Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Notices 28705 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

School Officials ................................................................................................ 35 1 60/60 35 

Police Officials ................................................................................................. 35 1 60/60 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. 

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 

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 


dwashington3 on PROD1PC60 with NOTICES
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

Measure name Number of 

respondents 

Number of 

responses per 

respondent 

Hours/ 

response 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

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: Food and Drug Administration, 

HHS. 

ACTION: 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. 

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. 


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