31958 Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 

National Vaccine Program Office, 

Department of Health and Human 

Services, Room 715–H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

Phone: (202) 690–5566; Fax: (202) 260– 

1165; e-mail: nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. section 300aa–1), 

the Secretary of Health and Human 

Services was mandated to establish the 

National Vaccine Program to achieve 

optimal prevention of human infectious 

diseases through immunization and to 

achieve optimal prevention against 

adverse reactions to vaccines. The 

National Vaccine Advisory Committee 

was established to provide advice and 

make recommendations to the Director 

of the National Vaccine Program on 

matters related to the Program’s 

responsibilities. The Assistant Secretary 

for Health serves as Director of the 

National Vaccine Program. 

These are special meetings of the 

NVAC. Discussions will surround issues 

related to the Novel Influenza A (H1N1) 

outbreak. The Committee will discuss 

the activities and actions of the various 

HHS agencies and Federal advisory 

committees that address vaccine issues 

as it relates to the mission of NVAC. 

Representatives of State and local health 

associations will also provide their 

perspective. 

For these special meetings, members 

of the public are invited to attend by 

teleconference via a toll-free call-in 

phone number. The call-in number will 

be operator assisted to provide members 

of the public the opportunity to provide 

comments to the Committee. Public 

participation and ability to comment 

will be limited to space and time 

available. Public comment will be 

limited to no more than three minutes 

per speaker. Pre-registration is required 

for both public attendance and 

comment. Individuals who plan to 

attend and need special assistance, such 

as accommodation for hearing 

impairment or other reasonable 

accommodations, should notify the 

designated contact person at least one 

week prior to the meeting. 

Any members of the public who wish 

to have printed material distributed to 

NVAC should submit materials to the 

Executive Secretary, NVAC, through the 

contact person listed above prior to 

close of business one week before each 

meeting (conference call). A draft 

agenda and any additional materials 

will be posted on the NVAC Web site 

(http://www.hhs.gov/nvpo/nvac/) prior 

to the meeting. 

Dated: June 29, 2009. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office. 

[FR Doc. E9–15782 Filed 7–2–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed 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 

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 3-year 

period of grant funding for each cohort. 

Clearance is requested for a 3-year 

period of data collection that spans FY 

2009 through FY 2012 during which 

Cohorts 3 and 4 will receive 3 years of 

data collection and Cohort 5 will receive 

2 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 9 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, 

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Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 31959 

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; 

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 grant 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—Followup Interviews (1 

Version). The GONA followup 

interviews will be conducted several 

weeks after the GONA in each 

community. Followup interviews will 

center around the four values 

(belonging, master, 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 in each funded community. 

Items are formatted as open-ended and 

semi-structured questions. The GONA 

followup interviews include 11 

questions and will take approximately 

60 minutes to complete. These followup 

interviews will occur during a site visit 

in year 1 of each grant 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 Followup Focus 

Group Moderator’s Guide (1 Version). 

The GONA followup 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 Followup 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 of each grant 

for Cohorts 3, 4 and 5. Focus group 

guides contain 11 items and 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 FollowUp 

Youth Focus Group Caregiver Consent 

form and youth will assent to 

participate using the GONA FollowUp 

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 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 of the grant 

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 of 

the grant. 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 of the 

grant 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 of the grant. 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 

grant. 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 and Version 2 

participants will include non-agency 

staff such as paraprofessional providers 

and/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 

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31960 Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 

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) of the grant. 

Two focus groups will be conducted 

with agency staff using Version 1, for a 

maximum total of 900 respondents 

across the life of the grant. One focus 

group will be conducted with nonagency staff using Version 2 for a 

maximum number of 450 participants 

across the life of the grant 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 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 3 years of 

the grant, 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 3 

years of the grant, to 100 Native youth 

from each funded community. The 

survey consists of 38 open and closedended 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 6 

dimensions focused an 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 

9 developmental levels of readiness 

within a community that must progress 

through. CRAs include 26 interview 

questions which address each of the 6 

community readiness dimensions; most 

items are formatted as open-ended 

questions with 3 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 obtaining 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. Crosscommunity 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 

activities. These data will be aggregated 

from existing data sources, some of 

which are attendance sheets, 

management information systems, etc. 

Grantees 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 activities) in each 

community will perform data 

abstraction and submission for a total of 

175 respondents and 2,100 hours across 

3 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 and/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 

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Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 31961 

respondents, the average annual number 

of responses, the time it will take for 

each response, and the average annual 

burden across 3 years of OMB clearance, 

which includes 3 years of data 

collection for Cohorts 3 and 4 and two 

years of data collection for Cohort 5. 

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 ....................................................................... 50 1 0.33 17 

GONA Follup Interviews ........................................................................... 75 1 1.0 75 

GONA Youth Followup 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 

Cross Community Data Collection Activities—Tier II: 

Service Provider Focus Groups—V. 2 ..................................................... 126 1 2.0 252 

C-KABS Adult Version .............................................................................. 2,234 1 0.75 1,676 

C-KABS Youth Version ............................................................................ 2,234 1 0.75 1,676 

Community Readiness Assessment1 ....................................................... 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. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: June 26, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–15915 Filed 7–2–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day-09–0556] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assisted Reproductive Technology 

(ART) Program Reporting System (0920– 

0559, exp. 9/30/2009)—Revision— 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The ART program reporting system is 

used to comply with section 2(a) of 

Public Law 102–493 (known as the 

Fertility Clinic Success Rate and 

Certification Act of 1992 (FCSRCA)), 42 

U.S.C. 263a–1(a)). FCSRCA requires 

each ART program to annually report to 

the Secretary through the CDC: the 

pregnancy success rates achieved by 

each ART program, the identity of each 

embryo laboratory used by the ART 

program, and whether the laboratory is 

certified or has applied for certification 

under the Act. The reporting system 

also makes it possible for the CDC to 

publish an annual success rate report to 

Congress as specified by the FCSRCA. 

This Revision request includes minor 

wording changes to improve the clarity 

of the question concerning preimplantation genetic diagnosis (PGD), 

and an increase in the total estimated 

burden hours due to an increase in the 

estimated number of responses. 

Information is collected electronically 

through the National ART Surveillance 

System (NASS), a Web-based interface, 

or by electronic submission of NASScompatible files. The NASS includes 

information about all ART cycles 

initiated by any of the ART programs 

practicing in the United States and its 

territories. The system also collects 

information about the pregnancy 

outcome of each cycle as well as a 

number of data items deemed important 

to explain variability in success rates 

across ART programs and individuals. 

Respondents are the 483 ART 

programs in the United States. 

Approximately 430 programs are 

expected to report an average of 321 

ART cycles each. The burden estimate 

includes the time for collecting, 

validating, and reporting the requested 

information. Information is collected on 

an annual schedule. 

There are no costs to the respondents 

other than their time. The total 

estimated annualized burden hours are 

89,720. 

Estimated Annualized Burden Hours 

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

ART Programs ................................................ NASS .............................................................. 430 321 39/60 

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