Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualitative Feedback on Agency Service Delivery, 82905-82906 [2023-26043]
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Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
and earnings, and education data? For
example, what is the earliest turnaround
time for reliably reporting that a TANF
case has closed? What are the timelines
involved in matching and working with
employment and earnings data and
education data?
4.6 What factors (e.g., demographic,
economic, policy, programmatic) should
be considered for presenting the work
outcomes measures in context? Are
there variables such as state economic
conditions that may impact state
outcomes and are outside a state TANF
program’s control?
4.7 In what ways should equity be
considered when implementing work
outcome measures? What are the
advantages of and/or possible
difficulties associated with reporting
data disaggregated by race, ethnicity,
gender, age, disability, other
demographic characteristics, or
geography to enable equity analyses
around work outcomes? 10
4.8 What technical assistance or
supports would be helpful for collecting
data for work outcomes? What obstacles
do you foresee and how can ACF and
its partners provide assistance to
overcome or manage those barriers?
4.9 Please describe the
characteristics of successful
partnerships between the public
workforce system and the TANF system
that support the collection of data for
the work outcomes measures required
by the FRA?
4.10 Please describe the specific
steps for a state to begin collecting and
reporting data and their estimated
duration. For example, please estimate
the timeframe for system changes to
generate a list of SSNs of work-eligible
individuals who left TANF in a given
quarter.
4.11 Are there any other questions
or issues related to the work outcomes
measures for which you wish to provide
comments?
4.12 HHS has determined that tribes
are NOT required to report work
outcomes measures as laid out in the
Fiscal Responsibility Act. However,
OFA is committed to supporting Tribal
TANF programs that wish to voluntarily
measure work outcomes for their
10 See
https://www.whitehouse.gov/wp-content/
uploads/2022/04/eo13985-vision-for-equitabledata.pdf.
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17:43 Nov 24, 2023
Jkt 262001
caseloads. As we explore this
possibility, what factors do we need to
better understand? What training or
technical assistance could support
Tribal TANF programs interested in
measuring work outcomes?
Authority: Fiscal Responsibility Act of
2023.
Ann Flagg,
Director, Office of Family Assistance.
[FR Doc. 2023–26100 Filed 11–22–23; 11:15 am]
BILLING CODE 4184–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1554]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA, 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 December
27, 2023.
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 0910–0697. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
82905
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Qualitative Feedback on Agency
Service Delivery
OMB Control Number 0910–0697—
Extension
FDA will garner qualitative customer
and stakeholder feedback using a variety
of methods in order to gain useful
insights into customer or stakeholder
perceptions, experiences, and
expectations; provide an early warning
of issues with service; or focus attention
on areas where communication,
training, or changes in operations might
improve delivery of products or
services. These collections will allow
for ongoing, collaborative, and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance.
Respondents to this collection of
information cover a broad range of
customers and stakeholders who have
specific characteristics related to certain
products or services regulated by FDA.
These stakeholders include members of
the general public, healthcare
professionals, industry, and others who
have experience with a product under
FDA’s jurisdiction.
In the Federal Register of May 25,
2023 (88 FR 33889), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but it was outside the scope of the PRA.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\27NON1.SGM
27NON1
82906
Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden per
response
Total hours
Focus groups ...........................................................
Customer comment cards/forms ..............................
Small discussion groups ..........................................
Customer satisfaction surveys .................................
Usability studies .......................................................
3,000
1,500
800
20,000
1,100
1
1
1
1
1
3,000
1,500
800
20,000
1,100
1.75 ...........................
0.25 (15 minutes) ......
1.75 ...........................
0.33 (20 minutes) ......
1 ................................
5,250
375
1,400
6,600
1,100
Total ..................................................................
........................
........................
........................
....................................
14,725
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 increased the
number of respondents for focus groups,
customer comment cards/forms,
customer satisfaction surveys, and
usability studies. This adjustment
results in an overall burden increase of
6,234 hours.
by using the search function. The OMB
control number for this information
collection is 0910–0119. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2023–26043 Filed 11–24–23; 8:45 am]
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.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Good Laboratory Practice
Requirements for Nonclinical
Laboratory Studies—21 CFR Part 58
[Docket No. FDA–2023–N–2894]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good Laboratory
Practice Requirements for Nonclinical
Laboratory Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Notice.
SUMMARY: The Food and Drug
Administration (FDA, we, or the
Agency) 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 December
27, 2023.
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
VerDate Sep<11>2014
17:43 Nov 24, 2023
Jkt 262001
OMB Control Number 0910–0119—
Extension
Sections 409, 505, 512, and 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 348, 355, 360b, and 360e) and
related statutes require manufacturers of
food additives, human drugs and
biological products, animal drugs, and
medical devices to demonstrate the
safety and utility of their product by
submitting applications to FDA for
research or marketing permits. Such
applications contain, among other
important items, full reports of all
studies done to demonstrate product
safety in man and/or other animals. In
order to ensure adequate quality control
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued good laboratory
practice (GLP) regulations for
nonclinical laboratory studies in part 58
(21 CFR part 58). The regulations
specify minimum standards for the
proper conduct of safety testing and
contain sections on facilities, personnel,
equipment, standard operating
procedures (SOPs), test and control
articles, quality assurance, protocol and
conduct of a safety study, records and
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
reports, and laboratory disqualification,
and include information collection
provisions.
Part 58 requires testing facilities
engaged in conducting toxicological
studies to retain, and make available to
regulatory officials, records regarding
compliance with GLPs. Records are
maintained on file at each testing
facility and examined there periodically
by FDA inspectors. The GLP regulations
require that, for each nonclinical
laboratory study, a final report be
prepared that documents the results of
quality assurance unit inspections, test
and control article characterization,
testing of mixtures of test and control
articles with carriers, and an overall
interpretation of nonclinical laboratory
studies. The GLP regulations also
require written records pertaining to: (1)
personnel job descriptions and
summaries of training and experience;
(2) master schedules, protocols and
amendments thereto, inspection reports,
and SOPs; (3) equipment inspection,
maintenance, calibration, and testing
records; (4) documentation of feed and
water analyses and animal treatments;
(5) test article accountability records;
and (6) study documentation and raw
data.
Description of Respondents:
Respondents to the collection of
information are sponsors of nonclinical
laboratory studies that support or are
intended to support applications for
research or marketing permits for
products regulated by FDA.
In the Federal Register of August 8,
2023 (88 FR 53492), we published a 60day notice soliciting comment on the
proposed collection of information. One
comment was received underscoring the
critical nature of language translations
in information exchange between
international communities but did not
suggest any modifications to our burden
estimates.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\27NON1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82905-82906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26043]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1554]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Qualitative Feedback
on Agency Service Delivery
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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 December 27, 2023.
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 0910-0697. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Qualitative Feedback on Agency Service Delivery
OMB Control Number 0910-0697--Extension
FDA will garner qualitative customer and stakeholder feedback using
a variety of methods in order to gain useful insights into customer or
stakeholder perceptions, experiences, and expectations; provide an
early warning of issues with service; or focus attention on areas where
communication, training, or changes in operations might improve
delivery of products or services. These collections will allow for
ongoing, collaborative, and actionable communications between the
Agency and its customers and stakeholders. It will also allow feedback
to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance.
Respondents to this collection of information cover a broad range
of customers and stakeholders who have specific characteristics related
to certain products or services regulated by FDA. These stakeholders
include members of the general public, healthcare professionals,
industry, and others who have experience with a product under FDA's
jurisdiction.
In the Federal Register of May 25, 2023 (88 FR 33889), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but it was outside
the scope of the PRA.
FDA estimates the burden of this collection of information as
follows:
[[Page 82906]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus groups................................ 3,000 1 3,000 1.75...................................... 5,250
Customer comment cards/forms................ 1,500 1 1,500 0.25 (15 minutes)......................... 375
Small discussion groups..................... 800 1 800 1.75...................................... 1,400
Customer satisfaction surveys............... 20,000 1 20,000 0.33 (20 minutes)......................... 6,600
Usability studies........................... 1,100 1 1,100 1......................................... 1,100
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 14,725
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 increased the number of respondents for
focus groups, customer comment cards/forms, customer satisfaction
surveys, and usability studies. This adjustment results in an overall
burden increase of 6,234 hours.
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26043 Filed 11-24-23; 8:45 am]
BILLING CODE 4164-01-P
