Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38197 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Reporting Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Annual Report 4 1 4 5 20 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA records, there are 

approximately four manufactures of 

automated blood cell separator devices. 

We estimate that the manufacturers will 

spend approximately 5 hours preparing 

and submitting the annual report. 

Other burden hours required for 

§ 864.9245 are reported and approved 

under OMB control number 0910–0120 

(premarket notification submission 

501(k), 21 CFR part 807, subpart E), and 

OMB control number 0910–0437 (MDR). 

Dated: July 24, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18354 Filed 7–30–09; 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: National Evaluation of the 

Comprehensive Community Mental 

Health Services for Children and Their 

Families Program: Phase VI–NEW 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) Center for Mental Health 

Services is responsible for the national 

evaluation of the Comprehensive 

Community Mental Health Services for 

Children and Their Families Program 

(Children’s Mental Health Initiative— 

CMHI) that will collect data on child 

mental health outcomes, family life, and 

service system development and 

performance. Data will be collected on 

26 service systems, and approximately 

5,541 children and families. 

Data collection for this evaluation will 

be conducted over a five-year period. 

Child and family outcomes of interest 

will be collected at intake and during 

subsequent follow-up sessions at sixmonth intervals. The length of time that 

individual families will participate in 

the study ranges from 12 to 24 months 

depending upon when they enter the 

evaluation. The outcome measures 

include the following: Child 

symptomatology and functioning, 

family functioning, satisfaction, and 

caregiver strain. The core of service 

system data will be collected every 18– 

24 months throughout the 5-year 

evaluation period, with a sustainability 

survey conducted in years 3 and 5. 

Service utilization and cost data will be 

tracked and submitted to the national 

evaluation every six months using two 

tools, the Flex Fund Tool and the 

Services and Costs Data Tool, to 

estimate average cost of treatment per 

child, distribution of costs, and 

allocation of costs across service 

categories. Service delivery and system 

variables of interest include the 

following: Maturity of system of care 

development in funded system of care 

communities, adherence to the system 

of care program model, and client 

service experience. We will also 

conduct a comprehensive evaluation of 

the CMHI’s data driven technical 

assistance; this component of the 

evaluation will employ a mixedmethods approach, combining 

qualitative and quantitative data to 

provide a comprehensive assessment of 

the continuous quality improvement 

(CQI) process in funded system of care 

communities. Specifically, data will be 

gathered through three complementary 

activities: A baseline survey of key 

constituents in all funded communities; 

a subsequent monitoring survey 

administered every two years to the 

same constituents; and biennial case 

studies of four selected communities. 

In addition, the evaluation will 

include three special studies: (1) The 

sector specific assessment and quasiexperimental comparison study will 

examine in more detail the outcomes 

and service experience of children from 

multiple child-serving sectors and, 

through child-level matching, compare 

these outcomes with those not receiving 

system of care services; (2) The Alumni 

Network Study will examine the 

effectiveness of the system of care 

Alumni Network Web site by evaluating 

end-user satisfaction and usability of the 

Web site and will also assess the 

collaboration between communities via 

a Web-based Networking and 

Collaboration Survey that will measure 

the nature and extent of the interaction 

between communities; (3) The Study of 

State Strategies for Sustainability will 

examine the state’s role in sustaining 

communities after federal funding 

ceases and describe effective strategies 

for sustaining funded systems of care. A 

short version of the sustainability 

survey developed for this evaluation 

will be used to gather this information. 

Internet-based technology such as 

Web-based surveys and data entry and 

management tools will be used in this 

evaluation. The measures of the national 

evaluation address the national outcome 

measures for mental health programs as 

currently established by SAMHSA. 

The average annual respondent 

burden is estimated below. The estimate 

reflects the average number of 

respondents in each respondent 

category, the average number of 

responses per respondent per year, the 

average length of time it will take to 

complete each response, and the total 

average annual burden for each category 

of respondent, and for all categories of 

respondents combined. 


PWALKER on DSK8KYBLC1PROD with NOTICES
38198 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

PHASE VI ESTIMATE OF RESPONDENT BURDEN

[Note: Total burden is annualized over a 5-year period] 

Instrument Respondent Number of 

respondents 

Total average 

number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

5-year average annual 

burden hours 

System of Care Assessment 

Interview Guide A. Core 

Agency Representative.

Key site informants ............ 1 598 3 1.00 1,794 359 

Interview Guide B. Project 

Director.

Interview Guide C. Family 

Representative/Representative of Family/Advocacy Organizations.

Interview Guide D. Program 

Evaluator.

Interview Guide E. Intake 

Worker.

Interview Guide F. Care Coordinator.

Interview Guide G. Direct 

Service Delivery Staff.

Interview Guide H. Care 

Review Participant.

Interview Guide I. Caregiver 

of Child or Youth Served 

by the Program.

Interview Guide L. Direct 

Service Staff from Other 

Public Child-Serving 

Agencies.

Interview Guide M. Care 

Record/Chart Review.

Interview Guide N. Other 

Staff.

Interview Guide O. Debriefing Document.

Interview Guide P. Youth 

Respondent.

Interview Guide Q. Youth 

Coordinator.

Interview Guide R. Cultural 

and Linguistic Competence Coordinator.

Interview Guide S. Social 

Marketing Communications Manager.

Child and Family Outcome Study 

Caregiver Information Questionnaire, Revised: Caregiver—Intake (CIQ–RC–I).Caregiver ............................ 2 5,541 1 0.37 2,032 406 

Caregiver Information Questionnaire, Revised: Staff 

as Caregiver—Intake 

(CIQ–RS–I).

Staff as Caregiver.

Caregiver Information Questionnaire, Revised: Caregiver—Follow-Up (CIQ– 

RC–F).

Caregiver ............................ 5,541 3 4 0.28 6,280 1,256 

Caregiver Information Questionnaire, Revised: Staff 

as Caregiver—Follow-Up 

(CIQ–RS–F).

Staff as Caregiver.

Caregiver Strain Questionnaire (CGSQ).Caregiver ............................ 5,541 5 0.17 4,627 925 

Child Behavior Checklist 

11⁄2–5 (CBCL 11⁄2–5).

Caregiver ............................ 5,541 5 0.33 9,226 1,845 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38199 

PHASE VI ESTIMATE OF RESPONDENT BURDEN—Continued 

[Note: Total burden is annualized over a 5-year period] 

Instrument Respondent Number of 

respondents 

Total average 

number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

5-year average annual 

burden hours 

Child Behavior Checklist 6– 

18 (CBCL 6–18).

Education Questionnaire, 

Revision 2 (EQ–R2).

Caregiver ............................ 5,541 5 0.33 9,226 1,845 

Living Situations Questionnaire (LSQ).Caregiver ............................ 5,541 5 0.08 2,300 460 

Behavioral and Emotional 

Rating Scale—Second 

Edition, Parent Rating 

Scale (BERS–2C).

Caregiver ............................ 4 4,909 5 0.17 4,099 820 

Columbia Impairment Scale 

(CIS).

Caregiver ............................ 5 5,348 5 0.08 2,219 444 

Parenting Stress Index 

(PSI).

Caregiver ............................ 6 2,030 5 0.08 846 169 

Devereux Early Childhood 

Assessment for Infants 

(DECA 1–18M).

Caregiver ............................ 7 1,528 5 0.08 637 127 

Devereux Early Childhood 

Assessment for Toddlers 

(DECA 18–36M).

Devereux Early Childhood 

Assessment (DECA 2– 

5Y).

Preschool Behavioral and 

Emotional Rating 

(PreBERS).

Caregiver ............................ 1,528 5 0.10 764 153 

Delinquency Survey, Revised (DS–R).Youth .................................. 8 3,624 5 0.13 2,416 483 

Behavioral and Emotional 

Rating Scale—Second 

Edition, Youth Rating 

Scale (BERS–2Y).

Youth .................................. 3,624 5 0.17 3,026 605 

Gain Quick–R: Substance 

Problem Scale (GAIN).

Youth .................................. 3,624 5 0.08 1,504 301 

Substance Use Survey, Revised (SUS–R).Youth .................................. 3,624 5 0.10 1,812 362 

Revised Children’s Manifest 

Anxiety Scales (RCMAS).

Youth .................................. 3,624 5 0.05 906 181 

Reynolds Adolescent Depression Scale—Second 

Edition (RADS–2).

Youth .................................. 3,624 5 0.05 906 181 

Youth Information Questionnaire, Revised—Intake 

(YIQ–R–I).

Youth .................................. 3,624 1 0.25 906 181 

Youth Information Questionnaire, Revised—FollowUp (YIQ–R–F).Youth .................................. 3,624 4 0.25 3,624 725 

Service Experience Study 

Multi-Sector Service Contacts, Revised: Caregiver—Intake (MSSC– 

RC–I).

Caregiver ............................ 5,541 1 0.25 1,385 277 


PWALKER on DSK8KYBLC1PROD with NOTICES
38200 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

PHASE VI ESTIMATE OF RESPONDENT BURDEN—Continued 

[Note: Total burden is annualized over a 5-year period] 

Instrument Respondent Number of 

respondents 

Total average 

number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

5-year average annual 

burden hours 

Multi-Sector Service Contacts, Revised: Staff as 

Caregiver—Intake 

(MSSC–RS–I).

Staff as Caregiver.

Multi-Sector Service Contacts, Revised: Caregiver—Follow-Up 

(MSSC–RC–F).

Caregiver ............................ 5,541 4 0.25 5,541 1,108 

Multi-Sector Service Contacts, Revised: Staff as 

Caregiver—Follow-Up 

(MSSC–RS–F).

Staff as Caregiver.

Cultural Competence and 

Service Provision Questionnaire, Revised 

(CCSP–R).

Caregiver ............................ 5,541 9 4 0.13 2,955 591 

Youth Services Survey for 

Families (YSS–F).

Caregiver ............................ 5,541 4 0.12 2,593 519 

Youth Services Survey 

(YSS).

Youth .................................. 3,624 4 0.08 1,203 241 

Comparison and Sector Study: Juvenile Justice 

Court Representative Questionnaire (CRQ).Court representatives ......... 10 212 5 0.50 530 106 

Electronic Data Transfer of 

Juvenile Justice Records.

Key site personnel ............. 212 5 0.03 35 7 

Comparison and Sector Study: Education 

Teacher Questionnaire (TQ) Teacher .............................. 212 5 0.50 530 106 

School Administrator Questionnaire (SAQ).School administrators ......... 212 5 0.50 530 106 

Electronic Data Transfer of 

Education Records.

Key site personnel ............. 212 5 0.03 35 7 

Comparison and Sector Study: Child Welfare 

Child Welfare Sector Study 

Questionnaire—Intake 

(CWSQ–I).

Care coordinators ............... 212 1 0.50 106 21 

Child Welfare Sector Study 

Questionnaire—Follow-Up 

(CWSQ–F).

Care coordinators ............... 212 4 0.50 424 85 

Electronic Data Transfer of 

Child Welfare Records.

Key site personnel ............. 212 5 0.03 35 7 

Sustainability Study 

Sustainability Survey: Brief 

Form.

Project Director .................. 79 2 0.17 26 5 

Sustainability Survey ........... Providers 11 ......................... 126 2 0.75 189 38 

Caregiver 11 ........................ 42 2 0.75 63 13 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38201 

PHASE VI ESTIMATE OF RESPONDENT BURDEN—Continued 

[Note: Total burden is annualized over a 5-year period] 

Instrument Respondent Number of 

respondents 

Total average 

number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

5-year average annual 

burden hours 

CQI Initiative Evaluation 

CQI Baseline Survey, WebBased.Key site personnel ............. 208 1 0.50 104 21 

CQI Monitoring Survey, 

Web-Based.

Key site personnel ............. 208 2 0.50 208 42 

CQI Local Focus Group 

Guide.

Key site personnel ............. 30 2 1.00 60 12 

CQI National Focus Group 

Guide.

National TA providers ......... 20 2 1.00 40 8 

Alumni Networking Study 

Networking and Collaboration Survey.Key site personnel ............. 248 2 0.50 248 50 

Alumni Network Web Site 

Satisfaction Survey.

Key site personnel, National TA providers, 

Branch staff.

458 2 0.25 229 46 

Services and Costs Study 

Flex Funds Data Dictionary/ 

Tool.

Local programming staff 

compiling/entering administrative data on children/ 

youth.

12 1,306 13 3 0.03 129 26 

Services and Costs Data 

Dictionary/Data Entry Application.

Local evaluator, staff at 

partner agencies, and 

programming staff compiling/entering service 

and cost records on children/youth.

5,541 14 100 0.05 27,705 5,541 

Summary of Annualized Burden Estimates for 5 Years 

Number of distinct respondents Number of 

responses per 

respondent 

Average 5- 

year burden 

per response 

(hours) 

Total annual burden (hours) 

Caregivers ........................... 5,541 0.9 2.2 10,959 

Youth ................................... 3,624 0.9 1.0 3,261 

Providers/Administrators ..... 598 10.8 1.0 6,593 

Total Summary ............ 9,763 13 ........................ 20,812 

1An average of 23 stakeholders in up to 26 grant communities will complete the System of Care Assessment interview. These stakeholders 

will include site administrative staff, providers, agency representatives, family representatives, and youth. 2 Number of respondents across 26 grantees (5223), in addition to 318 children/families from the comparison sample. Average based on a 5 

percent attrition rate at each data collection point. 3 Number of responses per respondent is five over the course of the study (once every 6 months for 24 months, with one baseline/intake response, and 4 follow-up responses). 4Approximate number of caregivers with children over age 5, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample. 5Approximate number of caregivers with children 3 and older, based on Phase IV data submitted as of 12/08. Also includes 318 children/families from the comparison sample. 6Approximate number of caregivers with either: (1) children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 12 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be 

administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08. 7Approximate number of caregivers with either: (1) children served at the roughly 7 early childhood-focused communities, for whom the instrument is required; or (2) children aged 0 to 5 at other communities, where the instrument is optional (we estimate that 1⁄3 of caregivers will be administered the instrument when it is optional). Estimates are based on Phase IV data submitted as of 12/08. 8Based on Phase IV finding that approximately 63 percent of the children in the evaluation were 11 years old or older. Also includes 318 children/families from the comparison sample. 


PWALKER on DSK8KYBLC1PROD with NOTICES
38202 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

9With the exception of the MSSC–R, respondents only complete Service Experience Study measures at follow-up points. See Footnote #3 for 

the explanation about the average number of responses per respondent. 10Approximate number of children/families in each sector, for the Sector and Comparison Study. This includes cases within the communities, 

as well as within the comparison sample. 11For each community, 1 respondent will be a caregiver and 3 respondents will be administrators/providers. 12Assumes that each community will use flexible funds expenditures on average for approximately one quarter of the children/youth enrolled. 13Assumes that three expenditures, on average, will be spent on each child/youth receiving flexible fund benefits. 14Assumes that each child/youth in system of care communities and in the comparison sample will have 100 service episodes, on average. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by August 28, 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: July 27, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–18317 Filed 7–30–09; 8:45 am] 

BILLING CODE 4162–20–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: National Evaluation of the 

Comprehensive Community Mental 

Health Services for Children and Their 

Families Program: Phase V (OMB No. 

0930–0280)—Revision 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) Center for Mental Health 

Services (CMHS) is responsible for the 

National Evaluation of the 

Comprehensive Community Mental 

Health Services for Children and Their 

Families Program, which collects data 

on child mental health outcomes, family 

life, and service system development 

and performance. Data will be collected 

on 30 service systems and roughly 8,810 

children and families. 

The data collection for this evaluation 

will be conducted for a 3-year period. 

The core of service system data will be 

collected twice (every 18 to 24 months) 

during the 3-year evaluation period. A 

sustainability survey will be conducted 

in selected years. Service delivery and 

system variables of interest include the 

following: Maturity of system of care 

development; adherence to the system 

of care program model; services 

received by youth and their families, 

and the costs of those services; and 

consumer service experience. 

The length of time that individual 

families will participate in the study 

ranges from 18 to 36 months depending 

on when they enter the evaluation. 

Child and family outcomes of interest 

will be collected at intake and during 

subsequent follow-up interviews at sixmonth intervals. Client service 

experience information is collected at 

these follow-up interviews. Measures 

included in an outcome interview are 

determined by the type of assessment 

(intake or follow-up), child’s age, and 

whether the respondent is the caregiver 

or a youth. 

The outcome measures include the 

following: Child symptomatology and 

functioning, family functioning, 

material resources, and caregiver strain. 

The caregiver interview package 

includes the Caregiver Information 

Questionnaire, Child Behavior 

Checklist, Behavioral and Emotional 

Rating Scale (BERS), Education 

Questionnaire, Columbia Impairment 

Questionnaire, Living Situations 

Questionnaire, Family Life 

Questionnaire, and Caregiver Strain 

Questionnaire at intake, and also 

includes the Multi-service Sector 

Contacts Form, Cultural Competence 

and Service Provision Questionnaire 

and the Youth Services Survey (a 

national outcome measurement tool) at 

follow-up assessments. Caregivers of 

children under age 6 complete the 

Vineland Screener to assess 

development, and do not complete the 

BERS. The Youth Interview package 

includes the Youth Information 

Questionnaire, Revised Children’s 

Manifest Anxiety Scale, Reynolds 

Depression Scale, BERS (youth version), 

Delinquency Survey, Substance Use 

Survey, GAIN-Quick: Substance 

Dependence Scale, and Youth Services 

Survey (youth version). 

The evaluation also includes three 

special studies: (1) An evidence-based 

practices study that examines the effects 

of various factors on the implementation 

and use of evidence-based treatments 

and approaches in system of care 

communities; (2) A cultural and 

linguistic competence study that 

examines the extent to which the 

cultural and linguistic characteristics of 

communities influence program 

implementation and provider 

adaptation of evidence-based 

treatments, and provider service 

delivery decisions based on provider 

culture and language; and (3) an 

evaluation of the communities’ use of 

reports produced by the national 

evaluation for continuous quality 

improvement. The national evaluation 

measures address the national outcome 

measures for mental health programs as 

currently established by SAMHSA. 

Table 1 summarizes which national 

evaluation components are unchanged 

from the original 2006 submission and 

which are new or changed. 

TABLE 1—STUDY COMPONENT AND INSTRUMENT REVISIONS FOR PHASE V RE-SUBMISSION

New or changed 

for 2009 

resubmission 

No change Nature of change 

System of Care Assessment 

Site Visit Tables ........................................................ ............................ X 

Interview Protocols ................................................... ............................ X 

Inter-Agency Collaboration Scale (IACS) ................. ............................ X 


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