Submission for Office of Management and Budget Review; Office of Community Services Affordable Housing and Supportive Services Demonstration Data Collection (Office of Management and Budget #: 0970-0628), 71371-71372 [2024-19695]
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Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
[FR Doc. 2024–19479 Filed 8–28–24; 4:15 pm]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Office of
Community Services Affordable
Housing and Supportive Services
Demonstration Data Collection (Office
of Management and Budget #: 0970–
0628)
Office of Community Services,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
AGENCY:
ACTION:
Request for public comments.
The Office of Community
Services (OCS), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services, is requesting an extension of
approval for a recently approved
information collection: OCS Affordable
Housing and Supportive Services
Demonstration (Office of Management
and Budget (OMB) #: 0970–0628,
Expiration Date: September 30, 2024).
This information collection was
originally approved for 6 months as an
emergency approval. In addition to
extending the approval, OCS seeks to
update the burden estimates to
accommodate an anticipated increase in
the number of grant recipients, as well
as to collect additional responses to
several of the instruments. OCS also
seeks to make updates to approved
forms.
SUMMARY:
Comments due October 3, 2024.
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
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
tkelley on LAP7H3WLY3PROD with NOTICES2
ADDRESSES:
VerDate Sep<11>2014
22:46 Aug 30, 2024
Jkt 262001
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION: OCS is
seeking to continue collecting the
information requested from grant
recipients under OMB #: 0970–0628. In
order to determine best practices in the
implementation of supportive services
in the affordable housing context and
describe how supportive services help
residents to improve well-being and
economic mobility, OCS will engage in
the following activities:
• Conducting interviews with
program directors and caseworkers to
understand program implementation.
• Conducting focus groups with
residents to understand their needs and
how the services funded by this grant
impacted their lives.
• Administering a self-sufficiency
matrix to residents receiving intensive
services to understand the impact of the
program on various domains of wellbeing.
• Conducting a questionnaire with
residents, to see if they were able to
access more services due to the funding.
• Collecting information from
program officers about the number and
types of services/events provided,
aggregate demographics of residents
served, partner organizations and
referrals, and how the housing
community was impacted by the grant
funding.
• Collecting narrative reports from
program officers about the progress of
implementation of the program.
This request is to extend the approved
collection period to 3 years, which will
permit OCS to complete the collection
with current grant recipients as well as
future grant recipients. With an
extended timeline, OCS will request
additional responses for several
approved instruments to observe
activities over the course of the full
project period for grant recipients. The
self-sufficiency matrix and service
receipt questionnaires will be
administered every 6 months during the
project period. The semi-annual
quantitative report mandatory and
optional forms will be required every 6
months, with a final cumulative report.
The quarterly narrative PPR will be
requested every quarter of the project
period.
OCS has developed substantially
revised 2024 versions of the semiannual quantitative report forms for the
mandatory and optional reports to
broaden the measures of service
delivery and outcomes to better
accommodate the universe of potential
services offered by future cohorts of
PO 00000
Frm 00122
Fmt 4703
Sfmt 4703
71371
grant recipients. The new mandatory
form combines the direct services and
referrals tabs of the original form into a
single tab where grant recipients will
report the number of individuals
receiving services through AHSSD
funding and through the organization’s
other funding sources, alongside the
information reported about referrals.
The new optional form broadens the list
of outcome measures that grant
recipients can choose to report for the
individuals they serve. In consideration
of the overall reporting burden for grant
recipients, the 2024 version of the forms
continue draw upon the service and
outcome categories that grant recipients
already use to report their Community
Services Block Grant-related activities
(OMB# 0970–0492). Additionally, the
2024 version of the forms request
cumulative counts across the grant
period, negating the need for a separate
final report.
Current grant recipients will be able
to choose between using the current
2023 version of the forms and the
revised 2024 version of the forms
through the completion of their current
project. New grant recipients will be
required to use the 2024 version of the
forms.
Respondents: There will be three
types of respondents to the proposed
instruments. First, the direct
beneficiaries, the clients receiving
supportive services, will participate in
the service receipt questionnaire, selfsufficiency matrix, and focus groups,
and they will also provide information
about their characteristics, needs, and
outcomes for the grant recipients’ semiannual quantitative reporting. Second,
the program directors and social
services staff will respond to interview
instruments tailored to their roles. Grant
recipients will also be asked to complete
quarterly narrative PPRs and semiannual quantitative reports to describe
their service delivery activities, and
outcomes.
Annual Burden Estimates
Burden estimates show the total
number of responses per respondent
over the next 3 years. The current grant
recipients (9 total) will be able to choose
between using the 2023 version of the
semi-annual quantitative report forms
and the 2024 version of those forms
through the completion of their current
project. New grant recipients (9 new
recipients estimated) will be required to
use the 2024 version of the forms.
U:\REGISTER\03SEN1.SGM
03SEN1
71372
Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
Instrument
Interviews with program directors ........................................
Interviews with caseworkers ................................................
Focus groups with residents ................................................
Self-sufficiency matrix ..........................................................
Service receipt questionnaire ..............................................
2023 Version—Semi-Annual Quantitative Report Mandatory Form ..........................................................................
2024 Version—Semi-Annual Quantitative Report Mandatory Form ..........................................................................
2023 Version—Semi-Annual Quantitative Report Optional
Form .................................................................................
2024 Version—Semi-Annual Report Optional Form ...........
Quarterly Narrative PPR ......................................................
Estimated Total Annual Burden
Hours: 1,411.5.
Authority: Section 1110, Social
Security Act, 42 U.S.C. 1310.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–19695 Filed 8–30–24; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0150]
Revocation of Authorization of
Emergency Use of In Vitro Diagnostic
Device for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Roche Molecular Systems, Inc,
for the cobas SARS-CoV–2 & Influenza
A/B nucleic acid test for use on the
cobas Liat System, that includes the
cobas SARS-CoV–2 & Influenza A/B
Quality Control Kit. FDA revoked the
Authorization under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as
requested by the Authorization holder.
The revocation, which includes an
explanation of the reasons for
revocation, is reprinted at the end of
this document.
DATES: The revocation of the
Authorization for the Roche Molecular
Systems, Inc.’s for the cobas SARS-CoV–
2 & Influenza A/B nucleic acid test for
use on the cobas Liat System, that
includes the cobas SARS-CoV–2 &
tkelley on LAP7H3WLY3PROD with NOTICES2
SUMMARY:
VerDate Sep<11>2014
22:46 Aug 30, 2024
Jkt 262001
Total
number of
responses
per
respondent
Total
number of
respondents
Average
burden
hours
per
response
1
1
1
3
3
1.5
1
1.5
1.5
.25
27
36
157.5
3,060
510
9
12
52.5
1,020
170
3
4
3
36
12
15
3
3
135
45
1
5
18
4
3
6
3
3
2
12
45
216
4
15
72
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
On September 14, 2020, FDA issued
the Authorization to Roche Molecular
Systems, Inc, for the cobas SARS-CoV–
2 & Influenza A/B nucleic acid test for
use on the cobas Liat System, subject to
the terms of the Authorization. Notice of
the issuance of this Authorization was
published in the Federal Register on
Frm 00123
Fmt 4703
Annual
burden
hours
18
36
105
680
680
Influenza A/B Quality Control Kit is
effective as of July 3, 2024.
ADDRESSES: Submit written requests for
a single copy of the revocation to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocation.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
PO 00000
Total
burden
hours
Sfmt 4703
November 20, 2020 (85 FR 74346), as
required by section 564(h)(1) of the
FD&C Act.
Subsequent updates to the
Authorization were made available on
FDA’s website. The authorization of a
device for emergency use under section
564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section
564(c) of the FD&C Act for issuance of
such authorization are no longer met
(section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such
revocation appropriate to protect the
public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorization Revocation Request
In a request received by FDA on June
21, 2024, Roche Molecular Systems,
Inc., requested the revocation of, and on
July 3, 2024, FDA revoked, the
Authorization for the Roche Molecular
Systems, Inc.’s cobas SARS-CoV–2 &
Influenza A/B nucleic acid test for use
on the cobas Liat System, that includes
the cobas SARS-CoV–2 & Influenza A/
B Quality Control Kit. Because Roche
Molecular Systems, Inc., notified FDA
that they have ceased the manufacture
and distribution of the cobas SARSCoV–2 & Influenza A/B nucleic acid test
for use on the cobas Liat System, that
includes the cobas SARS-CoV–2 &
Influenza A/B Quality Control Kit and
requested FDA revoke Roche Molecular
Systems, Inc.’s, cobas SARS-CoV–2 &
Influenza A/B nucleic acid test for use
on the cobas Liat System, that includes
the cobas SARS-CoV–2 & Influenza A/
B Quality Control Kit, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
U:\REGISTER\03SEN1.SGM
03SEN1
]]>Agencies
[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71371-71372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review; Office of
Community Services Affordable Housing and Supportive Services
Demonstration Data Collection (Office of Management and Budget #: 0970-
0628)
AGENCY: Office of Community Services, Administration for Children and
Families, U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Community Services (OCS), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services, is requesting an extension of approval for a recently
approved information collection: OCS Affordable Housing and Supportive
Services Demonstration (Office of Management and Budget (OMB) #: 0970-
0628, Expiration Date: September 30, 2024). This information collection
was originally approved for 6 months as an emergency approval. In
addition to extending the approval, OCS seeks to update the burden
estimates to accommodate an anticipated increase in the number of grant
recipients, as well as to collect additional responses to several of
the instruments. OCS also seeks to make updates to approved forms.
DATES: Comments due October 3, 2024. 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.
ADDRESSES: 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 copies of the proposed collection of information by
emailing [email protected]. Identify all emailed requests by
the title of the information collection.
SUPPLEMENTARY INFORMATION: OCS is seeking to continue collecting the
information requested from grant recipients under OMB #: 0970-0628. In
order to determine best practices in the implementation of supportive
services in the affordable housing context and describe how supportive
services help residents to improve well-being and economic mobility,
OCS will engage in the following activities:
Conducting interviews with program directors and
caseworkers to understand program implementation.
Conducting focus groups with residents to understand their
needs and how the services funded by this grant impacted their lives.
Administering a self-sufficiency matrix to residents
receiving intensive services to understand the impact of the program on
various domains of well-being.
Conducting a questionnaire with residents, to see if they
were able to access more services due to the funding.
Collecting information from program officers about the
number and types of services/events provided, aggregate demographics of
residents served, partner organizations and referrals, and how the
housing community was impacted by the grant funding.
Collecting narrative reports from program officers about
the progress of implementation of the program.
This request is to extend the approved collection period to 3
years, which will permit OCS to complete the collection with current
grant recipients as well as future grant recipients. With an extended
timeline, OCS will request additional responses for several approved
instruments to observe activities over the course of the full project
period for grant recipients. The self-sufficiency matrix and service
receipt questionnaires will be administered every 6 months during the
project period. The semi-annual quantitative report mandatory and
optional forms will be required every 6 months, with a final cumulative
report. The quarterly narrative PPR will be requested every quarter of
the project period.
OCS has developed substantially revised 2024 versions of the semi-
annual quantitative report forms for the mandatory and optional reports
to broaden the measures of service delivery and outcomes to better
accommodate the universe of potential services offered by future
cohorts of grant recipients. The new mandatory form combines the direct
services and referrals tabs of the original form into a single tab
where grant recipients will report the number of individuals receiving
services through AHSSD funding and through the organization's other
funding sources, alongside the information reported about referrals.
The new optional form broadens the list of outcome measures that grant
recipients can choose to report for the individuals they serve. In
consideration of the overall reporting burden for grant recipients, the
2024 version of the forms continue draw upon the service and outcome
categories that grant recipients already use to report their Community
Services Block Grant-related activities (OMB# 0970-0492). Additionally,
the 2024 version of the forms request cumulative counts across the
grant period, negating the need for a separate final report.
Current grant recipients will be able to choose between using the
current 2023 version of the forms and the revised 2024 version of the
forms through the completion of their current project. New grant
recipients will be required to use the 2024 version of the forms.
Respondents: There will be three types of respondents to the
proposed instruments. First, the direct beneficiaries, the clients
receiving supportive services, will participate in the service receipt
questionnaire, self-sufficiency matrix, and focus groups, and they will
also provide information about their characteristics, needs, and
outcomes for the grant recipients' semi-annual quantitative reporting.
Second, the program directors and social services staff will respond to
interview instruments tailored to their roles. Grant recipients will
also be asked to complete quarterly narrative PPRs and semi-annual
quantitative reports to describe their service delivery activities, and
outcomes.
Annual Burden Estimates
Burden estimates show the total number of responses per respondent
over the next 3 years. The current grant recipients (9 total) will be
able to choose between using the 2023 version of the semi-annual
quantitative report forms and the 2024 version of those forms through
the completion of their current project. New grant recipients (9 new
recipients estimated) will be required to use the 2024 version of the
forms.
[[Page 71372]]
----------------------------------------------------------------------------------------------------------------
Total number
Total number of responses Average Total burden Annual burden
Instrument of per burden hours hours hours
respondents respondent per response
----------------------------------------------------------------------------------------------------------------
Interviews with program 18 1 1.5 27 9
directors......................
Interviews with caseworkers..... 36 1 1 36 12
Focus groups with residents..... 105 1 1.5 157.5 52.5
Self-sufficiency matrix......... 680 3 1.5 3,060 1,020
Service receipt questionnaire... 680 3 .25 510 170
2023 Version--Semi-Annual 3 4 3 36 12
Quantitative Report Mandatory
Form...........................
2024 Version--Semi-Annual 15 3 3 135 45
Quantitative Report Mandatory
Form...........................
2023 Version--Semi-Annual 1 4 3 12 4
Quantitative Report Optional
Form...........................
2024 Version--Semi-Annual Report 5 3 3 45 15
Optional Form..................
Quarterly Narrative PPR......... 18 6 2 216 72
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,411.5.
Authority: Section 1110, Social Security Act, 42 U.S.C. 1310.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-19695 Filed 8-30-24; 8:45 am]
BILLING CODE 4184-24-P
