SS-Part A_03 13 2014

CDC currently collects annual progress and activity reports from awardees funded under the Division of Oral Health (DOH) State-based Oral Disease Prevention Program (Oral Health Management Information System, OMB No. 0920-0739, exp. 4/30/2014). The electronic reporting system has been in place since 2007 and was enhanced in 2008 to capture information about grantees’ success stories and environmental scanning activities. The information collected in the management information system (MIS) improved CDC’s ability to disseminate information about successful public health approaches that can be replicated or adapted for use in other states.

A new cooperative agreement was funded in 2013, and CDC plans to implement changes to the information collection. In this Revision ICR, CDC describes:

An increase in the number of awardees from 20 to 21.
Changes in the MIS platform and data elements. These changes will align the monitoring and evaluation framework for oral health awardees with the monitoring and evaluation framework used for a number of other programs in the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP).
A revised method of estimating burden that distinguishes between (i) the initial burden of populating the MIS, and (ii) routine MIS maintenance and report generation. The revised method provides a more accurate depiction of burden per respondent in comparison to the method presented in previous requests for OMB approval, which was based on a long-term average burden per response. There is no change in the frequency of reporting.

The planned changes will allow CDC to build upon existing data elements, integrate new performance measures and data elements into progress reporting, and better streamline performance monitoring, accountability and evaluation of state progress. In addition, the information gathered by the system will be used to provide technical assistance and training to grantees to increase their ability to meet program objectives and outcomes. OMB approval is requested for three years.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The CDC seeks to improve the oral health of the nation by targeting efforts to assist state health departments to build and/or maintain effective public health capacity for implementation, evaluation, and dissemination of best practices in oral disease prevention and advancement of oral health. Through a cooperative agreement program (Program Announcement DP13-1307), CDC will provide approximately $5.9 million per year over five years to 21 states. The new cooperative agreements went into effect in September 2013 and build on previous funded collaborations involving CDC and state programs. Three of the 21 awardees are funded at the Basic level (Component 1, infrastructure) and 18 are funded at the Enhanced level (Component 2) which includes additional activities [see Attachment 3. Awardees]. CDC funding will be used to strengthen awardees’ core oral health infrastructure and capacity; implement and expand evidence-based interventions that increase community-clinical linkages, such as school-based dental sealant programs; increase and maintain environmental systems level changes that supports healthy behaviors, such as community water fluoridation; implement strategies that improve the delivery of targeted clinical preventive services; and promote beneficial health systems changes. CDC funding will also help states reduce health disparities among high-risk populations including, but not limited to, those of lower socio-economic status, rural populations, Hispanic, African American and other ethnic groups.

CDC is currently approved to collect progress and activity information from state-based oral health programs (Oral Health Management Information System, OMB No. 0920-0739, exp. 4/30/2014). The electronic MIS has been in place since 2007 and was enhanced in 2008 to capture information about grantees’ success stories and environmental scanning activities. The electronic MIS employs a formal, systematic method of collecting information and standardizes the content of this information. Awardees have used the MIS to submit their annual progress reports to CDC.

CDC staff and grantees have identified opportunities to improve user satisfaction and the utility of the information collected. To better assist grantees in organizing their oral health program information and generating annual progress reports for cooperative agreement DP13-1307 in an efficient and effective manner, changes to the current reporting system are planned. Use of the MOLAR platform will be discontinued and awardees will report through an MIS platform with an updated interface, stronger search capabilities, the ability to generate data reports based on key words, and linking capabilities with other CDC funded programs. Although the MOLAR system included the majority of data elements needed for progress reporting, migrating oral health awardees to the updated system will allow CDC to collect new performance measures and data elements specifically required by cooperative agreement DP 13-1307, and will align the program monitoring framework for state oral health programs with the framework used for a number of other programs in the National Center for Chronic Disease Prevention and Health Promotion. This new cooperative agreement is less prescriptive and focuses more on outcomes than previous ones funded by the CDC Division of Oral Health. It also incorporates changes prompted by CDC adopting a new funding opportunity announcement (FOA). Some of the major changes include modifications in performance measures from using eight more prescriptive recipient activities to incorporating seven strategies each in two levels—Component 1 (Basic) state oral health programs and Component 2 (Enhanced) [see Attachment 3. Awardees; and Attachment 4. Performance Measures].

The information provided by States is used to monitor compliance with cooperative agreement requirements; identify training and technical assistance needs; evaluate the progress made in achieving national and program-specific goals; and respond to inquiries regarding program activities and effectiveness. The CDC is authorized to do collect this information under sections 301 (a) and 317 (k) (2) of the Public Health Service Act [42 U.S.C. section 241 (a) and 247b(k) (2)]. Copies of these Public Law sections are displayed in Attachment 1. The Catalog of Federal Domestic Assistance (CFDA) number is 93.283, “CDC Investigations and Technical Assistance.”

Privacy Impact Assessment

Overview of the Data Collection System

CDC's DOH focuses on providing support to state programs to prevent oral disease; promoting oral health nationwide; and fostering evidence based initiatives to enhance oral disease prevention in community settings. Awardees will enter information into an electronic management information system (MIS) and submit reports to CDC on an annual basis. The MIS allows state oral health programs to share and report relevant and purposeful information for planning, implementing, managing and monitoring their programs.

Data placed into the system produces annual reports as PDFs that grantees can use to upload into grants.gov. This procedure satisfies the routine, annual cooperative agreement reporting requirements. Progress reports are required once per year, but data entry can occur on a continuing basis. As a result, the MIS can also be used for ongoing program management, and supports more effective, data-driven technical assistance between DOH and grantees.

Methods used. The MIS is an authenticated Web based system. State users (respondents) must log into the system and enter the information.

Data collection partners and the length of time the information will be maintained. CDC partners providing data are grantee states funded through the CDC DOH State-based Oral Disease Prevention Program cooperative agreement. It is anticipated that the information will be maintained for as long as the Division of Oral Health continues to fund the cooperative agreement program.

Items of Information to be Collected

The only IIF information collected in the MIS is the name, work telephone number, and work email address for a point of contact for each grantee. The information is not disseminated or shared with the public. The MIS application is available only to authorized CDC personnel and partners.

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

No information is directed at or accessible by children under 13.

2. Purpose and Use of Information Collection

The mission of CDC DOH is to reduce the national burden of oral diseases. The MIS facilitates fulfillment of CDC’s and grantees’ obligations under the cooperative agreements; builds CDC’s capacity to monitor, evaluate, and compare individual programs; and supports CDC’s ability to assess and report aggregate information regarding the overall effectiveness of the program. The information collected through the MIS is used for program operations, management, and reporting purposes, including:

 Monitoring the use of federal funds

 Identifying the need for ongoing guidance, training, consultation, and technical assistance in all aspects of oral disease prevention and control

 Identifying successful and innovative strategies and public health interventions to reduce the burden of oral diseases

 Disseminating and sharing information among all grantees

 Evaluating the progress made by programs in achieving national and program-specific goals and objectives

 Evaluating and reporting on the overall effectiveness of the grantees

As a result of experience with interpreting the information collected, and interaction with grantees, CDC is able to provide more targeted technical assistance to grantees based on improved understanding of their individual strengths and weaknesses. We also learned that grantees share CDC’s interest in learning about successful public health interventions.

Privacy Impact Assessment

Purpose of the Information Collection. The information will be collected to assist states in organizing their oral health program information and generating annual progress reports for cooperative agreement DP13-1307 efficiently and effectively. In addition, the information fulfills reporting requirements and enhances the provision of technical assistance to the grantees.

Use of the Information. The information will be used to fulfill reporting requirements for the cooperative agreement and to enhance the provision of technical assistance to the grantees.

Information Sharing. The MIS application is an authenticated, internet application available to authorized CDC personnel and partners. The only IIF items collected are Name, Work email and Work Phone. Elements are only shared with authorized CDC Personnel as contact information for providing technical assistance to that specific grantee.

Impact on Respondents Privacy. The proposed data collection will have little or no effect on the respondent’s privacy.

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 through storing all program information in one system, enabling states to transfer data from one year to another to minimize data re-entry, and utilizing a standard set of data elements, definitions, and specifications across all programs.

The MIS uses the Internet’s standard communication protocols to control both access and communications by State program personnel. CDC provides State program personnel with access to program information via the Web. According to State grantees, through the automatic transfer of programmatic information, the MIS decreases the reporting burden on grantees significantly once the initial data are entered.

Other improved information technology components are the search queries and ability to export data using MS Excel, which could help to reduce the burden on states to respond to ad-hoc reports from funders and other stakeholders. The search feature also improves the ability to monitor program progress for CDC and the state. Another improved technology is integrating state data across CDC programs. This function allows states to monitor the extent of shared resources, such as staffing, leveraging of resources, partnerships and program activities with other state programs funded by CDC.

4. Efforts to Identify Duplication and Use of Similar Information

Respondents are recipients of CDC funding. There is no other source of up-to-date information about their objectives and activities.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this study.

6. Consequences of Collecting Information Less Frequently

There are no legal obstacles to reduce the burden.

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

There are no special circumstances related to the MIS, all guidelines of 5 CRF 1320.5 are met, and this project fully complies.

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 on December 11, 2013, Vol. 78, No. 238, pages 75352-75353 (see Attachment 2A). One public comment was received and acknowledged (Attachment 2B).

B. Consultation Outside the Agency

During the development of the previous electronic MIS reporting system (MOLAR), consultation with state grantees occurred to determine information needs of the state programs. An eight member workgroup consisting of funded states was established to provide ongoing feedback on the usability of the system. Suggestions from the workgroup were reviewed and considered for the development of the updated MIS. In addition, an external workgroup consisting of funded states, non-funded states, non-profits and academic institutions provided feedback on the data elements required for cooperative agreement DP13-1307.

9. Explanation of Any Payment or Gift to Respondents

Applicants or funding recipients do not receive payments or gifts for providing information.

10. Assurance of Confidentiality Provided to Respondents

The information collected in the MIS is secured by technical, physical, and administrative safeguards. A data contractor has been retained to assist with MIS development and security. Additional information is provided below.

Privacy Impact Assessment

A. Privacy Act Determination

Staff in CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) have reviewed this submission and determined that the Privacy Act is not applicable to the data collection. Respondents are state-based oral health programs providing information on their organizational goals, activities, performance metrics, and resources. Although one or more contact persons are identified for each responding health department, the contact person does not provide personal information.

B. Information Security

Data security is ensured in the event of unauthorized access to the application server and/or code.

Technical safeguards. The system requires external users to login with assigned user ids and passwords integrated into the application. CDC users access the system through integrated windows authentication which relies on Personal Identification Verification (PIV) cards in compliance with HSPD-12. There is no personal, private information in the user’s profile. Passwords are never displayed and are stored in an encrypted form. User IDs are also encrypted. Respondent data is submitted to CDC via standard Internet-based communications protocols. Access to potentially sensitive data elements such as financial data is restricted using additional password protection.

Physical safeguards. Information is stored on MIS servers that comply with CDC standards and policies. The servers are housed in a secure, guarded, controlled-access facility. The MIS is backed up nightly so the database can be restored to a previous state in the event of suspected data corruption.

Administrative safeguards. To ensure authorized access, user accounts are available only to authenticated administrators. All accounts are approved by a system administrator inside the CDC network and reviewed on an ongoing basis. If any account becomes suspect, that account is removed or altered by the system administrator. Inactive users are logged off after 45 minutes and are required to re-login. The Data Steward is also responsible for periodic reviews of the data to ensure its quality, accuracy, and timeliness of submission.

An identification badge is issued to all contractor staff. All employees of the contractor and its subcontractors are required to sign a non-disclosure agreement.

C. Consent

The respondents for the MIS are state oral health programs and not individuals. This information collection does not involve research with human subjects. IRB approval is not required.

D. Voluntary vs. Mandatory Response

Grantees are required to report through the MIS once a year as a condition of cooperative agreement funding.

11. Justification for Sensitive Questions

The MIS does not contain highly sensitive personal information; however, some of the respondent's financial, performance or personnel data could be viewed as somewhat sensitive. The collection of this information is integral to the purposes of the MIS. The security measures described above have been put in place to guard against inadvertent or inappropriate disclosure of information.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

CDC will fund 21 state health departments to implement state oral health programs. All awardees are funded at the Basic level (Component 1). In addition, 18 awardees are funded at the Enhanced level (Component 2). CDC will require funded states to report program information electronically through the MIS once per year. Screen shots of the MIS are included as Attachment 5.

CDC anticipates that burden to respondents will vary over the award period. The time commitments for data entry and training are greatest during the initial population of the MIS, typically in the first six to twelve months of funding. As a result, entering data into the MIS will occur in two phases. The first phase is the initial population of the MIS. The initial data entry will include setting up the action plan, including project objectives, uploading data on staff, partners and contracts and entering baseline data on the performance measures. For initial population of the MIS, the estimated burden per response is 6 hours for awardees funded at the Basic level, and 13 hours for awardees funded at the Enhanced level. To estimate annualized burden, this one-time activity is distributed over the three-year clearance period. For initial population of the MIS, the annualized number of respondents for Basic level awardees is 1 (3 awardees / 3 years of clearance). The annualized number of respondents for Enhanced level awardees is 6 (18 awardees / 3 years of clearance).

After the initial program data have been entered, the states will move into the ongoing maintenance phase of the system, which is limited to entering changes, annual progress information, performance measures data and new activities. CDC estimates that the burden estimate for annual reporting and ongoing maintenance is 3 hours per response for the 3 awardees funded at the Basic level, and 9 hours per response for the 18 awardees funded at the Enhanced level.

The total estimated annualized burden for all awardees is 255 hours, as summarized in Table A.12-A, below.

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)
Program Awardees Basic Level	Initial MIS Population	1	1	6	6
Program Awardees Basic Level	Annual Progress Report	3	1	3	9
Program Awardees Enhanced Level	Initial MIS Population	6	1	13	78
Program Awardees Enhanced Level	Annual Progress Report	18	1	9	162
	Total				255

B. Estimated Annualized Cost to Respondents

CDC anticipates that the state oral health program coordinator will assume the duty of managing the annual reporting process and coordinating data entry into the MIS. CDC identified salaries of program coordinators from 10 states to estimate the average hourly wage rate. Based on CDC’s calculation, the average hourly wage rate is $30.10/hour. The hourly wage does not include an estimate of benefits. The estimated annualized cost to respondents is $7,676 (see Table A.12-B below).

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
Program Awardees Basic Level	Initial MIS Population	1	6	$30.10	$181
	Annual Progress Report	3	9	$30.10	$271
	Initial MIS Population	6	78	$30.10	$2,348
	Annual Progress Report	18	162	$30.10	$4,876
	Total				$7,676

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

The information system is designed to use existing hardware within funded sites, and all respondents will have access to the Internet to use the information system. No capital or maintenance costs are expected beyond normal office requirements.

14. Annualized Cost to the Federal Government

The average annualized cost to the federal government is $38,550, as summarized in Table A.14-A. Major cost factors for the MIS include application design and development costs and system maintenance costs. The MIS developer and data collection contractor is Northrup-Grumman with oversight of the system by a CDC employee. The CDC employee serves as the data steward and participates in regular planning and coordination meetings with the contractor staff.

The ongoing maintenance costs and associated project support costs are assumed constant for the useful life of the system. If the specific performance measures required for awardees change over time, the MIS may require modifications. The costs associated with such modifications are undetermined and are not reflected here. However, it is assumed these changes would be minimal and thus easily incorporated into the overall system maintenance contract. The average annualized cost of the maintenance contract is estimated at $30,000

Table A.14-A. Annualized Cost to the Government

Cost Category	Avg. Annual Cost
Data Collection Contractor	$ 30,000
CDC GS-13 10% GS-13 @ 85,500/year	$ 8,550
Total	$ 38,550

15. Explanation for Program Changes or Adjustments

In this Revision request, the number of respondents will increase from 20 to 21 and the total estimated annualized burden will increase from 220 hours to 255 hours.

Use of the electronic MOLAR MIS will be discontinued and this IC will be “zeroed out.” For MOLAR, the average estimated burden per response was based on a long-term average of 11 hours. During the most recent OMB approval period, the frequency of reporting was changed from semi-annual to annual.

In this Revision, oral health awardees will report through a modified MIS platform that is better aligned with the monitoring and evaluation framework employed for other chronic disease programs. We will also implement a revised method of estimating burden. The revised method distinguishes between (i) the initial burden of populating the MIS, and (ii) routine MIS maintenance and report generation. It also distinguishes between the reporting burden for awardees funded at the Basic level and reporting burden for awardees funded at the Enhanced level. The revised method provides a more accurate depiction of burden per respondent in comparison to the method presented in previous requests for OMB approval. Four new ICs have been created. During the three year period of this Revision request, reports will be submitted to CDC once per year.

16. Plans for Tabulation and Publication and Project Time Schedule

A. Time schedule for the entire project

OMB approval is being requested for three years. Reports will be generated by the awardees per the funding requirements once a year, in April. Data collection will begin with initial funding in 2013 and will continue through 2018, the duration of the cooperative agreement program. An Extension or Revision request will be submitted to obtain OMB approval for data collection in the final years of the cooperative agreement program.

B. Publication plan

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

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 may include descriptive statistics and limited statistical modeling to examine predictors of specified outcomes.

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

The expiration date of OMB approval of the data collection will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions are being sought to the certification statement for this data collection.

File Type	application/msword
File Title	CDC ORAL HEALTH MANAGEMENT INFORMATION SYSTEM
Author	arp5
Last Modified By	CDC User
File Modified	2014-03-13
File Created	2014-02-19

SS-Part A_03 13 2014