Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 545 

(Authority: 42 U.S.C. 9858(a)(5); 42 U.S.C. 

9835; and 42 U.S.C. 9844) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–29230 Filed 1–5–21; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Administration and Oversight 

of the Unaccompanied Alien Children 

Program (OMB #0970–0547) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, 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 inviting public 

comments on revisions to an approved 

information 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 above. 

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: 

Description: ORR plans to revise six of 

the eight instruments currently 

approved under OMB #0970–0547. Four 

of the revised instruments will be 

incorporated into ORR’s new case 

management system, UAC Path. The 

other two revised instruments are and 

will remain PDF instruments. In 

addition, ORR plans to add two new 

instruments to this collection, both of 

which will be incorporated into UAC 

Path. Finally, ORR plans to remove one 

currently approved instrument from this 

collection. 

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. No 

revisions are currently requested; ORR 

plans to continue use of this form as-is. 

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. ORR updated the Spanish 

translation of this PDF instrument. 

3. Authorization for Release of 

Records (Form A–5): This instrument is 

used by attorneys, legal service 

providers, 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. ORR made the 

following revisions: 

Æ Added a section in which ORRfunded legal service providers are 

required to certify their representation 

of the child. 

Æ Added a separate area where 

sponsors may authorize the release of 

their records. 

Æ Updated the required supporting 

documentation for a representative of a 

federal/state government agency or the 

National Center for Missing and 

Exploited Children to further require 

that the requester specify the scope of 

their investigation and provide a case 

reference number. 

Æ Clarified in the instructions that 

ORR will not release any records that 

are clearly outside of the scope of a 

government agency’s investigation 

absent a court-issued subpoena or order. 

4. Notification of Concern (Form A–7): 

This instrument is used by home study 

and post-release service caseworkers, 

care provider case managers, and the 

ORR National Call Center to notify ORR 

of certain concerns that arise after a 

UAC is released from ORR custody. This 

is a new instrument that ORR plans to 

add to this collection. 

5. Event (Form A–9): This instrument 

is used by ORR care provider programs 

to document high-level information 

about situations that must be reported to 

ORR. Creating an Event is the first step 

in creating any type of incident report 

(see forms A–10A to A–10C below), PLE 

Report (see form A–10D below) or 

Notification of Concern (see form A–7 

above). After an Event is created, an 

incident report or Notification of 

Concern is created for each UAC 

involved in the incident and linked to 

the Event. For program-level events, one 

PLE Report is created and linked to the 

Event. Event information is visible in 

each individual report/notification 

report. This instrument was previously 

approved as part of ORR’s various 

incident reports (Forms A–10A to A– 

10D). ORR is listing it separately, as a 

new instrument, to better align 

instruments in this collection with how 

data will be entered in UAC Path. Some 

fields that were previously entered in 

each incident report have been moved 

into this instrument so that they only 

need to be entered once. The form also 

contains several new fields that capture 

additional information about the 

location and timeframe of the event. 

Please note that internal form number 

A–9 was previously assigned to the 

Program-Level Event Report. 

6. Emergency Significant Incident 

Report (SIR) and Addendum (Form A– 

10A): 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. ORR made the 

following revisions: 

Æ Revised the available options for 

the category and subcategory fields. 

Æ Added a question asking whether 

the incident is related to gang/cartel 

crimes, activities, or affiliation. 

Æ Added fields to capture additional 

detail on individuals involved in the 

incident, actions taken, and video 

footage. 

Æ Added fields to capture additional 

information related to reporting of 

incidents to child protective services, 

state licensing agencies, and local law 

enforcement. 

Æ Added a disposition field to 

indicate whether the incident is closed 

or if the incident is open and further 

action is required. 

Æ Updated functionality for the list of 

individuals who need to be notified of 

the incident so that it is auto-populated 


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546 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 

and notification emails can be sent from 

within the UAC Path system. 

Æ Updated internal form numbering 

so that reports and addendums are fall 

under the same form number. 

7. Significant Incident Report (SIR) 

and Addendum (Form A–10B): 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. ORR made the 

following revisions: 

Æ Revised the available options for 

the category and subcategory fields. 

Æ Added a question asking whether 

the incident is related to gang/cartel 

crimes, activities, or affiliation. 

Æ Added fields to capture additional 

detail on individuals involved in the 

incident, actions taken, and video 

footage. 

Æ Added fields to capture additional 

information related to reporting of 

incidents to child protective services, 

state licensing agencies, and local law 

enforcement. 

Æ Added a disposition field to 

indicate whether the incident is closed 

or if the incident is open and further 

action is required. 

Æ Updated functionality for the list of 

individuals who need to be notified of 

the incident so that it is auto-populated 

and notification emails can be sent from 

within the UAC Path system. 

Æ Updated internal form numbering 

so that reports and addendums are fall 

under the same form number. 

8. Sexual Abuse Significant Incident 

Report (SA/SIR) and Addendum (Form 

A–10C): This instrument is used by ORR 

care provider programs to inform ORR 

of allegations of sexual harassment, 

sexual abuse, and inappropriate sexual 

behavior that occurred while the UAC 

was in ORR custody. In some cases, an 

SA/SIR Addendum may be required to 

provide additional information obtained 

after the initial report. ORR made the 

following revisions: 

Æ Revised the available options for 

the category and subcategory fields. 

Æ Added a question asking whether 

the incident is related to gang/cartel 

crimes, activities, or affiliation. 

Æ Added fields to capture additional 

detail on individuals involved in the 

incident, actions taken, and video 

footage. 

Æ Added fields to capture additional 

information related to reporting of 

incidents to child protective services, 

state licensing agencies, and local law 

enforcement. 

Æ Added a disposition field to 

indicate whether the incident is closed 

or if the incident is open and further 

action is required. 

Æ Updated functionality for the list of 

individuals who need to be notified of 

the incident so that it is auto-populated 

and notification emails can be sent from 

within the UAC Path system. 

Æ Updated internal form numbering 

so that reports and addendums are fall 

under the same form number. 

9. Program-Level Event (PLE) Report 

and Addendum (Form A–10D): 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. 

ORR made the following revisions: 

Æ Revised the available options for 

the category and subcategory fields. 

Æ Added a question asking whether 

the incident is related to gang/cartel 

crimes, activities, or affiliation. 

Æ Added fields to capture additional 

detail on individuals involved in the 

incident, actions taken, and video 

footage. 

Æ Added fields to capture additional 

information related to reporting of 

incidents to child protective services, 

state licensing agencies, and local law 

enforcement. 

Æ Added a disposition field to 

indicate whether the incident is closed 

or if the incident is open and further 

action is required. 

Æ Updated functionality for the list of 

individuals who need to be notified of 

the incident so that it is auto-populated 

and notification emails can be sent from 

within the UAC Path system. 

Æ Updated internal form numbering 

so that reports and addendums are fall 

under the same form number. 

10. Hotline Alert (Form A–12): ORR is 

discontinuing this instrument. In UAC 

Path, the ORR National Call Center will 

use the Notification of Concern instead 

of the Hotline Alert. 

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

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden 

minutes 

per response 

Annual total 

burden hours 

Care Provider Facility Tour Request (Form A–1A) ......................................... 200 1 10 33 

Notice to UAC for Flores Visits (Forms A–4 & A–4s) ..................................... 20 1 15 5 

Authorization for Release of Records (Form A–5) .......................................... 4,000 1 15 1,000 

Notification of Concern (Form A–7) ................................................................. 60 75 15 1,125 

Event (Form A–9) ............................................................................................ 276 160 10 7,360 

Emergency Significant Incident Report and Addendum (Form A–10A) .......... 216 14 60 3,024 

Significant Incident Report and Addendum (Form A–10B) ............................. 216 491 60 106,056 

Sexual Abuse Significant Incident Report and Addendum (Form A–10C) ..... 216 47 60 10,152 

Program Level Event (Form A–10D) ............................................................... 216 7 60 1,512 

Estimated Annual Burden Hours Total ..................................................... ........................ ........................ ........................ 130,267 

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. Consideration will be given 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Notices 547 

to comments and suggestions submitted 

within 60 days of this publication. 

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. 2020–29276 Filed 1–5–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–4048] 

Safer Technologies Program for 

Medical Devices; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Safer Technologies 

Program for Medical Devices.’’ This 

final guidance describes a new, 

voluntary program for certain medical 

devices and device-led combination 

products that are reasonably expected to 

significantly improve the safety of 

currently available treatments or 

diagnostics that target an underlying 

disease or condition associated with 

morbidities and mortalities less serious 

than those eligible for the Breakthrough 

Devices Program. Devices and deviceled combination products are eligible 

for this program if they are subject to 

review under a premarket approval 

application (PMA), De Novo 

classification request (‘‘De Novo 

request’’), or premarket notification 

(510(k)), taking into account the specific 

eligibility factors described in this 

guidance. Consistent with the Agency’s 

statutory mission to protect and 

promote public health, FDA believes 

that this ‘‘Safer Technologies Program’’ 

or ‘‘STeP’’ will help patients have more 

timely access to these medical devices 

and device-led combination products by 

expediting their development, 

assessment, and review, while 

preserving the statutory standards for 

premarket approval, De Novo marketing 

authorization, and 510(k) clearance. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 6, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–4048 for ‘‘Safer Technologies 

Program for Medical Devices.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Safer Technologies 

Program for Medical Devices’’ to the 

Office of Policy, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Christina Savisaar, Center for Devices 


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