Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures, 1921-1922 [2024-00406]
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1921
Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices
nationally representative survey data to
learn more about where parents look for
and find information about Child Care
and Early Education (CCEE); how
parents assess the people, places, or
things that may offer CCEE information;
what types of CCEE information parents
look for; and how parents use
information to make CCEE selections.
The study aims to gather information
that may be used by Child Care Lead
Agencies to inform their consumer
education efforts.
Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
ADDRESSES:
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF has contracted with
NORC to implement this study, which
is part of the Consumer Education and
Parental Choice in Early Care and
Education (CEPC) project. The study
will select a nationally representative
sample from NORC’s probability-based
AmeriSpeak panel. The AmeriSpeak
panel provides sample coverage of
approximately 97 percent of the U.S.
population. It currently contains 48,900
panel members age 13 and over residing
in over 40,000 households. U.S.
households are randomly selected with
a known, non-zero probability from the
NORC National Frame, and then
recruited by mail, telephone, and by
field interviewers face-to-face. NORC’s
in-person recruitment enhances
representativeness for young adults,
lower socio-economic households, noninternet households, and other
households that are typically hard to
reach for statistical surveys of the
population.
We will collect information about (a)
where parents look for and find
Number of
respondents
(total over
request
period)
Instrument
Parent Survey Questionnaire (Section AE Only) ............................................
Parent Survey Questionnaire (Section A–DA) ................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
BILLING CODE 4184–23–P
Food and Drug Administration
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
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.
SUMMARY:
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1
1
Average
burden per
response
(in hours)
Total/annual
burden
(in hours)
.08
.25
168
375
Submit written comments
(including recommendations) on the
collection of information by February
12, 2024.
DATES:
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.
ADDRESSES:
[Docket No. FDA–2023–N–3743]
AGENCY:
Number of
responses per
respondent
(total over
request
period)
2,100
1,500
Estimated Total Annual Burden
Hours: 543.
Authority: Child Care and
Development Block Grant (CCDBG) Act
of 1990, as amended (42 U.S.C. 9857 et
seq.).
[FR Doc. 2024–00395 Filed 1–10–24; 8:45 am]
information about CCEE; (b) how
parents assess the people, places, or
things that may offer CCEE information;
(c) how easy or hard it is for parents to
find CCEE information, (d) the types of
CCEE information that parents look for
and say are helpful in choosing CCEE;
(e) information about the last time
parents made a decision about CCEE
and what information they tried to learn
about at that time; (f) parent’s
assessments of the CCEE options at the
time they made their last CCEE
decision; (g) how well parents’ CCEE
decision met their family’s needs; and
(h) demographic information about
families.
Respondents: AmeriSpeak panelists
who indicated that they have a young
child in the household will be invited
to complete the survey if they are at
least 18 years of age. If a household has
two or more panel members who reside
in a household with a young child, one
will be selected at random to complete
the survey, with preference given to
parents/legal guardians. Selected
panelists will be asked questions to
confirm eligibility for the survey,
including that the household has at least
one child under the age of 6 but not in
kindergarten.
Annual Burden Estimates:
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
E:\FR\FM\11JAN1.SGM
11JAN1
1922
Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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
(§§ 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) § 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 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 (§ 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.
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
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
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
21 CFR section
Total annual
records
Average burden
per
recordkeeping
Total hours
§ 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
1
1
1
2,500
2,500
5,000
20
20
20
50,000
50,000
100,000
5,000
1
5,000
20
100,000
Total ................................................
..............................
..............................
..............................
..............................
300,000
1
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
record per
recordkeepers
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
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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.
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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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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected].
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Number of record Total annual Average burden
21 CFR section recordkeepers per recordkeepers records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
