Expedited OMB Review and Public Comment; Proposed Information Collection Activity; Administration and Oversight of the Unaccompanied Alien Children Program, 21240-21241 [2020-07995]
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21240
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Expedited OMB Review and Public
Comment; Proposed Information
Collection Activity; Administration and
Oversight of the Unaccompanied Alien
Children Program
Office of Refugee Resettlement;
Administration for Children and
Families; U.S. Department of Health and
Human Services.
ACTION: Request for public comment.
AGENCY:
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is requesting expedited
review of an information collection
request from the Office of Management
and Budget (OMB) and inviting public
comments on the proposed collection.
The request consists of several forms
that allow the Unaccompanied Alien
Children (UAC) Program to monitor care
provider facility compliance with
federal laws and regulations, legal
agreements, and ORR policies and
procedures; and perform other
administrative tasks.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described in this notice.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Description: ACF is requesting that
OMB grant a 180-day approval for this
request under procedures for expedited
processing. A request for review under
normal procedures will be incorporated
into the submission under normal
procedures.
The components of this information
request include:
1. Care Provider Facility Tour Request
(Form A–1A): This instrument is used
by advocacy groups, faith-based
organizations, researchers, government
officials, and other stakeholders to
request tours of ORR care provider
facilities. After the request is received,
ORR documents its decision and details
regarding date and location of the tour,
if applicable, and provides the
completed form to the requester. This
instrument was previously approved
under OMB No. 0970–0498.
2. Notice to UAC for Flores Visits
(Forms A–4 & A–4s): This instrument is
used by care provider facilities to notify
UAC of upcoming visits by Flores
counsel (lawyers and volunteers from
the organization that originally
participated in the creation of the Flores
Settlement Agreement) and allow UAC
to add their name to a sign-up sheet if
they are willing to speak with Flores
counsel.
3. Authorization for Release of
Records (Form A–5): This instrument is
used by attorneys, legal service
providers, child advocates, government
agencies, and other stakeholders to
request UAC case file records. In most
cases, requesters are required to obtain
the signature of the subject of the record
request (UAC or their parent/legal
guardian or sponsor) and a witness.
4. Program Level Event (PLE) Report
(Form A–9): This instrument is used by
ORR care provider programs to inform
ORR of events that may affect the entire
care provider facility, such as an active
shooter or natural disaster. An updated
PLE Report is required for events that
occur over multiple days or if the
situation changes regarding the event.
5. Emergency Significant Incident
Report (SIR) and Addendum (Forms A–
10A & A–10B): This instrument is used
by ORR care provider programs to
inform ORR of urgent situations in
which there is an immediate threat to a
child’s safety and well-being that
require instantaneous action. In some
cases, an Emergency SIR Addendum
may be required to provide additional
information obtained after the initial
report.
6. Significant Incident Report (SIR)
and Addendum (Forms A–10C & A–
10D): This instrument is used by ORR
care provider programs to inform ORR
of situations that affect, but do not
immediately threaten, the safety and
well-being of a child. In some cases, an
SIR Addendum may be required to
provide additional information obtained
after the initial report.
7. Sexual Abuse Significant Incident
Report (SA/SIR) and Addendum (Forms
A–10E & A–10F): This instrument is
used by ORR care provider programs to
inform ORR of allegations of sexual
harassment, sexual abuse, and
inappropriate sexual behavior. In some
cases, an SA/SIR Addendum may be
required to provide additional
information obtained after the initial
report.
8. UAC Satisfaction Survey (Forms A–
11 & A–11s): This instrument is used by
ORR care provider programs to collect
information from UAC regarding their
experience while in ORR custody.
9. UAC Satisfaction Survey Aggregate
Data: This instrument is used by ORR
care provider programs to report
aggregate data from UAC Satisfaction
Survey forms submitted to ORR on a
quarterly and annual basis. ORR uses
this information to identify areas where
it can make programmatic
improvements.
10. Hotline Alert (A–12): This
instrument is used by ORR’s National
Call Center to inform ORR of allegations
sexual harassment, sexual abuse,
inappropriate sexual behavior, and
physical abuse that occurred while the
UAC was in ORR custody.
Respondents: ORR grantee and
contractor staff; advocacy groups, faithbased organizations, researchers, and
government officials; attorneys, legal
service providers, child advocates, and
government agencies; and other
stakeholders.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Instrument
Care Provider Facility Tour Request (Form A–1A) .........................................
Notice to UAC for Flores Visits (Forms A–4 & A–4s) .....................................
Authorization for Release of Records (Form A–5) ..........................................
Program Level Event Report (Form A–9) ........................................................
Emergency Significant Incident Report (Form A–10A) ...................................
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Annual
number of
responses per
respondent
200
20
4,000
1,500
1,640
E:\FR\FM\16APN1.SGM
1
1
1
1
1
16APN1
Average
burden
minutes
per response
10
15
10
20
20
Annual
burden
minutes
2,000
300
40,000
30,000
32,800
21241
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total
number of
respondents
Instrument
Emergency Significant Incident Report Addendum (Form A–10B) .................
Significant Incident Report (Form A–10C) .......................................................
Significant Incident Report Addendum (Form A–10D) ....................................
Sexual Abuse Significant Incident Report (Form A–10E) ...............................
Sexual Abuse Significant Incident Report Addendum (Form A–10F) .............
UAC Satisfaction Survey (Form A–11 & A–11s) .............................................
UAC Satisfaction Survey Aggregate Data .......................................................
Hotline Alert (Form A–12) ................................................................................
Estimated Annual Burden Total:
3,982,800.
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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Fax written comments on the
collection of information by May 18,
2020.
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 0910–0748. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–07995 Filed 4–15–20; 8:45 am]
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.
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission of Information on Pediatric
Uses of Medical Devices; Requirement
for Submission of Information on
Pediatric Subpopulations That Suffer
From a Disease or Condition That a
Device Is Intended To Treat, Diagnose,
or Cure Under Section 515A of the
Federal Food, Drug, and Cosmetic
Act—21 CFR 814
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Information on Pediatric Uses of
Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
1,360
80,340
25,630
5,980
4,190
72,840
235
80
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232;
Flores v. Reno Settlement Agreement, No.
CV85–4544–RJK (C.D. Cal. 1996).
Notice.
The Food and Drug
Administration (FDA) 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:
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
OMB Control Number 0910–0748—
Extension
Section 515A(a) of the Food, Drug,
and Cosmetic Act (21 U.S.C. 360e-1)
(FD&C Act) requires applicants who
submit certain medical device
applications to include readily available
information providing a description of
any pediatric subpopulations that suffer
from the disease or condition that the
device is intended to treat, diagnose, or
cure, and the number of affected
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
Annual
number of
responses per
respondent
1
1
1
1
1
1
4
1
Average
burden
minutes
per response
15
20
15
20
15
20
240
15
Annual
burden
minutes
20,400
1,606,800
384,450
119,600
62,850
1,456,800
225,600
1,200
pediatric patients. The information
submitted will allow FDA to track the
number of approved devices for which
there is a pediatric subpopulation that
suffers from the disease or condition
that the device is intended to treat,
diagnose, or cure and the review time
for each such device application.
These requirements apply to
applicants who submit humanitarian
device exemption requests (HDEs),
premarket approval applications (PMAs)
or PMA amendments or supplements, or
a product development protocol (PDP).
FDA expects to receive approximately
47 original PMA/PDP/HDE applications
each year, 1 of which FDA expects to be
HDEs. This estimate is based on the
average of FDA’s receipt of new PMA
applications. The Agency estimates that
11 of the estimated 47 original PMA
submissions will fail to provide the
required pediatric use information and
their sponsors will therefore be required
to submit PMA amendments. The
Agency also expects to receive
approximately 928 supplements that
will include the pediatric use
information required by section 515A(a)
of the FD&C Act and part 814 (21 CFR
part 814).
All that is required is to gather,
organize, and submit information that is
readily available, using any approach
that meets the requirements of section
515A(a) of the FD&C Act and part 814.
We believe that because the applicant is
required to organize and submit only
readily available information, no more
than 8 hours will be required to comply.
Furthermore, because supplements may
include readily available information on
pediatric populations by referencing a
previous submission, FDA estimates the
average time to obtain and submit the
required information is a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 2,392 hours.
Additionally, the document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff’’ describes how to
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21240-21241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07995]
[[Page 21240]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Expedited OMB Review and Public Comment; Proposed Information
Collection Activity; Administration and Oversight of the Unaccompanied
Alien Children Program
AGENCY: Office of Refugee Resettlement; Administration for Children and
Families; U.S. Department of Health and Human Services.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services (HHS), is requesting expedited review of an information
collection request from the Office of Management and Budget (OMB) and
inviting public comments on the proposed collection. The request
consists of several forms that allow the Unaccompanied Alien Children
(UAC) Program to monitor care provider facility compliance with federal
laws and regulations, legal agreements, and ORR policies and
procedures; and perform other administrative tasks.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, ACF is soliciting public comment on the specific aspects
of the information collection described in this notice.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be forwarded by emailing
[email protected]. Alternatively, copies can also be obtained
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation (OPRE), 330 C Street SW, Washington,
DC 20201, Attn: ACF Reports Clearance Officer. All requests, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ACF is requesting that OMB grant a 180-day approval
for this request under procedures for expedited processing. A request
for review under normal procedures will be incorporated into the
submission under normal procedures.
The components of this information request include:
1. Care Provider Facility Tour Request (Form A-1A): This instrument
is used by advocacy groups, faith-based organizations, researchers,
government officials, and other stakeholders to request tours of ORR
care provider facilities. After the request is received, ORR documents
its decision and details regarding date and location of the tour, if
applicable, and provides the completed form to the requester. This
instrument was previously approved under OMB No. 0970-0498.
2. Notice to UAC for Flores Visits (Forms A-4 & A-4s): This
instrument is used by care provider facilities to notify UAC of
upcoming visits by Flores counsel (lawyers and volunteers from the
organization that originally participated in the creation of the Flores
Settlement Agreement) and allow UAC to add their name to a sign-up
sheet if they are willing to speak with Flores counsel.
3. Authorization for Release of Records (Form A-5): This instrument
is used by attorneys, legal service providers, child advocates,
government agencies, and other stakeholders to request UAC case file
records. In most cases, requesters are required to obtain the signature
of the subject of the record request (UAC or their parent/legal
guardian or sponsor) and a witness.
4. Program Level Event (PLE) Report (Form A-9): This instrument is
used by ORR care provider programs to inform ORR of events that may
affect the entire care provider facility, such as an active shooter or
natural disaster. An updated PLE Report is required for events that
occur over multiple days or if the situation changes regarding the
event.
5. Emergency Significant Incident Report (SIR) and Addendum (Forms
A-10A & A-10B): This instrument is used by ORR care provider programs
to inform ORR of urgent situations in which there is an immediate
threat to a child's safety and well-being that require instantaneous
action. In some cases, an Emergency SIR Addendum may be required to
provide additional information obtained after the initial report.
6. Significant Incident Report (SIR) and Addendum (Forms A-10C & A-
10D): This instrument is used by ORR care provider programs to inform
ORR of situations that affect, but do not immediately threaten, the
safety and well-being of a child. In some cases, an SIR Addendum may be
required to provide additional information obtained after the initial
report.
7. Sexual Abuse Significant Incident Report (SA/SIR) and Addendum
(Forms A-10E & A-10F): This instrument is used by ORR care provider
programs to inform ORR of allegations of sexual harassment, sexual
abuse, and inappropriate sexual behavior. In some cases, an SA/SIR
Addendum may be required to provide additional information obtained
after the initial report.
8. UAC Satisfaction Survey (Forms A-11 & A-11s): This instrument is
used by ORR care provider programs to collect information from UAC
regarding their experience while in ORR custody.
9. UAC Satisfaction Survey Aggregate Data: This instrument is used
by ORR care provider programs to report aggregate data from UAC
Satisfaction Survey forms submitted to ORR on a quarterly and annual
basis. ORR uses this information to identify areas where it can make
programmatic improvements.
10. Hotline Alert (A-12): This instrument is used by ORR's National
Call Center to inform ORR of allegations sexual harassment, sexual
abuse, inappropriate sexual behavior, and physical abuse that occurred
while the UAC was in ORR custody.
Respondents: ORR grantee and contractor staff; advocacy groups,
faith-based organizations, researchers, and government officials;
attorneys, legal service providers, child advocates, and government
agencies; and other stakeholders.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Total number of responses minutes per Annual burden
of respondents per respondent response minutes
----------------------------------------------------------------------------------------------------------------
Care Provider Facility Tour Request (Form A-1A). 200 1 10 2,000
Notice to UAC for Flores Visits (Forms A-4 & A- 20 1 15 300
4s)............................................
Authorization for Release of Records (Form A-5). 4,000 1 10 40,000
Program Level Event Report (Form A-9)........... 1,500 1 20 30,000
Emergency Significant Incident Report (Form A- 1,640 1 20 32,800
10A)...........................................
[[Page 21241]]
Emergency Significant Incident Report Addendum 1,360 1 15 20,400
(Form A-10B)...................................
Significant Incident Report (Form A-10C)........ 80,340 1 20 1,606,800
Significant Incident Report Addendum (Form A- 25,630 1 15 384,450
10D)...........................................
Sexual Abuse Significant Incident Report (Form A- 5,980 1 20 119,600
10E)...........................................
Sexual Abuse Significant Incident Report 4,190 1 15 62,850
Addendum (Form A-10F)..........................
UAC Satisfaction Survey (Form A-11 & A-11s)..... 72,840 1 20 1,456,800
UAC Satisfaction Survey Aggregate Data.......... 235 4 240 225,600
Hotline Alert (Form A-12)....................... 80 1 15 1,200
----------------------------------------------------------------------------------------------------------------
Estimated Annual Burden Total: 3,982,800.
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 on respondents, including through the use of automated
collection techniques or other forms of information technology.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232; Flores v. Reno
Settlement Agreement, No. CV85-4544-RJK (C.D. Cal. 1996).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-07995 Filed 4-15-20; 8:45 am]
BILLING CODE 4184-45-P
