Document ID: FDA-2023-N-3743-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
Posted Date: 2023-09-19T04:00Z

[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64441-64443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20233]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3743]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Electronic Records; Electronic Signatures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection applicable to the 
electronic record signature provisions found in Agency regulations.

DATES: Either electronic or written comments on the collection of 
information must be submitted by November 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 20, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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

[[Page 64442]]

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-N-3743 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Good Laboratory Practice 
Requirements for Nonclinical Laboratory Studies.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Electronic Records; Electronic Signatures--21 CFR Part 11

OMB Control Number 0910-0303--Revision

    This information collection supports implementation of statutory 
and regulatory authorities that govern criteria for the acceptance of 
electronic records, electronic signatures, and handwritten signatures 
executed to electronic records as equivalent to paper records. Agency 
regulations in part 11 (21 CFR part 11), provide for the submission of 
records and reports and establish that information may be submitted to 
FDA electronically provided that we have stated our ability to accept 
the records electronically in an Agency-established public docket and 
that the other requirements of part 11 are met. The regulations apply 
to records in electronic form that are created, modified, maintained, 
archived, retrieved, or transmitted, under any records requirements set 
forth in Agency regulations and to electronic records submitted under 
requirements of the Federal Food, Drug, and Cosmetic Act and the Public 
Health Service Act, even if such records are not specifically 
identified in Agency regulations.
    Regulations in part 11, subpart B (Sec. Sec.  11.10 through 11.70) 
and) require the establishment of standard operating procedures to 
ensure appropriate use of and precautions for systems using electronic 
records and signatures, including the following: (1) Sec.  11.10 
specifies procedures and controls for persons who use closed systems to 
create, modify, maintain, or transmit electronic records; (2) Sec.  
11.30 specifies procedures and controls for persons who use open 
systems to create, modify, maintain, or transmit electronic records; 
and (3) Sec.  11.50 specifies procedures and controls for persons who 
use electronic signatures.
    Regulations in subpart C (Sec. Sec.  11.100 through 11.300) require 
specific controls to ensure the security and integrity of electronic 
signatures based upon use of identification codes in combination with 
passwords.
    On March 3, 2023 (88 FR 13018), we revised the regulations. Before 
using an electronic signature in an electronic record required by FDA, 
a person must submit a letter of nonrepudiation to FDA (Sec.  
11.100(c)). Letters of nonrepudiation are required under Sec.  
11.100(c)(1) to certify that a person's electronic signatures are 
intended to be the legally binding equivalent of traditional 
handwritten signatures. The regulations were amended to update the 
address for submission of a certification in paper form and to provide 
an option for electronic submission. The regulations were also amended 
to communicate that information on where to submit the certification 
may be found on FDA's website, currently available at: https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement.
    We estimate the burden of the information collection as follows:

[[Page 64443]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Sec.   11.100; submission of nonrepudiation letters................           5,000                1            5,000                1            5,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR section              Number of      record per     Total annual         per         Total hours
                                   recordkeepers   recordkeepers      records      recordkeeping
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Sec.   11.10; controls for                 2,500               1           2,500              20          50,000
 closed systems.................
Sec.   11.30; controls for open            2,500               1           2,500              20          50,000
 systems........................
Sec.   11.50; signature                    5,000               1           5,000              20         100,000
 manifestations.................
Sec.   11.300; controls for                5,000               1           5,000              20         100,000
 identifications and passwords..
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    Total.......................  ..............  ..............  ..............  ..............         300,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have increased our estimated burden. We 
assume 5,000 nonrepudiation letters will be submitted annually. We 
arrived at this figure by looking at the average number of 
nonrepudiation letters received through March 2023. We further assume 
that half of the estimated respondents will establish controls for open 
systems and half will establish controls for closed systems. Finally, 
we assume all respondents will establish controls for the remaining 
technical specifications required by the regulations.

    Dated: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20233 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P