SS-Part A Justification 08-07-2015

Monitoring and Reporting System for the

National Tobacco Control Program

Part A: Justification

August 7, 2015

Contact: Christopher J. Kissler, MPH

Telephone: 770.488.5374

E-mail: [email protected]

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. a. Public Health Service Act 42 U.S.C. 247b (k)(2), Section 317(k)(2)

b. Comprehensive Smoking Education Act of 1984

c. Comprehensive Smokeless Tobacco Health Education Act of 1986

2. List of Awardees

3. a. Federal Register Notice

b. Summary of Public Comments

4. a. Work Plan Tool

b. Budget Tool

• The Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion supports tobacco control activities conducted by departments of health in states, territories, tribal organizations, and the District of Columbia (collectively referred to as “states-based” programs in this information collection request). The respondent universe consists of the 53 tobacco control programs (TCP). Sampling methods will not be employed.

• States receive cooperative agreement funding to implement evidence-based tobacco control strategies and activities. CDC plans to collect information related to each awardee’s strategies and activities, and the process and outcome performance measures outlined by the cooperative agreement program.

• Information will be collected once per year as part of the awardee’s annual progress report. Information will be used to monitor awardee progress towards project goals and objectives, for quality improvement, and to respond to inquiries from the Department of Health and Human Services, Congress, and other sources. The annual report is also necessary for awardees to apply for yearly continuation of funding.

• Information will be collected through an Excel-based Performance and Budget Reporting System comprised of a Work Plan Tool and a Budget Tool.

• Information will be entered by the contractor into an Access database. Awardee strategies and activities, priority populations, and progress toward annual and project period objectives will be analyzed. Measures of central tendency will be used to analyze information to inform technical assistance needs and areas for improvement across programs.

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The National Center for Chronic Disease Prevention and Health Promotion cooperative agreements DP15-1509, National State-Based Tobacco Control Programs and DP14-1410PPHF14, Public Health Approaches for Ensuring Quitline Capacity continue to support efforts since 1999 to build state health department infrastructure and capacity to implement comprehensive tobacco control programs.

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 of this cooperative agreement program is to improve public health programs and systems for achieving measurable health impact.

State health departments in all 50 states, District of Columbia, Puerto Rico and Guam (Attachment 2) are funded to implement evidence-based environmental, policy, and systems strategies and activities under these cooperative agreements to achieve four national goals:

• Prevent initiation of tobacco use among youth and young adults

• Promote quitting among adults and youth

• Eliminate exposure to secondhand smoke

• Identify and eliminate tobacco-related disparities among population groups

CDC’s Best Practices – 2014 recommends that states establish and sustain comprehensive tobacco control programs that contain the following overarching components (1) state and community interventions; (2) mass-reach health communication interventions; (3) cessation interventions; (4) surveillance and evaluation; and (5) infrastructure, administration and management

CDC requests OMB approval to collect information from these awardees to monitor their progress and assist them in achieving their work plan goals and objectives. Awardees will monitor and report progress on their work plan objectives, activities, and performance measures. Two related tools have been developed to collect this information: a Work Plan Tool (Attachment 4a.) and a Budget Tool (Attachment 4b.).

CDC plans to begin using the proposed performance monitoring tools immediately upon receipt of OMB approval.

2. Purpose and Use of the Information Collection

The information collected will enable the accurate, reliable, uniform and timely submission to CDC of each awardee’s work plans and progress reports, including strategies, activities and performance measures. The information collected and reporting requirements have been carefully designed to align with and support the goals outlined in the National State-Based Tobacco Control Programs cooperative agreements. Collection and reporting of the information will occur in an efficient, standardized, and user-friendly manner that will generate a variety of routine and customizable reports. Each awardee will be able summarize activities and progress towards meeting work plan strategies and performance measure targets. CDC will also have the capacity to generate reports that describe activities across multiple awardees. In addition, CDC will use the information collection to respond to inquiries from HHS, Congress and other stakeholder inquiries about program activities and their impact.

There are significant advantages to collecting information with these reporting tools:

• The data structures and business rules will help awardees formulate performance measures that are specific, measurable, achievable, relevant and time-framed (SMART). This formulation is intended to facilitate successful achievement of performance measures and is integral to CDC’s evaluation strategy for the program.

• The information being collected provides crucial information about each awardee’s work plan, activities, partnerships and progress over the award period.

• Awardees will have the capacity to enter updates on an ongoing basis, facilitating real time communications with and interim review by CDC, resulting in more timely technical assistance. The ability to enter updates as activities occur may also result in more complete enumeration of funded efforts.

• Capturing the required information uniformly will allow CDC to formulate ad hoc analyses and reports.

• The proposed budget tracking component of the Budget tool will assure proper disbursement of and accounting for funds awarded.

CDC will use the information collected to monitor each awardee’s progress and to identify facilitators and challenges to program implementation and achievement of outcomes. Monitoring allows CDC to determine whether an awardee is meeting performance and budget goals and to make adjustments in the type and level of technical assistance provided to them, as needed, to support attainment of their performance measures. 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. Finally, the information collection will allow CDC to monitor the increased emphasis on partnerships and programmatic collaboration, and is expected to reduce duplication of effort, enhance program impact and maximize the use of federal funds.

Working with the CDC contractor, program awardees will use the information collected to manage and coordinate their activities and to improve their efforts to reduce tobacco use, exposure to SHS, tobacco related disparities, and associated disease, disability, and death.

The tools will allow awardees to fulfill their annual reporting obligations under the cooperative agreement in an efficient manner by employing user-friendly instruments to collect necessary information for annual progress reports and continuation applications including work plans. This approach, which enables awardees to save pertinent information from one reporting period to the next, will reduce the administrative burden on the yearly continuation application and the progress review process. Awardee program staff will be able to review the completeness of data needed to generate required reports, enter basic summary data for reports at least annually, and finalize and save required reports for upload into other reporting systems as required.

The information collection is designed to address specific outcomes outlined in the National State-Based Tobacco Control Programs cooperative agreement. CDC will use the results of this information collection to evaluate the model for future program reporting efforts.

3. Use of Improved Information Technology and Burden Reduction

The CDC contractor has developed the Work Plan Tool and the Budget Tool using the Excel platform. Comparable tools developed by the contractor are currently being used to collect progress and activity information for cooperative agreement DP13-1305, State Public Health Actions to Prevent and Control Diabetes, Heart Disease, Obesity and Associated Risk Factors and Promote School Health (OMB No. 0920-1059, expiration date 3/31/2018). Since the use of Excel, Word and similar Microsoft products is common, we think these user-friendly interfaces will be easier and more intuitive for awardees to use than special-purpose tools or software. Use of Excel and Word will require very little training and awardees will use the templates provided to record and update grant information. Awardees will submit their continuation application for funding, which will include completed Excel spreadsheets, tailored for their specific work plans, and Word documents by uploading them at www.grants.gov on an annual basis. The contractor will input the data into an Access database for analysis and reporting.

The tools improve information quality by minimizing errors and redundancy. Having all of the information collected in the same place in the same manner will reduce the level of burden attributable to redundancy and reduce the workload to enter and maintain the data. Programs will be able to transfer data from one year to another to minimize data re-entry.

Other elements such as awardee plan requirements for the area of emphasis in each award type, data reporting and the terms that are used to define similar data requirements often vary greatly from one awardee to another. With the tools, the use of a standard set of data elements, definitions and specifications at all levels will help to improve the quality and comparability of performance information that is received by CDC for multiple awardees and multiple award types. Further, standardization will enhance the consistency of plans and reports, enable cross-program analysis, and will facilitate a higher degree of reliability by ensuring that the same information is collected on all strategies and performance measures. Finally, the report generation capabilities of the system will reduce the respondent burden associated with paper-based reports. Without the reporting tools 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 tools will consolidate 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. In addition, CDC has developed two tools (Comprehensive Tobacco Control and Prevention: Infrastructure Measurement [OMB Number 0920-0879], and Training/Technical Assistance Needs Assessment [currently being pilot tested]) to assist state-based TCPs in assessing their program infrastructure, identify funded programs’ infrastructure-related technical assistance and support needs, and to inform ongoing CDC programmatic monitoring efforts (collectively referred to the Infrastructure, Administration, Management component of Best Practices for Comprehensive Tobacco Control Programs. The purposes of the information collected using the CMI Tool and Training/Technical Needs Assessment will assist state-based TCPs in assessing their program infrastructure, identify funded programs’ infrastructure-related technical assistance and support needs, and to inform ongoing CDC programmatic monitoring efforts. The tools complement and support the progress and activity information collected under this OMB request.

Under a prior cooperative agreement program, CDC was approved to collect progress and activity information from state TCP under OMB No. 0920-0870, expiration date 12/31/2015. This program is ending and the clearance will be discontinued upon receipt of final reports. The new information collection request is therefore not duplicative of reporting described under 0920-0870.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection.

6. Consequences of Collecting the Information Less Frequently

Reports will be collected annually. The annual progress report is due 120 days before the end of the budget period and serves as a non-competing continuation application. Less frequent reporting would undermine accountability efforts at all levels and negatively impact monitoring awardee progress. The annual reporting schedule ensures that CDC responses to inquiries from HHS, the, Congress and other stakeholders are based on timely and up-to-date information.

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

This request fully complies with the regulation 5 CFR 1320.5.

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

A. Federal Register Notice

A Notice was published in the Federal Register/Volume 80, Number 108/Page 32129 on Friday, June 05, 2015 (see Attachment 3a) for public comment. One public comment was received and CDC provided acknowledgement of receipt (see Attachment 3b).

B. Other Consultations

The data collection instruments were designed collaboratively by CDC staff and the data collection contractor. Consultation will continue throughout the implementation process. There were no external consultations.

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

Respondents are cooperative agreement awardees. The data collection does not involve research with human subjects. The information collection does not require consent from individuals or IRB approval.

10.1 Privacy Impact Assessment Information

A. Overview of Data Collection System

Information will be collected from awardees using Excel and Word-based reporting tools. Awardees will submit their continuation application for funding, which will include completed Excel spreadsheets, tailored for their specific work plans, and Word documents by uploading them at www.grants.gov on an annual basis. CDC’s data management contractor will enter the files into an Access database to facilitate grantee-specific and aggregate analysis. Data placed into the system produces reports as PDFs that awardees can use to upload into other reporting systems as required. This procedure satisfies routine cooperative agreement reporting requirements. Progress reports are required once per year, but data entry can occur on a real-time basis. As a result, the reporting tools can also be used for ongoing program management, and support more effective, data-driven technical assistance between NCCDPHP and awardees.

B. Information to be Collected

Each awardee is required to provide a work plan and budget plan that at a minimum includes:

• Activities and timelines to support achievement of FOA outcomes.

  • Performance Measures (including outcomes) – initial baseline and targets; progress reported annually

  • Work Plan (Maximum of 25 pages) – initial work plan and annual updates; annual progress reported through continuation applications

  • Successes –reported annually as part of work plan progress

  • Challenges - reported annually as part of work plan progress

• A summary of administration and assessment processes to ensure successful implementation and quality assurance that includes an initial budget and annual updates.

• Staff and administrative roles and functions to support implementation of the award.

Awardees will use the information collection tools (templates) to enter information about their personnel, work plan strategies, performance measures, milestones and activities, resources, budget, and evaluation plans. The tools will also collect information about the staffing resources dedicated by each awardee as well as partnerships with external organizations. The templates require awardees to define their performance measures in action-oriented SMART format (Specific, Measurable, Achievable, Relevant, and Time-Framed).

C. How Information will be Shared and Purpose

The tools support the collection and reporting of information that will be used by CDC to help assess the impact of funding. The information collected will be used to describe, evaluate and enhance opportunities for collaborative efforts and partnerships. Information reported to CDC will be accessible to CDC Project Officers and CDC’s data management contractor. Having all this information in a single and secure database will allow CDC Project Officers to search across multiple programs, help ensure consistency in documenting progress and technical assistance, enhance accountability of the use of federal funds, and provide timely reports as frequently requested by HHS and Congress.

D. Impact on Respondent Privacy

The Performance Monitoring and Budget Reporting Tool will collect a limited amount of information in identifiable form (IIF) for key program staff (e.g., Program Director). However, no personal contact information will be collected. All data will be reported in aggregate form, with no identifying information included. Because data is maintained in a secure, password protected system, and information will be reported in aggregate form, there is no impact on respondent privacy.

E. Voluntary or Mandatory Provision of Data

Awardees are required to provide data as a condition of cooperative agreement funding.

F. Consent to Sharing and Submission of Data

While consent is not required to report aggregate data, awardee consent will be obtained if specific state data is used for publications, reports or other publicly disseminated information.

G. Information Security

Aggregated information will be stored on an internal CDC SQL server subject to CDC’s information security guidelines. The reporting tools will be hosted on NCCDPHP’s Intranet Application platforms, which undergo security certification and accreditation through CDC’s Office of the Chief Information Security Officer. CDC staff, evaluation and technical assistance, and training contractors will have varying levels of access to the system with role-appropriate security training, based on the requirements of their position(s).

H. Privacy Act Determination

Staff in the NCCDPHP 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 governmental agencies (state departments of health). Although contact information is obtained for each awardee, the contact person provides information about the organization, not personal information. No system of records will be created under the Privacy Act.

11. Justification for Sensitive Questions

The proposed tools do not collect sensitive information.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

Current respondents are 53 cooperative agreement awardees. Awardees will report information to CDC about their activities, progress, performance measures and budget. Two information collection instruments will be used: an Excel-based Work Plan Tool (Attachment 4a), and an Excel-based Budget Tool (Attachment 4b). The same instruments will be used for all information collection and reporting.

Each awardee will submit an Annual Work Plan Progress Report using the Excel-based Work Plan Tool (Attachment 4a). The estimated burden per response is 3 hours for each Annual Work Plan Progress report.

Each awardee will submit an Annual Budget Progress Report using the Excel-based Budget Tool (Attachment 4b). The estimated burden per response is 2 hours for each Annual Budget Progress Report.

In Year 1, each awardee will have additional burden related to initial population of the Excel-based reporting tools. Initial population of the Work Plan Tool is estimated to be 6 hours per response, and initial population of the Budget Tool is estimated to be 4 hours per response. Initial population of the tools is a one-time activity which is annualized over 3 years in the burden table. Due to annualization, the 53 awardees are represented as 18 awardees (53/3) in the burden table. After completing the initial population of the tools, pertinent information only needs to be updated for each annual report.

Over the three-year period of this information collection request, the total estimated annualized burden for the current 53 current awardees is 445 hours, as summarized in Table A.12-A.

Table A.12-A. 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 Managers	Initial Population of the Work Plan Tool	18	1	6	108
	Annual Work Plan Progress Report	53	1	3	159
	Initial Population of the Budget Tool	18	1	4	72
	Annual Budget Progress Report	53	1	2	106
	Total				445

B. Estimated Annualized Cost to Respondents

A program manager will prepare the progress reports for each area. The average hourly wage for a program manager is $30.65. The hourly wage rates for program managers are based on wages for similar mid-to-high level positions in the public sector. The total estimated annualized cost is as summarized in Table A.12-B.

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

Type of respondents	Form Name	Number of respondents	Total burden (in hours)	Average Hourly Wage	Total Cost
State Tobacco Control Managers	Initial Population of the Work Plan Tool	18	6	$30.65	$3,310
	Annual Work Plan Progress Report	53	3	$30.65	$4,873
	Initial Population of the Budget Tool	18	4	$30.65	$2,207
	Annual Budget Progress Report	53	2	$30.65	$3,249
	Total				$13,639

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

Keepers

No capital or maintenance costs are expected. 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 average annualized cost to the federal government is $127,758, as summarized in Table A.14-A. Major cost factors for tool development include application design and development costs and system maintenance costs. The developer and data collection contractor is Deloitte Consulting, LLP.

Table A.14-A. Annualized Cost to the Federal Government
Cost Category	Total
CDC Personnel 50% GS-13 @ $85,500/year = $42,500 25% GS-14 @ $101,035/year = $25,258 Subtotal, CDC Personnel	$ 67,758
Data Collection Contractor	$ 60,000
Total	$ 127,758

15. Explanation for Program Changes or Adjustments

This is a new collection.

16. Plans for Tabulation and Publication and Project Time Schedule

A. Time schedule for the entire project

The cooperative agreement cycle is five years. OMB approval is being requested for three years. Reports will be generated by the awardees per the FOA requirements once a year due 120 days before the end of the budget period. Data collection began with the awarding of the grants and will continue throughout the funding cycle.

B. Publication plan

Information collected by the awardees will be reported in internal CDC documents and shared with state-based programs.

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.

A.16 - 1 Project Time Schedule

Activity Time Schedule
Notification of Tool Availability	Immediately upon OMB approval
User Training	Immediately upon OMB approval and ongoing through expiration date
Data Collection	1-36 months after OMB approval
Data Publication	Once annually
Data Analysis	1-36 months after OMB approval

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

The National State-Based Tobacco Programs cooperative agreement will display the expiration date for OMB approval of the information system data collection on its Internet home page.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification statement.

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