[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]
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