62384 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3452] 

Institutional Review Board Review of 

Individual Patient Expanded Access 

Submissions for Investigational Drugs 

and Biological Products; Guidance for 

Institutional Review Boards and 

Clinical Investigators; 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 final 

guidance for institutional review boards 

(IRBs) and clinical investigators entitled 

‘‘Institutional Review Board (IRB) 

Review of Individual Patient Expanded 

Access Submissions for Investigational 

Drugs and Biological Products.’’ FDA is 

issuing this final guidance to provide 

recommendations regarding the key 

factors and procedures IRBs should 

consider when reviewing individual 

patient expanded access submissions, 

including for reviews conducted by a 

single member of the IRB, to fulfill its 

obligations under FDA regulations. 

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. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 11, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2023–D–3452 for ‘‘Institutional Review 

Board (IRB) Review of Individual 

Patient Expanded Access Submissions 

for Investigational Drugs and Biological 

Products.’’ 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. 

• 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 this final 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; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–5683. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for IRBs and clinical 

investigators entitled ‘‘Institutional 

Review Board (IRB) Review of 

Individual Patient Expanded Access 

Submissions for Investigational Drugs 

and Biological Products.’’ FDA is 

issuing this guidance to provide 

recommendations regarding the key 

factors and procedures IRBs should 

consider when reviewing individual 

patient expanded access submissions, 

including for reviews conducted by a 

single member of the IRB, to fulfill its 

obligations under 21 CFR part 56. 


ddrumheller on DSK120RN23PROD with NOTICES1
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