Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32875 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Health Equity 

Technical Assistance Monitoring and 

Tracking; Use: The Centers for Medicare 

& Medicaid Services (CMS) Office of 

Minority Health (OMH) developed the 

CMS Equity Plan for Improving Quality 

in Medicare (CMS Equity Plan for 

Medicare). The Plan outlines CMS’ path 

to help advance health equity by 

improving the quality of care provided 

to minority and other underserved 

Medicare beneficiaries, particularly 

those with disparities in chronic 

diseases. CMS identified six highimpact priority areas based on a review 

of the evidence base and stakeholder 

input. These priorities encompass both 

system- and community-level 

approaches to achieve equity in 

Medicare. Priority 2: Evaluate 

Disparities Impacts and Integrate Equity 

Solutions Across CMS Programs, 

focuses on increasing understanding of 

the impact CMS programs have on 

health disparities and on identifying, 

developing and integrating proven 

solutions to improve their impact on 

vulnerable populations. 

CMS created a Health Equity 

Technical Assistance (TA) email 

(HealthEquityTA@cms.hhs.gov) to 

support CMS programs as they integrate 

health equity into their programs. This 

TA offers guidance from health equity 

subject matter experts on a variety of 

topics including reviewing data to 

identify health disparities, identifying 

root causes of health disparities, gaining 

an organizational champion, building 

organizational capacity to address 

health disparities, implementing 

interventions, tracking success of 

intervention, and serves as a portal to 

access health equity resources. Form 

Number: CMS–10669 (OMB control 

number: 0938—New); Frequency: 

Occasionally; Affected Public: Private 

sector (Business or other For-profits); 

Number of Respondents: 274; Total 

Annual Responses 274; Total Annual 

Hours: 23. (For policy questions 

regarding this collection contact 

Alexandra Bryden at 410–786–2076). 

Dated: July 11, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–15146 Filed 7–13–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: U.S. Repatriation Program 

Forms. 

OMB No.: 0970—NEW (two of the 

forms have prior OMB No: [SSA–3955 & 

SSA–2061]) 

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. 

Overall, the Program manages two 

major activities, Emergency and Nonemergency Repatriation Activities. The 

ongoing routine arrivals of individual 

repatriates and the repatriation of 

individuals with mental illness 

constitute the Program Non-emergency 

activities. Emergency activities are 

comprised of group repatriations 

(evacuations of 50–500 individuals) and 

emergency repatriations (evacuations of 

500 or more individuals). Operationally, 

these activities involve different kinds 

of preparation, resources, and 

implementation. However, the core 

Program policies and administrative 

procedures are essentially the same. The 

Program provides services through 

agreements with local repatriation 

service providers (e.g. States, federal 

agencies, non-governmental agencies, 

etc.). For the purpose of this Program, 

local repatriation service provider (local 

provider) has the same definition of 

‘‘agency’’ as defined under 45 CFR 212.1 

(i). 

1. The HHS Repatriation Program 

Emergency and Group Processing Form: 

Under 45 CFR 211 and 212, ORR 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 emergencies and group 

repatriations. Individuals interested in 

receiving Repatriation assistance will 

complete appropriate portions of this 

form. State personnel will utilize this 

form as a guide to perform an initial 

eligibility and needs assessment. An 

authorized federal staff from the ACF 

will make final eligibility 

determinations through the approval of 

this form. 

2. The U.S. Repatriation Program 

Privacy and Repayment Agreement 


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32876 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

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 ORR 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 services 

received while in the Program. This 

form is to be completed by eligible 

repatriates or authorized legal 

custodian. Exception applies to 

unaccompanied minors and individuals 

eligible under 45 CFR 211, if no legal 

custodian is identified. 

3. Relinquish Repatriation Services 

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 Program 

assistance. This form is to be completed 

by eligible repatriates or authorized 

legal custodian. Exception applies to 

unaccompanied minors and individuals 

eligible under 45 CFR 211, if no legal 

custodian is identified. 

4. The U.S. Repatriation Program 

Emergency Financial Form: Under 

Section 1113 of the Social Security Act, 

ORR 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 ORR. This form 

is to be utilized and completed by ORR 

local providers to request 

reimbursement of reasonable and 

allowable costs, both administrative and 

actual temporary services, after 

emergency activities. 

5. The U.S. Repatriation Program 

Non-emergency Reimbursement Form: 

Under Section 1113 of the Social 

Security Act, ORR is authorized to 

provide temporary assistance directly or 

through arrangements, in accordance 

with agreements providing for payment, 

as may be determined by ORR. This 

form is to be utilized and completed by 

ORR local providers to request 

reimbursement of reasonable and 

allowable costs, both administrative and 

actual temporary services. 

6. The U.S. Repatriation Program 

Financial Waiver 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 the 

repatriation local provider. Exception 

applies to unaccompanied minors and 

individuals eligible under 45 CFR 211, 

if no legal custodian is identified. 

7. The U.S. Repatriation Program 

Temporary Assistance Extension 

Request Form: Under 45 CFR 211 & 212 

temporary assistance may be furnished 

beyond the 90 days eligibility period. 

This form is to be completed by the 

eligible repatriates, authorized legal 

custodian, or the repatriation local 

provider. This form should be submitted 

to ORR or its authorized grantee 14 days 

prior to the expiration of the 90 days 

eligibility period. 

8. The U.S. Repatriation Program 

Individual Case Management Report 

and Financial Claim Form: Under 

Section 1113 of the Social Security Act, 

ORR is authorized to provide temporary 

assistance directly or through 

agreements with public and private 

agencies. This form is to be utilized and 

completed by ORR local provider to 

request reimbursement of reasonable 

and allowable costs, both administrative 

and actual temporary services. This 

form should also be utilized by the local 

repatriation provider for submit case 

updates. This forms is to be completed 

by authorized local providers. 

Respondents: Repatriation Program 

local repatriation service provider and 

individuals repatriated or evacuated by 

DOS from overseas. These respondents 

are authorized under Title XI, Section 

1113 of the Social Security Act (42 

U.S.C. 1313), Executive Order 12656 

(amended by E.O. 13074, February 9, 

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

13286, February 28, 2003), and 45 CFR 

211 & 212. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

U.S. Repatriation Program Emergency and Group Processing Form ... 500 or more ...... 1 ....................... 0.15 75 or more. 

U.S. Repatriation Program Privacy and Repayment Agreement Form: 1000 or more .... 1 ....................... 0.05 50 or more. 

U.S. Repatriation Program Relinquish Temporary Assistance Form ..... 50 or more ........ 1 ....................... 0.05 0.8 or more. 

U.S. Repatriation Program Emergency and Group Financial Form ....... 4 or more .......... 1 ....................... .20 4 or more. 

U.S. Repatriation Program Non-emergency Monthly Financial Statement Form.53 or more ........ 1 ....................... 0.20 10.6 or more. 

U.S. Repatriation Program Loan Waiver Request Form ........................ 100 or more ...... 1 ....................... 1 100 or more. 

U.S. Repatriation Program Temporary Assistance Extension Request 

Form.

500 or more ...... 1 ....................... 0.20 100 or more. 

U.S. Repatriation Program Individual Case Management Report ......... 1000 or more .... 1 or more .......... 0.20 200 or more. 

Estimated Total Annual Burden 

Hours: 540.4. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

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 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 


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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32877 

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. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15149 Filed 7–13–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0341] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drugs 

for Investigational Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: Fax written comments on the 

collection of information by August 15, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0117. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

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. 

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. 

New Animal Drugs for Investigational 

Use 

OMB Control Number 0910–0117— 

Extension 

FDA has the authority under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to approve new animal 

drugs. A new animal drug application 

(NADA) cannot be approved until, 

among other things, the new animal 

drug has been demonstrated to be safe 

and effective for its intended use(s). In 

order to properly test a new animal drug 

for an intended use, appropriate 

scientific investigations must be 

conducted. Under specific 

circumstances, section 512(j) of the 

FD&C Act (21 U.S.C. 360b(j)) permits 

the use of an investigational new animal 

drug to generate data to support an 

NADA approval. Section 512(j) of the 

FD&C Act authorizes us to issue 

regulations relating to the 

investigational use of new animal drugs. 

Our regulations in 21 CFR part 511 set 

forth the conditions for investigational 

use of new animal drugs and require 

reporting and recordkeeping. The 

information collected is necessary to 

protect the public health. We use the 

information to determine that 

investigational animal drugs are 

distributed only to qualified 

investigators, adequate drug 

accountability records are maintained, 

and edible food products from treated 

food-producing animals are safe for 

human consumption. We also use the 

information collected to monitor the 

validity of the studies submitted to us 

to support new animal drug approval. 

Reporting: Our regulations require 

that certain information be submitted to 

us in a ‘‘Notice of Claimed 

Investigational Exemption for a New 

Animal Drug’’ (NCIE) to qualify for the 

exemption and to control shipment of 

the new animal drug and prevent 

potential abuse. The NCIE must contain, 

among other things, the following 

specific information: (1) Identity of the 

new animal drug, (2) labeling, (3) 

statement of compliance of any 

nonclinical laboratory studies with good 

laboratory practices, (4) name and 

address of each clinical investigator, (5) 

the approximate number of animals to 

be treated or amount of new animal 

drug(s) to be shipped, and (6) 

information regarding the use of edible 

tissues from investigational animals 

(§ 511.1(b)(4) (21 CFR 511.1(b)(4)). If the 

new animal drug is to be used in foodproducing animals, e.g., cattle, swine, 

chickens, fish, etc., certain data must be 

submitted to us to obtain authorization 

for the use of edible food products from 

treated food-producing animals 

(§ 511.1(b)(5)). We require sponsors 

upon request to submit information 

with respect to the investigation to 

determine whether there are grounds for 

terminating the exemption 

(§ 511.1(b)(6)). We require sponsors to 

report findings that may suggest 

significant hazards pertinent to the 

safety of the new animal drug 

(§ 511.1(b)(8)(ii)). We also require 

reporting by importers of investigational 

new animal drugs for clinical 

investigational use in animals 

(§ 511.1(b)(9)). The information 

provided by the sponsor in the NCIE is 

needed to ensure that the proposed 

investigational use of the new animal 

drug is safe and that any edible food 

will not be distributed without proper 

authorization from FDA. Information 

contained in an NCIE submission is 

monitored under our Bio-Research 

Monitoring Program. This program 

permits us to monitor the validity of the 

studies and to ensure the proper use of 

the drugs is maintained by the 

investigators. 

Recordkeeping: If the new animal 

drug is only for tests in vitro or in 

laboratory research animals, the person 

distributing the new animal drug must 

maintain records showing the name and 

post office address of the expert or 

expert organization to whom it is 

shipped and the date, quantity, and 

batch or code mark of each shipment 

and delivery for a period of 2 years after 

such shipment or delivery (§ 511.1(a)(3) 

and (b)(3)). We require complete records 

of the investigation, including records of 

the receipt and disposition of each 

shipment or delivery of the 

investigational new animal drug 

(§ 511.1(b)(7)). We also require records 

of all reports received by a sponsor from 

investigators to be retained for 2 years 

after the termination of an 

investigational exemption or approval of 

a new animal drug application 

(§ 511.1(b)(8)(i)). 

Description of Respondents: 

Respondents to this collection of 

information are persons who use new 

animal drugs for investigational 

purposes. Investigational new animal 

drugs are used primarily by drug 

industry firms, academic institutions, 

and the government. Investigators may 

include individuals from these entities, 

as well as research firms and members 

of the medical professions. 

In the Federal Register of February 

22, 2018 (83 FR 7735), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 


sradovich on DSK3GMQ082PROD with NOTICES