if respondents have not reduced the Improper Payment Rate to below the threshold, they submit a new Corrective Action Plan for the following 

year. An average of two responses per respondent over a 3 year period is used to calculate annual burden estimates. 

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. 

Authority: 45 CFR part 98 subpart K. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–26684 Filed 11–14–24; 8:45 am] 

BILLING CODE 4184–87–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Administration of 

Psychotropic Medication to 

Unaccompanied Children (New 

Collection) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Refugee 

Resettlement (ORR), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services is inviting public comment on 

the proposed collection. The request 

consists of two forms that will allow the 

Unaccompanied Children (UC) Bureau 

to obtain informed consent from 

authorized consenters and informed 

assent or agreement from 

unaccompanied children for the 

administration of psychotropic 

medication. 

DATES: Comments due December 16, 

2024. The Office of Management and 

Budget (OMB) must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

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. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 


khammond on DSKJM1Z7X2PROD with NOTICES
90296 Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The ORR UC Bureau is 

proposing two new forms: Psychotropic 

Medication Informed Consent (Form 

MMH–1) and Psychotropic Medication 

Assent Notice (Form MMH–2). The 

proposed information collection is 

necessary to allow the ORR UC Bureau 

to comply with a court order and 

improve processes for the 

administration of psychotropic 

medication. On June 29, 2018, Plaintiffs 

filed their Federal class action lawsuit 

in the Central District of California, 

western division, captioned Lucas R. et 

al. v. Becerra et al. (Case No. 2:18–CV– 

05741 DMG PLA), asserting claims 

under the Flores consent decree, the 

Trafficking Victims Protection 

Reauthorization Act, the Due Process 

clause, and the First Amendment. 

Plaintiffs allege violation of 

unaccompanied children rights in 

decisions regarding family reunification, 

placement in restrictive facilities, 

services for children with disabilities, 

administration of psychotropic 

medication, and access to legal 

assistance. On May 3, 2024, the Court 

granted final approval for the settlement 

agreements of the Plaintiffs’ claims for 

disabilities, psychotropic medication, 

and legal assistance. As part of the 

settlement agreement for the 

psychotropic medication claim, ORR is 

required, whenever possible, to obtain 

informed consent for the administration 

of psychotropic medication and provide 

certain information to the authorized 

consenter. Additionally, ORR is 

required to provide a written notice and 

obtain informed assent or agreement 

from children aged 14 or older before 

administering psychotropic medication. 

The psychotropic medication settlement 

agreement must be fully implemented 

by August 3, 2026, but data collection 

must be implemented by February 3, 

2025, to ensure compliance with the 

Agreement. 

Respondents: Care provider grantees 

and contractors. 

ANNUAL BURDEN ESTIMATES

Form 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total annual 

burden hours 

Psychotropic Medication Informed Consent (Form MMH–1) .............................. 300 2 1.50 900 

Psychotropic Medication Assent Notice (Form MMH–2) ..................................... 300 1 0.75 225 

Estimated Total Annual Burden 

Hours: 1,125. 

Authority: 6 U.S.C. 279; 8 U.S.C. 

1232; 45 CFR part 410; Flores v. Reno 

Settlement Agreement, No. CV85–4544– 

RJK (C.D. Cal. 1996); Lucas R. et al. v. 

Becerra et al. (Case No. 2:18–CV–05741 

DMG PLA) Psychotropic Medication 

Settlement Agreement. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–26690 Filed 11–14–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4624] 

Nonclinical Safety Assessment of 

Oligonucleotide-Based Therapeutics; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Nonclinical Safety Assessment of 

Oligonucleotide-Based Therapeutics.’’ 

FDA is publishing this draft guidance 

which, when finalized, will provide 

recommendations on approaches for the 

nonclinical safety evaluation of 

oligonucleotide-based therapeutics 

(ONTs) to support clinical development 

and marketing of these products. ONTs 

present unique challenges and 

opportunities in the nonclinical 

evaluation of safety that differ in many 

regards from those appropriate for small 

molecule drugs or therapeutic proteins. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 14, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–4624 for ‘‘Nonclinical Safety 

Assessment of Oligonucleotide-Based 

Therapeutics.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 


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