Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures, 64441-64443 [2023-20233]
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Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices
64441
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Voluntary national retail program standards (August 2022)
Program self-assessments for element Nos. 1 through 8 ..
Program element No. 9; risk factor study and intervention
strategy.
Program Verification audit ...................................................
Program records; associated documentation/maintenance
of worksheets, assessments, associated program tools.
FDA Form 3958; VNRFP National Registry Report ............
Requests for program documentation (dedicated email) ....
Proposed Form FDA 5017; Waiver of Annual Maintenance
Requirement.
Proposed Form FDA 5018; Food Safety Inspection Officer
Annual Maintenance.
Proposed Form FDA 5019; Food Safety Inspection Officer
Nomination.
Total ..............................................................................
1 There
Total annual
responses
Average
burden
per response
Total hours
500
500
1
1
500
500
92.3 ................
333 .................
46,150
166,500
500
500
1
1
500
500
46.15 ..............
94.29 ..............
23,075
47,145
500
500
10
1
3
1
500
1,500
10
50
150
3.5
130
1
130
14
1
14
0.1 (6 minutes)
0.1 (6 minutes)
0.35 (21 minutes).
0.35 (21 minutes).
0.35 (21 minutes).
........................
........................
4,154
........................
283,121.5
43
5
are no capital or operational and maintenance costs associated with this collection of information.
Our estimate of burden for the
associated program activities as
identified in table 1 is based on our
experience with the information
collection, along with other regulatory
standards programs we administer.
Upon reorganizing the collection to
reflect the cumulative activities, we
have accounted for burden that may be
attributable recordkeeping for risk-factor
studies and verification tasks that may
have been previously overlooked. The
burden we attribute to completing and
submitting FDA Form 3958, ‘‘Voluntary
National Retail Food Regulatory
Program Standards FDA National
Registry Report,’’ is exclusive of other
program records, which we account for
in row 4. We have also accounted for
burden we assume will be attendant to
the completion and submission of
newly developed Agency forms. As a
result of these changes and adjustments,
the information collection reflects an
increase of 235,776.5 hours and 1,654
responses annually.
Dated: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20226 Filed 9–18–23; 8:45 am]
BILLING CODE 4164–01–P
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Number of
responses per
respondent
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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.
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
SUMMARY:
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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
E:\FR\FM\19SEN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
64442
Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices
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-201509-18/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
VerDate Sep<11>2014
18:21 Sep 18, 2023
Jkt 259001
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, PRAStaff@
fda.hhs.gov.
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
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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
(§§ 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) § 11.10
specifies procedures and controls for
persons who use closed systems to
create, modify, maintain, or transmit
electronic records; (2) § 11.30 specifies
procedures and controls for persons
who use open systems to create, modify,
maintain, or transmit electronic records;
and (3) § 11.50 specifies procedures and
controls for persons who use electronic
signatures.
Regulations in subpart C (§§ 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 (§ 11.100(c)). Letters of
nonrepudiation are required under
§ 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/aboutesg/appendix-g-letters-non-repudiationagreement.
We estimate the burden of the
information collection as follows:
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64443
Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
§ 11.100; submission of nonrepudiation letters ...................
5,000
1
5,000
1
5,000
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Number of
record per
recordkeepers
§ 11.10; controls for closed systems ...................................
§ 11.30; controls for open systems ......................................
§ 11.50; signature manifestations ........................................
§ 11.300; controls for identifications and passwords ...........
2,500
2,500
5,000
5,000
1
1
1
1
2,500
2,500
5,000
5,000
20
20
20
20
50,000
50,000
100,000
100,000
Total ..............................................................................
........................
........................
........................
........................
300,000
21 CFR section
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.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2023–D–2482]
Regulatory Considerations for
Prescription Drug Use-Related
Software; Draft Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Regulatory Considerations for
Prescription Drug Use-Related
Software.’’ This draft guidance describes
FDA’s application of its drug labeling
SUMMARY:
VerDate Sep<11>2014
18:21 Sep 18, 2023
Jkt 259001
authorities to certain software outputs
that are disseminated by or on behalf of
a drug sponsor for use with a
prescription drug or a prescription drugled, drug-device combination product,
which is assigned to the Center for Drug
Evaluation and Research or the Center
for Biologics Evaluation and Research as
the lead center.
DATES: Submit either electronic or
written comments on the draft guidance
by December 18, 2023 to ensure that the
Agency considers your comments on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
[FR Doc. 2023–20233 Filed 9–18–23; 8:45 am]
AGENCY:
Total annual
records
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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–
2023–D–2482 for ‘‘Regulatory
Considerations for Prescription Drug
Use-Related Software.’’ 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, 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
E:\FR\FM\19SEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of record per Total annual per Total hours
recordkeepers recordkeepers records recordkeeping
----------------------------------------------------------------------------------------------------------------
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..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 300,000
----------------------------------------------------------------------------------------------------------------
\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
