[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16268-16270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1105]


Electronic Systems, Electronic Records, and Electronic Signatures 
in Clinical Investigations: Questions and Answers; Draft Guidance for 
Industry; 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the availability of a draft guidance for industry entitled ``Electronic 
Systems, Electronic Records, and Electronic Signatures in Clinical 
Investigations: Questions and Answers.'' The draft guidance provides 
information for sponsors, clinical investigators, institutional review 
boards (IRBs), contract research organizations (CROs), and other 
interested parties on the use of electronic systems, electronic 
records, and electronic signatures in clinical investigations of foods, 
medical products, tobacco products, and new animal drugs under FDA 
regulations. This draft guidance revises the draft guidance for 
industry issued in June 2017 entitled ``Use of Electronic Records and 
Electronic Signatures in Clinical Investigations Under 21 CFR part 11--
Questions and Answers'' and, when finalized, will supersede the 
guidance for industry entitled ``Computerized Systems Used in Clinical 
Investigations'' (May 2007).

DATES: Submit either electronic or written comments on the draft 
guidance by May 15, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 16269]]

     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-2017-D-1105 for ``Electronic Systems, Electronic Records, and 
Electronic Signatures in Clinical Investigations: Questions and 
Answers.'' 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; 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 
Office of Policy, Guidance and Policy Development, 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: Elizabeth Kunkoski, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002, 301-
796-6439, [email protected]; Diane Maloney, 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, [email protected]; 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-
796-6539, [email protected]; Yuguang Wang, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
Rm. 4A-012, College Park, MD 20740, 240-402-1757, 
[email protected]; the Center for Tobacco Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Silver Spring, 
MD 20993-0002, 240-402-7970, [email protected]; or Eric Nelson, 
Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Pl., MPN #4, Rm. 106, HFV-230, Rockville, MD 20855, 240-402-
5642, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Electronic Systems, Electronic Records, and Electronic 
Signatures in Clinical Investigations: Questions and Answers.'' The 
draft guidance provides information for sponsors, clinical 
investigators, IRBs, CROs, and other interested parties on the use of 
electronic systems, electronic records, and electronic signatures in 
clinical investigations of foods, medical products, tobacco products, 
and new animal drugs. The goals of the draft guidance are to (1) update 
recommendations for applying and implementing data integrity and data 
security controls, including the use of audit trails and the protection 
of records in the current environment of electronic systems used in 
clinical investigations; (2) provide additional recommendations on the 
risk-based approach to validation of electronic systems described in 
the guidance for industry ``Part 11, Electronic Records; Electronic 
Signatures--Scope and Application'' (August 2003); and (3) facilitate 
the use of electronic systems, electronic records, and electronic 
signatures to improve the quality and efficiency of clinical 
investigations.
    In the Federal Register of June 21, 2017 (82 FR 28277), FDA 
announced the availability of the draft guidance entitled ``Use of 
Electronic Records and Electronic Signatures in Clinical

[[Page 16270]]

Investigations Under 21 CFR part 11--Questions and Answers.'' FDA 
received numerous comments on the draft guidance, and those comments 
were considered as the guidance was revised. A summary of changes 
includes clarifying recommendations for the following: (1) using a 
risk-based approach for validation of electronic systems used in 
clinical investigations; (2) preparing for FDA inspections of sponsors 
and CROs when electronic systems are owned, controlled, or outsourced 
by the sponsors and CROs for use in clinical investigations; (3) 
implementing, maintaining, and retaining audit trail information; (4) 
determining the suitability of information technology (IT) service 
providers contracted by sponsors or other regulated entities to provide 
IT services in clinical investigations; and (5) implementing and 
applying data integrity controls, data security solutions, and 
electronic source data principles to digital health technology used in 
clinical investigations. This guidance revises the draft guidance 
issued in June 2017 and, when finalized, will supersede the guidance 
for industry entitled ``Computerized Systems Used in Clinical 
Investigations'' (May 2007).
    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 ``Electronic 
Systems, Electronic Records, and Electronic Signatures in Clinical 
Investigations: Questions and Answers.'' 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 the 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 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 511 have been approved under OMB control number 0910-0117; and the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05362 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


