Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 64581 

to Congress to help inform strategies 

and policies to assist foreign national 

victims of human trafficking. 

Respondents: Trafficking Victim 

Assistance Program Grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

Client Characteristics and Enrollment Form .................................................... 1100 1 .3 330 

Client Service Use and Delivery Form ............................................................ 1100 1 .25 275 

Client Case Closure Form ............................................................................... 1100 1 .167 183.7 

Barriers to Service Delivery and Monitoring Form .......................................... 91 5 .167 75.985 

TVAP Spending Form ...................................................................................... 261 1 .75 195.75 

Partnership Development Enrollment Form .................................................... 261 1 .25 65.25 

Partnership Development Exit Form ................................................................ 261 1 .083 21.663 

Training Form .................................................................................................. 261 4 .5 522 

Technical Assistance Form ............................................................................. 261 4 .5 522 

Estimated Total Annual Burden 

Hours: 2,191. 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35), 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, 330 C Street SW, 

Washington DC 20201. 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 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. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–27185 Filed 12–14–18; 8:45 am] 

BILLING CODE 4184–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Annual 

Survey of Refugees (OMB #0907–0033) 

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) within the 

U.S. Department of Health and Human 

Services (HHS) seeks to continue data 

collection for the Annual Survey of 

Refugees with minor updates to improve 

survey administration procedures. The 

Annual Survey of Refugees is a yearly 

sample survey of refugees entering the 

U.S. in the previous five fiscal years. No 

changes to the survey instrument or 

estimated response burden are 

proposed. 

DATES: Comments due within 30 days of 

publication. 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. 

ADDRESSES: 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. 

Copies of the proposed collection may 

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 

should be identified by the title of the 

information collection. Email address: 

OPREinfocollection@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Description: Data from the Annual 

Survey of Refugees are used to meet the 

Office of Refugee Resettlement’s 

Congressional reporting requirements, 

as set forth in the Refugee Act of 1980 

(Section 413(a) of the Immigration and 

Nationality Act). The Office of Refugee 

Resettlement makes aggregated survey 

findings available to the general public 

and uses findings for the purposes of 

program planning, policy-making, and 

budgeting. 

Respondents: The Annual Survey of 

Refugees secures a nationallyrepresentative sample of refugee 

households arriving in the United States 

in the previous five fiscal years. 


amozie on DSK3GDR082PROD with NOTICES1
64582 Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual burden 

hours 

ORR–9 (Annual Survey of Refugees) ................................. 6000 2000 1 0.5 1000 

Pre-survey information form ................................................ 6000 2000 1 0.05 100 

Estimated Total Annual Burden 

Hours: 1,100. 

Authority: Sec. 413.[8 U.S.C. 1523]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–27235 Filed 12–14–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3454] 

Manufacturing Site Change 

Supplements: Content and 

Submission; 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 ‘‘Manufacturing Site 

Change Supplements: Content and 

Submissions; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

This guidance describes the decisionmaking steps that FDA recommends to 

determine whether a premarket 

approval application (PMA) supplement 

should be submitted when a 

manufacturer intends to change the 

manufacturing site (including a change 

to the processing, packaging, or 

sterilization site) of its legally marketed 

PMA-approved device. This guidance 

also discusses the general factors FDA 

intends to consider when determining 

whether to conduct an establishment 

inspection prior to approval of a site 

change supplement. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 17, 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– 

2015–N–3454 for ‘‘Manufacturing Site 

Change Supplements: Content and 

Submission; 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 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Manufacturing Site 


amozie on DSK3GDR082PROD with NOTICES1