Sup Sta A_13ZC

Supporting Statement: Part A

Case Studies to Explore Interventions that Support, Build, and Provide Legacy Awareness for Young Breast Cancer Survivors

Supported by:

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Public Health Service

Department of Health and Human Services

December 18, 2013

Government Project Officer:

Temeika L. Fairley, PhD

Health Scientist

Designated Federal Officer, ACBCYW

Office of Program and Policy Information

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

4770 Buford Hwy, NE MS K52

Atlanta GA 30341

OFFICE: 770-488-4518

FAX: 770-488-4760

Table of Contents

Part A: Justification

A1. Circumstances Making the Collection of Information Necessary

A2. Purpose and Use of Information Collection

A3. Use of Improved Information Technology and Burden Reduction

A4. Efforts to Identify Duplication and Use of Similar Information

A5. Impact on Small Businesses or Other Small Entities

A6. Consequences of Collecting the Information Less Frequently

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A9. Explanation of Any Payment or Gift to Respondents

A10. Assurance of Confidentiality Provided to Respondents

A11. Justification for Sensitive Questions

A12. Estimates of Annualized Burden Hours and Costs

A12-1.Estimated Annualized Burden Hours

A12-2.Cost to Respondents

A13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

A14. Annualized Cost to the Federal Government

A15. Explanation for Program Changes or Adjustments

A16. Plans for Tabulation and Publication and Project Time Schedule

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

A18. Exceptions to Certification for Paperwork Reduction Act

Attachments

1a Authorizing Legislation: Young Women’s Breast Health Education and Awareness Requires Learning Young Act of 2009

1b Authorizing Legisation: Public Health Service Act, Research and Investigation

2 Federal Register Notice

3 Case Study Framework

4 Site Selection Matrix

5 Similarities and Differences Across Case Types

6a Data Collector Non-disclosure Agreement

6b Introductory Letter

6c Introductory Email

6d Site Visit Preparation Call

6e Worksheet for Identifying Site Visit Interviewees

6f Worksheet for Scheduling Site Visit Interviews

7a Document Review Form

7b Observation Form

8 Interview Guide Matrix

9 Informed Consent

10a In-depth Interview Guide for Program Directors/Principal Investigators (Organizations that receive CDC DP11-1111 funding)

10b In-depth Interivew Guide for Program Managers (Organizations that receive CDC DP11-1111 funding)

10c In-depth Interview Guide for Program Staff Members (Organizations that receive CDC DP11-1111 funding)

10d In-depth Interview Guide for Program Partners (Organizations that receive CDC DP11-1111 funding)

11a In-depth InterviewGuide for Program Directors/Principal Investigators (Organizations that do not receive CDC DP11-1111 funding)

11b In-depth Interview Guide for Program Managers (Organizations that do not receive CDC DP11-1111 funding)

11c In-depth Interview Guide for Program Staff Members (Organizations that do not receive CDC DP11-1111 funding)

11d In-depth Interview Guide for Program Partners (Organizations that do not receive CDC DP11-1111 funding)

12 IRB Approval Letter

Overview

CDC plans to conduct exploratory case studies of up to 12 organizations to improve understanding of how these organizations develop and implement structured support services and/or educational materials for young breast cancer survivors (YBCS). Each selected organization will serve as a unique case and the unit of analysis. Eligible organizations include academic institutions, hospitals and cancer centers, non-profit organizations, and state health departments. A subset of organizations will be those that receive CDC funding to conduct activities for YBCS and a subset of organizations will be those that do not receive CDC funding for these activities. Information will be collected primarily through interviews with program directors/principal investigators, program managers, staff, and partner organizations. A maximum of 10 interviews will be conducted at each case study site. CDC will compile an inventory of activities being conducted across a variety of types of organizations, and the barriers and facilitators that are relevant to these efforts. The information to be collected will be used to identify promising practices that can be shared with all interested organizations to strengthen collaboration, planning, implementation, and sustainability of efforts to assist YBCS. OMB approval is requested for one year.

Case Studies to Explore Interventions that Support, Build, and Provide Legacy Awareness for Young Breast Cancer Survivors

1. Justification

A1. Circumstances Making the Collection of Information Necessary

About 1 in 8 (12%) women in the US will develop invasive breast cancer during their lifetime, and breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer (American Cancer Society [ACS], 2013). Furthermore, breast cancer is the leading cause of death in women aged 20 to 59. Although breast cancer can feel like an overwhelming diagnosis for any woman, young women may experience even more difficulties in adapting to treatment and follow-up care. Young breast cancer survivors (YBCS) are defined as women diagnosed with breast cancer under 45 years of age. For YBCS, the disease can be more serious, treatment is often multimodal and more toxic, and side effects can be more severe than for older women (Bloom, Stewart, Chang, & Banks, 2008; Bloom, Stewart, Oakly-Girvan, Banks, Shema, 2011). In addition, YBCS have higher locoregional recurrence (LRR) rates compared to older women, and they are more likely to die of the disease due to a poorer survival rate in early-stage diagnoses (Gnerlich et al., 2009).

In addition, the reproductive and psychosocial health needs of YBCS (e.g., counseling about premature menopause, fertility changes) are often overlooked. Recent studies have shown that YBCS experience more psychological morbidities and emotional distress and experience different types of fears and anxieties than older survivors, especially related to reproductive health (Howard-Anderson et al., 2012). However, there is limited evidence to support those strategies that are most effective in mitigating the short- and long-term effects of breast cancer in this population. Therefore, it is imperative that organizations seeking to meet the psychosocial needs of YBCS are effective in developing and disseminating information and providing support services to YBCS, their families, caregivers, and healthcare providers.

In March 2010, as part of the Patient Protection and Affordable Care Act, Congress passed the Young Women’s Breast Health Education and Awareness Requires Learning Young Act (Public Law 111-148, Sec. 10413; see Attachment 1a), which directed the CDC to develop and implement national campaigns to educate young women (particularly those at increased risk) and health care providers about breast cancer risk and early diagnosis. As a result of this Act, CDC responded to the critical need for improved education for health care providers, young women, (specifically those at increased risk for breast cancer), and caregivers about the need for increased access to support services for YBCS and their families/caregivers, by establishing cooperative agreements with select organizations serving YBCS. Specifically, CDC awarded 3-year cooperative agreements to seven organizations under the Funding Opportunity Announcement DP11-1111, Developing Support and Educational Awareness for Young (< 45 years of age) Breast Cancer Survivors in the United States (U.S.).

Funding Opportunity Announcement DP11-1111 aims to provide additional resources to organizations that have demonstrated a capacity to reach YBCS, health care providers, and caregivers and implement interventions that seek to provide support services and develop educational and awareness resources aimed at enhancing patient and provider knowledge of health behaviors, knowledge, attitudes, abilities (KAB) and other strategies that can reduce the risk of recurrences, development of new malignancies, chronic disease onset, and improving overall health and quality of life. This funding provides each organization with the resources to create new or enhance ongoing initiatives related to the provision of structured support services and the development of educational resources for YBCS. This program addresses the following “Healthy People 2020” focus areas: (1) increasing the proportion of cancer survivors who report physical health-related quality of life similar to the general population; (2) reducing the overall cancer death rate; and (3) reducing the female breast cancer death rate (United States Department of Health and Human Services [HHS], Healthy People 2020, 2011).

In addition to the organizations participating in the DP11-1111 cooperative agreement, many organizations nationwide are currently developing and/or implementing initiatives to provide educational resources and support services to YBCS, their families/caregivers, and/or health care providers who provide services to YBCS. There are many different kinds of organizations involved in these kinds of interventions, including but not limited to: universities and academic centers; hospitals and cancer centers; non-profit organizations; and state health departments. In addition to sharing similar target audiences, these entities may employ similar tools and strategies to reach their target audiences, and plan and implement key intervention activities.

CDC proposes to conduct multiple case studies with up to 12 organizations that have developed or are implementing structured support services and/or educational materials for YBCS. The approach to conducting these case studies will be guided by a set of structured research questions and sub-questions designed to explore organizations’ strategies and activities with respect to their YBCS interventions. CDC’s authority to collect this information is provided by the Public Health Service Act, 42 USC 241, Research and Investigation (Attachment 1b). The case study research questions and sub-questions align with proposed indicators, data sources, methodology, and analyses of interest to CDC (see Attachment 3, Case Study Framework). The specific research questions guiding this project include:

• What are the core components of the DP11-1111 cooperative agreement?

• What are the factors that affect the implementation of DP11-1111 programmatic activities?

• What support services and educational resources have organizations developed and/or implemented as a part of their intervention targeting YBCS?

• What are the factors that affect the implementation of support services and educational resources?

• How have CDC’s technical assistance (TA) and support activities contributed to grantees’ capacity and sustainability efforts?

• How have organization’s interventions affected awareness for, access to, and utilization of support services and educational resources among YBCS, health care providers, and families/caregivers?

• How have DP11-1111 grantees’ interventions affected knowledge, attitudes and behaviors among YBCS, health care providers, and families/caregivers related to the risks for breast cancer in young women?

The proposed case studies are intended to serve as an exploration of implementation activities to provide lessons learned and inform the defining of promising practices for other national organizations and academic institutions to plan and implement interventions targeting YBCS. Each organization will serve as a unique case within the multicase study project. Cases were selected using purposeful sampling to allow for the selection of cases that provide the most in-depth information about the YBCS interventions as relevant to the study (Patton, 1990) (Attachment 4). Select cases also have a shared interest in similar target populations (YBCS, families/caregivers of YBCS, and health care providers providing services to YBCS). Select cases include two overarching program types: (1) Organizations currently receiving funding through the DP11-1111 cooperative agreement, and (2) Organizations that do not receive funding through the DP11-1111 cooperative agreement.

Given that CDC could only fund a limited number of YBCS interventions, a main purpose of including up to 12 cases, including organizations currently funded by the DP11-1111 cooperative agreement and organizations receiving funding and support from other entities, is to provide a broader understanding of YBCS interventions across various types of organizations and create an “inventory” of existing efforts across the U. S. aimed at providing education and support to YBCS. CDC does not intend to “match” selected grantee and nonfunded organizations in order to carry out these case studies, or determine the specific effect of CDC funding; rather, CDC anticipates that including both grantee and nonfunded organizations will allow CDC to identify and explore distinct similarities and differences between these two case types with respect to specific organizational attributes (see Attachment 5, Similarities and Differences across Case Types).

Privacy Impact Assessment

The proposed study involves a minimum amount of information in identifiable form (IIF); the information to be obtained through interviews concerns organizational activities and priorities rather than personal matters and is not considered highly sensitive. Respondents will be recruited from the organizations that implement YBCS interventions and have been selected for case study participation. The data collection contractor, ICF International (ICF), will have access to contact information for the Program Director/Principal Investigator of each selected organization, including telephone numbers and e-mail addresses, in order to recruit and schedule their participation in the case study.

IIF will be stored separately from response data. A linking file will be created and available only to senior project management at the data collection contractor, ICF International. This information only will be used to ensure completeness of the data files. The linking file will include the role of the respondent and their organization (and will not include the individual’s name or contact information), the date of interview, and the code assigned to the data file. This will ensure that no personally identifiable information, outside of the individual’s role and organization, is re-linkable. In addition, all data collectors will be asked to complete a Data Collector Non-disclosure Agreement prior to conducting data collection during site visits (Attachment 6a) and will be trained on the project’s protocol and procedures related to security requirements and privacy.

During interviews, respondents may be asked to identify and describe entities and key staff members and/or partners, who have familiarity with or responsibility for their organization’s YBCS interventions. No contact information will be collected for individuals who are discussed during the interviews with key respondents. The purpose of collecting information about key staff and partners is to guide CDC in identifying the number and types of individuals that should be engaged in similar efforts across various settings. The information collected will be concentrated on the roles of individuals engaged in YBCS efforts, not personal information about the individual in that role.

Overview of the Data Collection System

Case studies will be conducted with up to 12 organizations over an approximate 12-month period to explore the capacity of select organizations to serve YBCS, the strategies and tools used by organizations to support YBCS, and the factors that affect implementation of these strategies.

Upon OMB approval, each site will be sent an Introductory Letter and Introductory Email (Attachments 6b & 6c) to provide them with detailed information about the case study project, including roles and expectations and to confirm their participation in the project. Each site will be asked to participate in a 2.5 day site visit for data collection via interviews with pre-identified individuals that support the YBCS intervention(s) within each organization and on-site observation of program implementation. CDC will schedule a conference call with each site and use the Script for Site Visit Preparation to schedule case study site visits (Attachments 6d); site staff will be asked to assist in planning their organization’s respective case study site visit. Sites will help to identify the most appropriate key staff members and partners to participate in case study interviews and determine appropriate times/locations for each interview (Attachments 6e & 6f). Any changes to the schedule and/or individuals selected for participation will be discussed with the site until a final schedule is agreed up on. Site visits will be conducted by teams of two ICF (contractor staff), including at least one senior staff member and one supporting staff member.

Prior to scheduled case study site visits, CDC will systematically review pertinent program documents for each respective case (see Attachment 7a, Document Review Form). In addition, CDC will share data that DP11-1111 funded organizations report (e.g., performance monitoring data) with ICF team members to inform understanding of grantee programs prior to each site visit (note that that these data are different than those being collected via these case studies). Information related to organizational structure, YBCS intervention activities, program capacity, program sustainability, and intended outcomes of each YBCS intervention will be assessed to provide site reviewers/interviewers with foundational information about each organization and their YBCS intervention(s). Preparing for the site visit in this way will help interviewers keep the interview focused on new information that is not already available from existing sources, thus avoiding unnecessary burden on respondents. In addition, ICF site visit staff will record on-site observations of key programmatic activities (see Attachment 7b, Observation Form). These activities will provide important context for interpreting interview findings, but will not impose burden on respondents.

In-depth interview (IDI) guides are tailored for each respondent type and include questions and probes designed to gather the most pertinent information across respondent types, with some questions and probes asked across all respondent types and some questions and probes specific to individual respondent types (see Attachment 8, Interview Guide Matrix). During site visits, in-depth interviews will be conducted with up to 10 identified key staff and partners at each site. Respondents at each site will typically include a Program Director/Principal Investigator (1), Program Manager (1), Program Staff Members (5), and Program Partners (3). At the start of each interview, the interviewer will explain the nature of the data collection to each interview respondent. The interview will include an oral consent process that indicates the voluntary nature of participation as well as the purposes and uses of the information collection (Attachment 9). To reduce burden and ensure that questions are tailored to each respondent type, separate interview guides have been created for organizations that have received CDC DP11-11111 funding (Program Directors/Principal Investigators (Attachments 10a); Program Managers/Coordinators (Attachments 10b); Program Staff Members (Attachments 10c); and Program Partners (Attachments 10d)); and for organizations that did not receive CDC DP11-11111 funding (Program Directors/Principal Investigators (Attachment 11a); Program Managers/Coordinators (Attachments 11b); Program staff (Attachments 11c); and Program Partners (Attachments 11d). Personal information in identifiable form (IIF) will not be collected.

Items of Information to be Collected

The document review will include a comprehensive review of pertinent program documents from each selected site, such as annual reports, budgets, evaluation documents, marketing materials, and YBCS intervention materials.

The topics to be addressed during the site visit interviews, using the interview guides, include:

• Organizational context

  • Mission

  • History

  • Setting/infrastructure

  • Role in the organization

• Implementation of the DP11-1111 cooperative agreement

  • Core components of the cooperative agreement

  • Training/technical assistance

  • Resources

  • Facilitators

  • Barriers

• Implementation of the YBCS organization

  • Intervention overview, history, and rationale

  • Intervention execution

  • Implementation fidelity

  • Resources

  • Facilitators

  • Barriers

• Evaluation

  • Knowledge

  • Measurement

  • Facilitators

  • Barriers

• Partnerships

  • Development and engagement

  • Contribution to the intervention

• Capacity and sustainability

  • Capacity to meet the requirements of the cooperative agreement

  • Capacity to implement the intervention

  • Capacity to evaluate

  • Sustainability of the intervention

• Perceptions

  • Awareness

  • Access

  • Utilization

  • YBCS knowledge, attitudes, and beliefs (KAB)

  • Value of the cooperative agreement

  • Value of the YBCS intervention

  • Lessons learned

  • Recommendations

To minimize burden on respondents, skilled interviewers will utilize in-depth interview (IDI) guides to ask only the most relevant questions and probes for each respondent type. On-site program observation will focus on documenting details regarding programs’ processes for planning and implementing key YBCS intervention activities.

The unit of analysis is the site/organization that is implementing the YBCS intervention. The information collected will be analyzed and the results used to develop both site-specific and cross-site reports.

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

This information collection does not involve Web-based data collection methods or refer respondents to Websites. There are no Websites with content directed at children under 13 years of age. There are no issues of privacy related to Web-based data collection for this information collection.

A2. Purpose and Use of Information Collection

The purpose of the proposed case studies is to explore implementation activities of organizations targeting YBCS through the use of support services and/or educational resources. CDC will use the findings from this study for the following purposes:

• Describe the DP11-1111 cooperative agreement in terms of implementation of the core programmatic activities, and gain a deeper understanding of the challenges and achievements.

• Inventory the educational resources and support services organizations have developed and/or use to target YBCS, and describe the process used to develop, implement, and evaluate these strategies.

• Highlight barriers and facilitators that organizations face in developing, implementing, and/or evaluating interventions targeting YBCS.

• Identify similarities and differences among the organizations receiving funding through the DP11-1111 cooperative agreement and other organizations serving YBCS in terms of organizational factors, capacity, resources, and other contextual factors.

• Identify lessons learned that can be shared with both DP11-1111 grantees and nonfunded organizations to strengthen planning, implementation, and sustainability of YBCS efforts.

• Gain a better understanding of CDC’s role in sustaining YBCS interventions and activities by increasing the knowledge base and facilitating collaboration among YBCS-focused organizations.

• Inform priority areas and activities carried out by CDC’s Advisory Committee on Young Women with Breast Cancer for developing and informing initiatives to increase knowledge of breast cancer among young women.

• Inform promising practices that can be used by other organizations in various settings to reach and provide support to YBCS.

Privacy Impact Assessment Information

The unit of analysis for this project is the organization implementing any YBCS intervention(s).

The proposed data collection will focus on the characteristics and activities of sites/organizations, not that of individual respondents. Contact information collected for respondents will be used to schedule interviews; however, only the individual’s role, organization, email address, and telephone number will be recorded in the data linking file. The respondent’s contact information will remain separate from the data collection. No other personal identifiers will be collected. Contact lists for respondents will be destroyed after interview is completed.

A3. Use of Improved Information Technology and Burden Reduction

The proposed information collection is exploratory in nature, primarily based on qualitative data collection related to programs’ characteristics and activities through in-depth interviews and on-site observations. To minimize burden on respondents and to streamline the on-site interviews, CDC will summarize pertinent information for interviewers from existing, publicly available sources and conduct a pre-site visit document review of required cooperative agreement reports previously submitted to CDC’s Procurement and Grants Office (PGO). Examples of documents previously submitted to PGO could include, but are not limited to, the following:

• Annual progress reports

• Annual budgets

• Evaluation documents (e.g., logic models, evaluation plans, data collection instruments)

• Marketing materials

• Toolkits

A4. Efforts to Identify Duplication and Use of Similar Information

The proposed information collection is unique and does not duplicate the information currently being collected by CDC or other entities. For those organizations that are currently funded under the DP11-1111 cooperative agreement, the information to be collected through in-depth interviews is not available from the awardee’s routine progress reports or conference calls with CDC project officers. For those organizations not funded through the cooperative agreement, there is no existing data documenting implementation of their YBCS intervention. Therefore, data collected via case studies will be unique and necessary to build CDC’s understanding of each organization’s experience in planning, implementing, and evaluating YBCS interventions and the context for which these interventions are implemented.

A5. Impact on Small Businesses or Other Small Entities

Some small organizations, such as selected national organizations currently implementing YBCS interventions, will participate in the case studies. Specifically, they will be asked to participate in in-depth interviews and on-site observations as part of the case study site visits. There are no specific requirements for small businesses or ongoing requirements.

A6. Consequences of Collecting the Information Less Frequently

This information collection is critical to expanding CDC’s understanding of current efforts to provide educational resources and support services to YBCS. Data will be collected from each site at one time point. Without this information, CDC’s Division of Cancer Prevention and Control, and CDC’s Advisory Committee on Breast Cancer in Young Women (ACBCYW), will have limited capacity to plan and assist initiatives for YBCS.

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances relating to the guidelines of 5 CFR 1320.5 and the project fully complies.

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A8a. The 60-Day Federal Register Notice was published on July 15, 2013, Vol. 78, No. 135, pages 42076-42078] (see Attachment 2). No public comments were received.

A8b. Key informant interviews were conducted with leaders from DP11-1111 grantee organizations to better understand the current strategies being implemented; information gathered through these interviews informed the overall design of this study and the development of specific research questions. All data collection instruments, including the in-depth interview (IDI) guides, document review form, and observation form, were designed with input from members of the YBCS project team at CDC and ICF.

A9. Explanation of Any Payment or Gift to Respondents

Interview respondents will not receive any payment or gifts for their participation in this data collection effort.

A10. Assurance of Confidentiality Provided to Respondents

As previously stated, this information collection will focus on the characteristics and activities of sites/organizations, not that of individual respondents or personal matters. This information is not considered to be highly sensitive. Contact information collected for respondents will be used to schedule interviews; however, only the individual’s role, organization, email address, and telephone number will be recorded in the data linking file. All IIF will be stored separately from response data. A linking file will be created and available only to ICF project management staff. This information will only be used to ensure completeness of the data files. The linking file will include the role of the respondent and their organization (it will not include the individual’s name or contact information), the organization or institution with which they are affiliated, the date of the case study site visit/interview, and the code assigned to the data file. This will ensure that no personally identifiable information, outside of the individual’s role and organization/institution can be linked to response data. The linking file will be an administrative file used by the ICF International team and will not be available to CDC staff. Outside of the linking file, no personal identifiers will be maintained that would allow contractor team members or CDC staff to link a participant’s responses to his or her name. The IIF used for recruitment and scheduling purposes will not be linkable to the response data collected subsequently.

Organizations currently receiving funding through the DP11-1111 cooperative agreement are required to participate in the case study if requested to do so by CDC as stated within the DP11-1111 cooperative agreement; however, participation in interviews is voluntary for all participants, including both those that represent DP11-1111 funded organizations and those not funded through the DP11-1111 cooperative agreement. Information about participating organizations, not individuals, will be summarized in final reports for CDC.

IRB approval has been obtained for conduct of these case studies (Attachment 12).

A. Privacy Act Determination

CDC has determined that Privacy Act does not apply. Respondents will be providing information about their roles as representatives of these organizations and will not provide personal information during the interviews. The contractor, ICF International, will maintain a minimum amount of identifiable contact information (IIF, including name, role, work telephone number and work email address) in order to schedule interviews with respondents. Respondents will provide information on organizational structure, infrastructure, and YBCS-specific intervention activities. The IIF will be maintained in a document that is separate from the interview response data and separate from the linking file, which will contain only respondent role and organization to ensure that response data remain de-identified.

Selected respondents will be asked to identify organizations and individuals who are key staff and/or partners familiar with or responsible for their organization’s YBCS intervention(s). No contact information will be collected for these individuals. The focus of this study is in the roles of the individuals engaged, and not the person/individual in that role.

2. Safeguards

Although the data collection contractor will have temporary access to identifiable information for recruitment and scheduling purposes, response data will not be recorded in a manner that can be linked to respondent identifiers. Each interview respondent will be assigned a unique identifier code. Information collected during case study interviews will be stored and analyzed by identifier code. The personal contact information for respondents will not be shared with CDC or used for reporting purposes. All data collected will be compiled in site-specific and cross-site reports that do not contain any personal identifiers.

Audio recordings of the interviews will be destroyed after the notes and/or transcripts are complete. All electronic project files (e.g. digital audio recordings, notes and transcripts) will be stored at ICF on a project shared drive on ICF’s secure network servers; only project staff who have been authorized by the project manager can access the shared drive. All paper files will be stored and locked in a project file cabinet at ICF, which will be accessible only to select project staff. All data files (e.g., notes, documents, data) will be destroyed three years following the completion of the project.

3. Consent

The data collection contractor will explain the nature of the data collection to each interview respondent. The interview will include an oral consent process that indicates the voluntary nature of participation as well as the purposes and uses of the information collection. The script for the oral consent is provided in Attachment 9, which includes the statement, “Data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law.” Attachment 9 also describes the safeguards to prevent connecting responses to specific responses, such as the method for assigning codes to interviews, the destruction of the list of names and contact information upon completion of interview scheduling, and the aggregate nature of the analysis and reporting.

4. Nature of Participation

As previously stated, organizations currently receiving funding through the DP11-1111 cooperative agreement are required to participate in this information collection as stated within the DP11-1111 cooperative agreement. However, participation in interviews is voluntary for all participants for individuals that represent DP11-1111 funded organizations or those not funded through the DP11-1111 cooperative agreement.

A11. Justification for Sensitive Questions

The interview guides do not ask any personally invasive or sensitive questions . Some of the information relates to perceived organizational impact could be interpreted as “sensitive” by respondent(s). Provision of the information by respondents is voluntary and respondents will be assured that there is no penalty if he/she decides not to respond, either to the information collection as a whole or to any particular question.

A12. Estimate of Annualized Burden Hours and Costs

1. Estimated Annualized Burden Hours

Information will be collected in-person through in-depth interviews with key individuals from up to 12 participating organizations. CDC estimates that 7 of the participating organizations will be from the private sector (4 organizations that receive CDC funding, and 3 that do not receive CDC funding). CDC also anticipates that 5 of the 12 participating organizations will be from the state, local, and tribal government sector (3 organizations that receive CDC funding, and 2 that do not receive CDC funding). A summary of proposed participants, by type and CDC funding status, is provided in Attachment 4, Site Selection Matrix.

Interviews will be conducted with a maximum of 10 respondents per site. Respondents at each site will consist of: 1 Program Director/Principal Investigator, 1 Program Manager, up to 5 Program Staff Members, and up to 3 Program Partners. A tailored in-depth interview (IDI) guide will be developed for each type of respondent. Some questions will be asked of all respondents, and some questions will be specific to the type of respondent. The estimated length of the interview for each Program Director/Principal Investigator is 2 hours (see Attachments 10a and 11a). For all other respondents, the estimated length of the interview is 1 hour (see Attachments 10b, 10c, 10d, 11b, 11c, and 11d).

Each participating organization will work with CDC and the data collection contractor to identify appropriate key informants and to schedule their interviews. The Worksheet for Identifying Site Visit Interviews is included as Attachment 6e. The estimated burden per response is 1 hour. The Worksheet for Scheduling Site Visit Interviews is included as Attachment 6f. The estimated burden per response is 2 hours.

For all information collection, the total estimated burden to respondents is 168 hours, as summarized in Table A12-1 below.

Table A12-1. Estimated Annualized Burden Hours

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hr)	Total Burden (in hr)
Private Sector Organizations	Worksheet for Identifying Site Visit Interviews	7	1	1	7
	Worksheet for Scheduling Site Visit Interviews	7	1	2	14
	IDI Guide for Program Directors/ Principal Investigators	7	1	2	14
	IDI Guide for Program Managers	7	1	1	7
	IDI Guide for Program Staff Members	35	1	1	35
	IDI Guide for Program Partners	21	1	1	21
State, Local, and Tribal Government Organizations	Worksheet for Identifying Site Visit Interviews	5	1	1	5
	Worksheet for Scheduling Site Visit Interviews	5	1	2	10
	IDI Guide for Program Directors/ Principal Investigators	5	1	2	10
	IDI Guide for Program Managers	5	1	1	5
	IDI Guide for Program Staff Members	25	1	1	25
	IDI Guide for Program Partners	15	1	1	15
	Total				168

2. Estimated Annualized Burden Costs

Table A12-2 presents the calculations for cost of annualized burden hours. Average hourly wage estimates were obtained from the U.S. Department of Labor, Bureau of Labor Statistics. The average annual salary of $114,850 for general and operational managers was used to calculate the hourly wage of $55.22 for Program Directors/Principal Investigators and Program Partners.  The average annual salary of $64,460 for social and community service managers was used to calculate the hourly wage of $30.99 for Program Managers. For Program Staff, the average annual salary of $53,100 for health educators was used to calculate the hourly wage of $25.53. The estimated annualized cost to respondents is $6,136, as summarized below in Table A.12-2.

Table A12-2. Estimated Annualized Cost to Respondents

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Average Hourly Wage	Total Burden (in hours)	Total Cost
Private Sector Organizations	Worksheet for Identifying Site Visit Interviews	7	1	1	$25.53	7	$179
	Worksheet for Scheduling Site Visit Interviews	7	1	2	$25.53	14	$357
	IDI Guide for Program Directors/ Principal Investigators	7	1	2	$55.22	14	$773
	IDI Guide for Program Managers	7	1	1	$30.99	7	$217
	IDI Guide for Program Staff Members	35	1	1	$25.53	35	$894
	IDI Guide for Program Partners	21	1	1	$55.22	21	$1,160
State, Local, and Tribal Government Organizations	Worksheet for Identifying Site Visit Interviews	5	1	1	$25.53	5	$128
	Worksheet for Scheduling Site Visit Interviews	5	1	2	$25.53	10	$255
	IDI Guide for Program Directors/ Principal Investigators	5	1	2	$55.22	10	$552
	IDI Guide for Program Managers	5	1	1	$30.99	5	$155
	IDI Guide for Program Staff Members	25	1	1	$25.53	25	$638
	IDI Guide for Program Partners	15	1	1	$55.22	15	$828
	Total					132	$6,136

A13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no other costs to respondents or record keepers.

A14. Annualized Cost to the Federal Government

Government personnel – Governmental costs for this project include personnel costs for federal staff involved in providing oversight and guidance for the planning and design of the YBCS multicase study, development of data collection instruments and OMB materials, collection and analysis of the data, and reporting. These activities involve approximately 5 percent of two GS-14 behavioral scientists’ and one GS-12 public health advisor’s time. Assuming a $100,000 annual salary for behavioral scientists and an $70,000 annual salary for public health advisors, the total estimated annualized cost to the Federal Government is $13,500.

Contracted data collection –The project design and data collection is being conducted under a contract with CDC’s data collection contractor, ICF International. Approximately $645,195 of ICF International’s current contract ($921,707) with CDC is dedicated for this information request to plan, implement, and analyze the data collection.

Table A14-1. Estimated Annualized Cost to the Federal Government
Labor:
5% Behavioral Scientist’s time for project, planning, management, OMB review, analysis of findings, and report writing	$5,000
5% Behavioral Scientist’s time for project, planning, management, OMB review, analysis of findings, and report writing	$5,000
5% Public Health Advisor’s time for project, planning, management, OMB review, analysis of findings, and report writing	$3,500
Contractor	$645,195
Total estimated cost	$658,695

A15. Explanation for Program Changes or Adjustments

This is a new data collection.

A16. Plans for Tabulation and Publication and Project Time Schedule

A16-1 Survey Time Schedule
Activity	Time Schedule
Send introductory letters	1 month after OMB approval
Hold telephone call to plan case study site visit	2 months after OMB approval
Conduct document review	2 months after OMB approval
Conduct case study site visits	3-12 months after OMB approval
Analyze and Report on case study findings	12-16 months after OMB approval

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB expiration date will be displayed. No exemption is requested.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

Not applicable. No certification exemption is being sought.

References

American Cancer Society (2013). Breast cancer: What are the key statistics about breast cancer? Retrieved March 1, 2013, from http://www.cancer.org/cancer/breastcancer/

detailedguide/breast-cancer-key-statistics

Bloom, J. R., Stewart, S. L., Oakley-Girvan, I., Banks, P.J., & Shema, S. (2011, May 2). Quality

of life younger breast cancer survivors: Persistence of problems and sense of well-being [e-pub ahead of print]. Psychooncology, 1–9. doi: 10.1002/pon.1965

Gnerlich, J.L, Deshpande, A.D., Jeffe, D.B., Sweet, A., White, N., & Margenthaler, J.A. (2009). Elevated breast cancer mortality in women younger than age 40 years compared with older women is attributed to poorer survival in early-stage disease. Journal of the American College of Surgeons, 208(3), 341–347.

Howard-Anderson, J., Ganz, P.A., Bower J.E., Stanton, A.L. (2012). Quality of life, fertility

concerns, and behavioral health outcomes in younger breast cancer survivors: a systematic review. Journal of the National Cancer Institute, 2012 March 7;104(5):386–405.

Patton, M. (1990). Qualitative evaluation and research methods (pp. 169-186). Beverly Hills, CA: Sage.

United States Department of Health and Human Services. Office of Disease Prevention and Health Promotion. Healthy People 2020. Washington, DC. Available at http://www.healthypeople.gov/2020/default.aspx. Accessed May 31, 2013.

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