Announcement of the Award Two Single-Source Program Expansion Supplement Grant to Southwest Keys, Inc., Austin, TX., 39647-39648 [2016-14378]
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Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
39647
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
New Sponsor Form .........................................................................................
Transfer Request and Tracking Form .............................................................
Long Term Foster Care Placement Memo .....................................................
Travel Request Form for UC Long Term Foster Care ....................................
Notice of Transfer to ICE Chief Counsel and Change of Address .................
Care Provider Family Reunification Checklist .................................................
Release Request .............................................................................................
Discharge Notification ......................................................................................
Verification of Release ....................................................................................
Child Advocate Referral and Appointment Form ............................................
Notice of Rights and Provision of Services Handout ......................................
Legal Service Provider List for UC ..................................................................
URM Application ..............................................................................................
Withdrawal of Application or Declination of Placement Form .........................
Standard Shelter Tour Request ......................................................................
Estimated Total Annual Burden
Hours: 172,636.
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. 2016–14350 Filed 6–16–16; 8:45 am]
sradovich on DSK3TPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
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16:48 Jun 16, 2016
Jkt 238001
55,200
1,000
279
20
2,320
55,200
55,200
716
55,200
250
58,000
58,000
350
10
60
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of the Award Two
Single-Source Program Expansion
Supplement Grant to Southwest Keys,
Inc., Austin, TX.
Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice of Award of two (2)
single-source program expansion
supplement grant to Southwest Keys,
Inc. (SWK), in Austin, TX.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces
the award of two (2) single-source
program expansion supplement grant
for $26,254,260 and $16,647,310 under
the Unaccompanied Children’s (UC)
Program to support a program
expansion supplement.
ORR has been identifying additional
capacity to provide shelter for potential
increases in apprehensions of
Unaccompanied Children at the U.S.
Southern Border. Planning for increased
shelter capacity is a prudent step to
ensure that ORR is able to meet its
responsibility, by law, to provide shelter
for Unaccompanied Children referred to
its care by the Department of Homeland
Security (DHS).
SWK has the infrastructure, licensing,
and experience to meet the service
requirements and the urgent need for
expansion of capacity.
DATES: Supplemental award funds will
support activities from October 1, 2015
through September 30, 2016.
SUMMARY:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
1
3
1
1
1
1
1
1
1
1
Average
burden hours
per response
.25/hour ..........
.25/hour ..........
.1/hour ............
.25/hour ..........
.1/hour ............
.1 ....................
.25 hour .........
.25/hour ..........
.1/hour ............
.50 ..................
.1/hour ............
.1 ....................
1 .....................
.1/hour ............
.1/hour ............
Total burden
hours
13,800
250
28
5
232
5,520
41,400
179
5,520
125
5,800
5,800
350
1
6
FOR FURTHER INFORMATION CONTACT:
Jallyn Sualog, Director, Division of
Children’s Services, Office of Refugee
Resettlement, 330 C Street SW.,
Washington, DC 20201. Email:
DCSProgram@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is
continuously monitoring its capacity to
shelter the unaccompanied children
referred to HHS, as well as the
information received from interagency
partners, to inform any future decisions
or actions.
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
experience, and appropriate level of
trained staff to meet those requirements.
The expansion of the existing program
and its services through this
supplemental award is a key strategy for
ORR to be prepared to meet its
responsibility to provide shelter for
Unaccompanied Children referred to its
care by DHS and so that the US Border
Patrol can continue its vital national
security mission to prevent illegal
migration, trafficking, and protect the
borders of the United States.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland Security
Act of 2002, which in March 2003,
transferred responsibility for the care and
custody of Unaccompanied Alien Children
from the Commissioner of the former
Immigration and Naturalization Service (INS)
to the Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement, Case
No. CV85–4544RJK (C.D. Cal. 1996), as well
as the William Wilberforce Trafficking
Victims Protection Reauthorization Act of
2008 (Pub. L. 110–457), which authorizes
post release services under certain conditions
to eligible children. All programs must
comply with the Flores Settlement
Agreement, Case No. CV85–4544–RJK (C.D.
E:\FR\FM\17JNN1.SGM
17JNN1
39648
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
Cal. 1996), pertinent regulations and ORR
policies and procedures.
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services,
Division of Grants Policy.
[FR Doc. 2016–14378 Filed 6–16–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–E–0681 and FDA–
2013–E–0676]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZILVER PTX DRUG
ELUTING PERIPHERAL STENT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for ZILVER
PTX DRUG ELUTING PERIPHERAL
STENT and is publishing this notice of
that determination as required by law.
FDA has made the determination
because of the submission of
applications by Boston Scientific
Scimed, Inc., to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of patents which claim that
medical device.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 16, 2016.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 14, 2016. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
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
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 Nos. FDA–
2013–E–0681 and FDA–2013–E–0676
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; ZILVER PTX DRUG
ELUTING PERIPHERAL STENT.’’
Received comments will be placed in
the dockets and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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://
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www.regulations.gov. Submit both
copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39647-39648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14378]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[CFDA Number: 93.676]
Announcement of the Award Two Single-Source Program Expansion
Supplement Grant to Southwest Keys, Inc., Austin, TX.
AGENCY: Office of Refugee Resettlement, ACF, HHS.
ACTION: Notice of Award of two (2) single-source program expansion
supplement grant to Southwest Keys, Inc. (SWK), in Austin, TX.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces the award of two (2) single-
source program expansion supplement grant for $26,254,260 and
$16,647,310 under the Unaccompanied Children's (UC) Program to support
a program expansion supplement.
ORR has been identifying additional capacity to provide shelter for
potential increases in apprehensions of Unaccompanied Children at the
U.S. Southern Border. Planning for increased shelter capacity is a
prudent step to ensure that ORR is able to meet its responsibility, by
law, to provide shelter for Unaccompanied Children referred to its care
by the Department of Homeland Security (DHS).
SWK has the infrastructure, licensing, and experience to meet the
service requirements and the urgent need for expansion of capacity.
DATES: Supplemental award funds will support activities from October 1,
2015 through September 30, 2016.
FOR FURTHER INFORMATION CONTACT: Jallyn Sualog, Director, Division of
Children's Services, Office of Refugee Resettlement, 330 C Street SW.,
Washington, DC 20201. Email: DCSProgram@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is continuously monitoring its capacity
to shelter the unaccompanied children referred to HHS, as well as the
information received from interagency partners, to inform any future
decisions or actions.
ORR has specific requirements for the provision of services. Award
recipients must have the infrastructure, licensing, experience, and
appropriate level of trained staff to meet those requirements. The
expansion of the existing program and its services through this
supplemental award is a key strategy for ORR to be prepared to meet its
responsibility to provide shelter for Unaccompanied Children referred
to its care by DHS and so that the US Border Patrol can continue its
vital national security mission to prevent illegal migration,
trafficking, and protect the borders of the United States.
Statutory Authority: This program is authorized by--
(A) Section 462 of the Homeland Security Act of 2002, which in
March 2003, transferred responsibility for the care and custody of
Unaccompanied Alien Children from the Commissioner of the former
Immigration and Naturalization Service (INS) to the Director of ORR
of the Department of Health and Human Services (HHS).
(B) The Flores Settlement Agreement, Case No. CV85-4544RJK (C.D.
Cal. 1996), as well as the William Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008 (Pub. L. 110-457), which
authorizes post release services under certain conditions to
eligible children. All programs must comply with the Flores
Settlement Agreement, Case No. CV85-4544-RJK (C.D.
[[Page 39648]]
Cal. 1996), pertinent regulations and ORR policies and procedures.
Christopher Beach,
Senior Grants Policy Specialist, Office of Administration, Office of
Financial Services, Division of Grants Policy.
[FR Doc. 2016-14378 Filed 6-16-16; 8:45 am]
BILLING CODE 4184-01-P
