Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 35801 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–14439 Filed 7–6–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Request 

for Assistance for Child Victims of 

Human Trafficking 

AGENCY: Office on Trafficking in 

Persons, Administration for Children 

and Families, HHS. 

ACTION: Request for Public Comment. 

SUMMARY: The Administration for 

Children and Families (ACF), Office on 

Trafficking in Persons (OTIP) is 

requesting a three-year extension of the 

form: Request for Assistance (RFA) for 

Child Victims of Human Trafficking 

(OMB #0970–0362, expiration 07/31/ 

2021). Minor revisions have been made 

to the form, including the addition of a 

few fields that will enable the OTIP 

Child Protection Specialist team to 

better understand the child’s specific 

needs, connect the child to appropriate 

services, and help ensure the safety of 

the child. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about 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 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: The Trafficking Victims 

Protection Act (TVPA) of 2000, as 

amended directs the Secretary of the 

U.S. Department of Health and Human 

Services (HHS), upon receipt of credible 

information that a foreign national 

minor may have been subjected to a 

severe form of trafficking in persons and 

is seeking assistance available to victims 

of trafficking, to promptly determine if 

the child is eligible for benefits and 

services to the same extent as refugees. 

HHS delegated this authority to the 

Office on Trafficking in Persons (OTIP). 

OTIP developed a form for case 

managers, attorneys, law enforcement 

officers, child welfare workers, and 

other representatives to report these 

trafficking concerns to HHS in 

accordance with the TVPA of 2000, as 

amended, and allow for OTIP to review 

the concerns and determine eligibility 

for benefits. 

Specifically, the form asks the 

requester for their identifying 

information, identifying information for 

the child, and information describing 

the potential trafficking concerns. The 

form takes into consideration the need 

to compile information regarding a 

child’s experiences in a traumainformed and child-centered manner 

and assists the requester in assessing 

whether the child may have been 

subjected to a severe form of trafficking 

in persons. The information provided 

through the completion of a Request for 

Assistance (RFA) for Child Victims of 

Human Trafficking form enables OTIP 

to make prompt determinations 

regarding a foreign national minor’s 

eligibility for assistance, facilitate the 

required consultation process should 

the minor receive interim assistance, 

and enable OTIP to assess and address 

potential child protection issues. OTIP 

also uses the information provided to 

respond to congressional inquiries, 

fulfill federal reporting requirements, 

and inform policy and program 

development that is responsive to the 

needs of victims. 

In 2019, OTIP launched Shepherd, an 

online case management system, to 

process requests for assistance and 

certification on behalf of foreign 

national minor and adult victims of 

trafficking. If a requester encounters 

issues submitting a request through 

Shepherd, they may submit the RFA 

form to OTIP as a password protected 

PDF to childtrafficking@acf.hhs.gov. 

Respondents: Representatives of 

governmental entities, members of the 

community, and nongovernmental 

entities providing social, legal, or 

protective services to foreign national 

minors in the United States who may 

have been subjected to severe forms of 

trafficking in persons. Furthermore, 

representatives within the community 

with a concern that a foreign national 

minor may have been subjected to 

severe forms of trafficking in persons 

may also use the RFA form. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

Request for Assistance for Child Victims of Human Trafficking ............................................................................... 1,200 1 1 1,200 400 

Estimated Total Annual Burden Hours: 400. 


khammond on DSKJM1Z7X2PROD with NOTICES
35802 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 

Authority: 22 U.S.C. 7105(b). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–14448 Filed 7–6–21; 8:45 am] 

BILLING CODE 4184–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1853] 

Unique Device Identification System: 

Form and Content of the Unique 

Device Identifier; 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, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Unique Device 

Identification System: Form and 

Content of the Unique Device Identifier 

(UDI).’’ This document describes the 

requirements for, and FDA’s 

recommendations regarding, the form 

and content of the UDI to help ensure 

that the UDIs developed under systems 

for the issuance of UDIs meet the 

objectives of the Unique Device 

Identification System Final Rule. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 7, 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– 

2016–D–1853 for ‘‘Unique Device 

Identification System: Form and 

Content of the Unique Device Identifier 

(UDI).’’ 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 ‘‘Unique Device 

Identification System: Form and 

Content of the Unique Device Identifier 

(UDI)’’ 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Diamant, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3210, Silver Spring, 

MD 20993–0002, 301–796–5995 or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This document is intended to assist 

labelers, as defined in 21 CFR 801.3, 

and FDA-accredited issuing agencies, as 

defined in 21 CFR 830.3, in complying 

with UDI labeling requirements, 

including by clarifying FDA’s 

interpretation of certain requirements 

under 21 CFR 801.40. Specifically, this 

guidance describes the requirements for, 

and FDA’s recommendations regarding, 

the form and content of the UDI to help 

ensure that the UDIs developed under 

systems for the issuance of UDIs meet 

the objectives of the Unique Device 

Identification System Final Rule, 78 FR 


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