Agency Information Collection Activities: Submission for OMB Review; Comment Request, 32947-32950 [2010-13824]
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at a minimum, the following
information: (1) Title of the standard; (2)
any reference number and date; (3)
name and address of the national or
international standards development
organization; (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply; and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
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VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. CDRH maintains a site on the
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
computer with access to the Internet.
Updated on a regular basis, the CDRH
home page includes the guidance as
well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 024’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
MedicalDevices.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ through the hyperlink at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
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DeviceRegulationandGuidance/
Standards/ucm123792.htm.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) either electronic
or written comments regarding this
document. It is only necessary to send
one set of comments. It is no longer
necessary to send two copies of mailed
comments. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
024. These modifications to the list or
recognized standards are effective upon
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publication of this notice in the Federal
Register.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13874 Filed 6–9–10; 8:45 am]
BILLING CODE 4160–01–S
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: Cross-community Evaluation of
the Native Aspirations Project—NEW
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA), Center for Mental Health
Services (CMHS) will conduct the
Cross-Community Evaluation of the
Native Aspirations Project. The crosscommunity evaluation has two tiers.
Community-specific activities (Tier 1)
are tied to key components of a
community plan developed in each
participating community that guides
program planning and local evaluation
through data-driven frameworks and
inquiry. Tier I activities will include
process and impact evaluation activities
to determine the stage of readiness of
communities to implement programs,
how accurately community plans reflect
the needs and characteristics of each
community, how well local resources
for American Indian/Alaska Native (AI/
AN) youth are mobilized, the experience
and impact of the Gathering of Native
Americans (GONA), and the impact of
the Native Aspirations program on the
community. Core cross-community data
collection activities (Tier II) are crosscommunity and include process and
impact indicators such as communitylevel knowledge and awareness of
suicide, violence, bullying, and
substance abuse; pro-social and helpseeking behaviors among Native youth;
and the provision of services specific to
Native youth through existing service
systems. Tier II activities are directly
tied to the primary objectives of the
Native Aspirations Project and are
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32947
designed to augment data collection
through the collection of communityand systems-level change measurement.
Activities include the Service Provider
Focus Groups and the Community
Knowledge, Awareness, and Behavior
Survey (C–KABS).
Data will be collected from Native
adults and youth involved in the
Community Mobilization Plan (CMP)
meeting and the Gathering of Native
Americans (GONA), key program
stakeholders, Native youth service
providers (e.g., teachers, mental health
providers, case workers, juvenile justice
providers), and other community
members (Native youth and adults).
Data collection will take place in 25 AI/
AN communities across three cohorts.
Data collection for the Native
Aspirations Cross-community
Evaluation will occur over a three-year
period of funding for each cohort.
Clearance is requested for a three-year
period of data collection that spans
FY2009 through FY2012 during which
Cohorts 3 and 4 will receive three years
of data collection and Cohort 5 will
receive two years of data collection with
the final year to be submitted in an
OMB renewal package. The following
describes the specific data collection
activities and the nine data collection
instruments to be used, followed by a
summary table of respondents and
respondent burden.
Community Specific Data Collection
Activities—Tier I
• GONA—Baseline Interviews (1
Version). Each participating community
will have the opportunity to hold a
GONA focused on youth violence,
bullying, substance abuse, and suicide
concerns. Community GONAs follow
four themes that correspond to
indigenous values and are core
resiliency factors for Native people.
These values—belonging, mastery,
interdependence, and generosity—are
the framework for this collaborative
community event that focuses on
individual and community healing,
envisioning community wellness,
mapping the assets of the community,
and committing action in the
community toward prevention efforts
centered on youth violence, bullying,
substance abuse, and suicide. Baseline
GONA interviews will be conducted
prior to the GONA in each community
and will center on the four values and
how respondents view and describe
their relationships in and with the
community; how people in the
community deal with youth violence,
bullying, substance abuse, and suicide;
community members’ willingness to
work together to address these issues;
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Federal Register / Vol. 75, No. 111 / Thursday, June 10, 2010 / Notices
community protective factors; and
suggestions for how community
members can work together to address
these issues. The GONA baseline
interviews will be conducted by
telephone in year 1 of funding with a
maximum of 6 adults per funded
community who will attend the GONA
in each Cohort. The total number of
participants across Cohorts 3, 4, and 5
for 3 years is 150. Items are formatted
as open-ended and semi-structured
questions. The GONA baseline
telephone interviews include 6 items
and will take approximately 20 minutes
to complete. By using either the GONA
Evaluation—Baseline Consent Form,
Phone Script or Verbal Consent Form,
verbal consent will be received from
each respondent prior to administration
of the GONA Baseline Interviews.
• GONA—Follow-up Interviews (1
Version). The GONA follow-up
interviews will be conducted several
weeks after the GONA in each
community. Follow-up interviews will
center around the four values
(belonging, mastery, interdependence,
and generosity) and respondents’
experience during the GONA;
participation in activities; views on
community relationships; knowledge of
the Native Aspirations Project;
knowledge of risk factors for youth
violence, bullying, substance abuse, and
suicide; community protective factors;
willingness of community members to
work together and suggestions for
working together; and next steps. The
GONA follow-up interviews will be
conducted in person with a total of 9
adult respondents who attended the
GONA from each of the funded
communities. Items are formatted as
open-ended and semi-structured
questions. The GONA follow-up
interviews include 11 questions and
will take approximately 60 minutes to
complete. These follow-up interviews
will occur during a site visit in year 1
for Cohorts 3, 4, and 5. The total number
of participants across the three cohorts
is 225. Each participant will provide
written consent prior to the interview
through the GONA Evaluation—Followup Interview Consent Form.
• GONA—Youth Follow-up Focus
Group Moderator’s Guide (1 Version).
The GONA follow-up focus groups will
be conducted several weeks after the
GONA with youth who attended the
GONA. The focus group moderator’s
guide follows the same content as the
GONA Follow-up Interviews (see
above). Cross-community evaluation
staff will conduct up to 2 focus groups
with youth in each funded community.
Focus groups will consist of a maximum
of 9 participants per group and will
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occur during a site visit in year 1 for
Cohorts 3, 4, and 5. Focus group guides
contain 11 items and the session will
last 2 hours. A total of 450 respondents
will participate in GONA focus groups.
Caregivers will give consent for youth to
participate using the GONA Follow-Up
Youth Focus Group Caregiver Consent
form and youth will assent to
participate using the GONA Follow-Up
Youth Focus Group Youth Assent form.
• Community Plan Focus Group
Moderator’s Guide (1 Version).
Respondents participating in the
Community Plan Focus Groups include
youth and adults who attended the
Community Mobilization Plan (CMP)
meeting in year 1. The guide consists of
questions designed to facilitate group
communication around the community
mobilization planning process, early
implementation of the plan, and
organizational and community
awareness and involvement. Focus
group guides contain 7 items and the
session will last 2 hours. The crosscommunity evaluation team will
conduct up to 3 focus groups with a
maximum of 9 participants each in year
1 for each funded community in Cohorts
3, 4, and 5. The total number of
participants across cohorts is 675.
Consent to participate will be obtained
from adult participants through the
Community Plan Focus Group Consent
form and youths’ caregivers will use the
Community Plan Focus Group Caregiver
Consent form to give consent and youth
will assent to participate using the
Community Plan Focus Group Youth
Assent—Attachment B.6).
• Community Plan In-depth
Interviews (2 Versions). The Community
Plan In-depth Interviews will be
conducted in person during year 3. The
interviews will be conducted with the
same individuals who participated in
the CMP focus groups; however, the
participants will be divided into two
groups with two respective guides.
Version 1 will be conducted with
participants who remained active in the
community mobilization process and
Version 2 will be used with respondents
who discontinued their involvement
with Native Aspirations. The interviews
will be used to gather information on
the CMP implementation process,
organizational and community
awareness and involvement with Native
Aspirations, and the impact of the
Native Aspirations program on the
community. The Community Plan Indepth Interview—Version 1 consists of
24 open-ended and semi-structured
questions and will take 60 minutes to
complete. Version 1 will be conducted
with up to 9 participants, including
Native youth and adults, in year 3 for
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a maximum total of 225 respondents
across Cohorts 3, 4, and 5. The
Community Plan In-depth Interview—
Version 2 consists of 11 open-ended and
semi-structured questions and will take
20 minutes to complete. Up to 9
respondents, including Native youth
and adults, will be interviewed using
Version 2 in year 3. The maximum total
of respondents from each funded
community across Cohorts 3, 4, and 5 is
225 for Version 2 over the life of the
project. Adult participants for both
versions will be required to provide
written consent prior to participation
using the Community Plan In-Depth
Interview V.1 Consent form or the
Community Plan In-Depth Interview V.2
Consent and youth participants will
need written caregiver consent collected
on the Community Plan Interview V.1 &
V.2 Caregiver Consent forms and youth
assent using the Community Plan
Interview V.1 & V.2 Youth Assent forms.
Cross Community Data Collection
Activities—Tier II
• Service Provider Focus Group
Moderator’s Guide (2 Versions). The
Service Provider Focus Groups are
designed to facilitate conversation and
information sharing with youth service
providers across communities to acquire
a broader understanding of provider and
service availability for Native youth.
Version 1 participants will include
agency staff such as teachers, mental
health professionals, justice providers,
and welfare providers. Version 2
participants will include non-agency
staff such as paraprofessional providers
or ‘‘natural helpers.’’ However, specific
provider types will be identified for
each participating community as a
function of their existence and number.
Version 1 of the focus group guides
consists of 9 items and Version 2
consists of 7 items, each with additional
sub-questions/probes covering the
availability of wellness and mental
health services, how agencies work
together, awareness of violence/suicide
prevention activities, and areas for
improvement. Focus groups will
include a maximum of 9 participants
per group, with up to 3 focus groups in
each community in each of years 1
(baseline) and 3 (follow up). Two focus
groups will be conducted with agency
staff using Version 1, for a maximum
total of 900 respondents across the life
of the project. One focus group will be
conducted with non-agency staff using
Version 2 for a maximum number of 450
participants for each Cohort. Focus
groups will last approximately 2 hours.
Written consent will be obtained prior
to focus group participation using the
Service Provider Focus Group V.1
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Consent form and Service Provider
Focus Group V.2 Consent form.
• Community Knowledge, Awareness,
and Behavior Survey (C–KABS)—Adult
Version. The C–KABS—Adult Version
is designed to gather knowledge and
awareness information from adult
community members related to suicide,
substance abuse, violence, and bullying.
In addition, respondents will report on
their exposure to Native Aspirations
Project activities regarding the
prevention of suicide, substance abuse,
violence, and bullying. Other constructs
include the availability of services,
knowledge of youth risk factors, and
stigma around and attitude toward
seeking services for wellness. The C–
KABS—Adult Version will be
administered annually, for all three
years of the project, to 100 Native adults
from each funded community. The
survey consists of 36 open and closedended questions that include Likert-type
agreement scales, prevalence scales and
questions, behavior scales and
questions, true/false items, and
demographic questions. The survey
takes approximately 45 minutes to
complete. A total of 7,500 respondents
will participate from Cohorts 3, 4, and
5. Written consent will be obtained
using the C–KABS Adult Consent form.
• Community Knowledge, Awareness,
and Behavior Survey (C–KABS)—Youth
Version. The C–KABS Youth Version
will be administered to youth
participants (age 11 and older) to gather
information about existing social norms
around help-seeking behavior, prosocial behavior (e.g., traditional Indian
activities) among youth, and the extent
to which respondent youth have been
exposed to risky behaviors (suicide,
violence, substance abuse, and/or
bullying), as well as their exposure to
prevention efforts for risky behaviors
related to the Native Aspirations Project.
The survey will also contain items about
youths’ access to pathways to risky
behaviors (e.g., how hard/easy is it to
get drugs/alcohol), access to and
awareness of/willingness to seek help
for these behaviors for themselves or
others, and youths’ engagement in risky
and protective behaviors. The C–KABS
Youth Version will be administered
annually, for all three years of the
project, to 100 Native youth from each
funded community. The survey consists
of 38 open and closed-ended questions
that include Likert-type agreement
scales, prevalence scales and questions,
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behavior scales and questions, true/false
items, and demographic questions. A
total of 7,500 youth will participate
from Cohorts 3, 4 and 5. Youths’
caregivers will provide consent for
youth to participate using the C–KABS
Youth Caregiver Consent form and
youth will assent to participate using
the C–KABS Youth Assent form.
• Community Readiness Assessment
(1 Version). The CRA addresses six
readiness dimensions focused on
identified social concern (i.e., youth
violence, bullying, and suicide). These
dimensions include (a) community
prevention efforts, (b) community
knowledge of prevention efforts, (c)
leadership, (d) community climate, (e)
knowledge about the problem, and (f)
resources for prevention efforts. In
addition, there are nine developmental
levels of readiness within which a
community must progress through.
CRAs include 26 interview questions
which address each of the six
community readiness dimensions; most
items are formatted as open-ended
questions with three items scored on a
scale of 1 to 10. During years 1 and 3,
CRAs will be conducted with each
funded community in Cohorts 3, 4, and
5 to address youth violence, bullying,
and suicide from a multi-faceted
perspective. Telephone interviews will
be conducted with up to six key
informants in the community.
Interviews will last 60 minutes and a
maximum of 300 respondents will be
interviewed. Overall readiness scores
will be determined based on key
informants’ responses and will indicate
the community’s status with respect to
each of these dimensions. Consent will
be obtained using either the Community
Readiness Assessment Verbal Consent
form or the Community Readiness
Assessment Written Consent form.
Data Abstraction and Submission. In
addition to the above described data
collection activities, data from existing
sources abstracted using the Data
Abstraction and Submission Form (i.e.,
management information systems (MIS),
administrative records, case files, etc.)
will be analyzed across communities to
support the impact stage of Tier I of the
cross-community evaluation. To
minimize data collection burden on
community members, this activity will
be tailored to key components identified
in the community plan and will be
developed around existing data systems
and related infrastructures. Cross-
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32949
community technical assistance
providers will assist in the
identification of existing data sources
and their relevance to locally planned
Native Aspirations activities. Data
elements may be requested from
educational systems, juvenile justice/
law enforcement sources, mental health
agencies, child welfare, Medicaid, and
community organizations (e.g., YMCA,
Boys and Girls Clubs, etc.). A maximum
of 10 data elements each will be
requested from education and juvenile
justice/law enforcement sources and a
maximum of 5 data elements each will
be requested from mental health, child
welfare, Medicaid, and community
organizations. These data will be
aggregated from existing data sources,
some of which are attendance sheets,
management information systems, etc.
Communities are responsible for
aggregating these data and submitting
them to the Native Aspirations Crosscommunity Evaluation team by mail,
electronic mail, or by uploading the
data. The burden associated with
accessing, aggregating, and submitting
existing data is approximately 6 hours
per activity per year. Data abstraction
and submission will occur two times
per year in each funded community in
Cohorts 3, 4 and 5. Seven respondents
(one each representing education,
juvenile justice, law enforcement,
mental health, child welfare, Medicaid,
and community organizations) in each
community will perform data
abstraction and submission for a total of
175 respondents and 2,100 hours across
three years of data collection for Cohorts
3, 4, and 5.
Given the expected variation in
available technology (e.g., Internet) and
geographic spread of the target
populations, flexible implementation
options for surveys include local
distribution or administration of
surveys, in-person group, and Internet
options and will be determined with
each participating community and used
when relevant and viable.
The average annual respondent
burden is estimated below. The estimate
reflects the average annual number of
respondents, the average annual number
of responses, the time it will take for
each response, and the average annual
burden across three years of OMB
clearance, which includes three years of
data collection for Cohorts 3 and 4 and
two years of data collection for Cohort
5.
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Federal Register / Vol. 75, No. 111 / Thursday, June 10, 2010 / Notices
ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES AND HOURS
Measure name
Number of
respondents
Number of responses per
respondent
Hours/response
Response
burden*
Community Specific Data Collection Activities—Tier I
GONA Baseline Interviews ............................................................................
GONA Follow-up Interviews ..........................................................................
GONA Youth Follow-up Focus Groups .........................................................
Community Plan Focus Groups ....................................................................
Community Plan In-depth Interviews—V. 1 ...................................................
Community Plan In-depth Interviews—V. 2 ...................................................
Service Provider Focus Groups—V. 1 ..........................................................
Service Provider Focus Groups—V. 2 ..........................................................
Cross Community Data Collection
Activities—Tier II
C–KABS Adult Version ..................................................................................
C–KABS Youth Version .................................................................................
Community Readiness Assessment ..............................................................
Data Abstraction and Submission Form ........................................................
........................
50
75
150
225
51
51
252
126
........................
1
1
1
1
1
1
1
1
..........................
0.33
1.0
2.0
2.0
1.0
0.33
2.0
2.0
........................
17
75
300
450
51
17
504
252
........................
2,234
2,234
84
156
........................
1
1
1
2.0
..........................
0.75
0.75
1.0
6.0
........................
1,676
1,676
84
1,872
Total ........................................................................................................
5,688
........................
..........................
6,974
*Rounded to the nearest whole number.
Written comments and
recommendations concerning the
proposed information collection should
be sent July 12, 2010 to: SAMHSA Desk
Officer, Human Resources and Housing
Branch, Office of Management and
Budget, New Executive Office Building,
Room 10235, Washington, DC 20503;
due to potential delays in OMB’s receipt
and processing of mail sent through the
U.S. Postal Service, respondents are
encouraged to submit comments by fax
to: 202–395–5806.
Dated: June 3, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–13824 Filed 6–9–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
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AGENCY: Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
SUMMARY: The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
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subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
This notice is also available on the
Internet at https://
www.workplace.samhsa.gov and https://
www.drugfreeworkplace.gov.
FOR FURTHER INFORMATION CONTACT: Mrs.
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 2–
1042, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were developed
in accordance with Executive Order
12564 and section 503 of Public Law
100–71. Subpart C of the Mandatory
Guidelines, ‘‘Certification of
Laboratories Engaged in Urine Drug
Testing for Federal Agencies,’’ sets strict
standards that laboratories must meet in
order to conduct drug and specimen
validity tests on urine specimens for
Federal agencies. To become certified,
an applicant laboratory must undergo
three rounds of performance testing plus
an on-site inspection. To maintain that
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certification, a laboratory must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories which claim to be in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines. A laboratory
must have its letter of certification from
HHS/SAMHSA (formerly: HHS/NIDA)
which attests that it has met minimum
standards.
In accordance with Subpart C of the
Mandatory Guidelines dated April 13,
2004 (69 FR 19644), the following
laboratories meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
ACL Laboratories, 8901 W. Lincoln
Ave., West Allis, WI 53227. 414–328–
7840/800–877–7016. (Formerly:
Bayshore Clinical Laboratory.)
ACM Medical Laboratory, Inc., 160
Elmgrove Park, Rochester, NY 14624.
585–429–2264.
Advanced Toxicology Network, 3560
Air Center Cove, Suite 101, Memphis,
TN 38118. 901–794–5770/888–290–
1150.
Aegis Analytical Laboratories, 345 Hill
Ave., Nashville, TN 37210. 615–255–
2400. (Formerly: Aegis Sciences
Corporation, Aegis Analytical
Laboratories, Inc.)
Alere Toxicology Services, 1111 Newton
St., Gretna, LA 70053. 504–361–8989/
800–433–3823. (Formerly: Kroll
Laboratory Specialists, Inc.,
Laboratory Specialists, Inc.)
Alere Toxicology Services, 450
Southlake Blvd., Richmond, VA
23236. 804–378–9130. (Formerly:
Kroll Laboratory Specialists, Inc.,
Scientific Testing Laboratories, Inc.;
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]]>Agencies
[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Notices]
[Pages 32947-32950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13824]
-----------------------------------------------------------------------
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: Cross-community Evaluation of the Native Aspirations Project--
NEW
The Substance Abuse and Mental Health Services Administration's
(SAMHSA), Center for Mental Health Services (CMHS) will conduct the
Cross-Community Evaluation of the Native Aspirations Project. The
cross-community evaluation has two tiers. Community-specific activities
(Tier 1) are tied to key components of a community plan developed in
each participating community that guides program planning and local
evaluation through data-driven frameworks and inquiry. Tier I
activities will include process and impact evaluation activities to
determine the stage of readiness of communities to implement programs,
how accurately community plans reflect the needs and characteristics of
each community, how well local resources for American Indian/Alaska
Native (AI/AN) youth are mobilized, the experience and impact of the
Gathering of Native Americans (GONA), and the impact of the Native
Aspirations program on the community. Core cross-community data
collection activities (Tier II) are cross-community and include process
and impact indicators such as community-level knowledge and awareness
of suicide, violence, bullying, and substance abuse; pro-social and
help-seeking behaviors among Native youth; and the provision of
services specific to Native youth through existing service systems.
Tier II activities are directly tied to the primary objectives of the
Native Aspirations Project and are designed to augment data collection
through the collection of community- and systems-level change
measurement. Activities include the Service Provider Focus Groups and
the Community Knowledge, Awareness, and Behavior Survey (C-KABS).
Data will be collected from Native adults and youth involved in the
Community Mobilization Plan (CMP) meeting and the Gathering of Native
Americans (GONA), key program stakeholders, Native youth service
providers (e.g., teachers, mental health providers, case workers,
juvenile justice providers), and other community members (Native youth
and adults). Data collection will take place in 25 AI/AN communities
across three cohorts. Data collection for the Native Aspirations Cross-
community Evaluation will occur over a three-year period of funding for
each cohort. Clearance is requested for a three-year period of data
collection that spans FY2009 through FY2012 during which Cohorts 3 and
4 will receive three years of data collection and Cohort 5 will receive
two years of data collection with the final year to be submitted in an
OMB renewal package. The following describes the specific data
collection activities and the nine data collection instruments to be
used, followed by a summary table of respondents and respondent burden.
Community Specific Data Collection Activities--Tier I
GONA--Baseline Interviews (1 Version). Each participating
community will have the opportunity to hold a GONA focused on youth
violence, bullying, substance abuse, and suicide concerns. Community
GONAs follow four themes that correspond to indigenous values and are
core resiliency factors for Native people. These values--belonging,
mastery, interdependence, and generosity--are the framework for this
collaborative community event that focuses on individual and community
healing, envisioning community wellness, mapping the assets of the
community, and committing action in the community toward prevention
efforts centered on youth violence, bullying, substance abuse, and
suicide. Baseline GONA interviews will be conducted prior to the GONA
in each community and will center on the four values and how
respondents view and describe their relationships in and with the
community; how people in the community deal with youth violence,
bullying, substance abuse, and suicide; community members' willingness
to work together to address these issues;
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community protective factors; and suggestions for how community members
can work together to address these issues. The GONA baseline interviews
will be conducted by telephone in year 1 of funding with a maximum of 6
adults per funded community who will attend the GONA in each Cohort.
The total number of participants across Cohorts 3, 4, and 5 for 3 years
is 150. Items are formatted as open-ended and semi-structured
questions. The GONA baseline telephone interviews include 6 items and
will take approximately 20 minutes to complete. By using either the
GONA Evaluation--Baseline Consent Form, Phone Script or Verbal Consent
Form, verbal consent will be received from each respondent prior to
administration of the GONA Baseline Interviews.
GONA--Follow-up Interviews (1 Version). The GONA follow-up
interviews will be conducted several weeks after the GONA in each
community. Follow-up interviews will center around the four values
(belonging, mastery, interdependence, and generosity) and respondents'
experience during the GONA; participation in activities; views on
community relationships; knowledge of the Native Aspirations Project;
knowledge of risk factors for youth violence, bullying, substance
abuse, and suicide; community protective factors; willingness of
community members to work together and suggestions for working
together; and next steps. The GONA follow-up interviews will be
conducted in person with a total of 9 adult respondents who attended
the GONA from each of the funded communities. Items are formatted as
open-ended and semi-structured questions. The GONA follow-up interviews
include 11 questions and will take approximately 60 minutes to
complete. These follow-up interviews will occur during a site visit in
year 1 for Cohorts 3, 4, and 5. The total number of participants across
the three cohorts is 225. Each participant will provide written consent
prior to the interview through the GONA Evaluation--Follow-up Interview
Consent Form.
GONA--Youth Follow-up Focus Group Moderator's Guide (1
Version). The GONA follow-up focus groups will be conducted several
weeks after the GONA with youth who attended the GONA. The focus group
moderator's guide follows the same content as the GONA Follow-up
Interviews (see above). Cross-community evaluation staff will conduct
up to 2 focus groups with youth in each funded community. Focus groups
will consist of a maximum of 9 participants per group and will occur
during a site visit in year 1 for Cohorts 3, 4, and 5. Focus group
guides contain 11 items and the session will last 2 hours. A total of
450 respondents will participate in GONA focus groups. Caregivers will
give consent for youth to participate using the GONA Follow-Up Youth
Focus Group Caregiver Consent form and youth will assent to participate
using the GONA Follow-Up Youth Focus Group Youth Assent form.
Community Plan Focus Group Moderator's Guide (1 Version).
Respondents participating in the Community Plan Focus Groups include
youth and adults who attended the Community Mobilization Plan (CMP)
meeting in year 1. The guide consists of questions designed to
facilitate group communication around the community mobilization
planning process, early implementation of the plan, and organizational
and community awareness and involvement. Focus group guides contain 7
items and the session will last 2 hours. The cross-community evaluation
team will conduct up to 3 focus groups with a maximum of 9 participants
each in year 1 for each funded community in Cohorts 3, 4, and 5. The
total number of participants across cohorts is 675. Consent to
participate will be obtained from adult participants through the
Community Plan Focus Group Consent form and youths' caregivers will use
the Community Plan Focus Group Caregiver Consent form to give consent
and youth will assent to participate using the Community Plan Focus
Group Youth Assent--Attachment B.6).
Community Plan In-depth Interviews (2 Versions). The
Community Plan In-depth Interviews will be conducted in person during
year 3. The interviews will be conducted with the same individuals who
participated in the CMP focus groups; however, the participants will be
divided into two groups with two respective guides. Version 1 will be
conducted with participants who remained active in the community
mobilization process and Version 2 will be used with respondents who
discontinued their involvement with Native Aspirations. The interviews
will be used to gather information on the CMP implementation process,
organizational and community awareness and involvement with Native
Aspirations, and the impact of the Native Aspirations program on the
community. The Community Plan In-depth Interview--Version 1 consists of
24 open-ended and semi-structured questions and will take 60 minutes to
complete. Version 1 will be conducted with up to 9 participants,
including Native youth and adults, in year 3 for a maximum total of 225
respondents across Cohorts 3, 4, and 5. The Community Plan In-depth
Interview--Version 2 consists of 11 open-ended and semi-structured
questions and will take 20 minutes to complete. Up to 9 respondents,
including Native youth and adults, will be interviewed using Version 2
in year 3. The maximum total of respondents from each funded community
across Cohorts 3, 4, and 5 is 225 for Version 2 over the life of the
project. Adult participants for both versions will be required to
provide written consent prior to participation using the Community Plan
In-Depth Interview V.1 Consent form or the Community Plan In-Depth
Interview V.2 Consent and youth participants will need written
caregiver consent collected on the Community Plan Interview V.1 & V.2
Caregiver Consent forms and youth assent using the Community Plan
Interview V.1 & V.2 Youth Assent forms.
Cross Community Data Collection Activities--Tier II
Service Provider Focus Group Moderator's Guide (2
Versions). The Service Provider Focus Groups are designed to facilitate
conversation and information sharing with youth service providers
across communities to acquire a broader understanding of provider and
service availability for Native youth. Version 1 participants will
include agency staff such as teachers, mental health professionals,
justice providers, and welfare providers. Version 2 participants will
include non-agency staff such as paraprofessional providers or
``natural helpers.'' However, specific provider types will be
identified for each participating community as a function of their
existence and number. Version 1 of the focus group guides consists of 9
items and Version 2 consists of 7 items, each with additional sub-
questions/probes covering the availability of wellness and mental
health services, how agencies work together, awareness of violence/
suicide prevention activities, and areas for improvement. Focus groups
will include a maximum of 9 participants per group, with up to 3 focus
groups in each community in each of years 1 (baseline) and 3 (follow
up). Two focus groups will be conducted with agency staff using Version
1, for a maximum total of 900 respondents across the life of the
project. One focus group will be conducted with non-agency staff using
Version 2 for a maximum number of 450 participants for each Cohort.
Focus groups will last approximately 2 hours. Written consent will be
obtained prior to focus group participation using the Service Provider
Focus Group V.1
[[Page 32949]]
Consent form and Service Provider Focus Group V.2 Consent form.
Community Knowledge, Awareness, and Behavior Survey (C-
KABS)--Adult Version. The C-KABS--Adult Version is designed to gather
knowledge and awareness information from adult community members
related to suicide, substance abuse, violence, and bullying. In
addition, respondents will report on their exposure to Native
Aspirations Project activities regarding the prevention of suicide,
substance abuse, violence, and bullying. Other constructs include the
availability of services, knowledge of youth risk factors, and stigma
around and attitude toward seeking services for wellness. The C-KABS--
Adult Version will be administered annually, for all three years of the
project, to 100 Native adults from each funded community. The survey
consists of 36 open and closed-ended questions that include Likert-type
agreement scales, prevalence scales and questions, behavior scales and
questions, true/false items, and demographic questions. The survey
takes approximately 45 minutes to complete. A total of 7,500
respondents will participate from Cohorts 3, 4, and 5. Written consent
will be obtained using the C-KABS Adult Consent form.
Community Knowledge, Awareness, and Behavior Survey (C-
KABS)--Youth Version. The C-KABS Youth Version will be administered to
youth participants (age 11 and older) to gather information about
existing social norms around help-seeking behavior, pro-social behavior
(e.g., traditional Indian activities) among youth, and the extent to
which respondent youth have been exposed to risky behaviors (suicide,
violence, substance abuse, and/or bullying), as well as their exposure
to prevention efforts for risky behaviors related to the Native
Aspirations Project. The survey will also contain items about youths'
access to pathways to risky behaviors (e.g., how hard/easy is it to get
drugs/alcohol), access to and awareness of/willingness to seek help for
these behaviors for themselves or others, and youths' engagement in
risky and protective behaviors. The C-KABS Youth Version will be
administered annually, for all three years of the project, to 100
Native youth from each funded community. The survey consists of 38 open
and closed-ended questions that include Likert-type agreement scales,
prevalence scales and questions, behavior scales and questions, true/
false items, and demographic questions. A total of 7,500 youth will
participate from Cohorts 3, 4 and 5. Youths' caregivers will provide
consent for youth to participate using the C-KABS Youth Caregiver
Consent form and youth will assent to participate using the C-KABS
Youth Assent form.
Community Readiness Assessment (1 Version). The CRA
addresses six readiness dimensions focused on identified social concern
(i.e., youth violence, bullying, and suicide). These dimensions include
(a) community prevention efforts, (b) community knowledge of prevention
efforts, (c) leadership, (d) community climate, (e) knowledge about the
problem, and (f) resources for prevention efforts. In addition, there
are nine developmental levels of readiness within which a community
must progress through. CRAs include 26 interview questions which
address each of the six community readiness dimensions; most items are
formatted as open-ended questions with three items scored on a scale of
1 to 10. During years 1 and 3, CRAs will be conducted with each funded
community in Cohorts 3, 4, and 5 to address youth violence, bullying,
and suicide from a multi-faceted perspective. Telephone interviews will
be conducted with up to six key informants in the community. Interviews
will last 60 minutes and a maximum of 300 respondents will be
interviewed. Overall readiness scores will be determined based on key
informants' responses and will indicate the community's status with
respect to each of these dimensions. Consent will be obtained using
either the Community Readiness Assessment Verbal Consent form or the
Community Readiness Assessment Written Consent form.
Data Abstraction and Submission. In addition to the above described
data collection activities, data from existing sources abstracted using
the Data Abstraction and Submission Form (i.e., management information
systems (MIS), administrative records, case files, etc.) will be
analyzed across communities to support the impact stage of Tier I of
the cross-community evaluation. To minimize data collection burden on
community members, this activity will be tailored to key components
identified in the community plan and will be developed around existing
data systems and related infrastructures. Cross-community technical
assistance providers will assist in the identification of existing data
sources and their relevance to locally planned Native Aspirations
activities. Data elements may be requested from educational systems,
juvenile justice/law enforcement sources, mental health agencies, child
welfare, Medicaid, and community organizations (e.g., YMCA, Boys and
Girls Clubs, etc.). A maximum of 10 data elements each will be
requested from education and juvenile justice/law enforcement sources
and a maximum of 5 data elements each will be requested from mental
health, child welfare, Medicaid, and community organizations. These
data will be aggregated from existing data sources, some of which are
attendance sheets, management information systems, etc. Communities are
responsible for aggregating these data and submitting them to the
Native Aspirations Cross-community Evaluation team by mail, electronic
mail, or by uploading the data. The burden associated with accessing,
aggregating, and submitting existing data is approximately 6 hours per
activity per year. Data abstraction and submission will occur two times
per year in each funded community in Cohorts 3, 4 and 5. Seven
respondents (one each representing education, juvenile justice, law
enforcement, mental health, child welfare, Medicaid, and community
organizations) in each community will perform data abstraction and
submission for a total of 175 respondents and 2,100 hours across three
years of data collection for Cohorts 3, 4, and 5.
Given the expected variation in available technology (e.g.,
Internet) and geographic spread of the target populations, flexible
implementation options for surveys include local distribution or
administration of surveys, in-person group, and Internet options and
will be determined with each participating community and used when
relevant and viable.
The average annual respondent burden is estimated below. The
estimate reflects the average annual number of respondents, the average
annual number of responses, the time it will take for each response,
and the average annual burden across three years of OMB clearance,
which includes three years of data collection for Cohorts 3 and 4 and
two years of data collection for Cohort 5.
[[Page 32950]]
Annualized Averages: Respondents, Responses and Hours
----------------------------------------------------------------------------------------------------------------
Number of
Measure name Number of responses per Hours/response Response
respondents respondent burden*
----------------------------------------------------------------------------------------------------------------
Community Specific Data Collection Activities-- .............. .............. .............. ..............
Tier I
GONA Baseline Interviews........................ 50 1 0.33 17
GONA Follow-up Interviews....................... 75 1 1.0 75
GONA Youth Follow-up Focus Groups............... 150 1 2.0 300
Community Plan Focus Groups..................... 225 1 2.0 450
Community Plan In-depth Interviews--V. 1........ 51 1 1.0 51
Community Plan In-depth Interviews--V. 2........ 51 1 0.33 17
Service Provider Focus Groups--V. 1............. 252 1 2.0 504
Service Provider Focus Groups--V. 2............. 126 1 2.0 252
Cross Community Data Collection .............. .............. .............. ..............
Activities--Tier II
C-KABS Adult Version............................ 2,234 1 0.75 1,676
C-KABS Youth Version............................ 2,234 1 0.75 1,676
Community Readiness Assessment.................. 84 1 1.0 84
Data Abstraction and Submission Form............ 156 2.0 6.0 1,872
---------------------------------------------------------------
Total....................................... 5,688 .............. .............. 6,974
----------------------------------------------------------------------------------------------------------------
*Rounded to the nearest whole number.
Written comments and recommendations concerning the proposed
information collection should be sent July 12, 2010 to: SAMHSA Desk
Officer, Human Resources and Housing Branch, Office of Management and
Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-5806.
Dated: June 3, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010-13824 Filed 6-9-10; 8:45 am]
BILLING CODE 4162-20-P
