SS_Section A_02 26 2016

MANAGEMENT INFORMATION SYSTEM FOR COMPREHENSIVE CANCER CONTROL PROGRAMS

OMB # 0920-0841 (exp. 3/31/2016)

Revision

SECTION A: JUSTIFICATION

February 26, 2016

Contact:

Brooke Steele, D.O.

Phone: (770) 488-4261

Fax: (770) 488-4335

E-mail: [email protected]

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

4770 Buford Highway, NE, MS K-57

Atlanta, GA 30341

TABLE OF CONTENTS

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

9. Explanation of Any Payment or Gift to Respondents

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

11. Institutional Review Board (IRB) and 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

1. Explanation for Program Changes or Adjustments

2. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

List of Attachments

1. Authorizing Legislation for the National Comprehensive Cancer Control Program (NCCCP)

2. 60-Day Federal Register Notice

3. List of NCCCP Awardees

4a. Current MIS Data Elements for NCCCP Awardees

4b. Summary of Changes to MIS Data Elements to Facilitate Reporting and Searching Standardized Measures

Goal: Collect, store, retrieve, share, and report accurate and timely information electronically from 65 cooperative agreement awardees that receive funding for participation in the National Comprehensive Cancer Control Program (NCCCP).

Intended Use: Monitor NCCCP awardee performance and provide timely and accurate responses to inquiries from Congress and other stakeholders.

Methods: Awardees will use the Management Information System (MIS) to monitor program outcomes and report progress to CDC semi-annually. CDC will retrieve information to respond to public inquiries.

Subpopulation: 65 NCCCP awardees

Data Analysis: Quantitative and qualitative analyses

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

This statement supports the request for clearance of a revision to electronic collection of information by the National Comprehensive Cancer Control Program (NCCCP), funded by the Comprehensive Cancer Control Branch of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS). OMB approval is requested for three years (Management Information System for Comprehensive Cancer Control Programs, OMB No. 0920-0841, exp. 3/31/2016). This information collection is authorized by the Public Health Service Act, Section 301, 241(a) (see Attachment 1).

The Comprehensive Cancer Control Branch manages the NCCCP, which provides funding to 65 state, tribal, territorial, and U.S. Affiliated Pacific Island health departments to design, implement, and evaluate comprehensive cancer control plans to reduce the burden of cancer locally. Support for these programs is a cornerstone of CDC efforts to reduce the burden of cancer throughout the nation. Awards to individual applicants are made for a five-year budget period. Continuation awards for subsequent budget periods are made on the basis of satisfactory progress in achieving both national and program-specific goals and objectives, as well as availability of funds.

In 2012, all 65 awardees successfully re-competed for funding under FOA (DP12-1205, “Cancer Prevention and Control Program for State, Territorial/U.S. Affiliated Pacific Island Jurisdictions [USAPIJ], and Tribal Organizations”) to implement cancer prevention and control programs to reduce morbidity, mortality, and related health disparities (see Attachment 3). Each awardee submits annual progress reports to CDC through the electronic MIS. Thirteen of the 65 awardees received additional cooperative agreements for a demonstration program aimed at accelerating the development of their policy and environmental approaches to cancer control (DP10-1017). NCCCP awardees that are funded through the demonstration program have submitted separate semi-annual reports on these activities.

In this revision request, CDC seeks OMB approval to continue using the MIS to collect, store, retrieve, share, and report accurate and timely information to monitor awardee performance and resource use for three years. The request will cover the last year of DP12-1205 and the first two years of the new cooperative agreement. The current expectation is that the overall goals of the next NCCCP Funding Opportunity Announcement will remain the same, with minor changes in the number of awardees and the data collection plan. A change request will be submitted, as needed.

Electronic reporting of core NCCCP data elements (see Attachment 4a) will continue for the new approval period with minor changes in content to increase standardization of reporting performance measures and to refine search capabilities (see Attachment 4b). The change in reporting project period and annual performance measures involves the addition of drop-down lists of indicators from the Library of Indicators and Data Sources (LIDS) to the MIS. This modification was recommended by CDC and awardees and will ease the burden of entering data in an open-ended format. It will also reduce the burden of abstracting and analyzing this information among evaluators who monitor and evaluate specific program outcomes. Modifications to the MIS search function include the addition of response options to help end users search for standardized performance outcomes. The demonstration program concludes in 2015. The separate progress reports related to these activities will be discontinued.

2. Purpose and Use of the Information Collection

The MIS is used to collect information about the financial and staffing resources dedicated to cancer control by each awardee; the types of cancer addressed by each awardee; their work plan objectives, activities, and partnerships; and their program evaluations, reports, and products. Awardees provide the information for resources and activities related to each cooperative agreement. The MIS collects a limited amount of information in identifiable form (IIF) for key program staff (e.g., Program Director, Coalition Chairperson). Awardees provide this information for key program staff hired or retained to help implement the award (e.g., Policy Taskforce Coordinator). The contact person only provides information about the new program, not personal information.

The MIS is designed to improve the capacity of the CDC, as well as each NCCCP awardee, to efficiently report information needed to monitor program progress, report performance measures, track changes in work plans, and document and report information required as a condition of cooperative agreement funding.

3. Use of Improved Information Technology and Burden Reduction

The MIS is based on well-defined information components and processes that foster consistency in data collection and reporting. The MIS takes advantage of technology to improve information quality by minimizing errors and redundancy. The MIS interface has been enhanced for usability, including increased use of drop-down menus and pre-formatted options. These modifications reduce the burden of entering data in open-ended format and facilitate the annual transfer of program and resource information that has not changed.

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 is intended to accomplish the following functions:

• Reduce both NCCCP awardee and CDC burden of program planning, reporting, and overall cooperative agreement administration.

• Standardize the NCCCP awardee reporting process to facilitate development of evaluation methods.

• Enable reporting information to be sorted and aggregated to assess the overall effectiveness of NCCCP and respond to stakeholder inquiries.

• Support a common monitoring and evaluation framework for core cancer prevention and control program activities.

The MIS design also allows CDC and awardee staff to access the data entry pages for data entry, data review, and collaboration on technical assistance. Awardee staff has used MIS to review the completeness of data necessary to submit required reports, enter basic summary data for reports, and finalize and save required reports for upload into Grants.gov.

4. Efforts to Identify Duplication and Use of Similar Information

The collection of progress report information is part of a federal reporting requirement for cooperative agreement awardees. 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 eliminates duplicative efforts under paper-based reporting systems. The information collected from NCCCP awardees is not available from other sources.

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

Semi-annual progress reports are required for NCCCP awardees funded through the DP12-1205 cooperative agreement. The semi-annual reporting schedule will be maintained during the first year of this three-year revision request, which is the final year of the DP12-1205 cooperative agreement.

CDC’s Division of Cancer Prevention and Control (DCPC) anticipates that DP12-1205 will be succeeded in 2017 by a new FOA based on similar objectives and comparable monitoring and evaluation information. DCPC is considering a change in the frequency of progress reporting, effective with the new FOA. Routine progress reporting may occur once per year (annually) instead of twice per year (semi-annually) during the second and third years of this three-year information collection request. During the development of the new FOA, DCPC will review the semi-annual reports submitted under DP12-1205 and consult with CDC’s Office of Financial Resources (OFR) to determine the optimal frequency of reporting for NCCCP awardees under the new FOA. If adequate data quality can be obtained with less burden to respondents, CDC will process a Change Request or Revision Request to adjust the estimated burden to respondents.

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

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

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

A. Federal Register Notice

A 60-day Notice was published in the Federal Register on 12/21/2015 (Volume 80, Number 244, pages 79341-79342) (see Attachment 2). No public comments were received in response to the Notice.

B. Other Consultations

The MIS was designed collaboratively by CDC staff and the data collection contractor. Consultation will continue throughout the system modification process.

9. Explanation of Any Payment or Gift to Respondents

Respondents do not receive payments or gifts for providing information.

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

Staff in the National Center for Chronic Disease Prevention and Health Promotion 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 and/or personally identifiable information. Respondents are state-, territorial/USAPIJ-, and tribal-based comprehensive cancer control programs. Although contact information is obtained for each program, the contact person provides information about the state, territorial, or tribal program, not personal information.

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

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

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

1. IRB Approval

The MIS information collection has been determined to be public health practice and not research involving human subjects; therefore, neither IRB approval nor consent from individuals are required. However, awardees are required to respond as a condition of cooperative agreement funding.

2. Sensitive Questions

The MIS instrument does not collect sensitive information. No personal information is requested. The MIS collects a limited amount of information in identifiable form (IIF) for key program staff (e.g., Program Director, Coalition Chairperson). Awardees provide the names of these individuals as well as their professional contact information. The contact person only provides information about the NCCCP program, not personal information.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

All 65 NCCCP awardees (FOA DP12-1205; see Attachment 3) will submit Data Elements for All NCCCP Programs through a web-based Management Information System (MIS). Screen shots are provided in Attachment 4a. Minor changes since the previous OMB approval are summarized in Attachment 4b. Respondents will report outcomes semi-annually during this clearance period. For routine reporting, the estimated burden per response is 2 hours.

In 2017, NCCCP awardees will transition to new cooperative agreements under a new funding opportunity announcement. At that time, CDC anticipates that awardees will incur 2 additional hours of burden for data entry and validation as they update work plans, objectives, etc. This one-time effort is represented in the burden table as “Initial MIS Population for New FOA.” The same data elements and the same MIS interface (Attachment 4a) are used for this process. The number of respondents is 22, which represents 65 awardees annualized over the requested 3-year clearance period.

For all data collection and reporting for cancer prevention and control programs, the total estimated annualized burden to respondents is 304 hours, as summarized in Table A.12-1.

OMB approval is requested for 3 years. CDC is considering a change in frequency of reporting (from semi-annual to annual), effective in years 2 and 3. This decision has not been finalized. To avoid under-estimation of respondent burden, the burden table accounts for semi-annual reporting throughout the 3-year clearance period. If a decision is made to change the frequency of reporting, CDC will process a Change Request or Revision Request, as needed, to adjust (reduce) total estimated annualized burden.

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

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden per Response (in hrs.)	Total Burden (in hrs.)
Program Director for State-, Tribal-, or Territorial-based Cancer Prevention and Control Program	Data Elements for All CPC Programs: Semi-annual Reporting	65	2	2	260
	Data Elements for All CPC Programs: Initial MIS Population for New FOA	22	1	2	44
	Total				304

B. Estimated Annualized Burden Costs to Respondents

Table B.12-1 displays the estimated annualized cost to respondents for reporting program progress information. 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 to respondents is $11,187 [(260 x $36.80) + (44 x $36.80)].

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

Type of Respondents	Form Name	No. of Respondents	Total Burden (in hrs.)	Average Hourly Wage	Total Cost
Program Director for State-, Tribal-, or Territorial-based Cancer Prevention and Control Program	Data Elements for All CPC Programs: Semi-annual Reporting	65	260	$36.80	$9,568
	Data Elements for All CPC Programs: Initial MIS Population for New FOA	22	44	$36.80	$1,619
	Total				11,187

*Hourly wage information is from the U.S. Department of Labor, Bureau of Labor Statistics website (www.data.bls.gov/cgi-bin/print.pl/oes/current/oes1191999.htm).

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

The MIS is designed to use existing hardware within funded sites, and all respondents currently have access to the Internet to use the information system. No capital or maintenance costs have been required. Additionally, there have been no start-up, hardware or software costs.

14. Estimates of Annualized Cost to the Federal Government

A. Development, Implementation, and Maintenance

The MIS developer and data collection contractor is Northrup-Grumman. Major cost factors related to deploying the MIS include development and testing costs, system maintenance costs, and the cost of oversight by CDC program staff. The total estimated annualized cost of the MIS is $143,587.

Tables A.14.1 and A.14.2 provide detailed breakdowns of the estimated annualized cost for each program component.

Table A.14.1 Estimated Annualized Cost for Collection of MIS-based NCCCP (DP12-1205) Data

Annualized cost of system development and implementation*	$103,587
Annual system maintenance contract	$40,000
Total annualized cost to the government	$143,587

* The annualized cost of system development and implementation is based on costs for NCCCP for the period July 1, 2015 to February 2016. Some development costs were reported in the previous OMB clearance period and are not included in the estimate for the upcoming three-year clearance period.

15. Explanation for Program Changes or Adjustments

In the previous OMB approval period, the total estimated annualized burden was 586 hours. In this Revision request, the total estimated annualized burden is 304 hours. This is a net reduction of 282 hours. The reductions are due to the following.

• In the previous 3-year approval period, the burden estimate included a one-time allocation of 4 hours per response for NCCCP awardees to enter information into the MIS under FOA DP12-1205. CDC anticipates that DP12-1205 will be succeeded in 2017 by a new FOA based on similar objectives and a comparable monitoring and evaluation plan. Although some of the information already in the MIS can be retained and reused, the revised burden table includes a similar one-time allocation of effort for initial population of the MIS with information that is specific to the new FOA. Due to the ability to retain and reuse data, the estimated burden per response for initial population of MIS is being reduced to 2 hours per response. The net reduction in total estimated annualized burden is 44 hours.

• During the period of this Revision request, routine semi-annual reporting will continue but the estimated burden per response is being reduced from 3 hours to 2 hours. The net result is a reduction of 130 hours.

• The previous OMB approval period included reporting requirements for 13 NCCCP awardees funded for participation in a demonstration program. The demonstration program has been completed and the associated reporting requirements are being discontinued. The revised burden table reflects discontinuation of initial population of the MIS for demonstration programs (-30 hours) and semi-annual reporting for demonstration programs (-78 hours). The net decrease in burden is 108 hours.

Table A.15-1. Changes to Estimated Annualized Burden to Respondents

Form Name	Previous Approval				Current Revision Request				Change
	Number of respondents	Frequency	Burden per response (in hours)	Total burden (in hours)	Number of respondents	Frequency	Burden per response (in hours)	Total burden (in hours)
Data Elements for All CPC Programs: Initial MIS Population	22	1	4	88	22	1	2	44	-44
Data Elements for All CPC Programs: Semi-annual Reporting	65	2	3	390	65	2	2	260	-130
Data Elements for CPC Demonstration Program: Initial MIS Population	5	1	6	30	0	0	0	0	-30
Data Elements for CPC Demonstration Program: Semi-annual Reporting	13	2	3	78	0	0	0	0	-78
	TOTAL			586	TOTAL			304	-282

16. Plans for Tabulation and Publication and Project Time Schedule

A. Time schedule for the entire project

The cooperative agreement cycle for DP12-1205 is 5 years. OMB approval is being requested for the final year of this FOA. Actual data collection for the DP12-1205 will begin immediately after OMB approval. Tables including beginning and ending dates for the collection of information for the FOA and other actions are provided below.

Table 16-1 Project Time Schedule for NCCCP Reporting
Activity	Time Schedule
Notify respondents	Within 2 weeks after OMB approval
Training	1 month after OMB approval
Ongoing support (as needed)	1 month after OMB approval
Analyses and Validation	2 months after OMB approval

B. Publication plan

DP12-1205-related information collected through the MIS will be reported in internal CDC documents and shared with CCC programs.

C. Analysis plan

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

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

The CCC MIS program will display the expiration date for OMB approval of the MIS 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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