0679 Ss 011608

DIVISION FOR HEART DISEASE AND STROKE PREVENTION

MANAGEMENT INFORMATION SYSTEM

OMB #0920-0679

Supporting Statement Part A and Part B

Request for Revision

January 2008

Contact:

Ron Todd

770-488-5329

Fax: 770-488- 8151

[email protected]

Division for Heart Disease and Stroke Prevention

National Center for Chronic Disease Prevention and Health Promotion

4770 Buford Highway, NE, MS K-47

Atlanta, Georgia 30341

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 and Efforts to Consult Outside the Agency

a. Federal Register Notification

b. Other Consultations

9. Explanation of Any Payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Nature

12. Estimates of Annualized Burden Hours and Costs

a. Estimated Annualized Burden Hours

b. Estimated Annualized Cost to Respondent

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

14. Annualized Cost to the Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

a. Time Schedule for the Proposed Project

b. Publication Plans

c. Analysis Plan

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

1. Respondent Universe and Sampling Methods

2. Procedures for the Collection of Information

3. Methods to Maximize Response Rates and Deal with Nonresponse

4. Tests of Procedures or Methods to be Undertaken

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or

LIST OF ATTACHMENTS

ABSTRACT

The Division for Heart Disease and Stroke Prevention (DHDSP), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC) requests OMB approval for a period of three years for a Revision of 0920-0679, “Cardiovascular Health Branch (CVHB), Management Information System (MIS).” Current OMB approval is scheduled to expire May 31, 2008. The request for a revision is based on the following changes: 1) The name of the information collection is being changed to reflect organizational changes within NCCDPHP. The name of the NCCDPHP unit collecting the information has changed from the Cardiovascular Health Branch to the Division for Heart Disease and Stroke Prevention. 2) Due to the recent integration of the WISEWOMAN program into the reorganized DHDSP, respondents will include WISEWOMAN awardees, as well as Heart Disease and Stroke Prevention Program awardees that were previously approved as respondents. The number of respondents will increase from 34 to 49. 3) Revisions will be made to the data collection instrument to include questions relevant to the WISEWOMAN programs. 4) Due to the increase in respondents and the changes to the questions, the estimated burden hours and costs have increased.

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

This statement supports the request for clearance of electronic collection of information by State Heart Disease and Stroke Prevention Programs (HDSPP) and WISEWOMAN Programs funded by the Division for Heart Disease and Stroke Prevention (DHDSP) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

In 1998, the U.S. Congress provided funding for the Centers for Disease Control and Prevention (CDC) to initiate a national, state-based heart disease and stroke prevention program. As funding allows, the CDC strategic plan calls for establishing a comprehensive national heart disease and stroke prevention program that supports state-based programs in all states and territories. In 2007 under Program Announcement CDC-RFA-DP07-704, the CDC’s Division for Heart Disease and Stroke Prevention funded 33 states and the District of Columbia to address heart disease and stroke selected through a competitive peer review process, and managed as CDC cooperative agreements. Awards are made for five [5] years and may be renewed through a continuation application. This program is authorized under sections 301(a) and 317b(k)(2) of the Public Health Service (PHS) Act, [42 U.S.C. sections 241(a) and 247b(k)(2)], as amended (see Attachment 1).

Heart Disease and Stroke Prevention Programs are population-based, State public health programs that design, implement, and evaluate public health prevention and control strategies to reduce disease, disability and death related to heart disease and stroke, and to reach those populations with disparities related to cardiovascular disease. Support for these programs is a cornerstone of DHDSP efforts to reduce the burden of cardiovascular disease throughout the nation.

The DHDSP also provides funding for 15 WISEWOMAN projects in 14 states. The WISEWOMAN program offers screening tests for chronic disease and lifestyle interventions designed to change behavioral risk factors for chronic disease. WISEWOMAN was authorized through a legislative supplement to the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Public Law 101-354). This program is authorized under sections 1501-1509 [42 U.S.C. 300k-300n-4a] of the Public Health Service Act, as amended (see Attachment 1).

Only States/Territories/Tribes or their bona fide agents who receive funding under Section 1501 of the Public Health Service Act for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) are eligible for WISEWOMAN funds. WISEWOMAN programs (13 state health departments and 2 tribal organizations) are funded through Program Announcement 03022 and are managed as CDC cooperative agreements. Awards are made for five [5] years and may be renewed through a continuation application. All NBCCEDP-funded programs are required to submit continuation applications and semi-annual progress reports consistent with federal requirements in response to the Government Performance and Results Act of 1993.

Since the inception of the HDSPP and WISEWOMAN programs, pursuant to federal regulations, the CDC has requested submission of twice yearly progress reports from each HDSP and WISEWOMAN program. The progress information collected is used to identify training and technical assistance needs; monitor compliance with cooperative agreement requirements; evaluate progress made in achieving national and program-specific goals; and respond to inquiries regarding program activities and effectiveness. One way of collecting a portion of this information for WISEWOMAN programs is the automated WISEWOMAN Reporting System (OMB #0920-0612, exp. 1/31/2010). OMB #0920-0612 is the quantitative data collection of individual-level measures for participants in the WISEWOMAN program. Measures include (but are not limited to) blood pressure, total cholesterol, height, weight, and blood glucose. The MIS system (OMB #0920-0679) (Attachment 3) collects information used in progress reports and continuation applications such as program goals and objectives, staffing, and documents or products produced by funded programs. The MIS does not collect quantitative data on individual-level measures such as blood pressure covered in OMB #0920-0612.

The current MIS-based reporting mechanism (0920-0679) is used to maintain individual state information and to standardize the information reported by these programs. The web-based MIS employs a more formal, systematic method of collecting progress reports and continuation applications. This facilitates the CDC’s ability to fulfill its obligations under the cooperative agreements to: monitor, evaluate and compare individual programs; and to assess and report aggregate information regarding the overall effectiveness of the State Heart Disease and Stroke Prevention and WISEWOMAN Programs. The MIS also supports CDC’s goal of reducing the burden of disease related to heart disease and stroke by enabling staff to more effectively identify the strengths and weaknesses of individual programs, and to disseminate information related to successful public health interventions implemented by funded programs.

2. Purpose and Use of the Information Collection

The MIS is designed to provide HDSP and WISEWOMAN Program information including mid-year and year-end reports. Reports include program goals, objectives, progress summaries, products, and administrative information. The mid-year report also serves as the continuation application to secure funding for the next fiscal year.

CDC uses information from MIS reports for program operations management and reporting purposes including:

• Identifying the need for ongoing guidance, training, consultation, and technical assistance in all aspects of heart disease and stroke prevention and control

• Evaluating the progress made by programs in achieving national (HP2010) and program-specific goals and objectives

• Identifying successful and innovative strategies and public health interventions that are part of a comprehensive heart disease and stoke prevention program

• Disseminating and sharing Best Practices information among all funded States

• Monitoring the use of federal funds

• Evaluating and reporting on the overall effectiveness of funded programs

This automated MIS improves CDC’s ability to perform these functions and responsibilities. More importantly, it enables CDC to utilize web-based technology to perform these functions in a more efficient manner. The frequency with which the information will be collected will remain the same as previously described.

The utility of the MIS is ensured due to the capability of such a system to collect standardized information from every State-based program. Standardizing and automating this information will enable CDC to sort the collected information to compare the effectiveness of different programs and intervention strategies in preventing heart disease and stroke, recognizing signs and symptoms, controlling high blood pressure and cholesterol, improving quality of care for those diagnosed with heart disease and stroke. Without the automated MIS, CDC would need to continue to use the time consuming, labor intensive manual analysis procedures.

3. Use of Improved Information Technology and Burden Reduction

The MIS information system is a centralized, web-based system that uses a relational data model to support the collection and reporting of information. Special attention has been given to ensuring the system is easy to use and collects information that can later be queried and summarized through its reporting capabilities. The MIS allows for electronic respondent reporting resulting in improved reporting and less burden for the respondent. More specifically, the system was developed with the following objectives:

• Shortening the time period for collecting information

• Standardizing the information collection and dissemination processes

• Identifying promising practices

• Measuring progress on program objectives

• Sharing knowledge and experience

• Reducing dependence on paper

Additionally, within the MIS, CDC is integrating questions related to progress on 2010 National Objectives. A variety of meaningful reports can be generated through the MIS using the information collected. These reports are designed to assist CDC and HDSP and WISEWOMAN Programs in program planning, measuring progress, and sharing principles for practice. The system generates both standardized and customizable reports that allow users to set their own parameters. Reports can be generated at two levels:

• National level reports – These reports represent aggregate level information across HDSP and WISEWOMAN. Reports can be generated across two or more program, or across all programs.

• Local level reports – These reports represent information that is specific to a single State’s activities.

The MIS fosters consistency of information through its uniform collection process and well-defined information components. This collection process takes advantage of technology that ensures a minimum number of errors, quality information, and no redundancy.

The system allows varying degrees of access for project officers at CDC. System access will range from read-only access to full recording privileges depending on the user’s role and needs. This ensures that stored information is accessible only through the password protection mechanism.

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 States from the CDC through the Division for Heart Disease and Stroke Prevention. The MIS consolidates information necessary for both continuation applications and progress reports so that information entered once can be used to generate two types of reports without having to duplicate efforts. The MIS does not cause duplication and in fact, eliminates duplicative efforts.

5. Impact on Small Businesses or Other Small Entities

No small businesses will participate in the MIS data collection.

6. Consequences of Collecting the Information Less Frequently

Reports are collected semi-annually in fulfillment of requirements outlined in Program Announcements CDC-RFA-DP07-704 and 03022. The reports are due at the mid-term and end of the budget period. Less frequent reporting will negatively impact monitoring progress of national and state efforts to prevent and control heart disease and stroke, and undermine accountability efforts at both levels. The twice-yearly reporting will allow the DHDSP to respond in a timely manner with up-to-date information to inquiries from Congress and other stakeholders.

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 the Agency

A. Federal Register Notification

A 60-day Federal Register Notice was published on August 16, 2007 (volume 72, page 46085). To date, there have been no public comments in response to the notice. A copy of the Federal Register notice is included in Attachment 2.

B. Other Consultations

Consultation efforts will occur throughout the system development process. An external user survey was done with eight States in November 2003 to get an overview of their job responsibilities, an assessment of their State’s program, and specific management information system (MIS) needs and ideas. In December 2003, a content discussion and usability study was done with 24 State heart disease and stroke prevention staff to: validate the proposed content for selected sections of the MIS; verify the overarching navigation and framework of the MIS; and identify any potential usability or design issues. In February 2004, a workgroup comprised of 8 State heart disease and stroke prevention program staff was organized to provide feedback into MIS content and design, and participate in the pilot testing phases. The data collection instrument, the list of participants, and comments from the external user survey and usability study can be found in Attachments 3, 4, and 5.

9. Explanation of Any Payment or Gift to Respondents

Participants in the MIS do not receive payments or gifts for providing information.

10. Assurance of Confidentiality Provided to Respondents

This Information Collection Request has been reviewed and it has been determined that the Privacy Act is not applicable. Respondents are state-based health departments providing information on their organizational goals, activities, performance metrics, and resources. Information collected through progress reports is used to identify training and technical assistance needs; monitor compliance with cooperative agreement requirements; evaluate progress in achieving goals; and to respond to inquires. Although one or more contact persons is identified for each responding health department, the contact person is speaking from their role as a representative of the health department. The information collection does not involve sensitive or personal information.

Data will be submitted to CDC using Internet-based communication protocols. A security plan has been developed that follows CDC protocol, and this security plan met CDC guidelines before electronic data collection began. Access to the MIS will be controlled by a password-protected login. The MIS allows varying degrees of access for project officers at CDC, state level officials, and other interested parties. System access can range from read-only access to full recoding privileges depending on the intended user. This assures that stored information is accessible yet secure.

Northrup Grumman, the system contractor, oversees compliance with the written security plan developed by the CDC National Center for Chronic Disease Prevention and Health Promotion.

11. Justification for Sensitive Questions

The MIS instrument does not collect sensitive information. No personal information is requested and no personal identifiers will be reported. A security plan establishing controlled access to the information and following CDC guidelines has been developed.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

49 respondents will provide input into the proposed system. Respondents reside in each of 38 States and the District of Columbia. The annual hour burden is estimated at 588 total hours based on 6 hours to complete a report twice per year. Table A.12-1 displays the annualized report burden computations.

Table A.12-1. Estimated Annualized Burden Hours

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
Heart Disease and Stroke Prevention Programs	34	2	6	408
WISEWOMAN Programs	15	2	6	180
Total				588

B. Estimated Annualized Cost to Respondents

Table 2 displays estimates of annualized cost to respondents for the hour burdens used to report program progress information. The hourly wage rates are based on averages of selected Program Managers and Program Staff taken from ten states as shown EPMIS reports.

Table A.12-2. Estimated Annualized Cost to Respondents

Type of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Average Hourly Wage Rate	Total Cost to Respondents
Heart Disease and Stroke Prevention Programs	34	2	6	$25.00	$10,200
WISEWOMAN Programs	15	2	6	$25.00	$4,500
Total					$14,700

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

The information system was designed to use existing hardware within funded sites, and all respondents currently have access to the internet to use the information system. 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

Development, Implementation, and Maintenance

Major cost factors for the progress reporting system include development of query and evaluation components, maintenance, and system modification costs based feedback from system users. The ongoing maintenance costs and associated project support costs are assumed to be constant for the useful life of the system. However, because this system gathers progress reporting information associated with specific performance measures required as part of 5 year Cooperative Agreements cycles with states, any change to these performance measures in the future may precipitate system modifications. The associated costs for such modifications are undetermined and are not reflected here. However, it is assumed these changes would be minimal and thus easily incorporated into the contractors overall system maintenance contract, a currently established government contract expenditure.

Table 3

Phase	Estimated Cost
Development	$12,000
Deployment	$15,000
Maintenance	$10,000
Technical Assistance	$23,000

15. Explanation for Program Changes or Adjustments

This is a Revision to 0920-0679 which expires on May 31, 2008. The request for a revision is based on the following changes: 1) the name of the program collecting the information has changed from the Cardiovascular Health Branch to the Division for Heart Disease and Stroke Prevention; 2) the number of respondents has increased from 34 to 49 to include WISEWOMAN programs that were integrated into DHDSP when it became a Division; 3) revisions have been made to the data collection instrument to include questions relevant to the WISEWOMAN program; and 4) due to the increase in respondents and the changes to the questions, the estimated burden hours and costs have increased.

16. Plans for Tabulation and Publication and Project Time Schedule

A. Time schedule for the entire project

A 3-year clearance is requested for this required semi-annual data collection. Actual data collection will begin in March 2008 or as soon as possible following OMB approval. A table including beginning and ending dates for the collection of information and other actions is provided below.

Table 16-1 Project Time Schedule
Activity	Time Schedule
Mid-year Progress Report	March 15, 2008
Year-end Progress Report	Sept. 30, 2008
On-going Support (as required)	After OMB approval

B. Publication plan

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

C. Analysis plan

CDC will not use complex statistical methods for analyzing information. All information will be aggregated and reported in internal documents. Statistical analyses will be limited to simple tabulations.

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

The MIS program will display the expiration date for OMB approval of the data collection on its Internet home page.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions to the certification statement are identified in Item 19 of OMB form 83-I.

B. Collections of Information Employing Statistical

Methods

CDC will not use any statistical methods to select respondents because all funded HDSPPs will use the MIS system. Public law requires application submission and financial reporting by the actual recipients of funding. Statistical methods cannot be used to reduce burden or improve accuracy of results because of the nature of the program.

All HDSP and WISEWOMAN programs are currently required to submit annual progress reports. The MIS will allow funded programs to submit their progress reports semi-annually by entering information into the system, thus eliminating the need for additional written reports. The MIS will enable CDC to identify training and technical assistance needs, monitor compliance with cooperative agreement requirements, evaluate progress made in achieving center-specific goals, and obtain information needed to respond to Congressional and other inquiries regarding program activities.

1. Respondent Universe and Sampling Methods

CDC does not plan to use any statistical methods to select any respondents because all funded programs will be required to use the progress reporting system. The expected response rate for the collection as a whole is 49 (all currently funded states and the District of Columbia).

2. Procedures for the Collection of Information

The information will be collected using the described password protected web-based system. Respondents will log into the system at their worksite computer and provide progress reporting information through prompted data entry points.

The respondents will receive training on use of the application and on the required report content prior to their first reporting deadline of March 15, 2007. Respondents will be informed of their reporting deadlines via semi-annual notification letters received from the Procurement and Grants Office (PGO) and via emails sent by CVHB to all known users of the system. Respondents will not be re-interviewed or contacted for data validation.

3. Methods to Maximize Response Rates and Deal with Nonresponse

Respondents are required to file twice yearly progress reports in order to continue to receive level federal funding in support of their state heart disease and stroke prevention programs. Respondents are encouraged to use the web-based system to file these reports, but are not required to do so. Therefore, no efforts will be made to maximize respondent use rates. However, rates are expected to be 100%.

4. Tests of Procedures or Methods to be Undertaken

The system has undergone rigorous application testing, including fidelity and usability testing of system design, accuracy and comprehension testing of proposed data elements and pilot testing of the online system. These tests were performed using less than 10 respondents per test. Respondents were culled from the external workgroup (see Attachments 3 & 4).

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and /or Analyzing Data

No individuals will be consulted on statistical aspects of the design as statistical methods will not be used in analysis of the information.

The individuals responsible for design of the data collection system include:

Ron Todd, Cardiovascular Health Branch, Centers for Disease Control and Prevention, (770) 488-5329, [email protected]

Jeanne Casner, Northrop Grumman Mission Systems (contractor), (678) 530-3522, [email protected]

The individual responsible for data collection and analysis:

Ron Todd, Cardiovascular Health Branch, Centers for Disease Control and Prevention, (770) 488-5329, [email protected]

C. LIST OF ATTACHMENTS

ATTACHMENT 1: Applicable Sections of Laws or Regulations

ATTACHMENT 2: Federal Register Notice Announcing the 60-Day Public Comment Period

ATTACHMENT 3: Participants in the Usability and Pilot Tests

ATTACHMENT 4: Usability Testing Results

ATTACHMENT 5: Proposed MIS Data Collection Instrument

16