Submission for OMB Review; Comment Request, 39268-39269 [2016-14244]

Download as PDF 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 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