Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 5199 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden 

minutes 

per response 

Annual total 

burden hours 

Placement Authorization (Form P–1) .............................................................. 216 278 5 5,004 

Authorization for Medical, Dental, and Mental Health Care (Form P–2) ........ 216 278 5 5,004 

Notice of Placement in a Restrictive Setting (Form P–4/4s) ........................... 15 34 20 170 

Long Term Foster Care Placement Memo (Form P–5) .................................. 30 3 15 23 

UAC Referral (Form P–7) ................................................................................ 16 3,250 60 52,000 

UAC Referral—Intakes Placement Checklist (Form P–7) ............................... 16 9 30 72 

Care Provider Checklist for Transfers to Influx Care Facilities (Form P–8) ... 216 10 15 540 

Medical Checklist for Transfers (Form P–9A) ................................................. 216 27 5 486 

Medical Checklist for Influx Transfers (Form P–9B) ....................................... 216 63 10 2,268 

Transfer Request (Form P–10A)—Grantee Case Manager ............................ 216 37 25 3,330 

Transfer Request (Form P–10A)—Contractor Case Coordinator ................... 250 37 20 3,083 

Influx Transfer Request (Form P–10B) ........................................................... 216 63 25 5,670 

Transfer Summary and Tracking (Form P–11) ............................................... 216 37 10 1,332 

Program Entity (Form P–12) ............................................................................ 216 12 30 1,296 

UAC Profile (Form P–13) ................................................................................. 216 241 45 39,042 

ORR Transfer Notification—ORR Notification to ICE Chief Counsel of 

Transfer of UAC and Request .....................................................................

to Change Address/Venue (Form P–14) ......................................................... 216 37 10 1,332 

Family Group Entity (Form P–15) .................................................................... 16 188 5 251 

Influx Transfer Manifest (Form P–16) .............................................................. 3 12 20 12 

Influx Transfer Manual and Prescreen Criteria Review (Form P–17) ............. 216 43,333 30 4,679,964 

Estimated Annual Burden Hours Total: .................................................... ........................ ........................ ........................ 4,800,879 

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 

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. 2021–01085 Filed 1–15–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Phase II Evaluation Activities 

for Implementing a Next Generation 

Evaluation Agenda for the Chafee 

Foster Care Program for Successful 

Transition to Adulthood—Extension 

(OMB #0970–0489) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) at the U.S. 

Department of Health and Human 

Services (HHS) requests an extension to 

continue data collection for the Phase II 

Evaluation Activities for Implementing 

a Next Generation Evaluation Agenda 

for the Chafee Foster Care Program for 

Successful Transition to Adulthood 

(OMB #0970–0489; Previously titled: 

Phase II Evaluation Activities for 

Implementing a Next Generation 

Evaluation Agenda for the Chafee Foster 

Care Independence Program). 

Information collection activities 

requested include interviews, focus 

group discussions and administrative 

data collection. There are no changes 

proposed to the currently approved 

materials. 

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 

OPREinfocollection@acf.hhs.gov. 

Alternatively, copies can also be 

obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. All requests, 

emailed or written should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The ACF, Office of 

Planning, Research, and Evaluation 

(OPRE) requests public comment on a 

proposed extension to a currently 

approved information collection for the 

Chafee Foster Care Program for 

Successful Transition to Adulthood 

(previously known as the Chafee Foster 

Care Independence Program). Activities 

include preliminary visits to discuss the 

evaluation process with program 

administrators and site visits to each 

program to speak with program leaders, 

partners and key stakeholders, front-line 

staff, and participants. These formative 

evaluations will determine programs’ 

readiness for more rigorous evaluation 


khammond on DSKJM1Z7X2PROD with NOTICES
5200 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 

in the future. The activities and 

products from this project will help 

ACF to fulfill the ongoing legislative 

mandate for program evaluation 

specified in the Foster Care 

Independence Act of 1999. 

Respondents: Semi-structured 

interviews will be held with program 

leaders, partners and stakeholders, and 

front-line staff as well as young adults 

being served by the programs. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

Outreach email for discussion with program administrators 

and staff ............................................................................... 38 1 8 304 152 

Outreach email for Focus Group Recruiters ....................... 96 1 8 768 384 

Discussion Guide for program leaders ................................ 23 1 1 23 12 

Discussion Guide for program partners and stakeholders .. 14 1 1 14 7 

Discussion Guide for program front-line staff ...................... 66 1 1 66 33 

Focus Group Guide for program participants ...................... 240 1 2 480 240 

Estimated Total Annual Burden 

Hours: 828. 

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 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Title IV–E of the Social Security 

Act, IV–E § 477(g) (1–2), as amended by the 

Foster Care Independence Act of 1999. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–01086 Filed 1–15–21; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2358] 

Authorizations of Emergency Use of 

Two Biological Products During the 

COVID–19 Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of two Emergency Use 

Authorizations (EUAs) (the 

Authorizations) under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) for 

biological products for use during the 

COVID–19 pandemic. FDA issued one 

Authorization for a biological product as 

requested by Pfizer, Inc, and one 

Authorization for a biological product as 

requested by ModernaTX, Inc. The 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized products. The 

Authorizations follow the February 4, 

2020, determination by the Secretary of 

Health and Human Services (HHS) that 

there is a public health emergency that 

has a significant potential to affect 

national security or the health and 

security of U.S. citizens living abroad 

and that involves a novel (new) 

coronavirus. The virus, now named 

SARS–CoV–2, causes the illness 

COVID–19. On the basis of such 

determination, the Secretary of HHS 

declared on March 27, 2020, that 

circumstances exist justifying the 

authorization of emergency use of drugs 

and biological products during the 

COVID–19 pandemic, pursuant to the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

The Authorizations, which include an 

explanation of the reasons for issuance, 

are reprinted in this document. 

DATES: The Authorization for Pfizer, Inc. 

is effective as of December 11, 2020; the 

Authorization for ModernaTX, Inc. is 

effective as of December 18, 2020. 

ADDRESSES: Submit written requests for 

single copies of the EUAs 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 Authorizations may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorizations. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4340, 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 the 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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES