[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27900-27901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09399]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Decentralized Clinical Trials for Drugs, Biological Products, and 
Devices; Draft Guidance for Industry, Investigators, and Other 
Stakeholders; 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the availability of a draft guidance for industry, investigators, and 
other stakeholders entitled ``Decentralized Clinical Trials for Drugs, 
Biological Products, and Devices.'' This draft guidance provides 
recommendations for sponsors, investigators, and other stakeholders 
regarding the implementation of decentralized clinical trials (DCTs) 
for drugs, biological products, and devices. In this draft guidance, a 
DCT refers to a clinical trial where some or all of the trial-related 
activities occur at locations other than traditional clinical trial 
sites.

DATES: Submit either electronic or written comments on the draft 
guidance by August 1, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 ``Decentralized Clinical Trials for Drugs, 
Biological Products, and Devices.'' 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 the draft 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 draft 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; Diane Maloney, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 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 Ave., Bldg. 22, Rm. 2223, Silver 
Spring, MD 20993, 301-796-9567.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for 
industry, investigators, and other stakeholders entitled 
``Decentralized Clinical Trials for Drugs, Biological Products, and 
Devices.'' This guidance fulfills the requirements set forth in section

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3606(a)(1) of the Food and Drug Omnibus Reform Act (FDORA). The content 
described in section 3606(b) of FDORA is further addressed through this 
guidance's reference to FDA's draft guidance for industry, 
investigators, and other stakeholders entitled ``Digital Health 
Technologies for Remote Data Acquisition in Clinical Investigations'' 
(December 2021). In this draft guidance, a DCT refers to a clinical 
trial where some or all of the 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 
or in local healthcare facilities that are close to trial participants' 
locations.
    DCTs may involve different levels of decentralization. In fully 
decentralized clinical trials, all activities take place at locations 
other than traditional trial sites. In hybrid DCTs, some activities 
involve in-person visits by trial participants to traditional clinical 
trial sites, and other visits or activities are conducted at locations 
other than traditional clinical trial sites. FDA's regulatory 
requirements are the same for DCTs and traditional site-based clinical 
trials.
    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 remotely 
acquire data. 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.
    The investigator in a DCT is responsible for the conduct of the DCT 
and oversight of individuals delegated to perform trial-related 
activities. In a DCT, the investigator still ensures that appropriate 
informed consent is obtained, the investigational product is 
appropriately administered in accordance with the protocol, and other 
required safety and efficacy assessments are done with appropriate 
documentation. Specific issues related to the feasibility, design, 
implementation, or analysis of a DCT should be discussed with the 
relevant FDA review division.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Decentralized Clinical Trials for Drugs, Biological Products, and 
Devices.'' 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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 part 312, 
including Form FDA 1572, have been approved under OMB control number 
0910-0014; the collections of information in 21 CFR part 812 and 
812.140 have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR parts 50 and 56 have been approved 
under OMB control number 0910-0130.

III. Electronic Access

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

    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09399 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P