SS-Part A 01 10 2012

Authorizing legislation, Sections 301 (a) and 317 (k) of the Public Health Service Act
FRN and Comments on FRN
1. Federal Register Notice
2. Comments on Federal Register Notice
DNPAO “Recommended Community Strategies and Measurements to Prevent Obesity in the United States: Implementation and Measurement Guide”
Program Nomination
1. Nomination Form: Microsoft Word format
2. Nomination Form: Web-based format (screen shots from Zoomerang)
3. Nomination Solicitation Email
Site Visit Planning
1. Site Visit Availability Calendar
2. Suggested Interviewees Form
3. Notification of Selection (email and letter)
4. FAQs
5. Site Visit Schedule Instructions and Template
Lead Administrator Interview Guide
Evaluator Interview Guide
Program Staff Interview Guide
Interview Guide for Public and Private Sector Partners/Other Stakeholders
Environmental Observation Form
Non-Disclosure agreement for Data Collection Contractors
Oral Informed Consent Form
Expert Consultants Site Selection Guidance Document

A. Justification

A.1 Circumstances Making the Collection of Information Necessary

Obesity is a medical condition that affects over one-third of the adult population in the United States—more than 72 million people—and 17% of children. From 1980 through 2008, obesity rates for adults doubled and rates for children tripled. Obesity has physical, psychological, and social consequences for adults and children. Children and adolescents are now developing obesity-related diseases, such as type 2 diabetes, that in the past were seen only in adults. Other health consequences of obesity include coronary heart disease, cancers, high blood pressure, and stroke. Moreover, the financial costs of obesity-related medical care costs were estimated in 2008 to be as high as $147 billion.

The causes of obesity in the United States are complex and numerous, and they occur at social, economic, environmental, and individual levels.¹To address the complex nature of obesity, the Centers for Disease Control and Prevention (CDC) encourages states to adopt public health strategies that address obesity through environmental change and policies that promote healthy eating and physical activity.² CDC’s Division of Nutrition, Physical Activity and Obesity (DNPAO) currently provides cooperative agreement funding to 25 states to support statewide coordination of nutrition, physical activity and obesity-related efforts involving a variety of public- and private-sector partners. The program focuses on the use of policy and environmental approaches for increasing physical activity; increasing consumption of fruits and vegetables; increasing breastfeeding initiation, duration, and exclusivity; reducing consumption of sugar-sweetened beverages; reducing consumption of high-energy dense foods; and reducing television viewing.

Many of the obesity control strategies supported through the cooperative agreement program are based on “Recommended Community Strategies and Measurements to Prevent Obesity in the United States: Implementation and Measurement Guide,” a guidance document published by CDC in 2009³ (see Attachment 3). The recommendations include 24 specific strategies that local governments can adopt to encourage and support healthy eating and active living. The recommendations were based on an extensive literature review and DNPAO consultation with experts in obesity prevention, aimed at identifying the types of environments and policies that would be most likely to be effective. Although some states have a number of years of experience with implementing the obesity prevention approaches, the majority of states are in the early stages of implementation. The recommendations thus represent a starting point for addressing the obesity epidemic in the United States.

CDC’s DNPAO plans to collect information about the effectiveness, in practice, of a selected group of the 24 recommended strategies that are currently being implemented by CDC-funded awardees and other organizations. The initial information collection will consist of pre-evaluation assessments aimed at highlighting achievements and identifying the most promising strategies for further development, evaluation through rigorous methods, and dissemination for widespread use. The pre-evaluation assessments involve a systematic process for nominating, screening and assessing promising interventions that is also useful for informing the field about prevalent practices and providing constructive feedback and technical assistance to implementers. The method has been used successfully by the Robert Wood Johnson Foundation (RWJ),⁴ DNPAO and others in the public health field as a cost-effective way of identifying practices that are both promising and ready for outcome evaluations. The pre-evaluation assessments will be based on a Systematic Screening and Assessment (SSA) method employed in a previous study funded by the Robert Wood Johnson Foundation (RWJF), Early Assessment of Programs and Policies to Prevent Childhood Obesity. Over two years the project reviewed practices, programs and local policies that affect children’s environments relevant to obesity, and identified 20 innovations ready for outcomes-focused evaluation that are deemed plausible in producing large effects on children’s diet or physical activity, reaching a meaningful population of children, and meeting criteria for changing the prevalence of childhood obesity at a population level. DNPAO subject matter experts served as scientific consultants for that study. DNPAO is requesting OMB approval to examine some of the strategies identified in its 2009 guidelines using similar SSA methodology. Information will be collected through in-person interviews at up to 23 sites. Findings will be used to improve immediate efforts and to inform future efforts to replicate these nutrition and physical activity strategies for promoting health and preventing obesity.

The proposed information collection is consistent with CDC’s commitment to programs that reduce the health and economic consequences of the leading causes of death and disability. Authority to collect information is provided under Sections 301 (a) and 317 (k) of the Public Health Service Act (Attachment 1). OMB approval is requested for two years. If additional funding becomes available, CDC may request OMB approval to extend or expand the pre-evaluation assessment information collection.

Privacy Impact Assessment

The proposed study involves a minimum amount of information in identifiable form (IIF). Primary respondents will be sites implementing an obesity prevention or control program based on one of CDC’s 24 recommended strategies. Sites will be recruited from both CDC-funded programs and non-CDC-funded programs within the United States through on-line forums supported by CDC and other national partners (i.e., obesity prevention listservs supported by CDC and other national partners, email messages and an announcement posted on DNPAO’s website). The unit of analysis for this study is the program implementation site, including the partner organizations participating in the program effort. The collection of IIF is necessary to support site selection and coordination of semi-structured interviews with key informants at each assessment site.

Overview of the Data Collection System

The proposed study involves two types of data collection that entail burden to respondents: (1) collection of program nomination forms to identify a pool of candidate programs, and to determine which ones will be selected for pre-evaluation assessment, and (2) collection of information needed to coordinate and conduct semi-structured interviews with key respondents at each program site. During the site review of each selected program, members of the data collection team will also (3) collect contextual information on program implementation through direct observation. The third category of information collection does not entail burden to respondents.

Items of Information to be Collected

Nomination and Selection

Programs will be required to submit an 18 question nomination form, which can be completed in Microsoft Word and mailed to CDC’s data collection contractor (Attachment 4a) or completed on-line through a web-based survey, like Zoomerang (Attachment 4b). Nominations will be solicited through on-line forums (i.e., obesity prevention listservs supported by CDC and other national partners, email messages and an announcement posted on DNPAO’s website) (Attachment 4c). The program nomination form will collect information to enable an initial assessment of the program’s suitability for further evaluation. The topics addressed in this form include:

General Program Description
Potential Impact of the Program
Program’s Reach to Target Population
Program’s Acceptability to Stakeholders
Feasibility of Implementation
Feasibility of Adoption
Transportability/Generalization
Program Sustainability
Sustainability of Health Effects
Staff/Organizational Capacity

Site Selection Process

Once nominated programs are screened for eligibility, the program descriptions that are determined to be eligible will be reviewed by a group of subject matter expert specialists who are experts in the obesity prevention field. Some are paid external consultants to CDC, and others may be CDC federal employees who are acting within the scope of their employment. There will be 9 or fewer external (non-CDC) expert consultants paid to review nominations. The expert consultants will review program nomination descriptions using pre-determined selection criteria. See Attachment 13, Expert Consultants Site Selection Guidance Document, for the complete guidance document that experts will use to make their selections. The subject matter experts will meet to discuss the nominated sites and recommend their top sites to CDC. CDC’s DNPAO staff will make the final selection of sites to be visited based on the feedback provided by the expert panelists.

Site Visit Coordination and Pre-Evaluation Assessment Interviews

Upon selection, information will be collected from nominated programs to determine potential site review dates (Attachment 5a) and interviewees (Attachment 5b). Nominated programs will be notified of their selection and invited to participate by mail and email (Attachment 5c). Programs will also receive FAQs (Attachment 5d) about the pre-evaluation assessment to help them understand the process, effort entailed, and public health benefit.

The primary information collection involves in-person interviews at site visits. Intensive semi-structured individual interviews will be conducted with approximately 12 key informants at each site. Respondents at each site will typically include: the lead administrator, three program staff, an evaluator, seven public and private sector partners/other stakeholders. Public and private sector partners/other stakeholders will be drawn from state, local, and tribal government sector and the private sector. To reduce burden and ensure that questions are tailored to each respondent type, separate interview guides have been created for the Lead Administrator (Attachment 6); Evaluator (Attachment 7); Program Staff (Attachment 8); and Public and Private Sector Partners/Other Stakeholders (Attachment 9). Environmental observations will also be conducted at each site (Attachment 10) by the site visitor team. Since this form is completed by the team it does not present any burden to respondents.

The topics to be addressed during the site visit interviews include:

History of the Initiative
Description of the Initiative
Stakeholder Involvement
Evaluation of the Initiative
Funding for the Initiative

During the interview, some participants will be asked to identify organizations and individuals who are key staff or partners in their efforts. 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 improve CDC’s understanding of the organizations that are interested and engaging in policy, systems and environmental change work, and to identify the types of individuals (by role) within those organizations who should be engaged. Our primary interest is in the roles of the individuals engaged, not the person in those roles. Site reviews will be conducted by teams of two staff members representing CDC’s data collection contractor, ICF International (hereafter referred to as ICF Macro). The data collection contractor will have access to respondents’ information in identifiable form (IIF), i.e., names, role in their organization, telephone numbers, and e-mail addresses, in order to schedule their participation in the pre-evaluation assessment site visit interviews. The information to be obtained concerns organizational activities and priorities rather than personal matters, and is not considered highly sensitive. IIF will be stored by the data collector, ICF Macro. The IIF used for scheduling purposes will not be linkable to the response data collected subsequently and will be stored in a separate file from the data collected. The interviewee's name will be listed as a participant in the site visit report; however, the interviewee's name will not be associated with specific quotes or comments without written permission from the interviewee for each instance of usage. No information of a personal or sensitive nature will be collected. Sites are not required to participate in the pre-evaluation assessment study and participation in the site visit interviews is voluntary for individual respondents.

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

This information collection includes the option for web-based data collection for the initial nomination submission process that will result in a program description. Sites will be invited through on-line forums (i.e., obesity prevention listservs supported by CDC and other national partners, email messages and an announcement posted on DNPAO’s website) (Attachment 4c) to nominate programs. There are no websites with content directed at children under 13 years of age. The invitation posted to the listservs will include a Microsoft Word template that programs can fill out and return, as well as a link to an on-line version, built in the Zoomerang website, of the nomination form where they can complete and submit the same information on-line (Attachment 4b shows screenshots of the survey and live link: http://www.zoomerang.com/Survey/WEB22CMCSHWU7W/). There are no issues of privacy related to web-based data collection for this IC. Individuals can choose to nominate organizations without providing their own names or contact information.

A.2 Purpose and Use of the Information

The pre-evaluation assessments will provide information about nutrition, physical activity and obesity policy and environmental change focused strategies at the state and community level, and are important to the overall identification of promising practices and strategies in obesity prevention. Through this process, CDC will be able to identify ways that promising practices, selected from the 24 previously recommended strategies for encouraging and supporting healthy eating and active living, can be adopted by local governments, CDC grantees or other organizations. The pre-evaluation assessments will determine the initiatives’ desired outcomes, explore the plausibility that the initiatives can produce those outcomes, consider the feasibility of fully implementing the initiatives, offer technical assistance to the program implementers, and determine options for further evaluation. Findings will be disseminated to the broader population of grantees, communities and states implementing efforts to prevent obesity, thereby enhancing the reach and effectiveness of CDC’s efforts in this area.

Information collected in this study will be used to:

Identify promising practices in nutrition, physical activity, and obesity used by DNPAO’s grantees and others in the obesity prevention field.

Provide feedback and technical assistance to the initiative developers, implementers and managers.

Assess the evaluation readiness of obesity prevention initiatives to encourage the judicious use of scarce evaluation resources.

Share findings with CDC grantees, including grantees from DNPAO, Communities Putting Prevention to Work (CPPW) and Community Transformation Grant (CTG) initiatives, and others working in the field to increase their capacity to both implement and evaluate these types of promising interventions.

CDC will develop a variety of reports and publications to ensure dissemination of the pre-evaluation assessment findings to the sites and other key stakeholders. These reports include topline and site visit summary reports. CDC will also oversee the development of a manuscript over the course of the study. The topics to be addressed and publications will be developed once the pre-evaluation assessment findings are available to ensure that they focus on the issues most salient to the sites and stakeholders at that time.

Privacy Impact Assessment Information

As noted earlier, the unit of analysis is the program that is participating in the effort at each site (CDC grantees or non-CDC grantee organizations). Contact information collected for respondents will be used to schedule interviews; however, only the individual’s role, organization, and state/community will be recorded in the data linking file. For the pre-evaluation assessment, CDC is primarily interested in the organizational partners involved in implementing the programs/policies and the roles of the individuals within those organizations who are involved, not the individual in that role. As a result, collection of names is not necessary. 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. During the interviews, the site visitor will take detailed notes. However, no other recording of any kind will be made. The handwritten notes from the interviews will be kept with the site visitor at all times while on site or in secured storage. Site visitors will be instructed to destroy handwritten notes upon completion of their reports. Destruction of all hard copy documents will be accomplished by shredding and any electronic files will be deleted.

Two site specific reports are expected: topline reports and site visit summary reports. In topline reports, the site visitors will briefly summarize site visit findings and the site visitors’ impressions of the program. Topline reports will be shared only with the project team. The site visit summary report will provide findings from the site visits and will be provided to the lead administrator of the program. The names and roles of interviewees will be listed as part of the methods section, but no quotes will be attributed to any person by name or role. An overall summary report will also be created summarizing and synthesizing findings across sites with similar focus areas and identifying common strengths and weaknesses across the different focus areas in this study.

As can be seen in the list of data collection elements, the information being collected pertains to the organization and site and not to the specific respondent; hence the proposed data collection will have little or no effect on the respondent’s privacy.

A.3 Use of Improved Information Technology and Burden Reduction

For the convenience of respondents, CDC will accept nomination forms either through a website or a paper form. Both methods have the same content.

Electronic data collection methods are not applicable to the semi-structured interviews, which are based on qualitative methods and are designed to gather contextual information about each program and the community in which it is being implemented. To minimize redundancy, the interview guides are based on a unified evaluation scheme, but have been tailored to target different respondent groups for information about specific issues and experiences. This strategy supports the collection of all information needed for complete pre-evaluation assessment, but minimizes burden to respondents and avoids overlap in questions for respondent groups except in circumstances where a variety of perspectives is needed to fully address an evaluation question. In addition, the interview discussions may be customized based upon the chosen strategies in each community. To facilitate and streamline the on-site interviews, interviewers will review the brief program summaries and documents provided by the site as well as any existing, publicly available sources prior to each site visit. For example, information for some sites funded by CDC may be available from their routine reports and abstracted in advance, or sites may provide other background documents for site visitors to review prior to their visit. The intent is to streamline interviews as much as possible by ensuring that all site visit team members are generally familiar with the specific activities of each site in advance of the interviews.

Only the minimum information necessary for the purposes of this project will be collected.

A.4 Efforts to Identify Duplication and Use of Similar Information

Consultation with CDC and an advisory group of key experts has lead to the conclusion that there is no duplication between this study and other activities. Although CDC-funded state nutrition, physical activity and obesity grantees submit progress reports to DNPAO, and participate in routine conference calls, the detailed contextual information to be collected through on-site interviews is not available from these sources. CDC also hopes to learn about programs that are funded through other (non-CDC) sources. Information about programs funded through non-CDC sources is not available.

A.5 Impact on Small Businesses or Other Small Entities

The primary respondents for the pre-evaluation assessments are sites implementing nutrition and physical activity programs or policies and their partner organizations. A small number of businesses may be involved as respondents. Examples include community gardens, local farms, local storefronts, or food cart operators. Participation in the interviews is voluntary and does not involve a record-keeping requirement.

A.6 Consequences of Collecting the Information Less Frequently

Without the proposed information collection, CDC will have to engage in more costly forms of data collection to identify potential promising practices or will only be able to use anecdotal information, from site visit reports or annual grantee reports, to disseminate information about particular practices to grantees and others working on obesity prevention projects.

There are no legal obstacles to reducing the burden.

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This project fully complies with all guidelines of 5 CFR 1320.5. There are no special circumstances.

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

As required by 5 CFR 1320.8(d), a Notice for public comments was published in the Federal Register on September 1, 2011 (Vol. 76, No. 170, pp. 54472-54473; see Attachment 2a). XXX comments were received in response to this notice. Attachment 2b presents these comments and CDC’s response.

B. Subject matter experts were consulted to provide feedback and input on the content of data collection instruments and methodology employed for this study. Specific personnel involved in this process are:

Table A.8-A. Staff within the Agency and Consultants Outside of the Agency Consulting on Study and Study Protocol

Non-CDC Staff

Amy A. Eyler, PhD, CHES

Associate Research Professor

Prevention Research Center in St. Louis

George Warren Brown School of Social Work

Washington University in St. Louis

Phone: 314.362.9642

E-mail: [email protected]

Steven P. Hooker, PhD

Director, Prevention Research Center

Research Associate Professor, Department of Exercise Science

Graduate Director, MPH in Physical Activity & Public Health

Phone: 803.777.0266

Email: [email protected]

Angie Tagtow, MS, RD, LD

Owner, Environmental Nutrition Solutions

Co-convener, Iowa Food Systems Council

Managing Editor, Journal of Hunger & Environmental Nutrition

Phone: 515.367.5200

Emila: [email protected]

Jessica Osborne, MURP, MUD

Active Community Environments Coordinator

Colorado Physical Activity & Nutrition Program

Phone: 303.692.2725

Email: [email protected]

Staff from CDC’s Division of Nutrition, Physical Activity and Obesity

Jan Jernigan

Technical Monitor and Principal Investigator

Program Development and Evaluation Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5224

E-mail: [email protected]

Gayle Payne

Behavioral Scientist
Team Lead and Principal Investigator

Program Development and Translation

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.8050

Email: [email protected]

Diane Thompson

Technical Monitor and Principal Investigator

Program Development and Evaluation Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.6049

E-mail: [email protected]

Gia Rutledge

Health Scientist

Program Development and Evaluation Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5661

Email: [email protected]

Marissa Zwald

CDC/ASPH Fellow

Program Development & Evaluation Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5545

Email: [email protected]

Katherine Thomas Reddy, MS*

Program Development Fellow

Program Development and Evaluation Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5435

Email: [email protected]

Sonia Kim, PhD*

Epidemiologist

Nutrition Branch

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5156

Email: [email protected]

Tom Schmid, PhD*

Team Lead

Research and Development Team,

CDC/ONDIEH/NCCDPHP/DNPAO

Phone: 770.488.5471

Email: [email protected]

Additionally, selected CDC project officers and scientists* who have worked closely with DNPAO sites on project implementation plans were consulted on the content, areas of emphasis, and feasibility of the information collection plan and instruments. Their comments and recommendations have been incorporated. The names of these staff are indicated by an * in Table A.8-A.

A.9 Explanation of Any Payment or Gift to Respondents

No remuneration will be provided to any of the sites (CDC grantees or non-CDC grantee organizations) for participating in the pre-evaluation assessment study. Grantees and non-grantees voluntarily agree to participate in the pre-evaluation assessments.

A.10 Assurance of Confidentiality Provided to Respondents

Privacy safeguards that will be instituted to protect respondents include de-identification of response data obtained through interviews, physical security controls, and administrative controls (described in detail below). CDC has determined that the data collection is exempt from IRB approval requirements. Data collection contractors will be subject to a non-disclosure agreement (Attachment 11).

Privacy Impact Assessment Information

A. Privacy Act Determination

Staff in CDC’s Information Collection Review Office have reviewed this submission and determined that the Privacy Act is not applicable. Respondents are employees or representatives of CDC awardee organizations or other public health organizations, local governments, or non-profit organizations. Respondents will be speaking from their roles as representatives of these organizations and will not provide personal information during the interviews. The data collection contractor, ICF Macro, 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 about organizational structure, infrastructure, strategy-based activities, and other activities. The interviewee's name and role will be listed as a participant in the site visit report; however, the interviewee's name will not be associated with specific quotes or comments. Reports also will not be shared with non-project staff unless written permission from the site is obtained and detailed information provided as to how and when report information would be shared. No information of a personal or sensitive nature will be collected. The contact information of those interviewed will not be maintained. The IIF will be maintained in a document that is separate from the interview response data. The individuals contacted during each year of data collection will be selected based on their roles with their program.

As discussed in Section A.1, some respondents will be asked to identify organizations and individuals who are key staff or partners in their efforts. No contact information will be collected for these individuals. The purpose of collecting this information is to improve CDC’s understanding of organizations that are interested in and engaging in policy, systems and environmental change work, and which roles within those organizations should be engaged. Our primary interest is in the roles engaged, and not the persons in those roles.

B. 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. The respondent’s name will be listed as a participant in the site visit report; however, their name will not be associated with specific quotes or comments. No information of a personal or sensitive nature will be collected. Because interviews will be conducted at each site with multiple respondents, response data also will not be indirectly identifiable on the basis of the respondent’s role. Reports also will not be shared with non-project staff unless written permission from the site is obtained and detailed information provided to as to how and when report information would be shared. Information collected during the in-depth interview will only be recorded in handwritten notes. The handwritten notes from the interviews will be kept with the site visitor at all times while on site or in a secured storage. Site visitors will destroy handwritten notes upon completion of their reports. Destruction of all hard copy documents will be accomplished by shredding. Any electronic files will be deleted. The personal contact information for respondents will not be shared with CDC or used for reporting purposes.

All electronic project files (e.g., interview guides, topline reports and full summary reports) will be stored at ICF Macro on a limited-access project share drive on ICF Macro’s secure network servers; only project staff who have been authorized by the project director can access the share drive. After project completion, all electronic files (e.g., documents, reports) will be archived on ICF Macro’s project share drive for five years and then deleted permanently. Any paper files will also be destroyed by shredding. All paper files will be stored and locked in a project file cabinet at ICF Macro, which will be accessible only to project staff authorized by the project director.

C. Consent

The data collection contractor’s pre-evaluation assessment study teams 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 informed consent is provided in Attachment 12. It will also include the statement that “Data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law” along with a description of the safeguards to prevent connecting responses to specific responders and the aggregate nature of the analysis and reporting.

D. Nature of Response

Sites and organizations that are selected for the pre-evaluation assessment study participate voluntarily and will be asked to identify a pool of potential respondents for the pre-evaluation assessment study interviews. Individual respondents will also participate in the interviews on a voluntary basis. No individuals are required to respond to the interviews or particular interview questions. Respondents will be informed of the voluntary nature of their participation as part of the oral informed consent process that precedes the interview (Attachment 12).

A.11 Justification for Sensitive Questions

The pre-evaluation assessment protocol will collect information about factors that impede or facilitate the implementation of obesity prevention programs and/or policies. Personal information about individual respondents will not be requested, however, respondents may provide professional judgments and opinions, as well as facts, during their interviews. Some of the information relates to organizational effectiveness and could be considered sensitive by a portion of respondents, however, the information is not considered highly sensitive because it is not personal in nature.

A.12 Estimates of Annualized Burden Hours and Costs

A.12.A Estimated Annualized Burden Hours

Pre-assessments will be conducted with 23 programs over the two-year period of this information collection request. Annualized estimates are based on pre-assessments with 12 programs per year, resulting in a slight over-estimation of total burden.

Programs will be selected through CDC review of an 18-question nomination form that can be submitted in hardcopy (Attachment 4a) or on-line (Attachment 4b). We expect to receive about 51 nominations from programs or organizations each year, completed by a lead administrator, program staff member or staff member representing a partner organization, The estimated burden per response is one hour. A notification will be sent via mail and email to sites that are selected for pre-assessment evaluation (Attachment 4c).

Upon notification of selection (Attachment 5c), the lead administrator for each site will be provided with materials to facilitate a site visit. These materials include the Site Visit Availability Calendar (Attachment 5a), the Suggested Interviewees Form (Attachment 5b) and a summary of Frequently Asked Questions (Attachment 5d). A staff member from the site will use the completed form to initiate contact with potential respondents and begin scheduling interviews. The estimated burden for each form is one hour, which includes time to review instructions and to participate in a call with CDC’s data collection contractor to discuss any logistical questions the site might have about the pre-evaluation assessment process. Each site will also be provided with Site Visit Schedule Instructions and Template (Attachment 5e) to refine the site visit plan and communicate it to the data collection contractor. The burden of completing this form, including background tasks, is estimated at five hours per response. The total estimated burden for site visit coordination, per site, is estimated at eight hours. Estimated burden hours are based on experience with similar site visit scheduling.

An average of 12 respondents will be interviewed at each site. The length of the interview and the questions asked will vary according to the type of respondents being interviewed. On average, respondents at each site will consist of the Lead Administrator (see Attachment 6); an evaluator (see Attachment 7); three additional staff members (see Attachment 8); and a mix of seven public and private sector partners/other stakeholders (see Attachment 9). We anticipate that, on average, the interviews with public and private sector partners/other stakeholders will involve four interviewees from the public sector (including: state, local, or tribal government), and three interviewees from the private sector. The estimated burden for the interview with each site’s Lead Administrator is two hours. The estimated burden for all other interviews is one hour per response.

The total estimated annualized burden is 291 hours, as summarized in Table A.12-A.

Table A.12-A. Estimated Annualized Burden Hours

Types of Respondent	Form Name	Number of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
Nominator	Nomination Form	51	1	1	51
Lead Administrator	Site Visit Availability Calendar	12	1	1	12
	Suggested Interviewees Form	12	1	1	12
	Site Visit Schedule Instructions and Template	12	1	5	60
	Interview Guide for Lead Administrator	12	1	2	24
Evaluator	Interview Guide for Evaluator	12	1	1	12
Program Staff	Interview Guide for Program Staff	36	1	1	36
Public Sector Partners (State, Local and Tribal Govt. Partners)	Interview Guide for Public and Private Sector Partners/Other Stakeholders	48	1	1	48
Private Sector Partners	Interview Guide for Public and Private Sector Partners/Other Stakeholders	36	1	1	36
				Total	291

A.12-B. Estimated Annualized Cost to Respondents

Average hourly wage estimates were obtained from the U.S. Department of Labor, Bureau of Labor Statistics. The estimated annualized cost to respondents is $10,827 as summarized below in Table A.12-B.

Table A.12-B. Estimated Annualized Cost to Respondents

Types of Respondent	Form Name	Number of Respondents	No. of Responses per Respondent	Average Hourly Wage*	Total Burden (in hours)	Total Cost
Nominator	Nomination Form	51	1	$33	51	$1,683
	Availability Calendar	12	1	$48	12	$576
Lead Administrator	Suggested Interviewee Planning Tool	12	1	$48	12	$576
	Site Visit Schedule Instructions and Template	12	5	$48	60	$2,880
	Interview Guide for Lead Administrator	12	1	$48	24	$1,152
Evaluator	Interview Guide for Evaluator	12	1	$33	12	$396
Program Staff	Interview Guide for Program Staff	36	1	$33	36	$1,188
Public Sector Partners (State, Local and Tribal Govt. Partners)	Interview Guide for Public and Private Sector Partners/Other Stakeholders	48	1	$33	48	$1,584
Private Sector Partners	Interview Guide for Public and Private Sector Partners/Other Stakeholders	36	1	$22	36	$792
					Total	$ 10,827

*Hourly wage information is from the U.S. Department of Labor, Bureau of Labor Statistics Web site (www.bls.gov/home.htm)

A.13 Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents other than their time.

A.14 Annualized Cost to the Federal Government

Two types of government costs will be incurred: 1) annualized contracted data collection and analysis costs of $386,949, and 2) annualized costs of $24,000 for government personnel overseeing the project. The total annualized cost is $410,949.

TableA.14-A. Estimated Annualized Cost to the Federal Government

Activity/Personnel		Total Cost
Data Collection Contractor
Scheduling and conducting site visits, collecting, summarizing and analyzing data, writing topline reports, site visit summaries and enhanced reports.		$386,949
CDC Personnel
Technical Monitor at 20% FTE (project management and oversight)		$24,000
Annualized Total Costs		$410,949

A.15 Explanation for Program Changes or Adjustments

This is a new data collection.

A.16 Plans for Tabulation and Publication and Project Time Schedule

CDC will develop a variety of reports and publications to ensure dissemination of the Pre-Evaluation Assessment findings to the sites and other key stakeholders. These reports include topline and full summary reports that will summarize findings after site visits. CDC will also oversee the development of a manuscript over the course of the evaluation. The topics to be addressed and publications to be targeted will be developed once the pre-evaluation assessment findings are available to ensure that they focus on the issues most salient to the sites and stakeholders at that time.

Table A.16-A. Project Time Schedule

Task	Time Schedule
Year 1: Notification of Nomination Process for Pre-Evaluation Assessments	January 2012
Expert Panelist Meeting to Discuss Nominees	March 2012
Notification of Selection for Pre-Evaluation Assessments	April 2012
Schedule & Coordinate Site Visits Introductory Email Conduct Preparatory Call Finalize Site Visit Dates Obtain Schedule & Finalize Logistics	April 2012 – June 2012 6 weeks in advance of site visit 5 weeks in advance of site visit 4 weeks in advance of site visit 2 weeks in advance of site visit
Completion of Year 1 Site Visits	May 2012 - July 2012
Completion of Year 1 Site Visit Reports	May 2012 – August 2012
Final Report Year 1	September 2012
Year 2 Notification of Nomination Process for Pre-Evaluation Assessments	August 2012
Year 2 Expert Panelist Meeting to Discuss Nominees	October 2012
Notification of Selection for Year 2 Pre-Evaluation Assessments	November 2012
Schedule & Coordinate Site Visits Introductory Email Conduct Preparatory Call Finalize Site Visit Dates Obtain Schedule & Finalize Logistics	December 2012 – March 2013 6 weeks in advance of site visit 5 weeks in advance of site visit 4 weeks in advance of site visit 2 weeks in advance of site visit
Completion of Year 2 Site Visits	January 2013 - April 2013
Completion of Year 2 Site Visit Reports	March 2013 - June 2013
Final Report Year 2	September 2013
Completion of 1 manuscript	July 2014

Target dates for data collection and analysis will be adjusted if OMB approval is not received by January 1, 2012. Final reports and manuscripts will be prepared during by July 2014.

Analysis Plan

The pre-evaluation assessment will identify promising practices in nutrition, physical activity, and obesity used by DNPAO grantees and other non-CDC funded obesity prevention programs. Findings will be used to improve immediate efforts and inform future efforts to achieve the goals of spreading and replicating these nutrition and physical activity strategies for promoting health and preventing obesity.

Data from interviews and observations will be analyzed for themes, patterns, and interrelationships relevant to an understanding of sites’ implementation, plausibility and readiness for rigorous evaluation. Based on systematic analysis of the data, study staff will produce descriptions of the mechanisms by which a site’s activities and interventions are implemented, and assessments of best practices and sites’ readiness for rigorous evaluation.⁴

The information gathered from each site will be analyzed separately and presented in topline summaries and site visit summary reports. Each of these reports is site-specific. These reports will be the basis for comparison of similar and contrasting patterns across sites. A technical assistance document may also be developed to help guide future implementation efforts.

A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

The expiration date will be displayed on all information collection instruments.

A.18 Exemptions to Certification for Paperwork Reduction Act Submissions

No exemption is requested.

References

Recommended Community Strategies and Measurements to Prevent Obesity in the United States: Implementation and Measurement Guide, MMWR, July 24, 2009, Vol. 58, No. RR-7. (http://ww.cdc.gov/mmwr/pdf/rr/rr5807.pdf)

Dawkins, N., Wethington, H., Kettle Khan, L., Grunbaum, J.A., Robin. L, Pitt Barnes, S., et al. (2010). Applying the Systematic Screening and Assessment Method to childhood obesity prevention. New Directions for Evaluation, 125, 33-49.

The Centers for Disease Control and Prevention. Obesity Halting the Epidemic by Making Health Easier: At a Glance, 2010. Atlanta, GA: Author retrieved April 5, 2011, from: http://www.cdc.gov/chronicdisease/resources/publications/aag/pdf/2010/AAG_Obesity_2010_Web_508.pdf

Keener, D., Goodman, K., Lowry, A., Zaro, S., & Kettel Khan, L. (2009). Recommended community strategies and measurements to prevent obesity in the United States: Implementation and measurement guide. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Trochim, W.M. (2006). The research methods knowledge base (2nd ed). Internet WWW page, at URL: http://www.socialresearchmethods.net/kb/ (version current as of August, 16, 2011).

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