81 FR 39268 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 116 (June 16, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 116 (June 16, 2016)
| Page Range | 39268-39269 | |
| FR Document | 2016-14244 |
[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)] [Notices] [Pages 39268-39269] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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: [email protected], 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
![39268 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices
and Evaluation, 330 C Street SW., Form 1: Demographic and Service programs in at-risk Tribal communities,
Washington, DC 20201, Attn: ACF Utilization Data. and engage in rigorous evaluation
Reports Clearance Officer. Email OMB No.: 0970–0389 (expired). activities to build the knowledge base
address: infocollection@acf.hhs.gov. All Description: Social Security Act, Title on home visiting among American
requests should be identified by the title V, Section 511 (42 U.S.C. 711), as Indian and Alaska Native populations.
of the information collection. amended by the Medicare Access and In Year 1 of the cooperative
The Department specifically requests Children’s Health Insurance Program agreement, grantees must (1) conduct a
comments on: (a) Whether the proposed (CHIP) Reauthorization Act of 2015 comprehensive community needs and
collection of information is necessary (Public Law (Pub. L.) 114–10), created readiness assessment and (2) develop a
for the proper performance of the the Maternal, Infant, and Early plan to respond to identified needs.
functions of the agency, including Childhood Home Visiting Program
Grantees will be required to conduct or
whether the information shall have (MIECHV) and authorized the Secretary
update a needs and readiness
practical utility; (b) the accuracy of the of HHS (in Section 511(h)(2)(A)) to
assessment and develop an
agency’s estimate of the burden of the award grants to Indian tribes (or a
implementation plan to respond to
proposed collection of information; (c) consortium of Indian tribes), tribal
those needs, including a plan for
the quality, utility, and clarity of the organizations, or urban Indian
demographic and service utilization
information to be collected; and (d) organizations to conduct an early
data, performance measurement, and
ways to minimize the burden of the childhood home visiting program. The
continuous quality improvement, and
collection of information on legislation set aside 3 percent of the
participating in or conducting rigorous
respondents, including through the use total MIECHV program appropriation
evaluation activities. Grantees are
of automated collection techniques or (authorized in Section 511(j)) for grants
expected to submit the implementation
other forms of information technology. to tribal entities. Tribal MIECHV grants,
plan by the end of Year 1 of the grant,
Consideration will be given to to the greatest extent practicable, are to
with draft submission milestones
comments and suggestions submitted be consistent with the requirements of
throughout the first year. As part of the
within 60 days of this publication. the MIECHV grants to states and
non-competing continuation application
jurisdictions (authorized in Section
Robert Sargis, for Years 3–5 of the grant, Tribal
511(c)), and include conducting a needs
Reports Clearance Officer. MIECHV grantees will update their
assessment and establishing
implementation plans as necessary to
[FR Doc. 2016–14229 Filed 6–15–16; 8:45 am] quantifiable, measurable benchmarks.
The Administration for Children and ensure that the plan accurately reflects
BILLING CODE 4184–01–P
Families, Office of Child Care and Office activities to be completed throughout
of the Deputy Assistant Secretary for the remainder of the grant.
DEPARTMENT OF HEALTH AND Early Childhood Development, in Following each year that Tribal
HUMAN SERVICES collaboration with the Health Resources MIECHV grantees implement home
and Services Administration, Maternal visiting services, they must also submit
Administration for Children and and Child Health Bureau, awarded Form 1: Demographic and Service
Families grants for the Tribal MIECHV Program. Utilization Data.
The Tribal MIECHV grant awards Respondents: Tribal Maternal, Infant,
Submission for OMB Review;
support 5-year cooperative agreements and Early Childhood Home Visiting
Comment Request
to conduct community needs and Program Grantees. (The information
Title: Tribal Maternal, Infant, and readiness assessments, plan for and collection does not include direct
Early Childhood Home Visiting Program implement high-quality, culturally- interaction with individuals or families
Implementation Plan Guidance and relevant, evidence-based home visiting that receive the services).
ANNUAL BURDEN ESTIMATES
Average
Number of Total
Number of burden
Instrument responses per burden
respondents hours per
respondent hours
response
Tribal Maternal, Infant, and Early Childhood Home Visiting Implementation
Plan Guidance .............................................................................................. 25 1 1000 25,000
Tribal MIECHV Form 1 Demographic & Service Utilization Data & Service
Data .............................................................................................................. 25 1 500 12,500
Estimated Annual Burden Hours .............................................................. ........................ ........................ ........................ 37,500
Estimated Total Annual Burden of the information collection. Email proposed information collection should
Hours: 37,500. address: infocollection@acf.hhs.gov. be sent directly to the following: Office
OMB Comment: OMB is required to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Additional Information: Copies of the of Management and Budget, Paperwork
proposed collection may be obtained by make a decision concerning the Reduction Project, Email: OIRA_
writing to the Administration for collection of information between 30 SUBMISSION@OMB.EOP.GOV, Attn:
and 60 days after publication of this
Children and Families, Office of
document in the Federal Register.
Planning, Research and Evaluation, 330
Therefore, a comment is best assured of
C Street SW., Washington, DC 20201. having its full effect if OMB receives it
Attention Reports Clearance Officer. All within 30 days of publication. Written
requests should be identified by the title comments and recommendations for the
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![Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices 39269
Desk Officer for the Administration for DEPARTMENT OF HEALTH AND ACTION: Notice of award of two single-
Children and Families. HUMAN SERVICES source program expansion supplement
grants under the Unaccompanied
Robert Sargis, Administration for Children and Children’s (UC) Program.
Reports Clearance Officer. Families
[FR Doc. 2016–14244 Filed 6–15–16; 8:45 am] SUMMARY: The Administration for
[CFDA Number: 93.676]
BILLING CODE 4184–01–P Children and Families (ACF), Office of
Announcement of the Award of Two Refugee Resettlement (ORR), announces
Single-Source Program Expansion the award of two single-source program
Supplement Grants Under the expansion supplement grants for a total
Unaccompanied Children’s (UC) of $16,476,723 under the
Program Unaccompanied Children’s (UC)
AGENCY:Office of Refugee Resettlement, Program.
ACF, HHS.
Organization Location Amount
BCFS Health and Human Services ................................................................ San Antonio, TX ..................................................... $9,525,387
Southwest Key, Inc ......................................................................................... Austin, TX ............................................................... 6,951,336
ORR has been identifying additional experience, and appropriate level of DEPARTMENT OF HEALTH AND
capacity to provide shelter for potential trained staff to meet those requirements. HUMAN SERVICES
increases in apprehensions of The expansion of the existing program
Unaccompanied Children at the U.S. and its services through this Food and Drug Administration
Southern Border. Planning for increased supplemental award is a key strategy for [Docket No. FDA–2013–D–0350]
shelter capacity is a prudent step to ORR to be prepared to meet its
ensure that ORR is able to meet its responsibility to provide shelter for Use of International Standard ISO
responsibility, by law, to provide shelter Unaccompanied Children referred to its 10993–1, ‘Biological evaluation of
for Unaccompanied Children referred to care by DHS and so that the US Border medical devices—Part 1: Evaluation
its care by the Department of Homeland Patrol can continue its vital national and testing within a risk management
Security (DHS). security mission to prevent illegal process’’; Guidance for Industry and
The expansion supplement grants will Food and Drug Administration Staff;
migration, trafficking, and protect the
support the need to increase shelter Availability
borders of the United States.
capacity to accommodate the increasing
numbers of UCs being referred by DHS. Statutory Authority: This program is AGENCY: Food and Drug Administration,
Both grantees have the infrastructure, authorized by— HHS.
licensing, experience and appropriate (A) Section 462 of the Homeland Security ACTION: Notice of availability.
level of trained staff to meet the service Act of 2002, which in March 2003,
requirements and the urgent need for transferred responsibility for the care and SUMMARY: The Food and Drug
expansion of services. The grantees custody of Unaccompanied Alien Children Administration (FDA or Agency) is
provide residential services to UC in the from the Commissioner of the former announcing the availability of the
care and custody of ORR, as well as Immigration and Naturalization Service (INS) guidance entitled ‘‘Use of International
services to include counseling, case to the Director of ORR of the Department of Standard ISO 10993–1, ‘Biological
management, and additional support Health and Human Services (HHS). evaluation of medical devices—Part 1:
services to the family or to the UC and (B) The Flores Settlement Agreement, Case Evaluation and testing within a risk
their sponsor when a UC is released No. CV85–4544RJK (C.D. Cal. 1996), as well management process.’ ’’ FDA has
from ORR’s care and custody. as the William Wilberforce Trafficking developed this guidance document to
Victims Protection Reauthorization Act of assist industry in preparing Premarket
DATES: Supplemental award funds will
2008 (Pub. L. 110–457), which authorizes Applications (PMAs), Humanitarian
support activities from October 1, 2015, post release services under certain conditions Device Exceptions (HDEs),
through September 30, 2016. to eligible children. All programs must Investigational Device Applications
FOR FURTHER INFORMATION CONTACT: comply with the Flores Settlement (IDEs), Premarket Notifications
Jallyn Sualog, Director, Division of Agreement, Case No. CV85–4544–RJK (C.D. (510(k)s), and de novo requests for
Children’s Services, Office of Refugee Cal. 1996), pertinent regulations and ORR medical devices that come into direct
Resettlement, 330 C. Street SW., policies and procedures. contact or indirect contact with the
Washington, DC 20201. Email: human body in order to determine the
DCSProgram@acf.hhs.gov. Christopher Beach,
potential for an unacceptable adverse
SUPPLEMENTARY INFORMATION: ORR is Senior Grants Policy Specialist, Office of biological response resulting from
continuously monitoring its capacity to Administration, Office of Financial Services, contact of the component materials of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
shelter the unaccompanied children Division of Grants Policy.
the device with the body.
referred to HHS, as well as the [FR Doc. 2016–14267 Filed 6–15–16; 8:45 am] The purpose of this guidance is to
information received from interagency BILLING CODE 4184–01–P provide further clarification and
partners, to inform any future decisions updated information on the use of
or actions. International Standard ISO 10993–1,
ORR has specific requirements for the ‘‘Biological evaluation of medical
provision of services. Award recipients devices—Part 1: Evaluation and testing
must have the infrastructure, licensing, within a risk management process’’ to
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Document Created: 2016-06-16 00:37:27
Document Modified: 2016-06-16 00:37:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 39268 |
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