Submission for OMB Review; Comment Request, 39268-39269 [2016-14244]
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39268
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
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. 2016–14229 Filed 6–15–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Tribal Maternal, Infant, and
Early Childhood Home Visiting Program
Implementation Plan Guidance and
Form 1: Demographic and Service
Utilization Data.
OMB No.: 0970–0389 (expired).
Description: Social Security Act, Title
V, Section 511 (42 U.S.C. 711), as
amended by the Medicare Access and
Children’s Health Insurance Program
(CHIP) Reauthorization Act of 2015
(Public Law (Pub. L.) 114–10), created
the Maternal, Infant, and Early
Childhood Home Visiting Program
(MIECHV) and authorized the Secretary
of HHS (in Section 511(h)(2)(A)) to
award grants to Indian tribes (or a
consortium of Indian tribes), tribal
organizations, or urban Indian
organizations to conduct an early
childhood home visiting program. The
legislation set aside 3 percent of the
total MIECHV program appropriation
(authorized in Section 511(j)) for grants
to tribal entities. Tribal MIECHV grants,
to the greatest extent practicable, are to
be consistent with the requirements of
the MIECHV grants to states and
jurisdictions (authorized in Section
511(c)), and include conducting a needs
assessment and establishing
quantifiable, measurable benchmarks.
The Administration for Children and
Families, Office of Child Care and Office
of the Deputy Assistant Secretary for
Early Childhood Development, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, awarded
grants for the Tribal MIECHV Program.
The Tribal MIECHV grant awards
support 5-year cooperative agreements
to conduct community needs and
readiness assessments, plan for and
implement high-quality, culturallyrelevant, evidence-based home visiting
programs in at-risk Tribal communities,
and engage in rigorous evaluation
activities to build the knowledge base
on home visiting among American
Indian and Alaska Native populations.
In Year 1 of the cooperative
agreement, grantees must (1) conduct a
comprehensive community needs and
readiness assessment and (2) develop a
plan to respond to identified needs.
Grantees will be required to conduct or
update a needs and readiness
assessment and develop an
implementation plan to respond to
those needs, including a plan for
demographic and service utilization
data, performance measurement, and
continuous quality improvement, and
participating in or conducting rigorous
evaluation activities. Grantees are
expected to submit the implementation
plan by the end of Year 1 of the grant,
with draft submission milestones
throughout the first year. As part of the
non-competing continuation application
for Years 3–5 of the grant, Tribal
MIECHV grantees will update their
implementation plans as necessary to
ensure that the plan accurately reflects
activities to be completed throughout
the remainder of the grant.
Following each year that Tribal
MIECHV grantees implement home
visiting services, they must also submit
Form 1: Demographic and Service
Utilization Data.
Respondents: Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program Grantees. (The information
collection does not include direct
interaction with individuals or families
that receive the services).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
25
1
1000
25,000
25
1
500
12,500
Estimated Annual Burden Hours ..............................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Tribal Maternal, Infant, and Early Childhood Home Visiting Implementation
Plan Guidance ..............................................................................................
Tribal MIECHV Form 1 Demographic & Service Utilization Data & Service
Data ..............................................................................................................
........................
........................
........................
37,500
Estimated Total Annual Burden
Hours: 37,500.
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, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
VerDate Sep<11>2014
18:04 Jun 15, 2016
Jkt 238001
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
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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:
E:\FR\FM\16JNN1.SGM
16JNN1
39269
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
Desk Officer for the Administration for
Children and Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
Administration for Children and
Families
[FR Doc. 2016–14244 Filed 6–15–16; 8:45 am]
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), announces
the award of two single-source program
expansion supplement grants for a total
of $16,476,723 under the
Unaccompanied Children’s (UC)
Program.
SUMMARY:
[CFDA Number: 93.676]
BILLING CODE 4184–01–P
Notice of award of two singlesource program expansion supplement
grants under the Unaccompanied
Children’s (UC) Program.
ACTION:
Announcement of the Award of Two
Single-Source Program Expansion
Supplement Grants Under the
Unaccompanied Children’s (UC)
Program
Office of Refugee Resettlement,
ACF, HHS.
AGENCY:
Location
BCFS Health and Human Services ................................................................
Southwest Key, Inc .........................................................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Organization
San Antonio, TX .....................................................
Austin, TX ...............................................................
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).
The expansion supplement grants will
support the need to increase shelter
capacity to accommodate the increasing
numbers of UCs being referred by DHS.
Both grantees have the infrastructure,
licensing, experience and appropriate
level of trained staff to meet the service
requirements and the urgent need for
expansion of services. The grantees
provide residential services to UC in the
care and custody of ORR, as well as
services to include counseling, case
management, and additional support
services to the family or to the UC and
their sponsor when a UC is released
from ORR’s care and custody.
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,
VerDate Sep<11>2014
18:04 Jun 15, 2016
Jkt 238001
Amount
$9,525,387
6,951,336
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Cal. 1996), pertinent regulations and ORR
policies and procedures.
AGENCY:
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services,
Division of Grants Policy.
[FR Doc. 2016–14267 Filed 6–15–16; 8:45 am]
BILLING CODE 4184–01–P
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Food and Drug Administration
[Docket No. FDA–2013–D–0350]
Use of International Standard ISO
10993–1, ‘Biological evaluation of
medical devices—Part 1: Evaluation
and testing within a risk management
process’’; Guidance for Industry and
Food and Drug Administration Staff;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Use of International
Standard ISO 10993–1, ‘Biological
evaluation of medical devices—Part 1:
Evaluation and testing within a risk
management process.’ ’’ FDA has
developed this guidance document to
assist industry in preparing Premarket
Applications (PMAs), Humanitarian
Device Exceptions (HDEs),
Investigational Device Applications
(IDEs), Premarket Notifications
(510(k)s), and de novo requests for
medical devices that come into direct
contact or indirect contact with the
human body in order to determine the
potential for an unacceptable adverse
biological response resulting from
contact of the component materials of
the device with the body.
The purpose of this guidance is to
provide further clarification and
updated information on the use of
International Standard ISO 10993–1,
‘‘Biological evaluation of medical
devices—Part 1: Evaluation and testing
within a risk management process’’ to
SUMMARY:
E:\FR\FM\16JNN1.SGM
16JNN1
]]>Agencies
[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39268-39269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14244]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Tribal Maternal, Infant, and Early Childhood Home Visiting
Program Implementation Plan Guidance and Form 1: Demographic and
Service Utilization Data.
OMB No.: 0970-0389 (expired).
Description: Social Security Act, Title V, Section 511 (42 U.S.C.
711), as amended by the Medicare Access and Children's Health Insurance
Program (CHIP) Reauthorization Act of 2015 (Public Law (Pub. L.) 114-
10), created the Maternal, Infant, and Early Childhood Home Visiting
Program (MIECHV) and authorized the Secretary of HHS (in Section
511(h)(2)(A)) to award grants to Indian tribes (or a consortium of
Indian tribes), tribal organizations, or urban Indian organizations to
conduct an early childhood home visiting program. The legislation set
aside 3 percent of the total MIECHV program appropriation (authorized
in Section 511(j)) for grants to tribal entities. Tribal MIECHV grants,
to the greatest extent practicable, are to be consistent with the
requirements of the MIECHV grants to states and jurisdictions
(authorized in Section 511(c)), and include conducting a needs
assessment and establishing quantifiable, measurable benchmarks.
The Administration for Children and Families, Office of Child Care
and Office of the Deputy Assistant Secretary for Early Childhood
Development, in collaboration with the Health Resources and Services
Administration, Maternal and Child Health Bureau, awarded grants for
the Tribal MIECHV Program. The Tribal MIECHV grant awards support 5-
year cooperative agreements to conduct community needs and readiness
assessments, plan for and implement high-quality, culturally-relevant,
evidence-based home visiting programs in at-risk Tribal communities,
and engage in rigorous evaluation activities to build the knowledge
base on home visiting among American Indian and Alaska Native
populations.
In Year 1 of the cooperative agreement, grantees must (1) conduct a
comprehensive community needs and readiness assessment and (2) develop
a plan to respond to identified needs. Grantees will be required to
conduct or update a needs and readiness assessment and develop an
implementation plan to respond to those needs, including a plan for
demographic and service utilization data, performance measurement, and
continuous quality improvement, and participating in or conducting
rigorous evaluation activities. Grantees are expected to submit the
implementation plan by the end of Year 1 of the grant, with draft
submission milestones throughout the first year. As part of the non-
competing continuation application for Years 3-5 of the grant, Tribal
MIECHV grantees will update their implementation plans as necessary to
ensure that the plan accurately reflects activities to be completed
throughout the remainder of the grant.
Following each year that Tribal MIECHV grantees implement home
visiting services, they must also submit Form 1: Demographic and
Service Utilization Data.
Respondents: Tribal Maternal, Infant, and Early Childhood Home
Visiting Program Grantees. (The information collection does not include
direct interaction with individuals or families that receive the
services).
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Tribal Maternal, Infant, and Early Childhood 25 1 1000 25,000
Home Visiting Implementation Plan Guidance.....
Tribal MIECHV Form 1 Demographic & Service 25 1 500 12,500
Utilization Data & Service Data................
---------------------------------------------------------------
Estimated Annual Burden Hours............... .............. .............. .............. 37,500
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 37,500.
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, 330 C Street SW.,
Washington, DC 20201. Attention 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:
[[Page 39269]]
Desk Officer for the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-14244 Filed 6-15-16; 8:45 am]
BILLING CODE 4184-01-P
