Expedited OMB Review and Public Comment; Proposed Information Collection Activity; Administration and Oversight of the Unaccompanied Alien Children Program, 21240-21241 [2020-07995]

Download as PDF 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]]

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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