0920-0739 Revision Request Supporting Statement A_DOH_7_26_2017

0920-0739 Revision Request Supporting Statement A_DOH_7_26_2017.doc

CDC Oral Health Management Information System

OMB: 0920-0739

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CDC ORAL HEALTH MANAGEMENT INFORMATION SYSTEM


OMB No. 0920-0739








Request for Reinstatement with Change


Supporting Statement: Part A









Submitted by: Ali B. Danner, MPH

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Division of Oral Health

4770 Buford Highway, NE, Mailstop F-80

Atlanta, GA 30341

770-488-5630

Fax: 770-488-6080

[email protected]



July 26, 2017

Table of Contents


List of Attachments………………………………………………………………………..

3

Section A. Justification……………………………………………………………………

5

1. Circumstances Making the Collection of Information Necessary…………………..

5

2. Purpose and Use of Information Collection…………………………………………..

6

3. Use of Improved Information Technology and Burden Reduction…………………

7

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

7

5. Impact on Small Businesses or Other Small Entities……….………………………..

7

6. Consequences of Collecting Information Less Frequently…………………………..

7

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

8

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


8

9. Explanation of Any Payment or Gift to Respondents………………………………..

9

10. Protection of the Privacy and Confidentiality of Information Provided by
Respondents…………………………………………………………………………….


9

11. Institutional Review Board (IRB) and Justification for Sensitive Questions………

10

12. Estimates of Annualized Burden Hours and Costs…………………………………..

10

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

12

14. Annualized Cost to the Federal Government………………………………………...

12

15. Explanation for Program Changes or Adjustments…………………………………

13

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

13

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

14

18. Exceptions to Certification for Paperwork Reduction Act Submissions…………...

14



List of Attachments


Attachment 1. Authorizing Legislation

Attachment 2. 60-Day Federal Register Notice

Attachment 3. List of Awardees

Attachment 4. Required Performance Measures and Data Elements

Attachment 5. Oral Health Management Information System 2013-2018 Screen Shots

Attachment 6. CDC NCCDPHP Research Determination


  • Goal of the study: To continue using the CDC Oral Health Management Information System (MIS), a web-based organizational assessment tool, to collect data from 21 State Health Departments. The results of the data will help CDC understand state programs and their policies and practices as they implement CDC evidenced-based prevention and intervention strategies. In addition, MIS data will help CDC determine state-based training and technical assistance needs, monitor compliance with the cooperative agreement requirements, and evaluate progress made in achieving program-program specific goals.


  • Intended use of the resulting data: The results will inform how state-based public health programs are improving oral health outcomes in their states. It will also help CDC provide appropriate and targeted technical assistance where needed.


  • Methods to be used to collect: A web-based system that is password protected will be used to collect data from state-based oral health programs.


  • The subpopulation to be studied: 21 State-based Oral Health Programs.


  • How data will be analyzed: Progress reports submitted by awardees often contain qualitative state-specific examples. DOH will code and analyze data reports (in CDMIS) for themes. Coding will be done manually or using a CDC-approved qualitative software package.


Section A. Justification


1. Circumstances Making the Collection of Information Necessary


The CDC seeks to improve the oral health of the nation by building state and territorial oral health infrastructure; strengthening and enhancing oral health program capacity to monitor the population’s oral health status and behaviors; and supporting the development of effective programs to improve the oral health of children and adults. It also evaluates oral health program accomplishments; and informs key stakeholders – including policymakers of program successes.


The CDC Division of Oral Health (DOH) provides targeted support to state-based oral health programs (OHPs) to prevent oral disease and promote good oral health and evidence-based prevention interventions in community settings. Through the Cooperative Agreement DP13-1307, CDC has provided $6 million per year over 5 years in funding to 21 state awardees with the goal of strengthening their OHPs’ infrastructure and reducing health disparities among high-risk groups. The CDC is authorized to do this 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 in Attachment 1. The Catalog of Federal Domestic Assistance (CFDA) number is 93.283.


The CDC Oral Health Management Information System (MIS) helps state awardees to organize their oral health program information and generate annual progress reports for cooperative agreement (DP13-1307) in an efficient manner. CDC requires submission of an annual status report from each state awardee. The information provided by state awardees helps to monitor compliance with cooperative agreement requirements; identify training and technical assistance needs; evaluate progress made in achieving national and program-specific goals; and to respond to inquiries regarding program activities and effectiveness. Previously, CDC used a variety of other methods to collect state-level information, which included the initial cooperative agreement application, continuing applications for each budget period, and periodic progress and financial status reports.


In an effort to centralize collection and minimize burden on respondents, CDC developed the automated MIS to maintain individual awardee information and to standardize the information reported by these programs. The electronic MIS employs a formal, systematic method of collecting information and standardizes the content of the information reported. Even though there are two levels of awardees—basic and enhanced—all 21 enter data into the same MIS [see also Section A.8B]. OMB approval for the electronic reporting system expired on 5/31/2017. CDC requests a reinstatement with change to continue collecting information for an additional two years. Changes made included the move of Success Stories content from one section of the MIS to another—i.e., from the Planning Tab to the Program Information Tab. This move did not affect the burden upon awardees. The total estimated annualized burden hours and content decreased for state awardees from 255 hours (2014) to 171 hours (present), as they no longer had to repeat the entry of administrative data into the MIS after Grant Year-01—i.e., administrative data copies forward into subsequent grant years [See also Section A.15].


Over the past three years, CDC DOH has gained invaluable information from progress reports submitted by awardees into the MIS. Awardees have cited the CDC cooperative agreement funding as being very critical to sustaining their state oral health program. In addition, CDC funding has been critical in implementing our evidenced-based prevention interventions–school-based sealant program and community water fluoridation activities.


2. Purpose and Use of Information Collection


The information collected assist states in organizing their oral health program information and generating annual progress reports for cooperative agreement DP13-1307. In addition, the information fulfills reporting requirements for the FOA and enhances the provision of technical assistance to the awardees.


The mission of CDC’s Division of Oral Health is to reduce the national burden of oral diseases. The MIS was designed to facilitate fulfillment of CDC’s and the awardees’ obligations under the DP13-1307 cooperative agreement. This includes the CDC’s capacity to monitor, evaluate, and compare individual programs, and its 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 awardees

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

evaluating and reporting on the overall effectiveness of the awardees


Through interpreting collected information and interacting with awardees, CDC DOH is able to provide targeted technical assistance to awardees based on improved understanding of their individual strengths and weaknesses. DOH has also learned that awardees share CDC’s interest in learning about successful public health interventions.


3. Use of Improved Information Technology and Burden Reduction


The information collected involves the use of modern, state-of-the-art information technology to support the acquisition and reporting requirements described in the funding announcement:


exploit the capabilities of the internet to provide state access to the database

provide a methodology for efficient and secure submission of annual state reports


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 through the internet. For example, the user browses through a series of pre-formatted screens that display each group of state program data such as program activity, staffing, administrative, financial, and advisory body information. Further selected portions of state program data, such as financial data, are restricted to specific states and/or selected state personnel only.


MIS developers gathered feedback from end-users through a Beta Test to determine potential reporting burden (2013). Beta Test results revealed that the transfer feature prevents awardees from having to re-type information from the previous year. Therefore, the MIS copy feature allows for decreased administrative burden.

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. Without this information, CDC would lack the capacity to effectively manage the DP13-1307 cooperative agreement activities and/or monitor progress of awardees.


5. Impact on Small Businesses or Other Small Entities


Data collection will not involve small businesses.


6. Consequences of Collecting Information Less Frequently


There are no legal obstacles to reduce the burden. Because the data collection is intermittent, collecting information on a less frequent basis would leave CDC unable to monitor adequately the awarded program’s progress to assess needed technical assistance, gauge program outcomes, and determine the effectiveness of interventions.



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 is in full compliance.


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 January 19, 2017, Vol. 82, No. 12, pages 6554-6556 (Attachment 2a). No public comments were received.


B. Consultation outside the Agency


In conjunction with the initial implementation of the MIS, DOH consulted with state awardees to determine information needs of the state programs. FOA DP13-1307 includes two levels of awardees — Basic and Enhanced. Component 1 awardees are basic capacity or beginner state oral health programs (OHPs) responsible for promoting change that leads to the advancement of state oral health objectives. Component 2 awardees are enhanced OHPs whose purpose is to maintain basic capacity for collective impact and also implement and expand evidence-based interventions. All awardees funded under this FOA have reporting and monitoring obligations; however, awardees funded under Component 2 must monitor and report progress on the performance measures related to the strategies under both Component 2 and the performance measures for Component 1. Both Component 1 and 2 awardee information are collected in one system (MIS).


Table 1. FOA DP13-1307 Grantee States


  1. Component 1 (Basic):



Idaho

Hawaii

New Hampshire


  1. Component 2 (Enhanced):

Colorado

Connecticut

Georgia

Iowa

Kansas

Louisiana

Maryland

Michigan

Minnesota

Mississippi

New York

North Dakota

Rhode Island

South Carolina

Vermont

Virginia

West Virginia

Wisconsin



9. Explanation of Any Payment or Gift to Respondents


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


10. Protection of the Privacy and Confidentiality of Information Provided by Respondents


CDC has reviewed this Information Collective Request and has determined that the Privacy Act is not applicable to the data collection. Respondents are state-based health departments that only provide information on their organizational goals, activities, performance metrics, and resources. State awardees are required to report through the MIS once a year as a condition of cooperative agreement funding. Each health department identifies one or more contact person as a point-of-contact for the MIS, but the contact person does not provide personal information.


Technical, physical, and administrative safeguards secure the information collected in the MIS. For example, User Names and Passwords are required for each CDC program and awardee staff member accessing the system. A CDC’s data contractor (Northrop Grumman) assisted with the MIS development and security. Additional information provided below. Data security is in place in the event of unauthorized access to the application server and/or code.


Technical safeguards: The system uses the Logon.DLL to authenticate the user in the CDC NT Domain, or, in the case of non-CDC users, against the system’s own list of users and passwords. The user must login before accessing their information. There is no personal, private information in the user’s profile. Passwords are stored in an encrypted form and never displayed. User IDs are encrypted. Respondent submits data to CDC through standard internet-based communications protocols. Access to potentially sensitive data elements, such as financial data, requires additional password protection and is restricted.


Physical safeguards: Information is stored on MIS servers that comply with CDC standards and policies. The servers are in a secure, guarded, controlled-access facility. The MIS database updates nightly in the event of data corruption.


Administrative safeguards: To ensure authorized access, user accounts are available only to authenticated administrators. A System administrator approves and reviews all accounts inside the CDC network on an ongoing basis. If any account becomes suspect, the system administrator removes or alters that account. After 90 minutes, inactive users automatically are logged-off and are required to re-log in. The Data Steward is also responsible for periodic reviews of the data to ensure its quality, accuracy, and timeliness of submission.


All contractor personnel receive an identification badge. All employees of the contractor (Northrop Grumman) and its subcontractors are required to sign a non-disclosure agreement.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions


The respondents for the MIS are state-based oral health programs and not individuals—i.e., the MIS does not contain sensitive personal information. IRB approval is not required for this information collection. For information collected, security measures as described above are in place to guard against inappropriate disclosure of information. Data reported to the MIS is program-level information, not individual level information.


12. Estimates of Annualized Burden Hours and Costs


A. Estimated Annualized Burden Hours


All information collection takes place annually and electronically through the MIS and there are no changes in methods. The CDC estimates that the current burden is 3 hours for the 3 basic-level respondents and 9 hours for the 18 enhanced-level respondents. The estimated burden includes both system maintenance and annual progress reporting for both the basic- and enhanced-level respondents in the MIS. Although only annual progress reports are required, states may enter updates into the MIS at any time. CDC uses all information collected to monitor awardees’ progress and provide any technical assistance or follow-up support needed.


The total estimated annualized burden hours are 171. The total burden hours are summarized in Table A.12-A, below.


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



Estimated Annualized Burden of Hours



Type of Respondents

Form Name

No. of Respondents

No. of Responses per Respondent

Average Burden per Response (in hours)

Total Burden (in hours)

Program Awardees Basic Level

Annual Progress Report

3

1

3

9

Program Awardees Enhanced Level

Annual Progress Report

18

1

9

162

Total

171



B. Estimated Annualized Cost to Respondents


To determine the estimated average wage rate of $50.00 per hour, the salaries of state oral health program managers were averaged for 6 awardees. The hourly wage is a straight calculation that does not include an estimate of benefits. The hourly wage multiplied by the total estimated burden to respondents result in an estimated total annualized cost to respondents of $8,550 (see Table A.12-B below).



Table A.12-B. 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

Total Cost to Respondents

Program Awardees Basic Level

3

1

3

$50.00

$450

Program Awardees Enhanced Level

18

1

9

$50.00

$8,100

Total

$8,550

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


The information system uses the existing hardware within funded sites, and all respondents currently have access to the internet to use the information system. Use of the system requires no capital or maintenance costs beyond normal office requirements.


14. Annualized Cost to the Federal Government


Phase I development costs for the MIS (now complete) were described in the original Information Collection Request. The current Phase II costs include the cost of a contract with the data collection contractor (Northrop Grumman, Atlanta, Georgia), responsible for ongoing system maintenance and user training, and the cost associated with oversight of the system by a CDC employee. The CDC employee serves as the data steward and participates in periodic planning and coordination meetings with the contractor personnel.


The ongoing maintenance costs and associated project support costs are constant for the useful life of the system. The estimated average annualized cost of the maintenance contract is at $42,000 over 12 months.


The total estimated annualized cost to the Federal government is $46,800.


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


Cost Category

Avg. Annual Cost

Data Collection Contractor

$42,000

CDC GS-13, 5% @ $96,000/year

$ 4,800

Total

$46,800

15. Explanation for Program Changes or Adjustments


This reinstatement with change information collection includes an updated version of a previously approved OMB package (OMB Control Number 0920-0739, expiration date 5/31/2017). Initial data entry for DP13-1307 in the CDC Oral Health Management Information System (MIS) began when the cooperative agreement started. Minor changes made to the user interface helped improve the user experience, and the content and user burden for each screen remained unchanged. The total estimated annualized burden hours for awardees decreased from 255 hours (2014) to 171 hours (present) as they no longer have to repeat initial data entry. The reinstatement permits CDC to collect the final progress report that is due from awardees by 11/30/2018, including any reports submitted after the due date.


Although there are no changes to the current data collection instrument (i.e., CDMIS), the screenshots will not be the same as the 2014 OMB package. The 2014 OMB screenshots were drafts of the MIS at the time of submission, and were refined as the 2014 OMB package went through the approval process. During the 2014 OMB approval process, the Division of Oral Health (DOH) leadership requested some draft sections be omitted (i.e., Environmental Assessment, Technical Assistance Module); and others added (i.e., Success Stories, Annual Performance Report). DOH took this action to support the description in the Funding Opportunity Announcement (FOA) and align with CDC/ATSDR guidance for developing FOA for non-research funding opportunities. DOH received OMB approval with the draft MIS screenshots and not the final version. Any sequence changes made and finalized did not change the user burden.


16. Plans for Tabulation and Publication and Project Time Schedule


Time schedule for the entire project: Current activities include maintenance and updating of the MIS reporting system based on state awardee requests and enhancing search functions within the system. The state awardees’ final report under the current FOA is due to CDC on 11/30/2018. Because OMB approval for the electronic reporting system expired 5/31/2017, CDC is requesting reinstatement of OMB approval for two years. This will allow CDC to receive the final reports for awardees under the current FOA, and provide any technical assistance or follow-up as needed to ensure final reports are complete and accurate.


Publication plan: Information collected through the MIS is an internal CDC documents, such as reports on the analysis of awardee-submitted evaluation reports, and shared with state and territorial awardees as external reports. Pre-Defined Reports provide a quick and easy way for CDMIS users to access data across tabs. The Office of Informatics and Information Resource Management (OIIRM) within the National Center for Chronic Disease Prevention and Health Promotion will continue to work with all programs that use MIS to provide reports that provide useful information that assist in fulfilling CDC’s public health mission.


Analysis plan: CDC will not use complex statistical methods for analyzing information. CDC will take all information and aggregate and report in internal documents. Statistical analyses will be limited to simple tabulations.


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


The display of the OMB expiration date is not in appropriate.


18. Exceptions to Certification for Paperwork Reduction Act Submissions


There are no exceptions to the certification.

14


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