[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35311-35313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1414]


Institutional Review Board Review of Individual Patient Expanded 
Access Requests for Investigational Drugs and Biological Products 
During the COVID-19 Public Health Emergency; Guidance for Institutional 
Review Boards and Clinical Investigators; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry 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.'' To facilitate 
patient access to investigational drugs for treating COVID-19, FDA is 
issuing this guidance to provide recommendations regarding the key 
factors and procedures IRBs should consider when reviewing requests--
including when such reviews are conducted by a single-member of an 
IRB--for individual patient expanded access. Given the public health 
emergency presented by COVID-19, this guidance is being implemented 
without prior public comment because FDA has determined that prior 
public participation is not feasible or appropriate, but it remains 
subject to comment in accordance with the Agency's good guidance 
practices.

DATES: The announcement of the guidance is published in the Federal 
Register on June 9, 2020. The guidance is immediately in effect, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices.

ADDRESSES: You may submit 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

[[Page 35312]]

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-2020-D-1414 for ``Institutional Review Board (IRB) Review of 
Individual Patient Expanded Access Requests for Investigational Drugs 
and Biological Products During the COVID-19 Public Health Emergency.'' 
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.
     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.
    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 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: Juanita Marner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-8078.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
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.'' 
There is currently an outbreak of respiratory disease caused by a novel 
coronavirus. The virus has been named SARS-CoV-2, and the disease it 
causes has been named Coronavirus Disease 2019 (COVID-19). On January 
31, 2020, the Department of Health and Human Services (HHS) issued a 
declaration of a public health emergency related to COVID-19 and 
mobilized the Operating Divisions of HHS. The public health emergency 
declaration was renewed on April 21, 2020. In addition, on March 13, 
2020, the President declared a national emergency in response to COVID-
19.
    FDA is issuing this guidance to provide recommendations regarding 
the key factors and procedures IRBs, including for reviews conducted by 
a single-member, should consider when reviewing individual patient 
expanded access submissions for patient access to investigational drugs 
for treating COVID-19.
    Under FDA regulations, three categories of expanded access are 
available: Expanded access for individual (also known as single) 
patients, including for emergency use; expanded access for 
intermediate-size patient populations; and ``treatment'' expanded 
access for larger populations. This guidance applies to individual 
patient expanded access requests, as outlined in 21 CFR 312.310. The 
recommendations in this guidance are intended to assist IRBs in 
conducting efficient reviews of individual patient expanded access 
requests.
    In light of the public health emergency related to COVID-19 
declared by the Secretary of HHS, FDA has determined that prior public 
participation for this guidance is not feasible or appropriate and is 
issuing this guidance without prior public comment (see section 
701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 
10.115(g)(2)). This guidance document is being implemented immediately, 
but it remains subject to comment in accordance with the Agency's good 
guidance practices statute and regulation.
    This guidance is intended to remain in effect for the duration of 
the public health emergency related to COVID-19 declared by HHS, 
including any renewals made by the Secretary in accordance with section 
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). 
However, the recommendations described in the guidance are expected to 
assist the Agency more broadly in its continued efforts to facilitate 
access to drugs through expanded access beyond the termination of the 
COVID-19 public health emergency and reflect the Agency's current 
thinking on this issue. Therefore, within 60 days following the 
termination of the public health

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emergency, FDA intends to revise and replace this guidance with any 
appropriate changes based on comments received on this guidance and the 
Agency's experience with implementation.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Institutional Review Board (IRB) Review of 
Individual Patient Expanded Access Requests for Investigational Drugs 
and Biological Products During the COVID-19 Public Health Emergency.'' 
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

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; the collections of information relating 
to the protection of human subjects and IRBs have been approved under 
OMB control number 0910-0130; and the collections of information in 
FDA's guidance for industry on ``Individual Patient Expanded Access 
Applications: Form FDA 3926'' have been approved under OMB control 
number 0910-0814.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or 
https://www.regulations.gov.

    Dated: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12429 Filed 6-8-20; 8:45 am]
 BILLING CODE 4164-01-P