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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 90297 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Ronald Wange, Center for Drug 

Evaluation and Research (HFD–510), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

3342, Silver Spring, MD 20903, 301– 

796–1304. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Nonclinical Safety Assessment of 

Oligonucleotide-Based Therapeutics.’’ 

ONTs represent a rapidly evolving 

therapeutic modality, which is seeing 

application to a broad range of 

indications, including rare diseases, and 

have the potential to act on therapeutic 

targets that are not amenable to the 

action of small molecule drugs or 

therapeutic proteins. To further support 

the development of ONTs, FDA is 

publishing this draft guidance which, 

when finalized, will assist sponsors in 

optimizing the design of their 

nonclinical development package for 

ONTs. 

The scope of the draft guidance 

includes single-stranded or doublestranded ONTs created synthetically or 

derived naturally, with native or 

modified backbone or nucleoside 

structures that increase or decrease 

expression and/or function of proteins. 

Examples of included oligonucleotides 

are antisense, small interfering RNA, 

microRNA, transfer RNAs, decoys, and 

aptamers. Immune stimulatory 

oligonucleotides (e.g., CpG motifs acting 

via Toll-like receptors) are excluded, as 

are Center for Biologics Evaluation and 

Research-regulated ONTs (e.g., DNA/ 

RNA vaccines, messenger RNA, virally 

delivered ONTs, and RNA used for gene 

editing). 

ONTs present unique opportunities 

and challenges in the nonclinical 

evaluation of safety that differ in many 

regards from that appropriate for small 

molecule drugs or therapeutic proteins. 

This draft guidance provides specific 

recommendations on approaches for the 

nonclinical safety evaluation of ONTs to 

support clinical development and 

marketing of these products. The draft 

guidance, when finalized, will provide 

recommendations on the nonclinical 

evaluation of oligonucleotides in 

multiple areas, including genotoxicity, 

safety pharmacology, general toxicity, 

carcinogenicity, and reproductive and 

developmental toxicity. These 

recommendations have been developed 

based on industry best practices and 

Agency experience to date with this 

category of drug products. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Nonclinical Safety Assessment of 

Oligonucleotide-Based Therapeutics.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR parts 50 and 56 

pertaining to protection of human 

subjects have been approved under 

OMB control number 0910–0130. The 

collections of information in 21 CFR 

part 58 pertaining to good laboratory 

practice for nonclinical laboratory 

studies have been approved under OMB 

control number 0910–0119. The 

collections of information in 21 CFR 

201.56 and 201.57 pertaining to content 

and format of labeling for human 

prescription drug and biological 

products have been approved under 

OMB control numbers 0910–0572. The 

collections of information in 21 CFR 

parts 210 and 211 pertaining to current 

good manufacturing practice have been 

approved under OMB control number 

0910–0139. The collections of 

information in 21 CFR part 312 relating 

to the content and format of 

investigational new drug applications 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 relating 

to the content and format of new drug 

applications have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 601 relating to the content and 

format of biologics license applications 

are approved under OMB control 

number 0910–0338. The collections of 

information for MEDWATCH Adverse 

Event and Product Experience Reporting 

system have been approved under OMB 

control number 0910–0291. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 


khammond on DSKJM1Z7X2PROD with NOTICES
90298 Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices 

Dated: November 6, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26682 Filed 11–14–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing or 

Collaboration: Novel Kinase Inhibitory 

Aplithianines 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute 

(NCI), an institute of the National 

Institutes of Health (NIH), Department 

of Health and Human Services (HHS), is 

giving notice of the licensing and/or 

collaboration opportunities for the 

inventions listed below, which are 

owned by an agency of the U.S. 

Government and are available for 

licensing and/or collaboration to 

achieve expeditious commercialization 

of results of federally-funded research 

and development. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to these licensing or 

collaboration opportunities should be 

directed to: Taryn Dick, Ph.D., M.B.A., 

Technology Transfer Manager, NCI, 

Technology Transfer Center, Email: 

taryn.dick@nih.gov or Phone: 301–631– 

3007. 

SUPPLEMENTARY INFORMATION: 

Researchers at the NCI seek licensing 

and/or co-development research 

collaborations for a class of novel 

aplithianine-derived small molecule 

analogs that compete with ATP for 

binding on a range of clinically relevant 

kinases. In 2022, the NCI Molecular 

Targets Program (MTP) completed a 

screen of approximately 150,000 prefractionated natural products from the 

NCI Program for Natural Product 

Discovery (NPNPD). From this screen, a 

class of active compounds, named 

Aplithianines A & B (isolated from the 

marine organism Aplidium sp.), showed 

broad potential applicability to 

numerous kinases of importance, 

including but not limited to: 

• Oncogenic gene fusion DNAJB1– 

PRKACA (PKADJ): 

Æ Implicated in an ultra-rare 

adolescent liver cancer. 

• Wild type protein kinase A (PKA): 

Æ Implicated in Cushing’s Disease. 

• Protein kinase G (PKG): 

Æ Potential treatment of malaria. 

• Ccdc2-like kinases (CLK) 1 and 2: 

Æ Implicated in gastric cancer. 

• DYRK family of kinases: 

Æ Implicated in gastric or colon 

cancer as well as infections caused by 

a protozoa or parasites. 

This technology describes the 

Original Family of compounds filed. 

Subsequent to this filing, two additional 

cohorts of related, but patentably 

distinct cohorts of compounds, have 

been filed. Both the Second and the 

Third Cohorts comprise the same 

chemical scaffold of the broadest 

generic formula of this Original Family 

but represent patentably distinct 

subgenus formulas. 

BILLING CODE 4140–01–P 


khammond on DSKJM1Z7X2PROD with NOTICES