Proposed Information Collection Activity; Office of Refugee Resettlement Unaccompanied Refugee Minors Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970-0550), 15039-15040 [2023-04987]
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15039
Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Notices
• Information on the prevention
materials developed and disseminated
by the NRS.
• Information and analysis of the
latest trends and their impact on
runaway prevention.
The NRS will use two forms, one form
to collect relevant information disclosed
during calls, emails, and forum posts
and a second form to collect information
from chats. All data will be provided to
FYSB in the aggregate and no personally
identifiable data are collected.
The information collected will allow
FYSB to better understand the types of
services needed by youth contacting the
NRS, as well as to identify outreach and
prevention strategies to increase the
visibility of the NRS services among
youth experiencing housing instability,
homelessness, youth who run away, and
youth in crisis. Additionally, the
findings from this data collection will
be included in a required Report to
Congress to provide relevant and up-todate information on the status of youth
in crisis and runaway and homeless
youth nationwide.
Respondents: Youth and adults who
contact the National Runaway Safeline
during calls, chats, emails, and forum
posts.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per respondent
47,175
29,679
1
1
Youth in Crisis Form ..........................................................
NRS Live Chat Form .........................................................
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Request for public comments.
Estimated Total Annual Burden
Hours: 10,047.
Authority: Section 331 of the
Runaway and Homeless Youth Act
authorizes the award of grants for the
National Communication System for
Runaway and Homeless Youth (34
U.S.C. 11231).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–04992 Filed 3–9–23; 8:45 am]
BILLING CODE 4182–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Office of Refugee
Resettlement Unaccompanied Refugee
Minors Program Application and
Withdrawal of Application or
Declination of Placement Form (OMB
#0970–0550)
Office of Refugee Resettlement,
Administration for Children and
AGENCY:
The Office of Refugee
Resettlement (ORR) is requesting a
three-year extension with revisions of
the Unaccompanied Refugee Minors
(URM) Program Application and
Withdrawal of Application or
Declination of Placement Form (OMB
#0970–0550, expiration 08/31/2023).
Proposed revisions include additional
instructions, a small number of new
questions, dropping a few questions,
and rephrasing existing questions.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUMMARY:
Average
burden hours
per response
.23
.65
Total burden
hours
Annual
burden hours
10,850
19,291
3,617
6,430
SUPPLEMENTARY INFORMATION:
Description: The URM Program
Application is completed on behalf of
unaccompanied children in the United
States who are applying for entry into
the URM Program. The application
includes biographical data and
information on the child’s needs to
support placement efforts. The
Withdrawal of Application or
Declination of Placement Form is
completed when a child is no longer
interested in entering the URM Program
or is not interested in entering the
placement they were offered.
Respondents: Case managers,
attorneys, or other representatives
working with unaccompanied children
who are eligible for the URM Program.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
lotter on DSK11XQN23PROD with NOTICES1
Unaccompanied Refugee Minors Program Application .......
Withdrawal of Application or Declination of Placement
Form .................................................................................
Estimated Total Annual Burden
Hours: 685.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
VerDate Sep<11>2014
17:45 Mar 09, 2023
Jkt 259001
Total
number of
responses per
respondent
Frm 00070
Fmt 4703
Total burden
hours
Annual burden
hours
450
3
1.5
2,025
675
50
3
0.2
30
10
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
PO 00000
Average
burden hours
per response
Sfmt 4703
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
E:\FR\FM\10MRN1.SGM
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15040
Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Notices
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522(d).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–04987 Filed 3–9–23; 8:45 am]
BILLING CODE 4184–89–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3351]
Authorization of Emergency Use of an
In Vitro Diagnostic Device in Response
to an Outbreak of Mpox; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the issuance of an
Emergency Use Authorization (EUA)
(the Authorization) under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) in response to an outbreak of mpox.
FDA has issued an Authorization for an
in vitro diagnostic device as requested
by Cepheid. The Authorization
contains, among other things,
conditions on the emergency use of the
authorized product. The Authorization
follows the August 9, 2022,
determination by the Secretary of Health
and Human Services (HHS) that there is
a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves monkeypox virus. On the basis
of such determination, the Secretary of
HHS declared, on September 7, 2022,
that circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act, subject to terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of February 10, 2023.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:45 Mar 09, 2023
Jkt 259001
Submit written requests for
a single copy of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
ADDRESSES:
Jennifer Ross, Office of Counterterrorism
and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–8510 (this is
not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen public health protections
against biological, chemical, nuclear,
and radiological 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. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives (among other criteria).
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent
or agents or (B) an agent or agents that
may cause, or are otherwise associated
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
with, an imminently life-threatening
and specific risk to U.S. military
forces; 1 (3) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of U.S. citizens living
abroad, and that involves a biological,
chemical, radiological, or nuclear agent
or agents, or a disease or condition that
may be attributable to such agent or
agents; or (4) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d–6b) sufficient
to affect national security or the health
and security of U.S. citizens living
abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use in
an actual or potential emergency when
the Secretary of HHS has declared that
circumstances exist justifying the
authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
or 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc).
FDA may issue an EUA only if, after
consultation with the HHS Assistant
Secretary for Preparedness and
Response, the Director of the National
Institutes of Health, and the Director of
the Centers for Disease Control and
Prevention (to the extent feasible and
appropriate given the applicable
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\10MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15039-15040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Office of Refugee
Resettlement Unaccompanied Refugee Minors Program Application and
Withdrawal of Application or Declination of Placement Form (OMB #0970-
0550)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families (ACF), Department of Health and Human Services (HHS).
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR) is requesting a
three-year extension with revisions of the Unaccompanied Refugee Minors
(URM) Program Application and Withdrawal of Application or Declination
of Placement Form (OMB #0970-0550, expiration 08/31/2023). Proposed
revisions include additional instructions, a small number of new
questions, dropping a few questions, and rephrasing existing questions.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of the Paperwork Reduction Act of 1995, ACF is
soliciting public comment on the specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the proposed collection of
information and submit comments by emailing [email protected].
Identify all requests by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The URM Program Application is completed on behalf of
unaccompanied children in the United States who are applying for entry
into the URM Program. The application includes biographical data and
information on the child's needs to support placement efforts. The
Withdrawal of Application or Declination of Placement Form is completed
when a child is no longer interested in entering the URM Program or is
not interested in entering the placement they were offered.
Respondents: Case managers, attorneys, or other representatives
working with unaccompanied children who are eligible for the URM
Program.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Total number of responses hours per Total burden Annual burden
of respondents per respondent response hours hours
----------------------------------------------------------------------------------------------------------------
Unaccompanied Refugee Minors 450 3 1.5 2,025 675
Program Application............
Withdrawal of Application or 50 3 0.2 30 10
Declination of Placement Form..
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 685.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information
[[Page 15040]]
on respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted within 60 days of this
publication.
Authority: 8 U.S.C. 1522(d).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-04987 Filed 3-9-23; 8:45 am]
BILLING CODE 4184-89-P
