61144 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

and Availability provides advice to the 

Secretary and the Assistant Secretary for 

Health on a range of policy issues that 

includes (1) definition of public health 

parameters around safety and 

availability of the blood supply and 

blood products, (2) broad public health, 

ethical and legal issues related to 

transfusion and transplantation safety, 

and (3) the implications for safety and 

the availability of various economic 

factors affecting product cost and 

supply. 

In keeping with its established 

mission, the ACBSA will be asked to 

review and comment on previous 

ACBSA recommendations including 

elements of a strategic plan for 

transfusion and transplantation safety. 

The review is intended to align the 

transfusion and transplantation safety 

initiatives to the Secretary’s Strategic 

Initiatives and Key Inter-Agency 

Collaborations: (http://www.hhs.gov/

secretary/about/secretarialstrategic

initiatives2010.pdf). 

The Committee will also be asked to 

comment and make recommendations 

on prioritizing previous and outstanding 

recommendations in light of the 

Assistant Secretary for Health’s mission 

statement: ‘‘Mobilizing Leadership in 

Science and Prevention for a Healthier 

Nation’’ and strategic priorities: Creating 

Better Systems of Prevention; 

Eliminating Health Disparities and 

Achieving Health Equity; and Making 

Healthy People Come Alive for all 

Americans. 

The public will have opportunity to 

present their views to the Committee on 

both meeting days. A public comment 

session has been scheduled for 

November 5, 2010. Comments will be 

limited to five minutes per speaker and 

must be pertinent to the discussion. Preregistration is required for participation 

in the public comment session. Any 

member of the public who would like to 

participate in this session is encouraged 

to contact the Executive Secretary at 

his/her earliest convenience to register 

for time (limited to 5 minutes) and 

registration must be prior to close of 

business on November 3, 2010. It is 

requested that those who wish to have 

printed material distributed to the 

Committee provide thirty (30) copies of 

the document to the Executive 

Secretary, ACBSA, prior to close of 

business on November 3, 2010. If it is 

not possible to provide 30 copies of the 

material to be distributed, then 

individuals are requested to provide at 

a minimum one (1) copy of the 

document(s) to be distributed prior to 

the close of business on November 3, 

2010. It also is requested that any 

member of the public who wishes to 

provide comments to the Committee 

utilizing electronic data projection 

submit the necessary material to the 

Executive Secretary prior to close of 

business on November 3, 2010. 

Electronic comments must adhere to 

disability accessibility guidelines 

(Section 508 compliance). 

Dated: September 28, 2010. 

Richard A. Henry, 

Deputy Executive Secretary, Advisory 

Committee on Blood Safety and Availability. 

[FR Doc. 2010–24735 Filed 10–1–10; 8:45 am] 

BILLING CODE 4150–41–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. 

Proposed Project: Evaluation of 

Pregnant and Postpartum Women 

(PPW) Program 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Center for Substance Abuse 

Treatment (CSAT), is funding 11 fiscal 

year (FY) 2009 Services Grants for the 

Residential Treatment for Pregnant and 

Postpartum Women (PPW) Program. 

The purpose of the PPW Program is to 

provide cost-effective, comprehensive, 

residential treatment services for 

pregnant and postpartum women who 

suffer from alcohol and other drug use 

problems, and for their infants and 

children impacted by the perinatal and 

environmental effects of maternal 

substance use and abuse. 

Section 508 [290bb–1] of the Public 

Health Service Act mandates the 

evaluation and dissemination of 

findings of residential treatment 

programs for pregnant and postpartum 

women. This cross-site accountability 

assessment will assess project activities 

implemented for these services. 

CSAT is requesting approval for a 

total of 8,404 burden hours for this new 

data collection. CSAT is requesting 

approval for a total of 23 instruments. 

Of these 23 instruments, 18 instruments 

are client-level tools and 5 instruments 

are process-level tools. To examine the 

effectiveness and impact of the PPW 

program, the current design includes 

both client-level outcomes and process 

evaluation components. The purpose of 

the outcome evaluation component is to 

examine the extent to which grantees 

accomplish the five core goals specified 

by the PPW program request for 

applications (RFA). These goals include: 

• Decrease the use and/or abuse of 

prescription drugs, alcohol, tobacco, 

illicit and other harmful drugs (e.g., 

inhalants) among pregnant and 

postpartum women; 

• Increase safe and healthy 

pregnancies; improve birth outcomes; 

and reduce related effects of maternal 

drug abuse on infants and children; 

• Improve the mental and physical 

health of the women and children; 

• Improve family functioning, 

economic stability, and quality of life; 

and 

• Decrease involvement in and 

exposure to crime, violence, sexual and 

physical abuse, and child abuse and 

neglect. 

In order to help interpret client-level 

outcomes, the process evaluation will 

explore what grantees are actually 

doing, how well they are doing it, any 

challenges encountered, and strategies 

grantees used to address them. 

Data collection instruments will be 

used to collect outcome and process 

data for this cross-site accountability 

evaluation, program and treatment 

planning, and local evaluations. For 

clients, data will be collected from 

women at four time points (intake, 6- 

months post-intake, discharge, and 6- 

months post-discharge), consistent with 

the GPRA data collection schedule. The 

schedule for collecting child data is 

similar to the mothers, with the addition 

of a 3-month post-intake time point. The 

following interview instruments will be 

used for women, fathers/mother’s 

partner, and children: 

Women Focused Tools 

• BASIS–24® (psychological 

symptomology). 

• Child Abuse Potential Inventory 

(overall risk for child physical abuse). 

• Ferrans and Powers Quality of Life 

Index (quality of life measure). 

• Family Support Scale (helpfulness 

of sources of support to parents raising 

a young child). 

• Women’s Discharge Tool (services 

received, length of stay, treatment goals 

achieved). 

• Staff Completed Women’s Items 

(pregnancy status, problems and 

outcomes). 

• Items Administered to Women 

(children residing with mother in 


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Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61145 

treatment, tobacco use, physical abuse 

and sexual abuse in the past year). 

Father and Partner Focused Tools 

• Ferrans and Powers Quality of Life 

Index (quality of life measure). 

Child Focused Tools 

• Brief Infant Toddler Social and 

Emotional Assessment (children 12–35 

months; social and emotional 

assessment). 

• Child Data Collection Tool (all 

children; descriptive biopsychosocial 

measure). 

• Children’s Discharge Tool (all 

children; services received, length of 

stay, treatment goals achieved, whether 

child lived in the facility). 

• CRAFFT (children 11–17; 

adolescent substance use screen). 

• Newborn’s Medical Record Audit 

(childen birth-3 months; birth 

outcomes). 

• Parenting Relationship 

Questionnaire (children 2–17 years; 

parent’s relationship with child). 

• Parenting Stress Index (children 1 

month—12 years; parenting stress). 

• Social Skills Improvement System 

(children 3–17 years; social skills). 

• Trauma Symptom Checklist for 

Young Children (3–12 years; trauma 

symptoms). 

• Staff Completed Child Items 

(children 0–17; prematurity, child’s 

recent primary residence, whether child 

will reside in treatment with mother). 

• Staff Completed Newborn Items 

(children 0–3 months; prematurity, 

length of stay in hospital, neonatal 

intensive care unit (NICU), and 

treatment for neononatal abstinence 

syndrome). 

Note that all child focused tools are 

records reviews or administered as 

maternal interviews with the exception 

of CRAFFT, which is administered to 

the children directly. 

Process Evaluation Tools 

• Biannual Project Director 

Telephone Interview (interview with 

grantee project directors to clarify 

information reported in their biannual 

progress reports); 

• Site Visit Protocol—Client Focus 

Group (focus groups with clients to 

gather information about their 

experience in the program); 

• Site Visit Protocol—Clinical 

Director(s)/Supervisor(s) (interviews 

with both the director of clinical 

services for women and the director of 

clinical services for children to gather 

more specific information about clinical 

services); 

• Site Visit Protocol—Counselor(s) 

(interviews with counselors to gather 

information related to daily treatment 

operations and their experience in 

providing services); and 

• Site Visit Protocol—Program 

Director (interview with grantee 

program directors to gather information 

about overall PPW programmatic 

issues). 

All data will be collected using a 

combination of observation, records 

review, questionnaires, and personal 

interviews. CSAT will use this data for 

accountability reporting, and program 

monitoring to inform public policy, 

research, and programming as they 

relate to the provision of women’s 

services. Data produced by this study 

will provide direction to the type of 

technical assistance that will be 

required by service providers of 

women’s programming. In addition, the 

data will be used by individual grantees 

to support progress report efforts. 

The total annualized burden to 

respondents for all components of the 

PPW program is estimated to be 8,404 

hours. Table A–1 presents a detailed 

breakdown of the annual burden for all 

data collection instruments for all 

respondents (i.e., mother, child, project 

staff, partner/father (family members), 

medical staff, project director, clinical 

director, counselor, program director). 

The number of respondents for all childfocused tools is weighted, based on the 

percentage of children within the 

appropriate age bracket in the prior 

PPW evaluation. With the exception of 

the CRAFFT, all child-focused tools are 

completed for the child by the mother 

or project staff. The burden estimates, 

also summarized in Table A–2, are 

based on the reported experience of the 

2006 cohort, proprietary instrument 

developer estimates and experience, 

pre-testing of the additional items 

completed by staff and administered to 

women, and pre-testing of process 

evaluation measures. There are no direct 

costs to respondents other than their 

time to participate. 

TABLE A–1—DETAILED ANNUAL BURDEN FOR ALL INTERVIEWS & SURVEYS

Interviews and surveys Respondent Number of 

respondents 1

Responses 

per 

respondent 

Total 

responses 

Burden per 

resp. 

(hrs.) 

Total burden 

(hrs.) 

Child Focused Interviews: 

CRAFFT (11–17 yrs) 2 ................ Child .................... 70 5 350 0.08 28 

Brief Infant Toddler Social and 

Emotional Assessment (12–35 

mos) 3.

Mother ................. 141 5 705 0.17 120 

Child Data Collection Tool (0–17 

yrs) 4.

Mother ................. 440 2 880 0.75 660 

Parenting Relationship Questionnaire (2–17 yrs) 5.Mother ................. 387 5 1,935 0.25 484 

Parenting Stress Index (1 

month–12 yrs) 6.

Mother ................. 418 10 4,180 0.5 2,090 

Social Skills Improvement System (3–17 yrs) 7.Mother ................. 326 5 1,630 0.42 685 

Trauma Symptom Checklist for 

Young Children (3–12 yrs) 8.

Mother ................. 290 5 1,450 0.33 479 

Women Focused Interviews: 

BASIS–24® ................................. Mother ................. 440 4 1,760 0.25 440 

Child Abuse Potential Inventory Mother ................. 440 4 1,760 0.33 581 

Family Support Scale ................. Mother ................. 440 4 1,760 0.17 299 

Ferrans and Powers Quality of 

Life Index (Women).

Mother ................. 440 4 1,760 0.17 299 

Items Administered to Women ... Mother ................. 440 4 1,760 0.17 299 

Partners/Fathers Interview: 


jlentini on DSKJ8SOYB1PROD with NOTICES
61146 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

TABLE A–1—DETAILED ANNUAL BURDEN FOR ALL INTERVIEWS & SURVEYS—Continued 

Interviews and surveys Respondent Number of 

respondents 1

Responses 

per 

respondent 

Total 

responses 

Burden per 

resp. 

(hrs.) 

Total burden 

(hrs.) 

Ferrans and Powers Quality of 

Life Index (Partners).

Partner/Father ..... 110 2 220 0.17 37 

Staff Completed Items/Record Reviews at 11 Facilities: 

Children’s Discharge Tool (0–17 

yrs) 9.

Project Staff ......... 11 80 880 0.58 510 

Women’s Discharge Tool ........... Project Staff ......... 11 40 440 0.58 255 

Newborn’s Medical Record Audit 

(0–3 mos) 10.

Medical Staff ........ 11 25 275 0.08 22 

Staff Completed Newborn Items Medical Staff ........ 11 25 275 0.25 69 

Staff Completed Child Items (0– 

17 yrs) 11.

Project Staff ......... 11 400 4,400 0.08 352 

Staff Completed Women’s 

Items 12.

Project Staff ......... 11 160 1,760 0.17 299 

Process Evaluation: 

Biannual Project Director Telephone Interview.Project Director .... 11 2 22 1 22 

Site Visit Protocol—Client Focus 

Group 13.

Mother ................. 176 1 176 1.5 264 

Site Visit Protocol—Clinical Director/Supervisor.Clinical Director/ 

Supervisor.

22 1 22 2 44 

Site Visit Protocol—Counselor(s) Counselor ............ 33 1 33 1 33 

Site Visit Protocol—Program Director.Program Director 11 1 11 3 33 

Total ..................................... .............................. 4,701 ........................ 28,444 ........................ 8,404 

1 Data will be collected from women at four time points (intake, 6-months post-intake, discharge, and 6-months post-discharge), consistent with 

the GPRA data collection schedule. Figures in this table are based on 40 mothers per site with 2 children and 0.25 father/partner per mother. 

The schedule for collecting child data is similar to the mother’s with the addition of a 3-months post-intake time point with selected tools for a 

total of five time points. All child focused tools are completed by the mother or project staff, with the exception of CRAFFT. For fathers and partners, data will be collected at two points (intake and discharge). 2Based on 8% of 880 minor children ages 11 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 

3Based on 16% of 880 minor children ages 12–35 months at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 

4Based on 440 mothers having 2 minor children at intake and/or delivery. 

5Based on 44% of 880 minor children ages 2 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 

6Based on 95% of 880 minor children ages 1 month to 12 years (n = 836). For simplicity, this calculation assumes that 95% of mothers have 

two children in this age group and complete the tool for each child at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 7Based on 37% of 880 minor children ages 3 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 

8Based on 33% of 880 minor children ages 3 to 12 at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 

9Based on 1 staff member at each of the 11 programs completing the tool for 80 children at discharge. 

10Based on 31% of 880 minor children ages 0–3 months at intake or delivery. 11Based on 80 minor children per site ages 0 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge. 12Based on 1 staff member at each of the 11 programs completing items for 40 women at intake, 6 months, discharge, and 6-months post-discharge. 13Based on 2 focus groups with 8 mothers at each site. 

TABLE A–2—SUMMARY TOTAL ANNUAL RESPONDENT BURDEN

Respondent Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total hour 

burden 

Mothers ................................................................................ 440 ........................ 19,756 ........................ 6,700 

Partners/Fathers .................................................................. 110 ........................ 220 ........................ 37 

Children (11–17 yrs) ............................................................ 70 ........................ 350 ........................ 28 

Medical Staff ........................................................................ 11 ........................ 550 ........................ 91 

Project Staff ......................................................................... 11 ........................ 7,480 ........................ 1,416 

Project Director .................................................................... 11 ........................ 22 ........................ 22 

Clinical Director/Supervisor .................................................. 22 ........................ 22 ........................ 44 

Counselor ............................................................................. 33 ........................ 33 ........................ 33 

Program Director .................................................................. 11 ........................ 11 ........................ 33 

Total .............................................................................. 719 ........................ 28,444 ........................ 8,404 

Note: Total number of respondents 

represents the number of each type of 

respondent that will be completing at least 

one tool across eleven sites over one year of 

data collection. The number of respondents 

(719) reported on this table differs from Table 

A–1 total number of respondents (4,701) 

which reflects completion of all tools across 

eleven sites over one year of data collection. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by November 3, 2010 to: 

SAMHSA Desk Officer, Human 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61147 

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– 

7285. 

Dated: September 28, 2010. 

Elaine Parry, 

Director, Office of Management, Technology 

and Operations. 

[FR Doc. 2010–24847 Filed 10–1–10; 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: Assessment of the Underage 

Drinking Prevention Education 

Initiatives State Videos Project—New 

The Substance Abuse and Mental 

Health Services Administration’s Center 

for Substance Abuse Prevention (CSAP) 

is requesting Office of Management and 

Budget (OMB) approval of three new 

data collection instruments— 

• State Video Contacts Form. 

• Video Viewers Form. 

• Dissemination Update Online Form. 

This new information collection is for 

the assessment of the 2010–2013 

Underage Drinking Prevention 

Education Initiatives State Videos 

project. In 2007, four States participated 

in a pilot study to produce videos on the 

topic of underage drinking prevention. 

Based upon the success of those videos, 

10 additional States and 1 Territory 

were provided funds to produce videos 

in 2009. Contingent on available funds, 

CSAP hopes to invite approximately 10 

States/Territories per year to produce 

their own videos. 

Over the next 4 years, CSAP will 

conduct a process and outcome 

assessment of this project. The process 

assessment will focus on the 

experiences associated with planning 

and producing the State videos. The 

outcome assessment will examine the 

effectiveness of the State Videos project 

in meeting the core project objectives 

and will capture the State’s 

dissemination efforts. The process and 

outcome assessments will encompass 

State videos that will be produced in 

2010–2013 and those that were 

produced in 2007 and 2009. State 

contacts will be asked to update their 

dissemination information online if 

there have been changes in these figures 

during the previous 6 months, up 

through 2013. Additionally, data will be 

collected from viewers of the State 

videos using an online survey. 

The information will be collected 

from the primary contact employee 

designated by the States that have 

agreed to participate in the production 

of a video for the State Videos project. 

The viewers’ information will be 

collected from those who voluntarily 

decide to complete a short survey after 

seeing the video. 

SAMHSA/CSAP intends to support 

annual videos on State underage 

drinking prevention videos. The 

information collected will be used by 

CSAP to help plan for these annual 

video productions and provide 

technical assistance to the participating 

States. The collected information will 

also provide a descriptive picture of the 

initiative, indicate how the videos have 

been received, and highlight some 

factors that may be associated with 

successful dissemination outcomes. 

The information needs to be obtained 

using a combination of initial telephone 

interviews to collect process data, 

followed by online forms to collect 

outcome and dissemination data. A 

survey of viewers, collected online, will 

also be used to assess the effectiveness 

of the State videos in increasing 

awareness of the underage drinking 

prevention activities in these States. 

This information collection is being 

implemented under authority of Section 

501(d)(4) of the Public Health Service 

Act (42 U.S.C. 290aa). 

State staff members will be contacted 

once the video has been finalized. These 

State staff members will be asked to 

complete a short telephone interview 

that asks questions about the process of 

producing the State video. The State 

Video Contacts Form includes nine 

items about the State video, including: 

• State’s objectives for the video on 

underage drinking prevention. 

• Targeted audiences. 

• Satisfaction with technical 

assistance (TA) received. 

• Usefulness of preplanning 

materials. 

• Helpfulness of TA during different 

phases of production. 

• Recommendations for improving 

the process. 

• Recommendations for improving 

the content of the video. 

• Advice to other States interested in 

producing a video. 

If the State has disseminated the 

video at the time of the initial telephone 

interview, then they will also be asked 

to complete the second part of the State 

Video Contacts Form, which collects 

information on dissemination outcomes. 

The State Video Contacts Form includes 

19 items about the dissemination 

activities of the State’s video, including: 

• Time when they disseminated the 

video. 

• Methods of dissemination. 

• Number of people who viewed the 

video. 

• Number of DVDs and videotapes 

requested. 

• Effectiveness of the dissemination 

methods. 

• Factors that contributed to the 

effectiveness of dissemination. 

• Effect of TA received. 

• Effect of the video in raising 

awareness about underage drinking 

prevention successes in the State. 

• Effect of the video in raising 

awareness about underage drinking 

prevention challenges in the State. 

• Effectiveness of the video in 

presenting State’s/Territory’s prevention 

activities. 

• Feedback received. 

• Unintended positive outcomes. 

• Effect of TA in improving the 

capacity to provide effective prevention 

services. 

After the State points of contact have 

completed the State Video Contacts 

Form online, they will be requested to 

update dissemination activities online if 

there have been any changes during the 

past 6 months. This form includes seven 

items, including: 

• If there have been changes in 

dissemination during the past 6 months. 

• Most recent dissemination numbers 

by method. 

• Facilitation factors. 

• Additional feedback. 

• Additional unintended positive 

outcomes. 

Data will also be collected from 

viewers of the State videos. Each State 

video will include instructions to 

viewers on how to access the Video 

Viewers Form. The instructions may be 

a unique URL, or they may consist of 

instructions on each State’s Web site on 

underage drinking prevention. This 

information will allow the CSAP to 

provide feedback to the States on their 

video and to measure the effectiveness 

of their video. The Video Viewers Form 

includes 24 items about the video, 

including: 


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