81_FR_3440 81 FR 3427 - Announcing the Award of Six Single-Source Program Expansion Supplement Grants From the Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program

81 FR 3427 - Announcing the Award of Six Single-Source Program Expansion Supplement Grants From the Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration For Children And Families

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range3427-3429
FR Document2016-01033

The Administration for Children and Families (ACF), Office of Child Care (OCC), Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program, announces the award of single-source program expansion supplement grants to the Confederated Salish and Kootenai Tribes in Pablo, MT; Confederated Tribes of Siletz Indians in Siletz, OR; Inter-Tribal Council of Michigan in Sault Ste. Marie, MI; Red Cliff Band of Lake Superior Chippewa in Bayfield, WI; the Choctaw Nation of Oklahoma in Durant, OK; and the Cherokee Nation of Oklahoma in Tahlequah, OK. The Fiscal Year 2015 single-source program expansion supplement grants will support the expansion of the Tribal Early Learning Initiative (TELI) program.

Federal Register, Volume 81 Issue 13 (Thursday, January 21, 2016)
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3427-3429]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01033]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration For Children And Families

[CFDA Number: 93.508]


Announcing the Award of Six Single-Source Program Expansion 
Supplement Grants From the Tribal Maternal, Infant, and Early Childhood 
Home Visiting (Tribal MIECHV) Program

AGENCY: Office of Child Care, Administration for Children and Families, 
HHS.

ACTION: Notice of the award of six single-source program expansion 
supplement grants to grantees of the Tribal Maternal, Infant, and Early 
Childhood Home Visiting (Tribal MIECHV) Program.

-----------------------------------------------------------------------

SUMMARY: The Administration for Children and Families (ACF), Office of 
Child Care (OCC), Tribal Maternal, Infant, and Early Childhood Home 
Visiting (Tribal MIECHV) Program, announces the award of single-source 
program expansion supplement grants to the Confederated Salish and 
Kootenai Tribes in Pablo, MT; Confederated Tribes of Siletz Indians in 
Siletz, OR; Inter-Tribal Council of Michigan in Sault Ste. Marie, MI; 
Red Cliff Band of Lake Superior Chippewa in Bayfield, WI; the Choctaw 
Nation of Oklahoma in Durant, OK; and the Cherokee Nation of Oklahoma 
in Tahlequah, OK.
    The Fiscal Year 2015 single-source program expansion supplement 
grants will support the expansion of the Tribal Early Learning 
Initiative (TELI) program.

[[Page 3428]]


DATES: The period of support is September 30, 2015--September 29, 2016.

FOR FURTHER INFORMATION CONTACT: Rachel Schumacher, Director, Office of 
Child Care, 901 D Street, SW., Washington, DC 20024. Telephone: (202) 
401-6984; Email: [email protected].

SUPPLEMENTARY INFORMATION: In response to the success of the TELI 
pilot, the Office of Child Care has awarded single-source program 
expansion supplement awards to six Tribal MIECHV grantees for expansion 
of the TELI program.

Objectives of the TELI Expansion

    1. Identify and analyze systems issues, including obstacles that 
could block efforts to build and maintain partnerships, fully and 
effectively coordinate tribal early childhood development programs, and 
develop a menu of alternative interventions and strategies in line with 
tribal community values, traditions, and priorities.
    2. Develop tribally driven goals and concrete objectives in each 
local tribal community for building effective and efficient early 
childhood systems, high-quality programs, and improved outcomes for 
young children and families.
    3. Develop and carry out concrete community plans for supporting 
and strengthening cooperation, coordination, resource sharing and 
leveraging, and integration among programs that support young children 
and families in the tribal community.
    4. Share plans of action, barriers and challenges, opportunities 
and solutions, and the results of action plans with other tribal 
communities in an effort to further develop peer-learning 
relationships.
    Applications received from the grantees underwent objective review 
using criteria such as the applicants' ability to clearly describe the 
early learning and development programs that will participate in the 
TELI; their ability to describe existing challenges and strengths to 
collaboration across their participating early learning and development 
programs; and whether the submitted budget and budget justification 
narrative provided for reasonable project costs.

The Following Awards Are Made

    A single-source program expansion supplemental grant of $96,000 to 
the Confederated Salish and Kootenai Tribes in Pablo, MT, to support 
the development of a shared data system for its early childhood 
programs that include Head Start, Child Care, and Home Visiting that 
will allow programs to improve client services by increasing 
accessibility and reducing wait time and travel time between agencies; 
a more efficient client information system; promotion of long-term, 
cross-agency communication and collaboration; improved management 
systems; and expansion of deliverables such as service reports, outcome 
analysis, evaluation, assessment success, and other data-driven tools 
that in turn help to demonstrate the program's viability and value to 
community funding agencies.
    A single-source program expansion supplemental grant of $96,000 to 
the Confederated Tribes of Siletz Indians in Siletz, OR, to support the 
identification and analysis of systems issues, including the 
identification of obstacles that could block efforts to build and 
maintain partnerships; coordination of Siletz tribal early childhood 
development programs, and the development of a menu of alternative 
interventions and strategies, that honor tribal community values, 
traditions, and priorities; and the development of tribally driven 
goals and concrete objectives in each local tribal community that 
support building effective early childhood systems and the development 
of specific community plans that support and strengthen cooperation, 
coordination, resource-sharing and leveraging, and the integration of 
programs in the Siletz Service Area.
    A single-source program expansion supplemental grant of $120,000 to 
the Inter-Tribal Council of Michigan in Sault Ste. Marie, MI, to 
improve and increase the positive impact of services on families 
throughout the state through an early childhood system that will 
provide support and services across the full range of needs from the 
prenatal period through kindergarten entry; reflect and build on the 
strengths and wisdom of tribal community values and culture; maximize 
the use of resources to foster efficiency, yielding maximum impact for 
each investment; and ensure sustainability, consistency, and ease-of-
access at the community level through referral and transition processes 
that will effectively engage parents as key stakeholders.
    A single-source program expansion supplemental grant of $96,000 to 
the Red Cliff Band of Lake Superior Chippewa in Bayfield, WI, to 
support the identification and analysis of systems issues to develop a 
menu of alternative interventions and strategies that honor tribal 
community values, traditions, and priorities; development of tribally 
driven goals and concrete objectives in each local tribal community to 
build effective and efficient early childhood systems, high-quality 
programs, and improved outcomes for children and families; 
identification of service providers that support families with young 
children; provision of training that will deepen the understanding of 
Trauma-Informed Care and education on the identification and support 
for individuals experiencing a mental health crisis; and the 
development of a 5-year plan that identifies data needs for collection, 
storage, and data protection to improve the coordination and sharing of 
key child and family data.
    A single-source program expansion supplemental grant of $96,000 to 
the Choctaw Nation of Oklahoma in Durant, OK, for its coordinated 
effort between the following Choctaw Nation programs: Chahta Inchukka, 
Chahta Vlla Apela, Child Care Assistance (Child Care Development Fund), 
Head Start, Early Head Start (Early Head Start-Child Care Partnership), 
and the Child Development Day Care Program. Through this initiative, 
program directors will coordinate their programs to create and support 
a seamless, high-quality, early-childhood system; raise the quality of 
services to children and families across the pregnancy-to-kindergarten-
entry continuum; and identify and break down barriers to collaboration 
and systems improvement. The Choctaw Nation will commit a TELI 
coordinator to work across all of Choctaw's early childhood TELI 
programs; host a shared training for all early learning program staff 
that will provide professional development on a relevant early 
childhood topic and offer the opportunity for staff to learn about 
other programs and network; and complete research about potential data 
systems that will better coordinate the sharing of relevant child and 
family data across programs.
    A single-source program expansion supplemental grant of $96,000 to 
the Cherokee Nation of Oklahoma in Tahlequah, OK, to support 
collaboration between Cherokee PARENTS, Head Start, Early Head Start, 
and Child Care, and develop a holist approach to child development. The 
Cherokee Nation plans to develop a strategic work team comprised of a 
diverse group of stakeholders; share professional development between 
each program, including conferences and trainings; hold monthly parent/
cultural/community meetings; develop a unified assessment tool for 
assessing the needs of children and families; build a unified resource 
guide; give priority in referrals

[[Page 3429]]

between programs by identifying gaps, weaknesses, and shortfalls in 
program design; and focusing on shared resources to reduce duplicative 
and burdensome processes.

    Statutory Authority: Section 511 of the Title V of the Social 
Security Act, as added by Section 2951 of the Patient Protection and 
Affordable Care Act of 2010 (Pub. L. 111-148), and amended by the 
Protecting Access to Medicare Act of 2014 (Pub. L. 113-93) and the 
Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-
10).

Mary M. Wayland,
Senior Grants Policy Specialist, Division of Grants Policy, Office of 
Administration.
[FR Doc. 2016-01033 Filed 1-20-16; 8:45 am]
 BILLING CODE 4184-43-P



                                                                                 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices                                                          3427

                                                    these barriers through the conduct of a                 version of the BABI Web site and will                              provides a participant estimate, which
                                                    randomized, controlled intervention                     be instructed to log-on once a week to                             will be evenly distributed across control
                                                    trial of a Web site-based lifestyle                     view educational modules regarding                                 and intervention groups for each
                                                    program, Balance after Baby (BAB), that                 healthy lifestyle options and to enter                             information collection step (both groups
                                                    is adapted from the DPP and tailored                    and track their weight and physical                                complete the same questionnaires),
                                                    specifically for postpartum women with                  activity against their self-appointed                              annualized over a 3-year clearance
                                                    recent GDM.                                             goals. They will also have access to a                             period. Therefore, of the 190 women (63
                                                       The project aims to screen 293 (98                   web-based Lifestyle Coach who will                                 annualized) who attend the 6-week
                                                    annualized over 3 years) women with a                   communicate with them throughout the                               visit, the estimated number of
                                                    recent GDM pregnancy for enrollment                     first year of their participation.                                 participants returning for the 6-month
                                                    into the study, followed by assessments                    All participants will be required to                            visit is reduced to 180 (60 annualized),
                                                    at the following five post-partum time                  complete clinical assessment visits                                followed by 172 (57 annualized), 162
                                                    points: 6-Weeks, 6-months, 12-months,                   involving the completion of visit-                                 (54 annualized), and 154 (51
                                                    18-months, and 24-months. Of the                        specific questionnaires with integrated                            annualized) for the 12-, 18-, and 24-
                                                    estimated 190 (63 annualized) women                     food frequency questionnaires,
                                                                                                                                                                               month visits respectively. The average
                                                    who are anticipated to meet eligibility                 laboratory testing, and the collection of
                                                                                                                                                                               burden per questionnaire ranges from 8
                                                    requirements and attend the first study                 physical measurements such as height
                                                                                                                                                                               minutes for the BABI Screener
                                                    visit, approximately half will be                       and weight. The results of the two study
                                                                                                                                                                               Questionnaire up to 18 minutes for the
                                                    assigned to the control group and the                   arms, intervention and control, will be
                                                    other half will be assigned to the                                                                                         BABI 6-Month Questionnaire. The
                                                                                                            compared to assess whether the
                                                    intervention group. Women in the                                                                                           average burden hours per response for
                                                                                                            intervention significantly increased
                                                    control group will have access to a                                                                                        the 6-Week, 6-, 12-, 18-, 24-Month
                                                                                                            postpartum weight loss and decreased
                                                    ‘‘control version’’ of the BABI Web site,                                                                                  Questionnaires, and Block© Food
                                                                                                            glucose tolerance for women at
                                                    containing post-partum information                      increased T2DM risk.                                               Frequency Questionnaire (FFQ) are
                                                    such as the ‘‘It’s Never too Early to                      For the calculation of the estimated                            shown in the table below. Participation
                                                    Prevent Diabetes’’ tip sheet and links to               burden hours per study visit detailed in                           is voluntary and there are no costs to
                                                    other related public Web sites. Those                   the table below, a constant 5% rate of                             respondents other than their time.
                                                    assigned to the intervention group will                 exclusion and attrition was applied                                   The total estimated annualized
                                                    have access to the full, interactive                    between visits. The burden table                                   burden hours are 183.

                                                                                                           ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                  Avg.
                                                                                                                                                                                                   No. of
                                                                                                                                                                                 No. of                       burden per
                                                                 Type of respondents                                              Form name                                                   responses per
                                                                                                                                                                              respondents                      response
                                                                                                                                                                                                respondent      (in hrs.)

                                                    Women with a recent history GDM ................       BABI Screener Questionnaire ........................                         98                1           8/60
                                                                                                           BABI 6-Week Questionnaire ..........................                         63                1          17/60
                                                                                                           BABI 6-Month Questionnaire .........................                         60                1          18/60
                                                                                                           BABI 12-Month Questionnaire .......................                          57                1          14/60
                                                                                                           BABI 18-Month Questionnaire .......................                          54                1          14/60
                                                                                                           BABI 24-Month Questionnaire .......................                          51                1          15/60
                                                                                                           Block FFQ ......................................................             63                5          18/60



                                                    Leroy A. Richardson,                                    DEPARTMENT OF HEALTH AND                                           SUMMARY:   The Administration for
                                                    Chief, Information Collection Review Office,            HUMAN SERVICES                                                     Children and Families (ACF), Office of
                                                    Office of Scientific Integrity, Office of the                                                                              Child Care (OCC), Tribal Maternal,
                                                    Associate Director for Science, Office of the           Administration For Children And                                    Infant, and Early Childhood Home
                                                    Director, Centers for Disease Control and               Families                                                           Visiting (Tribal MIECHV) Program,
                                                    Prevention.                                                                                                                announces the award of single-source
                                                    [FR Doc. 2016–01099 Filed 1–20–16; 8:45 am]             [CFDA Number: 93.508]                                              program expansion supplement grants
                                                    BILLING CODE 4163–18–P
                                                                                                            Announcing the Award of Six Single-                                to the Confederated Salish and Kootenai
                                                                                                            Source Program Expansion                                           Tribes in Pablo, MT; Confederated
                                                                                                            Supplement Grants From the Tribal                                  Tribes of Siletz Indians in Siletz, OR;
                                                                                                            Maternal, Infant, and Early Childhood                              Inter-Tribal Council of Michigan in
                                                                                                            Home Visiting (Tribal MIECHV)                                      Sault Ste. Marie, MI; Red Cliff Band of
                                                                                                            Program                                                            Lake Superior Chippewa in Bayfield,
                                                                                                                                                                               WI; the Choctaw Nation of Oklahoma in
                                                                                                            AGENCY:  Office of Child Care,                                     Durant, OK; and the Cherokee Nation of
asabaliauskas on DSK9F6TC42PROD with NOTICES




                                                                                                            Administration for Children and                                    Oklahoma in Tahlequah, OK.
                                                                                                            Families, HHS.
                                                                                                                                                                                 The Fiscal Year 2015 single-source
                                                                                                            ACTION: Notice of the award of six
                                                                                                                                                                               program expansion supplement grants
                                                                                                            single-source program expansion
                                                                                                            supplement grants to grantees of the                               will support the expansion of the Tribal
                                                                                                            Tribal Maternal, Infant, and Early                                 Early Learning Initiative (TELI)
                                                                                                            Childhood Home Visiting (Tribal                                    program.
                                                                                                            MIECHV) Program.



                                               VerDate Sep<11>2014   18:26 Jan 20, 2016   Jkt 238001   PO 00000   Frm 00051       Fmt 4703     Sfmt 4703      E:\FR\FM\21JAN1.SGM    21JAN1


                                                    3428                         Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices

                                                    DATES:The period of support is                          include Head Start, Child Care, and                    of tribally driven goals and concrete
                                                    September 30, 2015—September 29,                        Home Visiting that will allow programs                 objectives in each local tribal
                                                    2016.                                                   to improve client services by increasing               community to build effective and
                                                    FOR FURTHER INFORMATION CONTACT:
                                                                                                            accessibility and reducing wait time and               efficient early childhood systems, high-
                                                    Rachel Schumacher, Director, Office of                  travel time between agencies; a more                   quality programs, and improved
                                                    Child Care, 901 D Street, SW.,                          efficient client information system;                   outcomes for children and families;
                                                    Washington, DC 20024. Telephone:                        promotion of long-term, cross-agency                   identification of service providers that
                                                    (202) 401–6984; Email:                                  communication and collaboration;                       support families with young children;
                                                                                                            improved management systems; and                       provision of training that will deepen
                                                    rachel.schumacher@acf.hhs.gov.
                                                                                                            expansion of deliverables such as                      the understanding of Trauma-Informed
                                                    SUPPLEMENTARY INFORMATION: In                           service reports, outcome analysis,                     Care and education on the identification
                                                    response to the success of the TELI                     evaluation, assessment success, and                    and support for individuals
                                                    pilot, the Office of Child Care has                     other data-driven tools that in turn help              experiencing a mental health crisis; and
                                                    awarded single-source program                           to demonstrate the program’s viability                 the development of a 5-year plan that
                                                    expansion supplement awards to six                      and value to community funding                         identifies data needs for collection,
                                                    Tribal MIECHV grantees for expansion                    agencies.                                              storage, and data protection to improve
                                                    of the TELI program.                                       A single-source program expansion                   the coordination and sharing of key
                                                    Objectives of the TELI Expansion                        supplemental grant of $96,000 to the                   child and family data.
                                                                                                            Confederated Tribes of Siletz Indians in                  A single-source program expansion
                                                       1. Identify and analyze systems                      Siletz, OR, to support the identification              supplemental grant of $96,000 to the
                                                    issues, including obstacles that could                  and analysis of systems issues,                        Choctaw Nation of Oklahoma in Durant,
                                                    block efforts to build and maintain                     including the identification of obstacles              OK, for its coordinated effort between
                                                    partnerships, fully and effectively                     that could block efforts to build and                  the following Choctaw Nation programs:
                                                    coordinate tribal early childhood                       maintain partnerships; coordination of                 Chahta Inchukka, Chahta Vlla Apela,
                                                    development programs, and develop a                     Siletz tribal early childhood                          Child Care Assistance (Child Care
                                                    menu of alternative interventions and                   development programs, and the                          Development Fund), Head Start, Early
                                                    strategies in line with tribal community                development of a menu of alternative                   Head Start (Early Head Start-Child Care
                                                    values, traditions, and priorities.                     interventions and strategies, that honor               Partnership), and the Child
                                                       2. Develop tribally driven goals and                 tribal community values, traditions, and               Development Day Care Program.
                                                    concrete objectives in each local tribal                priorities; and the development of                     Through this initiative, program
                                                    community for building effective and                    tribally driven goals and concrete                     directors will coordinate their programs
                                                    efficient early childhood systems, high-                objectives in each local tribal                        to create and support a seamless, high-
                                                    quality programs, and improved                          community that support building                        quality, early-childhood system; raise
                                                    outcomes for young children and                         effective early childhood systems and                  the quality of services to children and
                                                    families.                                               the development of specific community                  families across the pregnancy-to-
                                                       3. Develop and carry out concrete                    plans that support and strengthen                      kindergarten-entry continuum; and
                                                    community plans for supporting and                      cooperation, coordination, resource-                   identify and break down barriers to
                                                    strengthening cooperation,                              sharing and leveraging, and the                        collaboration and systems improvement.
                                                    coordination, resource sharing and                      integration of programs in the Siletz                  The Choctaw Nation will commit a TELI
                                                    leveraging, and integration among                       Service Area.                                          coordinator to work across all of
                                                    programs that support young children                       A single-source program expansion                   Choctaw’s early childhood TELI
                                                    and families in the tribal community.                   supplemental grant of $120,000 to the                  programs; host a shared training for all
                                                       4. Share plans of action, barriers and               Inter-Tribal Council of Michigan in                    early learning program staff that will
                                                    challenges, opportunities and solutions,                Sault Ste. Marie, MI, to improve and                   provide professional development on a
                                                    and the results of action plans with                    increase the positive impact of services               relevant early childhood topic and offer
                                                    other tribal communities in an effort to                on families throughout the state through               the opportunity for staff to learn about
                                                    further develop peer-learning                           an early childhood system that will                    other programs and network; and
                                                    relationships.                                          provide support and services across the                complete research about potential data
                                                       Applications received from the                       full range of needs from the prenatal                  systems that will better coordinate the
                                                    grantees underwent objective review                     period through kindergarten entry;                     sharing of relevant child and family data
                                                    using criteria such as the applicants’                  reflect and build on the strengths and                 across programs.
                                                    ability to clearly describe the early                   wisdom of tribal community values and                     A single-source program expansion
                                                    learning and development programs that                  culture; maximize the use of resources                 supplemental grant of $96,000 to the
                                                    will participate in the TELI; their ability             to foster efficiency, yielding maximum                 Cherokee Nation of Oklahoma in
                                                    to describe existing challenges and                     impact for each investment; and ensure                 Tahlequah, OK, to support collaboration
                                                    strengths to collaboration across their                 sustainability, consistency, and ease-of-              between Cherokee PARENTS, Head
                                                    participating early learning and                        access at the community level through                  Start, Early Head Start, and Child Care,
                                                    development programs; and whether the                   referral and transition processes that                 and develop a holist approach to child
                                                    submitted budget and budget                             will effectively engage parents as key                 development. The Cherokee Nation
                                                    justification narrative provided for                    stakeholders.                                          plans to develop a strategic work team
                                                    reasonable project costs.                                  A single-source program expansion                   comprised of a diverse group of
asabaliauskas on DSK9F6TC42PROD with NOTICES




                                                                                                            supplemental grant of $96,000 to the                   stakeholders; share professional
                                                    The Following Awards Are Made                           Red Cliff Band of Lake Superior                        development between each program,
                                                       A single-source program expansion                    Chippewa in Bayfield, WI, to support                   including conferences and trainings;
                                                    supplemental grant of $96,000 to the                    the identification and analysis of                     hold monthly parent/cultural/
                                                    Confederated Salish and Kootenai                        systems issues to develop a menu of                    community meetings; develop a unified
                                                    Tribes in Pablo, MT, to support the                     alternative interventions and strategies               assessment tool for assessing the needs
                                                    development of a shared data system for                 that honor tribal community values,                    of children and families; build a unified
                                                    its early childhood programs that                       traditions, and priorities; development                resource guide; give priority in referrals


                                               VerDate Sep<11>2014   18:26 Jan 20, 2016   Jkt 238001   PO 00000   Frm 00052   Fmt 4703   Sfmt 4703   E:\FR\FM\21JAN1.SGM   21JAN1


                                                                                 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices                                             3429

                                                    between programs by identifying gaps,                   the docket unchanged. Because your                     www.regulations.gov. Submit both
                                                    weaknesses, and shortfalls in program                   comment will be made public, you are                   copies to the Division of Dockets
                                                    design; and focusing on shared                          solely responsible for ensuring that your              Management. If you do not wish your
                                                    resources to reduce duplicative and                     comment does not include any                           name and contact information to be
                                                    burdensome processes.                                   confidential information that you or a                 made publicly available, you can
                                                      Statutory Authority: Section 511 of the               third party may not wish to be posted,                 provide this information on the cover
                                                    Title V of the Social Security Act, as added            such as medical information, your or                   sheet and not in the body of your
                                                    by Section 2951 of the Patient Protection and           anyone else’s Social Security number, or               comments and you must identify this
                                                    Affordable Care Act of 2010 (Pub. L. 111–               confidential business information, such                information as ‘‘confidential.’’ Any
                                                    148), and amended by the Protecting Access              as a manufacturing process. Please note                information marked as ‘‘confidential’’
                                                    to Medicare Act of 2014 (Pub. L. 113–93) and            that if you include your name, contact                 will not be disclosed except in
                                                    the Medicare Access and CHIP                            information, or other information that
                                                    Reauthorization Act of 2015 (Pub. L. 114–10).
                                                                                                                                                                   accordance with 21 CFR 10.20 and other
                                                                                                            identifies you in the body of your                     applicable disclosure law. For more
                                                    Mary M. Wayland,                                        comments, that information will be                     information about FDA’s posting of
                                                    Senior Grants Policy Specialist, Division of            posted on http://www.regulations.gov.                  comments to public dockets, see 80 FR
                                                    Grants Policy, Office of Administration.                  • If you want to submit a comment                    56469, September 18, 2015, or access
                                                    [FR Doc. 2016–01033 Filed 1–20–16; 8:45 am]             with confidential information that you                 the information at: http://www.fda.gov/
                                                    BILLING CODE 4184–43–P
                                                                                                            do not wish to be made available to the                regulatoryinformation/dockets/
                                                                                                            public, submit the comment as a                        default.htm.
                                                                                                            written/paper submission and in the                       Docket: For access to the docket to
                                                    DEPARTMENT OF HEALTH AND                                manner detailed (see ‘‘Written/Paper                   read background documents or the
                                                    HUMAN SERVICES                                          Submissions’’ and ‘‘Instructions’’).                   electronic and written/paper comments
                                                                                                            Written/Paper Submissions                              received, go to http://
                                                    Food and Drug Administration                                                                                   www.regulations.gov and insert the
                                                                                                               Submit written/paper submissions as                 docket number, found in brackets in the
                                                    [Docket No. FDA–2015–D–0839]                            follows:                                               heading of this document, into the
                                                                                                               • Mail/Hand delivery/Courier (for
                                                    Target Animal Safety Data                                                                                      ‘‘Search’’ box and follow the prompts
                                                                                                            written/paper submissions): Division of
                                                    Presentation and Statistical Analysis;                                                                         and/or go to the Division of Dockets
                                                                                                            Dockets Management (HFA–305), Food
                                                    Guidance for Industry; Availability                                                                            Management, 5630 Fishers Lane, Rm.
                                                                                                            and Drug Administration, 5630 Fishers
                                                                                                                                                                   1061, Rockville, MD 20852.
                                                    AGENCY:    Food and Drug Administration,                Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                                                                                      Submit written requests for single
                                                    HHS.                                                       • For written/paper comments
                                                                                                                                                                   copies of the guidance to the Policy and
                                                    ACTION:   Notice of availability.                       submitted to the Division of Dockets
                                                                                                                                                                   Regulations Staff (HFV–6), Center for
                                                                                                            Management, FDA will post your
                                                    SUMMARY:    The Food and Drug                                                                                  Veterinary Medicine, Food and Drug
                                                                                                            comment, as well as any attachments,
                                                    Administration (FDA or Agency) is                                                                              Administration, 7519 Standish Pl.,
                                                                                                            except for information submitted,
                                                    announcing the availability of a                                                                               Rockville, MD 20855. Send one self-
                                                                                                            marked and identified, as confidential,
                                                    guidance for industry (GFI) #226                                                                               addressed adhesive label to assist that
                                                                                                            if submitted as detailed in
                                                    entitled ‘‘Target Animal Safety Data                                                                           office in processing your requests. See
                                                                                                            ‘‘Instructions.’’
                                                    Presentation and Statistical Analysis.’’                   Instructions: All submissions received              the SUPPLEMENTARY INFORMATION section
                                                    The purpose of this document is to                      must include the Docket No. FDA–                       for electronic access to the guidance
                                                    provide recommendations to industry                     2015–D–0839 for Target Animal Safety                   document.
                                                    regarding the presentation and                          Data Presentation and Statistical                      FOR FURTHER INFORMATION CONTACT:
                                                    statistical analyses of target animal                   Analysis. Received comments will be                    Virginia Recta, Center for Veterinary
                                                    safety (TAS) data submitted to the                      placed in the docket and, except for                   Medicine (HFV–160), Food and Drug
                                                    Center for Veterinary Medicine (CVM)                    those submitted as ‘‘Confidential                      Administration, 7500 Standish Pl.,
                                                    as part of a study report to support                    Submissions,’’ publicly viewable at                    Rockville, MD 20855, 240–402–0840,
                                                    approval of a new animal drug. These                    http://www.regulations.gov or at the                   virginia.recta@fda.hhs.gov,
                                                    recommendations apply to TAS data                       Division of Dockets Management                         SUPPLEMENTARY INFORMATION:
                                                    generated from both TAS and field                       between 9 a.m. and 4 p.m., Monday
                                                    effectiveness studies conducted in                      through Friday.                                        I. Background
                                                    companion animals (e.g., dogs, cats, and                   • Confidential Submissions—To                          In the Federal Register of March 31,
                                                    horses) and food animals (e.g., swine,                  submit a comment with confidential                     2015 (80 FR 17047), FDA published the
                                                    ruminants, fish, and poultry).                          information that you do not wish to be                 notice of availability for a draft guidance
                                                    DATES: Submit either electronic or                      made publicly available, submit your                   entitled ‘‘Target Animal Safety Data
                                                    written comments on Agency guidances                    comments only as a written/paper                       Presentation and Statistical Analysis’’
                                                    at any time.                                            submission. You should submit two                      giving interested persons until June 1,
                                                    ADDRESSES: You may submit comments                      copies total. One copy will include the                2015, to comment on the draft guidance.
                                                    as follows:                                             information you claim to be confidential               FDA received two comments on the
                                                                                                            with a heading or cover note that states               draft guidance and those comments
                                                    Electronic Submissions                                  ‘‘THIS DOCUMENT CONTAINS                               were considered as the guidance was
asabaliauskas on DSK9F6TC42PROD with NOTICES




                                                      Submit electronic comments in the                     CONFIDENTIAL INFORMATION’’. The                        finalized. Some of the suggested
                                                    following way:                                          Agency will review this copy, including                changes were incorporated, and
                                                      • Federal eRulemaking Portal: http://                 the claimed confidential information, in               additional editorial changes were made
                                                    www.regulations.gov. Follow the                         its consideration of comments. The                     to improve clarity. The guidance
                                                    instructions for submitting comments.                   second copy, which will have the                       announced in this notice finalizes the
                                                    Comments submitted electronically,                      claimed confidential information                       draft guidance dated March 2015.
                                                    including attachments, to http://                       redacted/blacked out, will be available                   This GFI provides recommendations
                                                    www.regulations.gov will be posted to                   for public viewing and posted on http://               to industry regarding the presentation


                                               VerDate Sep<11>2014   18:26 Jan 20, 2016   Jkt 238001   PO 00000   Frm 00053   Fmt 4703   Sfmt 4703   E:\FR\FM\21JAN1.SGM   21JAN1



Document Created: 2018-02-02 12:33:28
Document Modified: 2018-02-02 12:33:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of the award of six single-source program expansion supplement grants to grantees of the Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program.
DatesThe period of support is September 30, 2015--September 29, 2016.
ContactRachel Schumacher, Director, Office of Child Care, 901 D Street, SW., Washington, DC 20024. Telephone: (202) 401-6984; Email: [email protected]
FR Citation81 FR 3427 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR