Submission for OMB Review; Request for Assistance for Child Victims of Human Trafficking

Citation86 FR 35801
Record Number2021-14448
Published date07 July 2021
SectionNotices
CourtChildren And Families Administration
35801
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
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 trauma-
informed 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.
A
NNUAL
B
URDEN
E
STIMATES
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 Traf-
ficking ............................................................................... 1,200 1 1 1,200 400
Estimated Total Annual Burden Hours: 400.
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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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