Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 65167 

federal building innovations in 

planning, design, and operations to 

reduce costs, enable agency missions, 

enhance human health and 

performance, and minimize 

environmental impacts. 

The purpose of the GBAC Meeting is 

to convene experts in buildings, 

including architects, material suppliers, 

construction contractors, environment, 

health, security and transportation to 

accelerate the successful transformation 

of the Federal building portfolio to 

sustainable technologies and practices. 

The Building and Grid Integration 

Task Group, Phase II will build on the 

recommendations of the first phase of 

this Task Group, to prioritize federal 

building and grid integration strategies 

and develop implementation plans and 

scenarios with future rate structures, 

including consideration of EVs and 

energy storage. 

The Data-Integrated Building Systems 

Task Group will document and 

recognize data-integrated building 

system (e.g., smart building system) use 

cases that demonstrate the business case 

and quantify the multiple benefits of 

integrating building technologies and 

systems. 

The conference calls will allow the 

task groups to develop consensus 

recommendations to the full Committee, 

which will, in turn, decide whether to 

proceed with formal advice to GSA 

based upon these recommendations. 

Meeting participants will provide 

advice and expertise regarding how the 

Office of Federal High-Performance 

Buildings can most effectively 

accomplish its mission. Subcommittees 

will present their findings to the full 

committee for feedback and direction. 

Participants will discuss topics about 

which the Committee would like to 

engage, especially those related to 

market failures that the Federal 

government might substantially impact 

with cost-effective solutions. 

Procedures for Attendance and Public 

Comment 

Contact Mr. Michael Bloom at 

michael.bloom@gsa.gov to register to 

attend the in-person meeting or listen to 

any of these conference calls. To attend 

any of these events, submit your full 

name, organization, email address, and 

phone number, and which you would 

like to attend. Requests to attend the 

conference calls must be received by 

5:00 p.m. EDT; on Friday, January 4, 

2019 (GSA will be unable to provide 

technical assistance to any listener 

experiencing technical difficulties. 

Testing access to the Web meeting site 

before the calls is recommended). 

Requests to attend the May 16, 2019 

meeting must be received by 5:00 p.m., 

EDT, on Friday, January 4, 2019. 

Contact Mr. Bloom to register to 

comment during the May 16, 2019 

meeting public comment period. 

Registered speakers/organizations will 

be allowed a maximum of five (5) 

minutes each, and will need to provide 

written copies of their presentations. 

Requests to comment at the meeting 

must be received by 5:00 p.m., EDT, on 

Friday, January 4, 2019. Written 

comments may be provided to Mr. 

Bloom by the same deadline. 

May 16, 2019 Meeting Agenda 

• Updates and introductions. 

• Building-grid integration task group 

findings & recommendations. 

• Lunchtime speaker (TBD). 

• Data-integrated building systems 

task group findings & recommendations. 

• Additional topics proposed by 

Committee members. 

• Public comment. 

• Next steps and closing comments. 

Dated: December 12, 2018. 

Kevin Kampschroer, 

Federal Director, Office of Federal HighPerformance Buildings, General Services 

Administration. 

[FR Doc. 2018–27437 Filed 12–18–18; 8:45 am] 

BILLING CODE 6820–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: U.S. Repatriation Program 

Forms 

OMB No.: 0970–0474 

Description: The United States (U.S.) 

Repatriation Program was established by 

Title XI, Section 1113 of the Social 

Security Act (Assistance for U.S. 

Citizens Returned from Foreign 

Countries) to provide temporary 

assistance to U.S. citizens and their 

dependents who have been identified by 

the Department of State (DOS) as having 

returned, or been brought from a foreign 

country to the U.S. because of 

destitution, illness, war, threat of war, 

or a similar crisis, and are without 

available resources immediately 

accessible to meet their needs. The 

Secretary of the Department of Health 

and Human Services (HHS) was 

provided with the authority to 

administer this Program. On or about 

1994, this authority was delegated by 

the HHS Secretary to the Administration 

for Children and Families (ACF) and 

later re-delegated by ACF to the Office 

of Refugee Resettlement. The 

Repatriation Program works with States, 

Federal agencies, and non-governmental 

organizations to provide eligible 

individuals with temporary assistance 

for up to 90-days. This assistance is in 

the form of a loan and must be repaid 

to the Federal Government. 

The Program was later expanded in 

response to legislation enacted by 

Congress to address the particular needs 

of persons with mental illness (24 

U.S.C. Sections 321 through 329). 

Further refinements occurred in 

response to Executive Order (E.O.) 

11490 (as amended) where HHS was 

given the responsibility to ‘‘develop 

plans and procedures for assistance at 

ports of entry to U.S. personnel 

evacuated from overseas areas, their 

onward movement to final destination, 

and follow-up assistance after arrival at 

final destination.’’ In addition, under 

E.O. 12656 (53 CFR 47491), 

‘‘Assignment of emergency 

preparedness responsibilities,’’ HHS 

was given the lead responsibility to 

develop plans and procedures in order 

to provide assistance to U.S. citizens 

and others evacuated from overseas 

areas. 

In order to effectively and efficiently 

manage these legislative authorities, the 

Program has been divided into two 

major activities, Emergencies and NonEmergencies Repatriation Activities. 

Operationally, these two Program 

activities involve different kinds of 

preparation, resources, and 

implementation. However, the core 

Program statute, regulations, policies 

and administrative procedures for these 

two Programs are essentially the same. 

The ongoing routine arrivals of 

individual repatriates and the 

repatriation of individuals with mental 

illness constitute the Program Nonemergency activities. Emergency 

Activities are characterized by 

contingency events such as civil unrest, 

war, threat of war or similar crisis, 

among other incidents. Depending on 

the type of event, number of evacuees 

and resources available, ACF will 

provide assistance utilizing two scalable 

mechanisms, emergency repatriations or 

group repatriations. Emergency 

repatriations assume the evacuation of 

500 or more individuals, while group 

repatriations assume the evacuation of 

50–500 individuals. 

The Program provides services 

through agreements with the States, U.S. 

Territories, Federal agencies, and Nongovernmental agencies. The list of 

Repatriation Forms is as follows: 

1. The HHS Repatriation Program: 

Emergency and Group Processing Form: 


amozie on DSK3GDR082PROD with NOTICES1
65168 Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 

Under 45 CFR 211 and 212, HHS is to 

make findings setting forth the pertinent 

facts and conclusions according to 

established standards to determine 

whether an individual is an eligible 

person. This form allows authorized 

staff to gather necessary information to 

determine eligibility and needed 

services. This form is to be utilized 

during emergency repatriation activities. 

Individuals interested in receiving 

Repatriation assistance will complete 

appropriate portions of this form. State 

personnel assisting with initial intake 

activities will use this form as a guide 

to perform a preliminary eligibility 

assessment. An authorized federal staff 

from the ACF will make final eligibility 

determinations. 

2. The HHS Repatriation Program: 

Privacy and Repayment Agreement 

Form: Under 45 CFR 211 and 212, 

individuals who receive Program 

assistance are required to repay the 

federal government for the cost 

associated to the services received. This 

form authorizes HHS to release personal 

identifiable information to partners for 

the purpose of providing services to 

eligible repatriates. In addition, through 

this form, eligible repatriates agree to 

accept services under the terms and 

conditions of the Program. Specifically, 

eligible repatriates commit to repay the 

federal government for all temporary 

services received through the Program. 

This form is to be completed by eligible 

repatriates or authorized legal 

custodians. Exemption applies to 

unaccompanied minors and individuals 

eligible under 45 CFR 211, if no legal 

custodian is identified. 

3. The HHS Repatriation Program: 

Refusal of Temporary Assistance Form: 

For individuals who are eligible to 

receive repatriation assistance but opt to 

relinquish services, this form is utilized 

to confirm and record repatriate’s 

decision to refuse receiving Program 

assistance. This form is to be completed 

by eligible repatriates or authorized 

legal custodian. Exemption applies to 

unaccompanied minors and individuals 

eligible under 45 CFR 211, if no legal 

custodian is identified. 

4. The HHS Repatriation Program: 

Emergency and Group Repatriation 

Financial Form: Under Section 1113 of 

the Social Security Act, HHS is 

authorized to provide temporary 

assistance directly or through utilization 

of the services and facilities of 

appropriate public or private agencies 

and organizations, in accordance with 

agreements providing for payment, as 

may be determined by HHS. This form 

is to be utilized and completed by 

agencies that have entered into an 

agreement with ORR to request 

reimbursement of reasonable and 

allowable costs, both administrative and 

actual temporary services. 

5. The HHS Repatriation Program: 

Non-emergency Monthly Financial 

Statement Form: Under Section 1113 of 

the Social Security Act, HHS is 

authorized to provide temporary 

assistance directly or through 

arrangements, in accordance with 

agreements providing for payment, as 

may be determined by HHS. This form 

is to be utilized and completed by the 

States and other authorized ORR 

agencies to request reimbursement of 

reasonable and allowable costs, both 

administrative and actual temporary 

services, associated to the direct 

provision of temporary assistance to 

eligible repatriates. 

6. The HHS Repatriation Program: 

Repatriation Loan Waiver and Deferral 

Request Form: In accordance with 45 

CFR 211 & 212 individuals who have 

received Repatriation assistance may be 

eligible to receive a waiver or deferral of 

their repatriation loan. This form is to 

be completed by eligible repatriates, 

authorized legal custodian, or 

authorized agency/individual. 

Exemption applies to unaccompanied 

minors and individuals eligible under 

45 CFR 211, if no legal custodian is 

identified. 

7. The HHS Repatriation Program: 

Temporary Assistance Extension 

Request Form: Under 45 CFR 211 & 212 

temporary assistance may be furnished 

beyond the 90 days eligibility period if 

the repatriate meets the qualifications 

established under Program regulations. 

This form is to be completed by the 

eligible repatriate, authorized legal 

custodian, or the authorized agency/ 

individual. This form should be 

submitted to ORR or its designated 

grantee generally 14 -day prior to the 

expiration of the 90 days eligibility 

period. 

8. The HHS Repatriation Program: 

State Request for Federal Support Form: 

During emergency repatriation 

activities, States activated by ORR are to 

use this form to request support and/or 

assistance from HHS, including but not 

limited to required pre-approval of 

expenditures, augmentation of State 

personnel, funding, reimbursement, 

among other things. 

Respondents: Designated state, 

federal, and/or non-governmental 

agencies/individuals and eligible 

repatriates. Responders are authorized 

by 42 U.S.C. 1313 and 24 U.S.C. 321– 

329; Executive Order 12656 (as 

amended by E.O. 13074, February 9, 

1998; E.O. 13228, October 8, 2001; E.O. 

13286, February 28, 2003); and 

regulations found under 45 CFR 211 & 

212. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

The HHS Repatriation Program: Emergency and Group 

Processing Form.

25,000 or more depending on 

the Emergency.

1 ..................... 0.30 7,500 or more. 

The HHS Repatriation Program: Privacy and Repayment 

Agreement Form.

1,000 will increase during 

emergencies.

1 ..................... 0.05 50 or more. 

The HHS Repatriation Program: Refusal of Temporary Assistance Form.15 or more ............................. 1 ..................... 0.05 0.75 or more. 

The HHS Repatriation Program: Emergency and Group Repatriation Financial Form.15 or more ............................. 1 ..................... 0.30 4.5 or more. 

The HHS Repatriation Program: Non-emergency Monthly Financial Statement Form.52 or more ............................. 12 ................... 0.30 187 or more. 

The HHS Repatriation Program: Repatriation Loan Waiver 

and Referral Request Form.

800 or more ........................... 1 ..................... 0.30 240 or more. 

The HHS Repatriation Program: State Request for Federal 

Support.

20 or more ............................. 1 ..................... 0.30 6 or more. 

The HHS Repatriation Program: Temporary Assistance Extension Request Form.50 or more ............................. 1 or more ....... 0.30 15 or more. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 65169 

Estimated Total Annual Burden 

Hours: 8,003. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW, Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–27398 Filed 12–18–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5966] 

Breakthrough Devices Program; 

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 the final 

guidance entitled ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff.’’ This guidance document 

describes policies that FDA intends to 

use to implement the new Breakthrough 

Devices Program, established by the 21st 

Century Cures Act (Cures Act). The 

Breakthrough Devices Program 

supersedes and combines elements from 

FDA’s Expedited Access Pathway (EAP), 

which was intended to facilitate the 

development and expedite review of 

certain devices that demonstrate the 

potential to address unmet medical 

needs, as well as the Priority Review 

Program, which implemented statutory 

criteria for granting priority review to 

premarket approval applications (PMAs) 

and applied those criteria to other types 

of premarket submissions for medical 

devices. This guidance is intended to 

clarify certain principles and features of 

the new program, the designation 

criteria for Breakthrough Devices, the 

designation request review process, the 

process for withdrawing from the 

program, as well as the recommended 

information device manufacturers 

should provide in their designation 

request for entrance into the program. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 19, 2018. 

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– 

2017–D–5966 for ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff.’’ 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. 

• 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.gpo.gov/ 

fdsys/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. 

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 


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