[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Proposed Rules]
[Pages 28277-28279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 312, and 812

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


Use of Electronic Records and Electronic Signatures in Clinical 
Investigations Under Part 11--Questions and Answers; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notification 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the availability of a draft guidance for industry entitled ``Use of 
Electronic Records and Electronic Signatures in Clinical Investigations 
under our regulations--Questions and Answers.'' The draft guidance 
provides guidance to sponsors, clinical investigators, institutional 
review boards (IRBs), contract research organizations (CROs), and other 
interested parties on the use of electronic records and electronic 
signatures under our regulations in clinical investigations of medical 
products. The draft guidance expands upon recommendations in the 
guidance for industry entitled ``Part 11, Electronic Records; 
Electronic Signatures--Scope and Application'' issued in August 2003 
(referred to as the 2003 part 11 guidance) for recommendations that 
pertain to FDA-regulated clinical investigations conducted under our 
regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 21, 2017.

ADDRESSES: You may submit comments 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-2017-D-1105 for ``Use of Electronic Records and Electronic 
Signatures in Clinical Investigations Under 21 CFR Part 11--Questions 
and Answers; Draft Guidance for Industry; Availability.'' 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.
     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

[[Page 28278]]

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.gpo.gov/fdsys/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.
    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; 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; or 
the Office of the Center Director, 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: Cheryl Grandinetti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; or Stephen Ripley, 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 Irfan 
Khan, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3563, Silver 
Spring, MD 20993-0002, 301-796-7100.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Use of Electronic Records and Electronic Signatures in 
Clinical Investigations under 21 CFR Part 11--Questions and Answers.'' 
The draft guidance provides guidance to sponsors, clinical 
investigators, IRBs, CROs, and other interested parties on the use of 
electronic records and electronic signatures under part 11 in clinical 
investigations of medical products. The draft guidance thus expands 
upon recommendations in the 2003 part 11 guidance for recommendations 
that pertain to FDA-regulated clinical investigations conducted under 
parts 312 and 812 and is limited to the scope and application of part 
11 requirements to such clinical investigations.
    Since 2003, advances in electronic technology have expanded the 
uses and capabilities of electronic systems in clinical investigations. 
In addition, electronic systems and technologies are used and managed 
in novel ways, services are shared or contracted between organizations 
in new ways, and electronic data flow between parties is more efficient 
and more prevalent. The standards and capabilities of electronic 
systems have improved, and features--such as audit trails, automated 
date-and-time stamps, appropriate validation, and the ability to 
generate copies and retain records--are standard components of many 
electronic systems.
    FDA's overall approach to the 2003 part 11 guidance was to provide 
a narrow and practical interpretation of part 11 requirements. FDA 
continues to support and promote such a narrow and practical 
interpretation in the draft guidance, including our intent to exercise 
enforcement discretion regarding specific part 11 provisions for 
validation, audit trails, record retention, and record copying. FDA 
reminds sponsors, however, that records must still be maintained or 
submitted in accordance with the underlying predicate rules, and the 
Agency can take regulatory action for noncompliance with such predicate 
rules. In addition, FDA continues to encourage sponsors and other 
regulated entities to use a risk-based approach, as introduced in the 
2003 part 11 guidance and further described in the draft guidance, when 
deciding to validate electronic systems, implement audit trails, or 
archive required records for clinical investigations. The draft 
guidance clarifies and expands upon recommendations for applying and 
implementing part 11 requirements, as appropriate, in the current 
environment of electronic systems used in clinical investigations.
    The draft guidance discusses the following: (1) Procedures that may 
be followed to help ensure that electronic records and electronic 
signatures meet FDA requirements and are considered to be trustworthy, 
reliable, and generally equivalent to paper records and handwritten 
signatures executed on paper, and (2) the use of a risk-based approach 
when deciding to validate electronic systems, implement audit trails 
for electronic records, and archive records that are pertinent to 
clinical investigations conducted under parts 312 and 812.
    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 the use of 
electronic records and electronic signatures for FDA-regulated clinical 
investigations conducted under parts 312 and 812. 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 
applicable statutes and regulations. This is not a significant 
regulatory action subject to Executive Order 12866.

II. Paperwork Reduction Act

    This draft guidance refers to previously approved collections of 
information that are found in regulations. These 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-
3520). This draft guidance pertains to sponsors, clinical 
investigators, IRBs, CROs, and other interested parties who use 
electronic records, electronic signatures, and electronic systems in 
FDA-regulated clinical investigations and who send certain information 
to FDA or others or who keep certain records and make them available to 
FDA inspectors. The collections of information in part 11 have been 
approved under OMB control

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number 0910-0303; the collections of information in part 312, including 
Sec. Sec.  312.41, 312.57, 312.58, 312.62, and 312.120, have been 
approved under OMB control number 0910-0014; and the collections of 
information in Sec.  812.140 have been approved under OMB control 
number 0910-0078. The use of electronic records, electronic signatures, 
and electronic systems (as described in the draft guidance) would not 
result in any new costs, including capital costs or operating and 
maintenance costs because sponsors and others already have experience 
using computer-based equipment and software necessary to be consistent 
with the draft guidance.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: June 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-12811 Filed 6-20-17; 8:45 am]
 BILLING CODE 4164-01-P