[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Pages 76481-76482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2870]


Conducting Clinical Trials With Decentralized Elements; Guidance 
for Industry, Investigators, and Other Interested Parties 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, investigators, and 
other interested parties entitled ``Conducting Clinical Trials With 
Decentralized Elements.'' This guidance provides recommendations 
regarding the implementation of decentralized elements in clinical 
trials for drugs, biological products, and devices. Decentralized 
elements allow trial-related activities to occur remotely at locations 
convenient for trial participants (e.g., telehealth visits with 
investigators or visits with local healthcare providers (HCPs)). FDA's 
regulatory requirements are the same for trials that include 
decentralized elements and trials that do not include decentralized 
elements. To help ensure the appropriate oversight trials with 
decentralized elements, the integrity of trial data, and the safety of 
trial participants, this guidance covers the responsibilities of 
sponsors and investigators. This guidance finalizes the draft guidance 
entitled ``Decentralized Clinical Trials for Drugs, Biological 
Products, and Devices'' issued on May 3, 2023.

DATES: The announcement of the guidance is published in the Federal 
Register on September 18, 2024.

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-2022-D-2870 for ``Conducting Clinical Trials With Decentralized 
Elements.'' 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 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; 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; or 
the Office of Policy, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
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: Ryan Robinson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3342, Silver Spring, MD 20993, 240-402-
9756; James Myers, Center for Biologics Evaluation and Research, Food 
and

[[Page 76482]]

Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911; Soma Kalb, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. G318, Silver Spring, MD 20993-0002, 
301-796-6359; or Paul Kluetz, Oncology Center of Excellence, Food and 
Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 2223, 
Silver Spring, MD 20993, 301-796-9567.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Conducting Clinical Trials With Decentralized Elements.'' 
Section 3606(a) of the Consolidated Appropriations Act, 2023 directs 
FDA to issue a final guidance that includes recommendations to clarify 
and advance the use of DCTs to support the development of drugs and 
devices. This guidance fulfills the requirements set forth in section 
3606(a)(2) of the Consolidated Appropriations Act, 2023. The content 
described in section 3606(b) of the Consolidated Appropriations Act, 
2023 is further addressed through this guidance's reference to FDA's 
guidance for industry, investigators, and other stakeholders entitled 
``Digital Health Technologies for Remote Data Acquisition in Clinical 
Investigations'' (December 2023).
    In this guidance, a decentralized clinical trial (DCT) refers to a 
clinical trial that includes decentralized elements where trial-related 
activities occur at locations other than traditional clinical trial 
sites. These trial-related activities may take place at the location of 
trial participants (e.g., their homes) or in local healthcare 
facilities that are close to trial participants' locations. FDA's 
regulatory requirements are the same for trials that include 
decentralized elements and trials that do not include decentralized 
elements.
    DCTs may include the use of local healthcare providers and local 
clinical laboratory facilities in the management of trial participants 
and the use of telehealth and digital health technologies to acquire 
data remotely. By allowing remote participation and reducing the need 
to travel for face-to-face visits, DCTs may enhance convenience for 
study participants, facilitate research on diseases affecting 
populations with limited mobility, and reduce the burden on caregivers.
    This guidance provides recommendations related to the incorporation 
of decentralized elements into clinical trials, including: (1) DCT 
design, conduct, and oversight; (2) conduct of remote clinical trial 
visits and activities including the use of local HCPs; (3) use of 
digital health technologies in DCTs; (4) the roles of sponsors and 
investigators in DCTs; (5) informed consent and institutional review 
board oversight of DCTs; (6) types of investigational products 
appropriate for study in DCTs; (7) packaging and shipping of 
investigational products in DCTs; (8) processes and procedures to 
ensure participant safety; and (9) use of software in DCTs.
    This guidance finalizes the draft guidance entitled ``Decentralized 
Clinical Trials for Drugs, Biological Products, and Devices'' issued on 
May 3, 2023 (88 FR 27900). FDA considered comments received on the 
draft guidance as the guidance was finalized. Changes from the draft to 
the final guidance include: (1) removal of language regarding the 
requirement to maintain a task log of local HCPs, (2) clarification 
about challenges related to data variability in DCTs, (3) updates to 
responsibilities for ensuring qualifications of local HCPs, and (4) 
clarifications on the need for a physical location for inspections. In 
addition, editorial changes were made to improve clarity.
    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 ``Conducting Clinical Trials With 
Decentralized Elements.'' 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 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 11 pertaining to electronic records and signatures have been 
approved under OMB control number 0910-0303. The collections of 
information in 21 CFR part 312 pertaining to investigational new drug 
applications, including Form FDA 1572, have been approved under OMB 
control number 0910-0014. The collections of information in 21 CFR part 
812 pertaining to investigational device exemption applications have 
been approved under OMB control number 0910-0078. The collections of 
information in 21 CFR parts 50 and 56 pertaining to the protection of 
human subjects, informed consent, and institutional review boards have 
been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    Dated: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21078 Filed 9-17-24; 8:45 am]
BILLING CODE 4164-01-P