Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40331-40332 [2016-14626]
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Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
the functions that are required for
institutional compliance with IRB
review set forth in the HHS regulations
at 45 CFR 46. Participating sites are
responsible for meeting other regulatory
obligations, such as obtaining informed
consent, overseeing the implementation
of the approved protocol, and reporting
unanticipated problems and study
progress to the sIRB. Participating sites
must communicate relevant information
necessary for the sIRB to consider local
context issues and state/local regulatory
requirements during its deliberations.
Participating sites are expected to rely
on the sIRB to satisfy the regulatory
requirements relevant to the ethical
review. Although IRB ethical review at
a participating site would be counter to
the intent and goal of this policy, the
policy does not prohibit any
participating site from duplicating the
sIRB. However, if this approach is taken,
NIH funds may not be used to pay for
the cost of the duplicate review.
Exceptions
Exceptions to this policy will be made
where review by the proposed sIRB
would be prohibited by a federal, tribal,
or state law, regulation, or policy.
Requests for exceptions that are not
based on a legal, regulatory, or policy
requirement will be considered if there
is a compelling justification for the
exception. The NIH will determine
whether to grant an exception following
an assessment of the need.
Effective Date
asabaliauskas on DSK3SPTVN1PROD with NOTICES
This policy applies to all competing
grant applications (new, renewal,
revision, or resubmission) with receipt
dates on or after May 25, 2017. Ongoing,
non-competing awards will not be
expected to comply with this policy
until the grantee submits a competing
renewal application. For contracts, the
policy applies to all solicitations issued
on or after May 25, 2017. For the
intramural program, the policy applies
to intramural multi-site studies
submitted for initial review after May
25, 2017.
Dated: June 14, 2016.
Lawrence Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–14513 Filed 6–20–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Now Is The Time (NITT)–
Project AWARE (Advancing Wellness
and Resilience in Education)
Evaluation—New
SAMHSA is conducting a national
evaluation of the Now is the Time
(NITT) initiative, which includes
separate programs—NITT Project
AWARE (Advancing Wellness and
Resilience in Education)—State
Educational Agency (SEA), Healthy
Transitions (HT), and two Minority
Fellowship Programs (Youth and
Addiction Counselors). These programs
are united by their focus on capacity
building, system change, and workforce
development.
NITT-Project AWARE, which is the
focus of this data collection, represents
a response to the third and fourth
components of President Obama’s NITT
Initiative: making schools safer and
focusing on access to mental health
services. The goal of NITT-Project
AWARE is to develop a comprehensive,
coordinated, and integrated program for
advancing wellness and resilience in
educational settings for school-aged
youth.
SAMHSA awarded NITT-Project
AWARE grants to 20 SEAs. Each SEA
proposed partnerships between at least
three high-need Local Educational
Agencies (LEAs) to develop a
coordinated and integrated plan of
services and strategies to address the
Project NITT-Project AWARE–SEA goals
and objectives. Project AWARE grantees
will plan and implement activities
designed to increase the capacity of
SEAs in three areas: (1) Increase mental
health awareness among school-aged
(K–12) youth; (2) train those who work
with school-aged children to identify
and respond to mental health issues in
children and young adults; and (3)
connect children, youth, and families
with mental health services. The
intention is to encourage cross-system
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
40331
collaboration and use evidence-based
strategies to address mental health
needs.
The Project AWARE evaluation will
examine the process and outcomes of
activities by SEA grantees and their LEA
and school partners. It will evaluate the
capacity of SEAs to effectively involve
family and youth, provide a culturally
and linguistically competent and
family-centered mental health service
array, and implement a process for
identifying need and delivering services
that is informed by data and
coordinated across child-serving
agencies. Evaluation questions have
been developed to understand grantee
context, planning, implementation,
outputs, and outcomes across each of
the NITT priority areas. Data collection
efforts that will support the evaluation
are described below.
AWARE Planning and
Implementation Activities Inventory
(AWARE Activities Inventory), to
capture information about all activities
supported by Project AWARE resources
during the grant period. The inventory
will be reviewed and updated on an
annual basis at the SEA level with the
grant project director, at the LEA level
with the grant program coordinators,
and at the school level with
coordinators in each participating
school. The questionnaires will guide
review and input of additional
information as needed for all activities
captured in the AWARE Activities
Inventory and conducted under Project
AWARE. Each questionnaire will be
conducted annually to review and
update the AWARE Activities Inventory
with 20 SEA-level respondents, 62 LEAlevel respondents, and 432 school-level
respondents.
SEA Collaborative Partner Survey
(SEA–CPS), to collect information about
collaborative processes and partnerships
at the state level to examine the
networks involved in successful
information sharing and collaborations
across child-serving agencies and the
families and youth they serve. SAMHSA
estimates that there will be 24
collaborative partner respondents at
each SEA grantee who will complete the
annual SEA–CPS.
Local Educational Agency
Collaborative Partner Survey (LEA–
CPS), to collect information about
collaborative processes and partnerships
at the local level to examine the
networks involved in successful
information sharing and collaborations
across child-serving agencies and the
families and youth they serve. The
survey will be administered twice
during the grant period, with 15
respondents in each of the 62 LEAs.
E:\FR\FM\21JNN1.SGM
21JNN1
40332
Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
Collaborative Partner Interview Guide,
to collect qualitative information about
collaborative processes and partner
roles. Approximately 160 core staff (8
SEA-level collaborative partners in each
SEA grantee) are expected to participate
in annual in-person and telephone
interviews.
School Information Systems Data
Abstraction Protocol, to capture
information from existing school
information systems about student
socio-demographics, school climate, and
school safety. The data abstraction
protocol will detail the procedure
through which the national evaluation
team will abstract data from each LEA
or school information system. These
data will be requested annually to cover
school-level measures from the 2014–
2015 through 2018–2019 school years.
School-level information will be
collected at the school level for all
sample schools (N = 432), but the
number of respondents is calculated
based on whether the school
information systems are consistent
across SEAs and/or LEAs, or whether
they vary from school to school. Based
on preliminary discussions with the
grantees, SAMHSA estimates that five
SEA grantees will be able to provide
data for all sample schools in the SEA
(N = 5 SEA respondents), the data will
be provided from LEAs in ten of the
SEA grantees (N = 30 LEA respondents),
and the remaining five SEA grantees
will have school information systems
and surveys that differ at the school
level (N = 90 school respondents).
Therefore 125 respondents will provide
the secondary data that covers the 432
sample schools.
Teacher Mental Health Literacy
Survey, to assess the mental health
literacy and associated knowledge and
skills of teachers in selected schools
participating in Project AWARE
activities. This survey will be
administered twice to a random sample
of teachers in selected schools in
partner LEAs, stratified by school type
and size. An average sample size of
approximately 24 teachers will be
selected from each of the 432 schools
selected to participate in the schoollevel coordinator questionnaire data
collection.
Existing Teacher and Student Survey
Data Abstraction Protocols, to compile
information from existing surveys to
examine school climate and safety. The
data abstraction protocol will be
customized for each SEA based on the
specific data collected by each state.
Data from existing teacher and student
surveys in selected schools (N = 432)
participating in the national evaluation
will be provided to the national
evaluation on an annual basis. The
number of respondents is calculated
based on whether the existing student
and teacher surveys are consistent
across SEAs and/or LEAs, or whether
they vary from school to school. Based
on preliminary discussions with the
grantees, SAMHSA estimates that 125
respondents will provide the secondary
student and teacher survey data that
covers the 432 sample schools.
Student Focus Groups Protocol, to
collect qualitative information about
student perceptions of school climate;
ability to identify signs of mental,
behavioral, or emotional health issues;
and student knowledge of school- and
community-level service access. The
evaluation team will conduct these
focus groups during site visits
conducted in 2016 and 2019. The
guided discussion protocol will focus
on participants’ general knowledge of
available resources, programs to support
AWARE activities, and overall
perceptions of school climate and
safety. The focus groups will be
conducted with approximately 8–10
students in each of four schools from
one LEA associated with each SEA
grantee, for a total of no more than 800
students participating in focus groups at
each of the two site visits. Each focus
group will last approximately one and a
half hours.
ANNUALIZED BURDEN HOURS
Number of
respondents
Instrument
Responses
per
respondent
Total number
of responses
Hours per
response
Total burden
hours
SEA leadership questionnaire .............................................
LEA coordinator questionnaire ............................................
School coordinator questionnaire ........................................
SEA-Collaborative Partner Survey ......................................
LEA-Collaborative Partner Survey .......................................
Collaborative partner interviews ..........................................
Teacher mental health literacy survey .................................
Student focus groups ...........................................................
School information systems data abstraction ......................
Student survey data abstraction ..........................................
Teacher school climate and school safety survey ..............
20
62
432
480
930
160
10,368
800
125
125
125
1
1
1
1
1
1
1
1
1
1
1
20
62
432
480
930
160
10,368
800
125
125
125
1
1
1
0.5
0.5
1
0.5
1.5
1.5
1.5
1.5
20
62
432
240
465
160
5,184
1,200
188
188
188
Total ..............................................................................
a 13,377
........................
13,627
........................
8,327
asabaliauskas on DSK3SPTVN1PROD with NOTICES
* This is an unduplicated count of total respondents.
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 21, 2016 to the SAMHSA
Desk Officer at the Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB). To
ensure timely receipt of comments, and
to avoid potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
commenters are encouraged to submit
VerDate Sep<11>2014
18:37 Jun 20, 2016
Jkt 238001
their comments to OMB via email to:
OIRA_Submission@omb.eop.gov.
Although commenters are encouraged to
send their comments via email,
commenters may also fax their
comments to: 202–395–7285.
Commenters may also mail them to:
Office of Management and Budget,
Office of Information and Regulatory
PO 00000
Frm 00074
Fmt 4703
Sfmt 9990
Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2016–14626 Filed 6–20–16; 8:45 am]
BILLING CODE 4162–20–P
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Agencies
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40331-40332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14626]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Now Is The Time (NITT)-Project AWARE (Advancing Wellness and
Resilience in Education) Evaluation--New
SAMHSA is conducting a national evaluation of the Now is the Time
(NITT) initiative, which includes separate programs--NITT Project AWARE
(Advancing Wellness and Resilience in Education)--State Educational
Agency (SEA), Healthy Transitions (HT), and two Minority Fellowship
Programs (Youth and Addiction Counselors). These programs are united by
their focus on capacity building, system change, and workforce
development.
NITT-Project AWARE, which is the focus of this data collection,
represents a response to the third and fourth components of President
Obama's NITT Initiative: making schools safer and focusing on access to
mental health services. The goal of NITT-Project AWARE is to develop a
comprehensive, coordinated, and integrated program for advancing
wellness and resilience in educational settings for school-aged youth.
SAMHSA awarded NITT-Project AWARE grants to 20 SEAs. Each SEA
proposed partnerships between at least three high-need Local
Educational Agencies (LEAs) to develop a coordinated and integrated
plan of services and strategies to address the Project NITT-Project
AWARE-SEA goals and objectives. Project AWARE grantees will plan and
implement activities designed to increase the capacity of SEAs in three
areas: (1) Increase mental health awareness among school-aged (K-12)
youth; (2) train those who work with school-aged children to identify
and respond to mental health issues in children and young adults; and
(3) connect children, youth, and families with mental health services.
The intention is to encourage cross-system collaboration and use
evidence-based strategies to address mental health needs.
The Project AWARE evaluation will examine the process and outcomes
of activities by SEA grantees and their LEA and school partners. It
will evaluate the capacity of SEAs to effectively involve family and
youth, provide a culturally and linguistically competent and family-
centered mental health service array, and implement a process for
identifying need and delivering services that is informed by data and
coordinated across child-serving agencies. Evaluation questions have
been developed to understand grantee context, planning, implementation,
outputs, and outcomes across each of the NITT priority areas. Data
collection efforts that will support the evaluation are described
below.
AWARE Planning and Implementation Activities Inventory (AWARE
Activities Inventory), to capture information about all activities
supported by Project AWARE resources during the grant period. The
inventory will be reviewed and updated on an annual basis at the SEA
level with the grant project director, at the LEA level with the grant
program coordinators, and at the school level with coordinators in each
participating school. The questionnaires will guide review and input of
additional information as needed for all activities captured in the
AWARE Activities Inventory and conducted under Project AWARE. Each
questionnaire will be conducted annually to review and update the AWARE
Activities Inventory with 20 SEA-level respondents, 62 LEA-level
respondents, and 432 school-level respondents.
SEA Collaborative Partner Survey (SEA-CPS), to collect information
about collaborative processes and partnerships at the state level to
examine the networks involved in successful information sharing and
collaborations across child-serving agencies and the families and youth
they serve. SAMHSA estimates that there will be 24 collaborative
partner respondents at each SEA grantee who will complete the annual
SEA-CPS.
Local Educational Agency Collaborative Partner Survey (LEA-CPS), to
collect information about collaborative processes and partnerships at
the local level to examine the networks involved in successful
information sharing and collaborations across child-serving agencies
and the families and youth they serve. The survey will be administered
twice during the grant period, with 15 respondents in each of the 62
LEAs.
[[Page 40332]]
Collaborative Partner Interview Guide, to collect qualitative
information about collaborative processes and partner roles.
Approximately 160 core staff (8 SEA-level collaborative partners in
each SEA grantee) are expected to participate in annual in-person and
telephone interviews.
School Information Systems Data Abstraction Protocol, to capture
information from existing school information systems about student
socio-demographics, school climate, and school safety. The data
abstraction protocol will detail the procedure through which the
national evaluation team will abstract data from each LEA or school
information system. These data will be requested annually to cover
school-level measures from the 2014-2015 through 2018-2019 school
years. School-level information will be collected at the school level
for all sample schools (N = 432), but the number of respondents is
calculated based on whether the school information systems are
consistent across SEAs and/or LEAs, or whether they vary from school to
school. Based on preliminary discussions with the grantees, SAMHSA
estimates that five SEA grantees will be able to provide data for all
sample schools in the SEA (N = 5 SEA respondents), the data will be
provided from LEAs in ten of the SEA grantees (N = 30 LEA respondents),
and the remaining five SEA grantees will have school information
systems and surveys that differ at the school level (N = 90 school
respondents). Therefore 125 respondents will provide the secondary data
that covers the 432 sample schools.
Teacher Mental Health Literacy Survey, to assess the mental health
literacy and associated knowledge and skills of teachers in selected
schools participating in Project AWARE activities. This survey will be
administered twice to a random sample of teachers in selected schools
in partner LEAs, stratified by school type and size. An average sample
size of approximately 24 teachers will be selected from each of the 432
schools selected to participate in the school-level coordinator
questionnaire data collection.
Existing Teacher and Student Survey Data Abstraction Protocols, to
compile information from existing surveys to examine school climate and
safety. The data abstraction protocol will be customized for each SEA
based on the specific data collected by each state. Data from existing
teacher and student surveys in selected schools (N = 432) participating
in the national evaluation will be provided to the national evaluation
on an annual basis. The number of respondents is calculated based on
whether the existing student and teacher surveys are consistent across
SEAs and/or LEAs, or whether they vary from school to school. Based on
preliminary discussions with the grantees, SAMHSA estimates that 125
respondents will provide the secondary student and teacher survey data
that covers the 432 sample schools.
Student Focus Groups Protocol, to collect qualitative information
about student perceptions of school climate; ability to identify signs
of mental, behavioral, or emotional health issues; and student
knowledge of school- and community-level service access. The evaluation
team will conduct these focus groups during site visits conducted in
2016 and 2019. The guided discussion protocol will focus on
participants' general knowledge of available resources, programs to
support AWARE activities, and overall perceptions of school climate and
safety. The focus groups will be conducted with approximately 8-10
students in each of four schools from one LEA associated with each SEA
grantee, for a total of no more than 800 students participating in
focus groups at each of the two site visits. Each focus group will last
approximately one and a half hours.
Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total number Hours per Total burden
Instrument respondents respondent of responses response hours
----------------------------------------------------------------------------------------------------------------
SEA leadership questionnaire.... 20 1 20 1 20
LEA coordinator questionnaire... 62 1 62 1 62
School coordinator questionnaire 432 1 432 1 432
SEA-Collaborative Partner Survey 480 1 480 0.5 240
LEA-Collaborative Partner Survey 930 1 930 0.5 465
Collaborative partner interviews 160 1 160 1 160
Teacher mental health literacy 10,368 1 10,368 0.5 5,184
survey.........................
Student focus groups............ 800 1 800 1.5 1,200
School information systems data 125 1 125 1.5 188
abstraction....................
Student survey data abstraction. 125 1 125 1.5 188
Teacher school climate and 125 1 125 1.5 188
school safety survey...........
-------------------------------------------------------------------------------
Total....................... \a\ 13,377 .............. 13,627 .............. 8,327
----------------------------------------------------------------------------------------------------------------
* This is an unduplicated count of total respondents.
Written comments and recommendations concerning the proposed
information collection should be sent by July 21, 2016 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays in OMB's receipt and processing
of mail sent through the U.S. Postal Service, commenters are encouraged
to submit their comments to OMB via email to:
OIRA_Submission@omb.eop.gov. Although commenters are encouraged to send
their comments via email, commenters may also fax their comments to:
202-395-7285. Commenters may also mail them to: Office of Management
and Budget, Office of Information and Regulatory Affairs, New Executive
Office Building, Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2016-14626 Filed 6-20-16; 8:45 am]
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