Notice2024-00406
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 8 (Thursday, January 11, 2024)</title>
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[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Notices]
[Pages 1921-1922]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00406]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3743]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, the Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by February 12, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0303. Also include the FDA docket
number found in brackets in the heading of this document.
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
[[Page 1922]]
20852, 301-796-5733, <a href="/cdn-cgi/l/email-protection#bdedeffceec9dcdbdbfddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="f8a8aab9ab8c999e9eb89e9c99d690908bd69f978e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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)
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 2, 2023 (88 FR 13018) (Docket No. FDA-2019-N-0646), 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:
<a href="https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement">https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement</a>.
In the Federal Register of September 19, 2023 (88 FR 64441), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
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 Number of record Total annual Average burden
21 CFR section recordkeepers per recordkeepers records per recordkeeping Total hours
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Sec. 11.10; controls for closed systems................ 2,500 1 2,500 20 50,000
Sec. 11.30; controls for open systems.................. 2,500 1 2,500 20 50,000
Sec. 11.50; signature manifestations................... 5,000 1 5,000 20 100,000
Sec. 11.300; controls for identifications and passwords 5,000 1 5,000 20 100,000
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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: January 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00406 Filed 1-10-24; 8:45 am]
BILLING CODE 4164-01-P
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