Part A_08282013

Monitoring and Reporting System for

Chronic Disease Prevention and Control Programs

Revision

OMB Approval Number 0920-0870

Part A: Justification

August 28, 2013

Contact: Christopher J. Kissler

Telephone: (770) 488 5374

E-mail: [email protected]

Office on Smoking and Health

National Center for Chronic Disease

Prevention and Health Promotion

Centers for Disease Prevention and Control

Atlanta, Georgia

TABLE OF CONTENTS

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purposes and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

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

8. Comments in Response to the Federal Register Notice

9. Explanation of Any payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Total Annual Cost Burden to

Respondents or Record Keepers

14. Estimates of Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

List of Attachments

1. Authorizing Legislation

   1. Public Health Service Act

   2. Comprehensive Smoking Education Act of 1984

   3. Comprehensive Smokeless Tobacco Health Education Act of 1986

2. Federal Register Notice

a. 60-day Federal Register Notice

b. Summary of Public Comments

3. List of Awardees

4. Management Information System Screenshots

Abstract

The Centers for Disease Control and Prevention (CDC) is currently approved to collect progress and activity information from awardees funded through Funding Opportunity Announcement CDC-RFA-DP09-901, Collaborative Chronic Disease, Health Promotion and Surveillance Program Announcement: Healthy Communities, Tobacco Control, Diabetes Prevention and Control, and Behavioral Risk Factor Surveillance System (BRFSS) (OMB 0920-0870, exp. date 11/30/2013). Current awardees include health departments in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.

The initial approval allowed CDC to collect progress reports describing awardee activities in four programmatic areas: tobacco control, Healthy Communities, diabetes prevention and control, and BRFSS. Separate reports were required for each program area. Since the initial approval, as a result of organizational and funding changes within CDC, funding through the DP09-901 cooperative agreement has been discontinued for three of the four components. Only the tobacco control program component is ongoing under the DP09-901 funding mechanism and will remain in place through March 28, 2014.

CDC requests OMB approval to continue the collection of progress and activity information from awardees for one year, with changes that reflect the changes in funded program components. There are no changes to information collection methods or the estimated burden per response. Awardees will continue to submit semi-annual progress and activity reports to CDC through a Web-based Management Information System (MIS). However, overall respondent burden will decrease due to discontinuation of reporting requirements for three program components: Healthy Communities, diabetes prevention and control, and BRFSS. OMB approval of this revision request will allow CDC to collect progress reports about tobacco control activities conducted during the Year-5 budget period (March 29, 2013 – March 28, 2014). These progress reports will be submitted to CDC in Fall 2013 and Spring 2014.

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

Background

Chronic diseases—including heart disease, cancer, stroke, diabetes, arthritis, and related risk factors, such as tobacco use, physical inactivity, poor diet, and obesity—are the leading causes of death and disability in the United States, accounting for 7 of every 10 deaths and affecting the quality of life of 90 million Americans. Chronic diseases represent 83% of all U.S. health care spending; medical care costs of people with chronic diseases account for more than 75% of the nation’s $2 trillion medical care costs. The direct and indirect costs of diabetes alone are $174 billion a year.

Tobacco use is the single most preventable cause of death and disease in the United States. Tobacco use causes heart disease and strokes, lung cancer and many other types of cancer, chronic obstructive pulmonary disease, lung disorders, pregnancy problems, sudden infant death syndrome, gum disease and vision problems. Approximately 443,000 Americans die from tobacco-related illnesses annually, causing more deaths than HIV/AIDS, alcohol use, cocaine use, heroin use, homicides, suicides, motor vehicle crashes, and fires combined. For every person who dies from tobacco use, 20 more people suffer with at least 1 serious tobacco-related illness. There are also severe socio-economic consequences of tobacco use as the U.S. spends approximately $193 billion annually in direct medical expenses and lost productivity.

Although chronic diseases are among the most common and costly health problems, they are also among the most preventable. CDC works with states, territories, tribal organizations, and the District of Columbia (collectively referred to as “state-based” programs) to develop, implement, manage, and evaluate chronic disease prevention and control programs, including tobacco control. Support and guidance for these programs have been provided through cooperative agreement funding and technical assistance, administered by CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). Partnerships and collaboration with other federal agencies, nongovernmental organizations, local communities, public and private sector organizations, and major voluntary associations have been critical to the success of these efforts.

In 2009, CDC announced a new cooperative agreement program for chronic disease prevention and health promotion programs (RFA DP09-901). The purpose of the program was to reduce the morbidity and premature mortality associated with chronic diseases and to eliminate associated health disparities by supporting capacity building, program planning, development, implementation, evaluation, and surveillance for chronic disease conditions and chronic disease-related risk factors. The program addressed the specific content areas of Healthy Communities, tobacco control, diabetes prevention and control, and state-based surveillance and data analysis for chronic disease prevention and health promotion through the BRFSS.

Due to organizational and funding changes within CDC, three programmatic components (Healthy Communities, diabetes prevention and control, and BRFSS) were discontinued from the original cooperative agreement program. Only the tobacco control component remains.

Awardees are health departments in states, territories, and the District of Columbia (see List of Awardees, Attachment 3).

CDC requests OMB approval to continue the collection of progress and activity information from awardees in order to document, monitor, and evaluate their progress toward accomplishing the objectives defined in their work plans during the last year of the cooperative agreement (March 29, 2013 – March 28, 2014).

CDC also requests OMB approval to reduce the data collection burden for each awardee by decreasing the number of program components responsible for reporting from four (Healthy Communities, tobacco control, diabetes prevention and control, and BRFSS) to one (tobacco control).

Progress and activity information will continue to be collected through the current electronic, Web-based Management Information System (MIS). Advantages of using the MIS include: 1) improved ease of use and overall reduction of burden to awardees, 2) a common set of performance metrics for describing program performance and improving program management, and 3) enhanced communication among programs, thus facilitating collaboration and information sharing.

This cooperative agreement program addresses and supports the following national initiatives and strategic plans:

• CDC’s Winnable Battles (Reducing Tobacco)

• HHS’s Strategic Plan (Promote Prevention and Wellness – Reduce Cigarette Consumption and Cigarette Smoking)

• Government Performance Results Modernization Act (Priority Goal – Reduce Cigarette Smoking)

• The National Prevention Council’s National Prevention Strategy – Americas Plan for Better Health (Tobacco Free Living)

• Healthy People 2020 (Tobacco Use)

• HHS’s Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the Department of Health and Human Services

• The Institute of Medicine’s, Ending the Tobacco Problem – A Blueprint for the Nation

CDC’s authority to conduct these activities is authorized by the Public Health Service Act (sections 301, 307, 310, and 311; 42 U.S.C. sections 241 and 247(b)(k)), the Comprehensive Smoking Education Act of 1984, and the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Attachments 1a-1c). The overarching goal is to improve public health programs and systems for achieving measurable health impact.

Privacy Impact Assessment

A) Overview of the Data Collection System

The MIS is the current mechanism for collecting progress and activity information from awardees. Awardee reports that summarize challenges, progress and accomplishment will continue to be collected on a semi-annual basis through the remainder of the cooperative agreement which ends March 28, 2014. Final reports will be due approximately 30 days after the end of the funding period. By requesting an additional year of clearance, CDC will ensure that awardees have adequate time to prepare and submit their final reports.

B) Items of Information to be Collected

The MIS will continue to collect information about the staffing resources dedicated to tobacco control program awardees. The MIS will also collect information about work plan objectives, activities, and partnerships. The MIS collects a limited amount of information in identifiable form (IIF) for key program staff (e.g., program director/program coordinator). Each awardee provides the names of these individuals as well as their professional contact information. The contact person only provides information about the state tobacco control program, not personal information. Information will be reported regarding the state-based tobacco control program; no personal information will be reported.

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

The MIS is a Web-based application. Access to The MIS is controlled by a password-protected login for authorized users. There is no Website content directed at children less than 13 years of age.

2. Purpose and Use of the Information Collection

The information collection enables the accurate, reliable, uniform and timely submission to CDC on awardee progress and activities. The information collected and reporting requirements have been carefully designed to align with and support the goals outlined in the cooperative agreement and the goals defined within the strategic plan for CDC’s Office on Smoking and Health. The MIS enables collection and reporting of the information in an efficient, standardized, and user-friendly manner. The MIS generates a variety of routine and customizable reports. The MIS also has the capacity to generate reports that describe activities across multiple states and/or programs.

CDC uses the information collected in the MIS to monitor each awardee’s progress and activities and to identify programmatic strengths and weaknesses. Monitoring allows CDC to determine whether an awardee is meeting performance goals and to make adjustments in the type and level of technical assistance provided to them, as needed, to support attainment of their objectives. CDC’s monitoring and evaluation activities also allow CDC to provide oversight of the use of federal funds, and to identify and disseminate information about successful prevention and control strategies implemented by awardees. These functions are central to the NCCDPHP’s broad mission of reducing the burden of chronic diseases and the Office of Smoking and Health’s national goals to (1) Prevent initiation of tobacco use among youth and young adults; (2) Promote tobacco use cessation among adults and youth; (3) Eliminate exposure to secondhand smoke; and (4) Identify and eliminate tobacco-related disparities

CDC also uses the information collected to respond to Congressional and stakeholder inquiries about tobacco control program activities, program implementation, and program impact. Finally, the information collected allows CDC to monitor the increased emphasis on partnerships and programmatic collaboration, which reduces duplication of effort, enhances program impact and maximizes the use of federal funds.

Awardees use the information collected to manage and coordinate activities and to improve their efforts to prevent and control tobacco use and secondhand smoke exposure. The MIS allows awardees to fulfill their reporting obligations under the cooperative agreement in an efficient manner by employing a single instrument to collect necessary information for progress reports and work plans. This approach, which enables awardees to save pertinent information from one reporting period to the next, reduces the administrative burden on the yearly continuation application and progress review process. Awardees are able to review the completeness of data necessary to submit required reports, enter basic summary data for reports, and finalize and save required reports for upload into Grants.gov.

The information collected is designed to address specific performance measures outlined in FOA DP09-901 related to infrastructure, capacity, and interventions.

Privacy Impact Assessment Information

The MIS is a centralized, Web-based system that supports the collection and reporting of information that will be used by CDC to help assess the impact of awardees. The MIS is used to describe, evaluate and enhance opportunities for collaborative efforts and partnerships. Having this information in a single and secure database allows CDC project officers to search across multiple programs, helps ensure consistency in documenting progress and technical assistance, and enhances accountability of the use of federal funds.

3. Use of Improved Information Technology and Burden Reduction

The MIS takes advantage of electronic database technology to improve information quality by minimizing errors and redundancy. The structure of the MIS minimizes or eliminates many elements that would otherwise be repeated within stand-alone systems. Having information collected in the same place in the same manner reduces the level of burden attributable to redundancy and reduces the workload to enter and maintain the data. Awardees are able to transfer data from one year to another to minimize data re-entry.

The MIS uses a standard set of data elements, definitions, and specifications at all levels that helps to improve the quality and comparability of performance information that is received by CDC. Standardization enhances the consistency of work plans, reports, and enables cross-program analysis. The report generation capabilities of the MIS reduce the respondent burden associated with paper-based reports. Without the automated, electronic, Web-based the MIS and the integrated approach to information collection and reporting, awardees and CDC would need to continue to use time consuming, labor intensive procedures for information collection and reporting.

4. Efforts to Identify Duplication and Use of Similar Information

The collection of this information is part of a federal reporting requirement for funds received by awardees. The MIS consolidates information necessary for both continuation applications and progress reports so that information entered once can be used to generate multiple types of reports without having to duplicate efforts. The information collected from awardees is not available from other sources.

5. Impact on Small Businesses or Other Small Entities

No small businesses participate in the MIS data collection.

6. Consequences of Collecting the Information Less Frequently

Less frequent reporting would negatively impact monitoring the progress and activities of awardees and undermine accountability efforts at all levels.

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

There are no special circumstances related to the MIS, and the request fully complies with the regulation.

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

A. Federal Register Notice

A Notice announcing this Revision request was published in the Federal Register on July, 22, 2013, Volume 78, Number 140, Pages 43886 – 43887 (Attachment 2a). The CDC received one public comment and provided a courtesy reply (Attachment 2b.)

B. Other Consultations

The MIS was designed collaboratively by CDC staff, awardees, and a system development contractor. Consultation has continued throughout the system development and implementation process.

9. Explanation of Any Payment or Gift to Respondents

Respondents will not receive payments or gifts for providing information.

10. Assurance of Confidentiality Provided to Respondents

1. Privacy Act Assessment. Staff in the CDC Information Collection Review Office have reviewed this Information Collection Request and have determined that the Privacy Act is not applicable. The data collection does not involve collection of sensitive or identifiable personal information. Respondents are state-based tobacco control programs funded through a cooperative agreement with CDC. Although contact information is obtained for each program, the contact person provides information about the state program, not personal information.

2. Security. Access to the MIS is controlled by a password-protected login. Access levels vary from read-only to read-write, based on the user’s role and needs. Each awardee has access to their own information and can decide the level of access for each user. The extent to which local partners may access an awardees’ information is decided by that awardee. Aggregated information is stored on an internal CDC SQL server subject to CDC’s information security guidelines. The MIS is hosted on the NCCDPHP’s Intranet and Internet Application platforms, which undergo security certification and accreditation through CDC’s Office of the Chief Information Security Officer.

3. Consent. The MIS data collection is not research involving human subjects. Respondents are cooperative agreement awardees. The information collected does not require consent from individuals or IRB approval.

4. Requirement to Respond. Awardees are required to respond as a condition of cooperative agreement funding.

11. Justification for Sensitive Questions

The MIS does not collect sensitive information. No personal information is requested. The MIS collects a limited amount of information in identifiable form (IIF) for key program staff (e.g., program director/program coordinator). Each awardee provides the names of these individuals as well as their professional contact information. The contact person only provides information about activities conducted under the collaborative award, not personal information.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

Current respondents are the 53 awardees of FOA DP09-901 (see Attachment 3), including the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Each awardee will report information to CDC twice per year. The estimated burden per response is 6 hours.

Information will be submitted to CDC electronically through a Web-based Management Information System (MIS, see Attachment 4). The total estimated annualized burden is 636 hours, as summarized in Table A.12-1.

Table A.12-1. Estimated Annualized Burden to Respondents

Type of respondents	Form Name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
State Tobacco Control Program	Management Information System	53	2	6	636

The number of responses per respondent, average burden per response, and total burden has been reduced since three programmatic components (Healthy Communities, diabetes prevention and control, and BRFSS) of the cooperative agreement have been discontinued. The total annualized total for information collection has been reduced from 2,532 hours to 636.

B. Estimated Annualized Cost to Respondents

The tobacco control program director/coordinator will prepare the annual progress report. The average hourly wage for a program director/coordinator is $30.65. The hourly wage rates for program director/coordinators are based on wages for similar mid-to-high level positions in the public sector. The total estimated annualized cost to respondents is $19,493, as summarized in Table B.12-1.

Table B.12-1. Estimated Annualized Cost to Respondents

Type of respondents	Number of respondents	Number of responses per respondent	Average burden per response	Average hourly wage	Total cost
State-Based Tobacco Control Program	53	2	6	$30.65	$19,493

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

The MIS is designed to use existing hardware within funded sites, and all awardees currently have access to the Internet to use the information system. Additionally, there are no start-up, hardware or software costs.

14. Estimates of Annualized Cost to the Federal Government

A. Development, Implementation, and Maintenance

The major cost factor for the MIS is related to maintenance of the system. The MIS maintenance is provided by the Northrup-Grumman. The total estimated annualized cost to the government for the remainder of the cooperative agreement is $72,833, as summarized in the table below.

Table A.14-1.

Phase	Implementation and Maintenance Phase	Average Annualized Cost Estimate
System Maintenance and Required Reports	Project Management and Support	$70,697
	Training	$2,186
	Total	$72,883

15. Explanation for Program Changes or Adjustments

The initial OMB approval was based on 53 awardees funded through one Funding Opportunity Announcement. Fifty-two (52) awardees were funded for four program components: tobacco control, diabetes prevention and control, Healthy Communities, and BRFSS. One awardee was funded for three program components (the District of Columbia was not funded for the Healthy Communities program component). Reports were submitted to CDC twice per year. The estimated burden per response was six hours, and the total estimated annualized burden was 2,532 hours.

Due to reorganization, funding and reporting requirements under the FOA were discontinued for three of the four components. The tobacco control component is still active for 53 awardees. The current Revision will allow these awardees to submit progress reports for their final year of tobacco control activities under the original FOA.

Program components that have been discontinued, and associated reduction in burden, are itemized as follows:

1. Diabetes prevention and control: 53 awardees x 2 responses/year x 6 hours/response = reduction of 636 burden hours per year

2. BRFSS: 53 awardees x 2 responses/year x 6 hours/response = reduction of 636 burden hours per year

3. Healthy Communities: 52 awardees x 2 responses/year x 6 hours/response = reduction of 624 burden hours per year.

During the period of this one-year Revision request, annualized burden will decrease from 2,532 hours to 636 hours, a net reduction of 1,896 hours.

16. Project Time Schedule and Plans for Publication and Analysis

A. Time schedule for the entire project

The cooperative agreement is in the fourth year of a 5-year programmatic funding cycle. OMB approval is being requested to continue the collection of progress and activity information from awardees for the remainder of the cooperative agreement which ends March 28, 2014. Semi-annual reports are due in the Fall and Spring. The additional clearance period will ensure that awardees have adequate time to prepare and submit final reports, after completion of activities in Spring 2014.

B. Publication plan

Information collected through the MIS will be reported in internal CDC documents and shared with awardees.

C. Analysis plan

CDC will not use complex statistical methods for analyzing information. All information will be aggregated and reported with no program identifiers present in external documents. Most statistical analyses will be descriptive. Statistical modeling may be included to examine predictors of specified outcomes.

A.16 - 1 Project Time Schedule

Activity Time Schedule
Notification of Electronic Tool Availability	Immediately upon OMB approval
User Training	Immediately upon OMB approval and ongoing through expiration date
Data Collection	Immediately upon OMB approval
Data Publication	Annually
Data Analysis	Immediately upon OMB approval

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

CDC will display the expiration date for OMB approval of the MIS collection of awardee progress and activity information on the login page.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification statement.