[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Notices]
[Pages 1921-1922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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: 
https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                          ----------------------------------------------------------------------------------------------
    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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