Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 62385 

Although FDA has issued guidance on 

expanded access requests, including 

expanded access for individual patients, 

the Agency is aware that IRBs seek 

further clarity on this topic. 

Under FDA regulations, there are 

three categories of expanded access: 

individual (also known as single) 

patient, including for emergency use; 

intermediate-size for intermediate-size 

patient populations; and ‘‘treatment’’ for 

larger populations. This guidance only 

applies to IRB review of individual 

patient expanded access submissions, as 

outlined in 21 CFR 312.310. The 

recommendations in this guidance are 

intended to provide additional clarity to 

assist IRBs in conducting efficient 

reviews of individual patient expanded 

access requests. 

In the Federal Register of June 9, 2020 

(85 FR 35311), FDA announced the 

availability of a guidance for IRBs and 

investigators entitled ‘‘Institutional 

Review Board (IRB) Review of 

Individual Patient Expanded Access 

Requests for Investigational Drugs and 

Biological Products During the COVID– 

19 Public Health Emergency: Guidance 

for IRBs and Clinical Investigators’’ 

(2020 COVID–19 guidance) to support 

public health efforts following a 

determination, under section 319 of the 

Public Health Service (PHS) Act (42 

U.S.C. 247d), by the Secretary of Health 

and Human Services that a public 

health emergency existed related to 

Coronavirus Disease 2019 (COVID–19 

public health emergency). The 2020 

COVID–19 guidance focused on 

addressing the COVID–19 public health 

emergency and was intended to remain 

in effect only for the duration of the 

COVID–19 public health emergency. 

However, the 2020 COVID–19 guidance 

explained we expected the 

recommendations would assist the 

Agency more broadly in its continued 

efforts to facilitate access to drugs 

through expanded access for individual 

patients beyond the COVID–19 public 

health emergency and that FDA would 

replace the 2020 COVID–19 guidance 

with any appropriate changes based on 

comments received and the Agency’s 

experience with implementation. FDA 

continues to believe that many of the 

recommendations set forth in the 2020 

COVID–19 guidance are applicable 

outside the context of the COVID–19 

public health emergency and are 

applicable to key factors and procedures 

IRBs should consider when reviewing 

individual patient expanded access 

submissions. In addition, in the Federal 

Register of March 13, 2023 (88 FR 

15417), FDA listed the 2020 COVID–19 

guidance as one of the guidances FDA 

was revising to continue in effect for 

180 days after the COVID–19 PHE 

declaration issued under the PHS Act 

expired on May 11, 2023, during which 

time FDA planned to further revise 

those guidances. Consistent with what 

we said in the Federal Register of 

March 13, 2023, FDA is therefore 

issuing this revised final guidance, 

which supersedes the 2020 COVID–19 

guidance. FDA revised the guidance to 

remove references to the COVID–19 

public health emergency and made 

editorial changes to improve clarity. 

FDA also clarified recommendations on 

IRB procedures and factors to consider 

for individual patient expanded access 

submissions. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with our good guidance 

practices regulation (21 CFR 

10.115(g)(3)) without initially seeking 

prior comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (see 21 CFR 10.115(g)(2) 

and section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because public 

health emergencies (PHEs) and the need 

to address individual patient expanded 

access submissions for patient access to 

investigational drugs for diagnosing, 

monitoring, or treating diseases or 

conditions related to PHEs may occur 

without notice and, as we have learned 

from experience during the COVID–19 

PHE, may hinder physicians seeking to 

treat their patients in a timely manner. 

It is thus important to public health to 

provide recommendations regarding the 

key factors and procedures IRBs should 

consider when reviewing requests. 

Interested parties had an opportunity to 

comment on the recommendations in 

the 2020 COVID–19 guidance, and FDA 

considered those comments when 

revising the guidance. Although this 

guidance document is being 

implemented immediately, it remains 

subject to comment in accordance with 

FDA’s good guidance practices 

regulation (§ 10.115(g)(3)(D)). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the current 

thinking of FDA on ‘‘Institutional 

Review Board (IRB) Review of 

Individual Patient Expanded Access 

Submissions for Investigational Drugs 

and Biological Products.’’ 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 part 312 and 

Form FDA 1571 have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR parts 50 and 56 relating to the 

protection of human subjects, informed 

consent, and IRBs have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR 312.300 through 312.320 relating to 

expanded access to investigational 

drugs for treatment use and Form FDA 

3926 have been approved under OMB 

control number 0910–0814. The 

collections of information in 21 CFR 

part 11 relating to electronic records and 

signatures have been approved under 

OMB control number 0910–0303. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: September 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19501 Filed 9–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the CDC/HRSA Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

Centers for Disease Control and 

Prevention (CDC)/HRSA Advisory 

Committee on HIV, Viral Hepatitis and 


ddrumheller on DSK120RN23PROD with NOTICES1
62386 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

STD Prevention and Treatment (CHAC) 

has scheduled a public meeting. 

Information about CHAC and the 

meeting can be found on the CHAC 

website at https://www.cdc.gov/faca/ 

committees/chachspt.html and the 

meeting website at https://targethiv.org/ 

ta-org/chac. 

DATES: Tuesday, October 24, 2023, 9 

a.m. to 4 p.m. Eastern Time (ET); and 

Wednesday, October 25, 2023, 9 a.m. to 

3 p.m. ET. 

ADDRESSES: This meeting will be hybrid, 

held both virtually through Zoom and in 

person at 5600 Fishers Lane, Pavilion 

Rooms 5A02, 5A03, and 5A04, 

Rockville, Maryland 20857. Advance 

registration is required to attend. Please 

visit the meeting website to register. The 

in-person registration deadline is 

Monday, October 16, 2023, at 5 p.m. ET; 

registration for virtual attendance will 

remain open. Prior to the meeting, each 

individual registrant will receive a 

registration confirmation along with an 

access link to the virtual meeting 

location. 

FOR FURTHER INFORMATION CONTACT: 

Shalonda Collins, Public Health 

Analyst, HIV/AIDS Bureau, HRSA, (301) 

945–0835; CHACAdvisoryComm@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: CHAC 

provides advice and recommendations 

to the Secretary of HHS (Secretary) on 

policy, program development, and other 

matters of significance concerning the 

activities under Section 222 of the 

Public Health Service Act, 42 U.S.C. 

217a. 

The purpose of the CHAC is to advise 

the Secretary of HHS, CDC Director, and 

HRSA Administrator regarding 

objectives, strategies, policies, and 

priorities for the prevention and 

treatment of HIV, viral hepatitis, and 

other STDs, including surveillance, 

epidemiologic, behavioral, health 

services, and laboratory research, 

identification of policy issues related to 

professional eduction, patient 

healthcare delivery, and prevention 

services; agency policies regarding 

health care delivery, research and 

training; strategic issues influencing the 

ability of CDC and HRSA to fulfill their 

missions’ programmatic efforts to 

prevent and treat HIV, viral hepatitis, 

and other STDs; and support to CDC 

and HRSA in their development of 

responses to emerging health needs 

related to these issues. 

During the October 24–25, 2023, 

meeting, CHAC will discuss issues 

related to reducing barriers and 

improving outcomes in HIV and 

Hepatitis C co-infection, payment 

models for addressing social 

determinants of health, incorporating 

stigma reduction in HIV care and 

treatment, as well as other special 

presentations. Agenda items are subject 

to change as priorities dictate. Refer to 

the CHAC meeting information page for 

any updated information concerning the 

meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may also submit 

written statements as further described 

below. Oral comments will be honored 

in the order they are requested and may 

be limited as time allows. Requests to 

submit a written statement or make oral 

comments to CHAC should be sent via 

the meeting website at https://

targethiv.org/ta-org/chac. Requests for 

oral comment must be received by 

October 17, 2023, at 5 p.m. ET to be 

considered. Written comments may be 

submitted to Shalonda Collins at the 

email address and/or phone number 

listed above prior to and up to 10 

business days after the meeting. Visit 

the meeting information page for 

additional details: https://targethiv.org/ 

ta-org/chac. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Shalonda Collins at the email 

address and/or phone number listed 

above at least 10 business days prior to 

the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–19542 Filed 9–8–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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: Center for Scientific 

Review Special Emphasis Panel; Societal and 

Ethical Issues in Research. 

Date: October 6, 2023. 

Time: 10:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Maria De Jesus Diaz Perez, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1000G, 

Bethesda, MD 20892, (301) 496–4227, 

diazperezm2@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 6, 2023. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–19506 Filed 9–8–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2748–23; DHS Docket No. USCIS– 

2014–004] 

RIN 1615–ZB79 

Extension and Redesignation of South 

Sudan for Temporary Protected Status 

Correction 

In Notice document 2023–19312 

beginning on page 60971 in the issue of 

Wednesday, September 6, 2023, make 

the following correction: 

On page 60976, in the first column, in 

the signature, in the first line 

‘‘Alejandro N. Mayorkas,Vienna’’ 

should read ‘‘Alejandro N. Mayorkas,’’. 

[FR Doc. C1–2023–19312 Filed 9–8–23; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0001] 

Agency Information Collection 

Activities; Revision of a Currently 

Approved Collection: Petition for Alien 

Fiance ́(e) 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 


ddrumheller on DSK120RN23PROD with NOTICES1