Notice2023-20474
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
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Published
September 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 182 (Thursday, September 21, 2023)</title>
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[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65177-65179]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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