Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28705-28706 [E9-14218]
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28705
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
School Officials ................................................................................................
Police Officials .................................................................................................
35
35
1
1
60/60
60/60
35
35
Total ..........................................................................................................
........................
........................
70
........................
Dated: June 11, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–14224 Filed 6–16–09; 8:45 am]
BILLING CODE 4163–18–P
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.
dwashington3 on PROD1PC60 with NOTICES
Project: Garrett Lee Smith Campus Case
Studies Funded Through the Garrett
Lee Smith Memorial Suicide Prevention
and Early Intervention Programs—New
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA), Center for Mental Health
Services (CMHS) is conducting up to six
campus case studies with Garrett Lee
Smith Memorial (GLS) Suicide
Prevention and Early Intervention
Campus Program grantees. The GLS
Campus Case Studies (CCS) build upon
campuses’ existing local evaluation
being implemented and funded through
the GLS grant program. The goal of the
CCS is to understand how a public
health approach is successfully applied
as a model for campus suicide
prevention efforts, and will explore, in
a systematic manner: The suicide
prevention related infrastructures and
supports (e.g., clinical and non-clinical)
that exist on up to six selected GLSfunded campuses; the various studentlevel factors that are related to suicide
prevention efforts (e.g., protective
factors, coping strategies, social norms,
and facilitators and barriers to student
VerDate Nov<24>2008
15:33 Jun 16, 2009
Jkt 217001
access and receipt of behavioral
healthcare); campus interdepartmental
collaboration and the relationship
between various efforts to promote
student mental health and wellness; and
the extent to which the campus
infrastructures and supports promote
and address these factors.
The data collected through this
project will contribute to the knowledge
base regarding a successful model for
suicide prevention that integrates
multiple prevention programs targeting
risk and protective behaviors which
place students at risk for a host of
negative mental and physical health
outcomes correlated with suicide,
including violence, stress, untreated
depression and mental illness, and
academic failure. The strategies
targeting various populations on
campus will also be discussed, as well
as the campus policies and procedures
which facilitate campus efforts related
to mental health promotion and crisis
response. The CCS design includes
three data collection strategies: (1) Case
study key informant interviews (CSIs);
(2) focus groups with students, faculty,
and staff; and (3) an Enhanced Module
to the OMB-approved Suicide
Prevention Exposure, Awareness and
Knowledge Survey—Student Version
(OMB No. 0930–0286) administered to a
sample of students. Data collection is
planned to commence in fall 2008. CCS
activities will be implemented on up to
six GLS-funded campuses.
The following describes the specific
data collection activities and the data
collection instruments to be used,
followed by a summary table of the
number of respondents and the
respondent burden:
• Enhanced Module for the SPEAKS.
The Enhanced Module will be added to
the OMB-approved Suicide Prevention
Exposure, Awareness, and Knowledge
Survey (SPEAKS)—Student Version
(OMB No. 0930–0286). The Enhanced
Module examines coping strategies,
help-seeking behaviors, awareness of
available mental health services, and
risk and protective factors across the
student population. Questions include
the availability of resources to provide
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
assistance to those at risk for suicide;
the types of coping strategies they use
when experiencing stress; from whom,
if anyone, they would seek help; if they
have dealt with mental health issues,
sought help, and experienced trauma;
and their use of protective factors. The
Enhanced Module is Web-based and
includes multiple-choice, Likert-scale,
and yes/no questions. The Enhanced
Module includes 16 items and will take
approximately 10 minutes to complete.
The Enhanced Module will be
administered at each campus once in
conjunction with the SPEAKS—Student
Version to a random sample of 200
students.
• Student Focus Group Moderator’s
Guide. This component will assess
student risk and protective factors
related to mental health, help-seeking
behaviors, and knowledge of prevention
activities on campus and their perceived
effectiveness. This will help researchers
more fully understand student-level
factors in relation to population-level
factors addressed by the Enhanced
Module for the SPEAKS. Questions
address stressors that different groups of
students face while in college, barriers
to seeking help, attitudes and stigma
related to seeking help, and the
accessibility of the campus counseling
center. Six of the following seven
groups of students will participate in
focus groups on each campus, as
decided by the campus: (1) First-year
students, (2) athletes, (3) international
students, (4) Lesbian, Gay, Bisexual, and
Transgender (LGBT) students, (5) Greek
life students, (6) graduate students, and
(7) residential advisors/peer educators.
Recruitment will be conducted by
campus project staff. Focus groups will
include a maximum of 9 students. Thus,
the total number of student focus group
participants will not exceed 324. Groups
will last approximately 90 minutes.
• Faculty/Staff Focus Group
Moderator’s Guide. The faculty and staff
focus groups will assess the campus’
approach to prevention, attitudes and
stigma around student mental health
and wellness on campus, campus
infrastructure supports for students who
need mental health help, and the
E:\FR\FM\17JNN1.SGM
17JNN1
28706
Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices
general campus climate around mental
health and wellness. Faculty and staff
will also describe their knowledge of
prevention activities on campus and
their perceived effectiveness of these
efforts. Local campus staff will recruit
appropriate respondents for the faculty
and staff focus groups to include a
maximum of 9 respondents per group.
The total number of participants will
not exceed 162 and groups will last
approximately 90 minutes.
• Case Study Key Informant
Interviews (7 versions). The Case Study
Key Informant Interviews (CSIs) include
7 qualitative interview versions: (1)
Administrator, (2) Counseling Staff, (3)
Coalition Member—Faculty, (4)
Prevention Staff, (5) Case Finder, (6)
Campus Police, and (7) Student Leader.
Local project staff will be responsible
for identifying appropriate respondents
for each CSI version and scheduling the
interview to occur during site visits by
the case study team. A total of 14
interviews will be conducted during
each campus site visit (a total of up to
192 interviews). The case study team
from Macro International Inc. will be
responsible for administering the
interviews and is trained in qualitative
interviewing. Fourteen individuals from
each of the campus sites will be selected
as key informants to participate in the
CSIs in the first and third stages of the
GLS Campus Case Studies, for a total of
64 respondents. Questions on the CSIs
include whether respondents are aware
of suicide prevention activities, what
the campus culture is, related to suicide
prevention, and what specific efforts are
in place to prevent suicide among the
campus population. Items are formatted
as open-ended and semi-structured
questions. The CSIs include 16 to 21
items and will take approximately 60
minutes to complete. On the second site
visit, the case study team will
incorporate preliminary findings from
the case studies in the interviews,
which may be modified to some extent
to collect more comprehensive
information and gather feedback from
local key informants surrounding the
context of the preliminary findings. The
CSIs for the second site visit will last 60
minutes.
The average annual respondent
burden is estimated below. This project
is scheduled to be completed in 12
months; thus, the table reflects the total
burden for one year, the project length.
The estimate reflects the total annual
respondents for the project (at which
time the CCS would conclude), the
average annual number of respondents,
the average annual number of responses,
the time it will take for each response,
and the average burden.
TOTAL AND ANNUAL AVERAGES: RESPONDENTS, RESPONSES AND HOURS
Number of
respondents
Measure name
Enhanced Module ............................................................................................
Focus Group—Student Version .......................................................................
Focus Group—Faculty Version .......................................................................
Focus Group—Staff Version ............................................................................
Interview—Student Leader Version .................................................................
Interview—Case Finder Version ......................................................................
Interview—Faculty Version ..............................................................................
Interview—Campus Police Version .................................................................
Interview—Counseling Staff Version ...............................................................
Interview—Prevention Staff Version ................................................................
Interview—Administrator Version .....................................................................
1,200
324
108
54
12
6
12
12
12
18
12
Total ..........................................................................................................
1,770
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 17, 2009 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: 202–395–6974.
dwashington3 on PROD1PC60 with NOTICES
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 8, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–14218 Filed 6–16–09; 8:45 am]
HHS.
BILLING CODE 4162–20–P
VerDate Nov<24>2008
15:33 Jun 16, 2009
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0648]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; PDUFA Pilot
Project Proprietary Name Review
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
1
1
1
1
1
1
1
1
1
1
1
Hours/
response
Response
burden
0.17
1.5
1.5
1.5
1
1
1
1
1
1
1
204
486
162
81
12
6
12
12
12
18
12
1,017
DATES: Fax written comments on the
collection of information by July 17,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
the title ‘‘PDUFA Pilot Project
Proprietary Name Review.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
E:\FR\FM\17JNN1.SGM
17JNN1
Agencies
[Federal Register Volume 74, Number 115 (Wednesday, June 17, 2009)]
[Notices]
[Pages 28705-28706]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14218]
-----------------------------------------------------------------------
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: Garrett Lee Smith Campus Case Studies Funded Through the
Garrett Lee Smith Memorial Suicide Prevention and Early Intervention
Programs--New
The Substance Abuse and Mental Health Services Administration's
(SAMHSA), Center for Mental Health Services (CMHS) is conducting up to
six campus case studies with Garrett Lee Smith Memorial (GLS) Suicide
Prevention and Early Intervention Campus Program grantees. The GLS
Campus Case Studies (CCS) build upon campuses' existing local
evaluation being implemented and funded through the GLS grant program.
The goal of the CCS is to understand how a public health approach is
successfully applied as a model for campus suicide prevention efforts,
and will explore, in a systematic manner: The suicide prevention
related infrastructures and supports (e.g., clinical and non-clinical)
that exist on up to six selected GLS-funded campuses; the various
student-level factors that are related to suicide prevention efforts
(e.g., protective factors, coping strategies, social norms, and
facilitators and barriers to student access and receipt of behavioral
healthcare); campus interdepartmental collaboration and the
relationship between various efforts to promote student mental health
and wellness; and the extent to which the campus infrastructures and
supports promote and address these factors.
The data collected through this project will contribute to the
knowledge base regarding a successful model for suicide prevention that
integrates multiple prevention programs targeting risk and protective
behaviors which place students at risk for a host of negative mental
and physical health outcomes correlated with suicide, including
violence, stress, untreated depression and mental illness, and academic
failure. The strategies targeting various populations on campus will
also be discussed, as well as the campus policies and procedures which
facilitate campus efforts related to mental health promotion and crisis
response. The CCS design includes three data collection strategies: (1)
Case study key informant interviews (CSIs); (2) focus groups with
students, faculty, and staff; and (3) an Enhanced Module to the OMB-
approved Suicide Prevention Exposure, Awareness and Knowledge Survey--
Student Version (OMB No. 0930-0286) administered to a sample of
students. Data collection is planned to commence in fall 2008. CCS
activities will be implemented on up to six GLS-funded campuses.
The following describes the specific data collection activities and
the data collection instruments to be used, followed by a summary table
of the number of respondents and the respondent burden:
Enhanced Module for the SPEAKS. The Enhanced Module will
be added to the OMB-approved Suicide Prevention Exposure, Awareness,
and Knowledge Survey (SPEAKS)--Student Version (OMB No. 0930-0286). The
Enhanced Module examines coping strategies, help-seeking behaviors,
awareness of available mental health services, and risk and protective
factors across the student population. Questions include the
availability of resources to provide assistance to those at risk for
suicide; the types of coping strategies they use when experiencing
stress; from whom, if anyone, they would seek help; if they have dealt
with mental health issues, sought help, and experienced trauma; and
their use of protective factors. The Enhanced Module is Web-based and
includes multiple-choice, Likert-scale, and yes/no questions. The
Enhanced Module includes 16 items and will take approximately 10
minutes to complete. The Enhanced Module will be administered at each
campus once in conjunction with the SPEAKS--Student Version to a random
sample of 200 students.
Student Focus Group Moderator's Guide. This component will
assess student risk and protective factors related to mental health,
help-seeking behaviors, and knowledge of prevention activities on
campus and their perceived effectiveness. This will help researchers
more fully understand student-level factors in relation to population-
level factors addressed by the Enhanced Module for the SPEAKS.
Questions address stressors that different groups of students face
while in college, barriers to seeking help, attitudes and stigma
related to seeking help, and the accessibility of the campus counseling
center. Six of the following seven groups of students will participate
in focus groups on each campus, as decided by the campus: (1) First-
year students, (2) athletes, (3) international students, (4) Lesbian,
Gay, Bisexual, and Transgender (LGBT) students, (5) Greek life
students, (6) graduate students, and (7) residential advisors/peer
educators. Recruitment will be conducted by campus project staff. Focus
groups will include a maximum of 9 students. Thus, the total number of
student focus group participants will not exceed 324. Groups will last
approximately 90 minutes.
Faculty/Staff Focus Group Moderator's Guide. The faculty
and staff focus groups will assess the campus' approach to prevention,
attitudes and stigma around student mental health and wellness on
campus, campus infrastructure supports for students who need mental
health help, and the
[[Page 28706]]
general campus climate around mental health and wellness. Faculty and
staff will also describe their knowledge of prevention activities on
campus and their perceived effectiveness of these efforts. Local campus
staff will recruit appropriate respondents for the faculty and staff
focus groups to include a maximum of 9 respondents per group. The total
number of participants will not exceed 162 and groups will last
approximately 90 minutes.
Case Study Key Informant Interviews (7 versions). The Case
Study Key Informant Interviews (CSIs) include 7 qualitative interview
versions: (1) Administrator, (2) Counseling Staff, (3) Coalition
Member--Faculty, (4) Prevention Staff, (5) Case Finder, (6) Campus
Police, and (7) Student Leader. Local project staff will be responsible
for identifying appropriate respondents for each CSI version and
scheduling the interview to occur during site visits by the case study
team. A total of 14 interviews will be conducted during each campus
site visit (a total of up to 192 interviews). The case study team from
Macro International Inc. will be responsible for administering the
interviews and is trained in qualitative interviewing. Fourteen
individuals from each of the campus sites will be selected as key
informants to participate in the CSIs in the first and third stages of
the GLS Campus Case Studies, for a total of 64 respondents. Questions
on the CSIs include whether respondents are aware of suicide prevention
activities, what the campus culture is, related to suicide prevention,
and what specific efforts are in place to prevent suicide among the
campus population. Items are formatted as open-ended and semi-
structured questions. The CSIs include 16 to 21 items and will take
approximately 60 minutes to complete. On the second site visit, the
case study team will incorporate preliminary findings from the case
studies in the interviews, which may be modified to some extent to
collect more comprehensive information and gather feedback from local
key informants surrounding the context of the preliminary findings. The
CSIs for the second site visit will last 60 minutes.
The average annual respondent burden is estimated below. This
project is scheduled to be completed in 12 months; thus, the table
reflects the total burden for one year, the project length. The
estimate reflects the total annual respondents for the project (at
which time the CCS would conclude), the average annual number of
respondents, the average annual number of responses, the time it will
take for each response, and the average burden.
Total and Annual Averages: Respondents, Responses and Hours
----------------------------------------------------------------------------------------------------------------
Number of
Measure name Number of responses per Hours/ Response
respondents respondent response burden
----------------------------------------------------------------------------------------------------------------
Enhanced Module................................. 1,200 1 0.17 204
Focus Group--Student Version.................... 324 1 1.5 486
Focus Group--Faculty Version.................... 108 1 1.5 162
Focus Group--Staff Version...................... 54 1 1.5 81
Interview--Student Leader Version............... 12 1 1 12
Interview--Case Finder Version.................. 6 1 1 6
Interview--Faculty Version...................... 12 1 1 12
Interview--Campus Police Version................ 12 1 1 12
Interview--Counseling Staff Version............. 12 1 1 12
Interview--Prevention Staff Version............. 18 1 1 18
Interview--Administrator Version................ 12 1 1 12
---------------------------------------------------------------
Total....................................... 1,770 .............. .............. 1,017
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by July 17, 2009 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: 202-395-6974.
Dated: June 8, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-14218 Filed 6-16-09; 8:45 am]
BILLING CODE 4162-20-P