65398 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

reopening the comment period for the 

notice entitled ‘‘In-Home Disposal 

Systems for Opioid Analgesics; Request 

for Information’’ published in the 

Federal Register of April 4, 2023. FDA 

is reopening the comment period to 

allow interested persons additional time 

to develop and submit comments. 

DATES: FDA is reopening the comment 

period on the notice published April 4, 

2023 (88 FR 19959). Either electronic or 

written comments must be submitted by 

November 6, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 6, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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– 

2023–N–0917 for ‘‘In-Home Disposal 

Systems for Opioid Analgesics; Request 

for Information.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

• 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. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 4, 2023 (88 FR 

19959), FDA published a notice 

requesting information and comments 

that will assist the Agency in assessing 

whether in-home disposal products can 

be expected to meet the public health 

goal of mitigating the risk of nonmedical 

use or overdose if the Agency were to 

require drug manufacturers to make inhome disposal products available to 

patients under a risk evaluation and 

mitigation strategy. The Agency 

requested information and comments on 

the issues that were discussed at the 

public workshop convened by the 

National Academies of Sciences, 

Engineering, and Medicine’s Forum on 

Drug Discovery, Development, and 

Translation entitled ‘‘Defining and 

Evaluating In-Home Disposal Systems 

for Opioid Analgesics’’ on June 26 and 

27, 2023. Interested persons were 

originally given until August 28, 2023, 

to submit comments on in-home 

disposal systems for opioid analgesics. 

FDA is reopening the public docket to 

allow interested persons additional time 

to submit comments. We note that there 

is a listening session on October 5, 2023, 

with federally recognized American 

Indian and Alaska Native tribes on the 

safe disposal of opioid analgesics. The 

Agency believes that reopening the 

comment period for an additional 45 

days will allow adequate time for 

interested persons to submit comments 

without significantly delaying Agency 

decision-making on these important 

issues. FDA is reopening the comment 

period for 45 days, until November 6, 

2023. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20516 Filed 9–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 65399 

ACTION: Notice. 

SUMMARY: Pursuant to the Federal 

Advisory Committee Act, notice is 

hereby given that the Secretary’s 

Advisory Committee on Human 

Research Protections (SACHRP) will 

hold a meeting that will be open to the 

public. Information about SACHRP, the 

full meeting agenda, and instructions for 

linking to public access will be posted 

on the SACHRP website at http://

www.dhhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Wednesday, October 18, 2023, from 9:00 

a.m. until 5:00 p.m., and Thursday, 

October 19, 2023, from 9:00 a.m. until 

4:00 p.m. (times are tentative and 

subject to change). The confirmed times 

and agenda will be posted on the 

SACHRP website as this information 

becomes available. 

ADDRESSES: This meeting will be held in 

person and webcast. Members of the 

public may also attend the meeting via 

webcast. Instructions for attending via 

webcast will be posted at least one week 

prior to the meeting at https://

www.hhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

FOR FURTHER INFORMATION CONTACT: Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The Subpart A Subcommittee (SAS) 

was established by SACHRP in October 

2006 and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

The Subcommittee on Harmonization 

(SOH) was established by SACHRP at its 

July 2009 meeting and charged with 

identifying and prioritizing areas in 

which regulations and/or guidelines for 

human subjects research adopted by 

various agencies or offices within HHS 

would benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. 

The SACHRP meeting will open to the 

public at 9:00 a.m., on Wednesday, 

October 18, 2023, followed by opening 

remarks from Julie Kaneshiro, Acting 

Director of OHRP and Dr. Douglas 

Diekema, SACHRP Chair. The meeting 

will begin with an expert panel 

discussion on the ethical and regulatory 

considerations for the inclusion of 

LGBTQI+ populations in HHS research. 

This will be followed by discussion of 

IRB effectiveness, topic #4 of the 

recently published GAO report #GAO– 

23–104721, Institutional Review Boards: 

Actions Needed to Improve Federal 

Oversight and Examine Effectiveness. 

The meeting then will turn to a 

discussion of the best interests standard 

for permitting continued participation 

of subjects in a suspended or terminated 

research study. Following this the 

committee will discuss IRB review of 

research that may be considered 

uninformative. 

On Thursday, October 19th, the 

committee will welcome ADM Rachel 

Levine for commentary and remarks; 

this will be followed by continued 

discussion of the previous day’s topics. 

The meeting will adjourn by 4:00 p.m. 

October 19, 2023. 

Time will be allotted for public 

comment on both days of the meeting. 

The public may submit written public 

comment in advance to SACHRP@

hhs.gov no later than midnight October 

13, 2023, ET. Written comments will be 

shared with SACHRP members and may 

read aloud during the meeting. Public 

comment must be relevant to topics 

being addressed by the SACHRP. 

Dated: September 13, 2023. 

Julia G. Gorey, 

Executive Director, SACHRP. Office for 

Human Research Protections. 

[FR Doc. 2023–20577 Filed 9–21–23; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

Individually Measured Phenotypes to 

Advance Computational Translation in 

Mental Health (IMPACT–MH) (U01 & U24). 

Date: October 19–20, 2023. 

Time: 9:00 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Rebecca Steiner Garcia, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Bethesda, MD 20892–9608, 301–443–4525, 

steinerr@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

ALACRITY: Advanced Laboratories for 

Accelerating the Reach and Impact of 

Treatments for Youth and Adults with 

Mental Illness Centers. 

Date: October 19, 2023. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Regina Dolan-Sewell, 

Ph.D., Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Bethesda, MD 20852, (240) 796–6785, 

regina.dolan-sewell@nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

BRAIN Initiative: Brain Behavior 

Quantification and Synchronization—Data 

Coordination and Artificial Intelligence 

Center. 

Date: October 20, 2023. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Evon Abisaid, Ph.D., 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

6001 Executive Blvd., Bethesda, MD 20852, 

301–827–0399, ereifejes@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants, National Institutes of Health, HHS) 


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