[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65177-65179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3550]


Considerations for the Conduct of Clinical Trials of Medical 
Products During Major Disruptions Due to Disasters and Public Health 
Emergencies; Guidance for Industry, Investigators, and Institutional 
Review Boards; 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 
``Considerations for the Conduct of Clinical Trials of Medical Products 
During Major Disruptions Due to Disasters and Public Health 
Emergencies.'' This guidance recommends approaches that sponsors of 
clinical trials of medical products can consider when there is a major 
disruption to clinical trial conduct and operations due to disasters or 
public health emergencies, which can include but are not limited to 
hurricanes, earthquakes, military conflicts, infectious disease 
outbreaks, or bioterrorist attacks. The appendix to this guidance 
further explains those approaches by providing answers to questions 
that the Agency has received about conducting clinical trials during 
major disruptions.

DATES: The announcement of the guidance is published in the Federal 
Register on September 21, 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-3550 for ``Considerations for the Conduct of Clinical Trials 
of Medical Products During Major Disruptions Due to Disasters and 
Public Health Emergencies.'' 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.
    <bullet> 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

[[Page 65178]]

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 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, 301 796-2500, 
<a href="/cdn-cgi/l/email-protection#6a292e2f3825273a2a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="0b484f4e5944465b4b6d6f6a25636378256c647d">[email protected]</span></a>; 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, 240-402-7911; or Soma Kalb, 
Center for Devices and Radiological Health, 10903 New Hampshire Ave., 
Bldg. 66, Silver Spring, MD 20993-0002, 301-796-6359.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for 
industry, investigators, and institutional review boards entitled 
``Considerations for the Conduct of Clinical Trials of Medical Products 
During Major Disruptions Due to Disasters and Public Health 
Emergencies.'' Disasters and public health emergencies (PHEs) have the 
potential to cause major disruptions in the conduct of clinical trials 
for medical products. Such events can include, but are not limited to, 
weather events, military conflicts, infectious disease outbreaks, and 
bioterrorist attacks. The purpose of the guidance is to provide general 
considerations to assist sponsors, investigators, and institutional 
review boards in assuring the safety of trial participants, maintaining 
compliance with good clinical practice, and minimizing risks to trial 
integrity during disasters and PHEs that may lead to major disruption 
of clinical trial conduct and operations. The appendix to the guidance 
further explains these general considerations in a question-and-answer 
format.
    FDA recognizes that disasters and PHEs can cause major disruptions 
to the conduct of clinical trials of medical products. For example, 
disasters or PHEs can lead to population quarantines, trial site 
closures, travel limitations, interruptions to the supply chain for the 
investigational product, or other considerations related to the type of 
disaster or emergency. These challenges can create difficulties for 
complying with protocol-specified procedures, including administering 
or using the investigational product or adhering to protocol-specific 
visits and laboratory/diagnostic testing. This final guidance provides 
recommendations on how to manage major disruptions to clinical trials 
during disasters and PHEs to help ensure the protection of participants 
and the ability of clinical trials to generate evidence to support 
regulatory decision-making during these times.
    The final guidance provides recommendations for helping to address 
those challenges, including, among other things, recommendations 
related to the safety of trial participants, whether to continue or 
suspend a trial, protocol amendments and deviations, study monitoring, 
alternative delivery of the investigational product, remote safety and 
endpoint assessment, informed consent, and reporting of adverse events. 
Some of the recommendations in this final guidance provide less 
burdensome approaches that can be utilized, when appropriate, in the 
conduct of clinical trials during major disruptions due to a disaster 
or PHE and that are consistent with public health. For example, the 
guidance provides recommendations regarding a change to virtual, rather 
than in-person, clinical trial visits when necessary.
    In March 2020, FDA first published the guidance for industry 
entitled ``Conduct of Clinical Trials of Medical Products During the 
COVID-19 Public Health Emergency'' (COVID-19 Conduct guidance) to 
support public health efforts following a declaration, under section 
319 of the Public Health Service (PHS) Act (42 U.S.C. 247d), by the 
Secretary of Health and Human Services of a public health emergency 
related to Coronavirus Disease 2019 (the disease caused by SARS-CoV-2). 
The COVID-19 Conduct guidance focused on addressing the COVID-19 PHE.
    In the Federal Register of March 13, 2023 (88 FR 15417), FDA listed 
the COVID-19-related guidance documents that would no longer be 
effective after the PHE declared under the PHS Act expired on May 11, 
2023. The March 13, 2023, notice also listed COVID-19-related guidance 
documents that FDA was revising to continue in effect for 180 days 
after the expiration of the PHE declaration to provide a period for 
stakeholder transition and then would no longer be in effect, and 
documents that FDA was revising to continue in effect for 180 days 
after the expiration of the PHE declaration, during which time FDA 
planned to further revise the guidances with any appropriate changes 
based on comments received and the Agency's experience with 
implementation. The COVID-19 Conduct guidance was included in the 
latter category and was revised to remain in effect for 180 days post-
expiration of the PHE declaration. FDA believes that most of the 
recommendations set forth in the COVID-19 Conduct guidance are 
applicable outside the context of the COVID-19 PHE to major disruptions 
to clinical trial conduct in the setting of disasters and PHEs more 
broadly. Consistent with what we said in the Federal Register of March 
13, 2023, FDA is therefore issuing this revised final guidance, which 
supersedes the

[[Page 65179]]

COVID-19 Conduct guidance. FDA's revisions include broadening the 
guidance's scope to apply during disasters and PHEs, removing several 
outdated questions, clarifying recommendations regarding use of risk-
based approaches for monitoring clinical investigations, clarifying 
recommendations concerning charging for investigational products, and 
making other editorial changes to improve clarity and consistency.
    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 disasters and 
PHEs may occur without notice and, as we have learned from experience 
during the COVID-19 PHE, may rapidly cause major disruptions to 
clinical trial conduct. It is thus important to public health to 
provide guidance on approaches to assure the safety of trial 
participants and minimize risks to trial integrity during such major 
disruptions. Moreover, portions of the guidance reflect a less 
burdensome approach that is consistent with public health and that can 
be used during a disaster or PHE when appropriate. Interested parties 
had an opportunity to comment on the recommendations in the COVID-19 
Conduct guidance, and FDA considered those comments when revising the 
guidance to apply those recommendations to disasters and public health 
emergencies more broadly. Although this guidance document is being 
implemented immediately, it remains subject to comment in accordance 
with FDA's good guidance practices regulation (Sec.  10.115(g)(3)(D)).
    The guidance represents the current thinking of FDA on 
``Considerations for the Conduct of Clinical Trials of Medical Products 
During Major Disruptions Due to Disasters and Public Health 
Emergencies.'' 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

    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 11 have been approved under OMB control number 0910-
0303; the collections of information in 21 CFR parts 50 and 56 have 
been approved under OMB control number 0910-0130; the collections of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; the collections 
of information in 21 CFR part 320 have been approved under OMB control 
number 0910-0630; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

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/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20474 Filed 9-20-23; 8:45 am]
BILLING CODE 4164-01-P


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