OMB Package Supporting Statement

Racial and Ethnic Approaches to Community Health across the U.S. (REACH U.S.) Management Information System (MIS)

Project Officer:  Youlian Liao, MD
Division of Adult and Community Health (DACH)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
Centers for Disease Control and Prevention (CDC)
Atlanta, GA  30341
Telephone:  (770) 488-5299
Fax:  (770) 488-5974
Email:  Youlian.Liao@cdc.hhs.gov

Table of Contents

A.  Justification……………………………………………………………………… 3
	1.  Circumstances Making the Collection of Information Necessary…...…… 3
2.  Purposes and Use of Information Collection………………………………. 4
3.  Use of Improved Information Technology and Burden Reduction………. 5
	4.  Efforts to Identify Duplication and Use of Similar Information…………..6
	5.  Impact on Small Businesses or Other Small Entities……………………... 7
	6.  Consequences of Collecting the Information Less Frequently…………… 7
7.  Special Circumstances Relating to the Guidelines of 5 CFR 1320.5……... 7
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.................................. 8
	10.  Assurance of Confidentiality Provided to Respondents............................. 8
	11.  Justification for Sensitive Questions............................................................ 9
	12.  Estimates of Annualized Burden Hours and Costs.................................... 9
	13.  Estimates of Other Total Annual Cost Burden 
	to Respondents or Record Keepers..............................................................10
	14.  Estimates of Annualized Cost to the Federal Government.......................10
	15.  Explanation for Program Changes or Adjustments..................................11
16.  Plans for Tabulation and Publication and Project Time Schedule..........11
17.  Reason(s) Display of OMB Expiration Date is Inappropriate..................11
18.  Exceptions to Certification for Paperwork 
	Reduction Act Submissions...........................................................................11
B.  Collections of Information Employing Statistical Methods..............................12
	1.  Respondent Universe and Sampling Methods..............................................12
	2.  Procedures for the Collection of Information...............................................12
	3.  Methods to Maximize Response Rates and Deal with Nonresponse..........12
	4.  Tests of Procedures or Methods to be Undertaken......................................12
	5.  Individuals Consulted on Statistical Aspects and Individuals 
	Collecting and/or Analyzing Data.................................................................12

	

A.  Justification

1.  Circumstances Making the Collection of Information Necessary

In 1999, the Centers for Disease Control and Prevention (CDC) launched the Racial and Ethnic Approaches to Community Health (REACH) 2010 demonstration project as authorized by Public Health Service Act, Title 42 United States Code, Chapter 6A - Public Health Service, Subchapter II - General Powers and Duties, Section 241 Research and Investigation (42USC241).  (Attachment 1)  Beginning in 2007, the REACH 2010 program announcement will expire and a similar type of program, called Racial and Ethnic Approaches to Community Health across the US (REACH US), will begin funding communities under a new program announcement.  REACH US is authorized by Public Health Service Act, Title 42 United States Code, Chapter 6A Public Health Service, Subchapter II - General Powers and Duties, Section 241 Research and Investigation (42USC241) and Section 247b Project Grants for Preventive Health Services (42USC247b).  (Attachment 2)  The program is designed to eliminate racial and ethnic disparities in the following health priority areas:  breast and cervical cancer screening and management; cardiovascular disease; diabetes mellitus; adult/older adult immunizations, hepatitis B, and/or tuberculosis; asthma; and infant mortality.  Racial and ethnic groups targeted by REACH US include African Americans/Blacks, American Indians/Alaska Natives, Asians, Hispanics/Latinos, and Native Hawaiians/Other Pacific Islanders. The program is designed to:
•	Support community-based coalitions with high potential to implement and evaluate innovative strategies aimed at eliminating local racial/ethnic health disparities;
•	Document activities within local environments and analyze differences and similarities among environments;
•	Develop novel approaches that target effectiveness of programs aimed at eliminating health disparities nationally;
•	Provide the infrastructure to implement, coordinate, refine, and disseminate programmatic activities; and
•	Evaluate successful practice-based or evidence-based approaches/programs to impact population groups rather than individuals.
 
The REACH management information system (MIS) is a standardized, searchable, central repository of information about each REACH US project throughout the 5-year project period.  The REACH MIS is a customized internet-based support system that will be used for:
•	Project communication, planning, implementation, management, and evaluation;
•	Provision of technical assistance;
•	Dissemination of information on REACH US projects; and
•	Reporting (which includes within and across REACH US projects).
The MIS also allows REACH US program staff and grantees to perform remote data entry and retrieve data on grantees' program, progress, and evaluation activities. This system enables users to document and systematize activities related to organizational and community efforts. For REACH US program staff, use of the system is optional, and user documentation includes the creation and maintenance of technical reviews, consultation plans, site visit reports, and conference call notes.  For the grantees, user documentation includes specific program information about the target population(s) and health priority area(s); identification of goals, SMART objectives, logic models, and community action plan (CAP) as well as evaluation, sustainability, and dissemination plans; and the creation of process and performance indicators to monitor progress.  Grantees may use the system to meet evaluation reporting requirements contained within their cooperative agreements with CDC.  Collection of this data is necessary to show that the REACH US grantees are using their federal funds to meet the requirements of the cooperative agreement.  This data fits into CDC’s broader research agenda by focusing on the Health Protection Goal of Healthy People in Every Stage of Life which states that “all people, and especially those at greater risk of health disparities, will achieve their optimal lifespan with the best possible quality of health in every stage of life.”  There is no cost to users.  For purposes of this OMB Supporting Statement, grantee users are considered respondents.

The creation and warehousing of technical assistance documents by REACH US program staff is optional and under restricted viewing by REACH US grantees.  Final drafts of these documents will be view-only to the grantees.  REACH US grantees will perform their own data entry.  Users can only access information specific to their own project.  The system will allow users voluntarily to share their project deliverables in the Product section.  Users are supported with technical assistance and training, covering the usage of the system from the perspectives of both content and technical operations.  Although the use of this system is specified in the cooperative agreement, no adverse actions are imposed on grantees for refusing to use or discontinuing use of the REACH MIS.

Attachment 3 contains the complete REACH MIS design document and screen captures of the system.

2.  Purposes and Use of Information Collection
													
CDC’s REACH US grantees that use the system are considered respondents for the purpose of this supporting statement.  The REACH MIS provides a vehicle for grantees to store information regarding their program, resources, planning, CAP, and evaluation activities.  This information includes descriptions of specific program information related to the target population(s) and health priority area(s); identification of goals, SMART objectives, logic models, and interventions as well as evaluation, sustainability, and dissemination plans; performance indicator measures; and numerical indicator data.  Information collected is used to meet CDC’s reporting requirements as identified in the cooperative agreement for the REACH US program.  Grantees are required to submit reports twice per year to CDC.  The system will automatically generate a progress report that can be mailed to CDC’s Procurement and Grants Office.  Grantee/respondents have secure access to the web-based system at any time from any computer connected to the Internet.  

Although REACH 2010 grantees were given guidelines for writing their progress reports; there was no systematic format or layout for how they reported their findings.  Because of this lack of a common structure, CDC program staff found it more difficult to manage and analyze grantee data.  The REACH MIS offers a solution to this problem because the types of questions asked ensures that the grantees are including pertinent information regarding their program and evaluation activities and that CDC program staff will receive consistent and common data from all of the users.  Additionally, REACH MIS is an efficient and accessible means to document the challenging hurdles encountered as coalitions address health disparities issues.  Lessons learned can be applicable to other community and governmental organizations facing similar health change challenges, as well as other organizations seeking to document the naturally occurring lessons born of experience that are often lost due to the lack of such a recording system.  REACH MIS creates an electronic record of these events, allowing relatively easy, albeit secure, sharing of information.  Similar to the REACH Information Network (REACH IN) (OMB # 0920-0603), it also allows opportunities for qualitative analysis by grantees or CDC staff.  The consequences of not collecting any program data related to the national initiative to eliminate health disparities include reprimands from PGO for being in violation of CDC’s reporting requirements, reduced resource allocation to the REACH US Program, and/or missed opportunities to disseminate expertise, lessons learned, and outcomes related to eliminating racial and ethnic disparities.

A substantial benefit of the system is the reduction in respondent burden.  This reduction in burden is represented by the increased efficiency in documenting activities as they occur, rather than recollecting experiences when reports are prepared.

Use of the system has two primary benefits to the government.  Foremost and most practical is the increased quality, accuracy, consistency, comparability, and evaluability of the contents of REACH US grantee reports.  Simply put, CDC program staff is better able to make policy decisions based on improved reporting from its grantees.  The second benefit stems from the first.  Through better documentation of the challenges, and the mechanisms put into place to overcome these challenges, the public health field is better equipped to identify the most effective and efficient means to reduce racial and ethnic health disparities.  These efforts lead to improved public resource allocation in this area.  

3.  Use of Improved Information Technology and Burden Reduction

The REACH MIS is a customized web-based support system that is made available to grantees that are documenting activities related to organizational and community efforts.  The system is available through a secured Internet web interface.  Fundamentally, it is a system designed to reduce burden through the use of improved information technology.  This reduction in burden is represented by the increased efficiency in documenting activities as they occur, rather than recollecting experiences when reports are prepared.  Although users of the system can easily cut and paste any existing electronic narrative and numerical data into the system; they have the option of typing their program information (e.g., goals, objectives, community action plan, evaluation plan, etc.) directly into the MIS.  This save the users time because they will not have to type their reports into Microsoft Word and then need to cut and paste pieces of their progress report into the MIS.  While the system is available at all times, the assumption is that data entry occurs quarterly and reports are submitted to CDC bi-annually.

The system is automated to the extent that respondents have the option of generating a standard progress report with a single click.  This activity extracts specified data into a report format defined by CDC REACH US program staff that forms the basis of required progress and/or evaluation reports.  This generated report can be mailed to CDC’s Procurement and Grants Office.  The system is also designed that if a specific datum is used as an input, it is only asked for once.  Where ever appropriate and possible data is retrieved automatically for the user from previous data entries.  For example, after a respondent inputs the names of program staff, the system will use those names in other sections of the system, such as when identifying who completes certain tasks or activities.

4.  Efforts to Identify Duplication and Use of Similar Information

A centralized system of similar capability to the REACH MIS is currently available to REACH 2010 grantees (called REACH IN).  However, the cooperative agreement for REACH 2010 will expire in 2007, and a new program announcement will begin for the REACH US Program.  No other centralized system of similar capability for documentation, storage, and retrieval of program data are available to REACH US grantees.  Because REACH US is a newly funded program, no similar data is available.  The Information Network (REACH IN) clearance (OMB no. 0920-0603) will be discontinued upon receipt of approval for the new REACH U.S. MIS.

In addition to using the REACH MIS, there is a possibility that REACH US grantees will opt to also develop a system that is idiosyncratic to their organization.  However, CDC’s need for uniform and systematic documentation of all grantee efforts necessitates the creation of a single tool for such data warehousing.  

In its initial development, effort was made to establish the kind and extent of data the REACH MIS allows grantees to document.  These efforts included consulting various government officials with knowledge of the subject area, including Patricia Brindley, Preventive Health and Human Services Block Grant Program Consultant within the Division of Adult and Community Health; and Marion Anandappa within the Division of Nutrition and Physical Activity.  Both divisions are within the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) at CDC.  Ms. Brindley has worked with the Block Grant system for several years and is developing a new MIS for Block Grant.  Ms. Brindley communicated that based on her research, various performance management and improvement systems, project management systems, and data handling systems are available.  However, she did not find a tool that uses the latest technological advancements to collect population and program data, as offered by the REACH MIS.  Mr. Anandappa developed a MIS to collect data on rape-prevention education for the National Center for Injury Prevention and Control.  

Additionally, when developing the REACH IN system, CDC staff consulted with REACH 2010 grantees regarding their current access to tools that capture, evaluate, and report intervention activities related to capacity building, targeted action, and community and systems change and change among change agents.  Less than twenty five percent of these grantees indicated they had or planned to develop a “system” for collecting such data.  We relied on much of this consultation and previous feedback from the grantees during the initial development of REACH MIS.

Attempts were made to identify existing databases and web based systems to assist in collecting and evaluating community based activities as well as published literature on community based approaches to reduce health disparities.  Searches for existing web-based applications that would allow grantees to collect and document efforts found several systems utilized by other programs within NCCDPHP.  These systems do allow for data warehousing of local or other aggregate level data from their own grantees.  The REACH MIS was built from the basic foundations of these other systems, except that the REACH MIS will overcome the technological flaws inherent to those systems..

A literature search also was conducted to identify any existing data or evidence regarding scientifically valid interventions to address health disparities.  Many of these extrapolate their conclusions into recommending the need to identify targeted interventions.  In documenting the existence and impact of disparities related to the distribution of disease knowledge and self management to patients, Souraya (2002) indicates the need for improved information collection regarding interventions.  It is particularly important to collect formative outcome data that could inform the continuous improvement of interventions.  

While there are examples of local intervention efforts (e.g., Hae-Ra et al. 2002), the literature lacks research-based descriptions of specific interventions and methods used to gather, analyze, and evaluate activities geared toward reducing health disparities at the local level (i.e., building community capacity, developing targeted actions, changing existing systems and fostering change among change agents).  The literature search verifies a need for the results anticipated by the use of REACH U.S. MIS.

5.  Impact on Small Businesses or Other Small Entities

REACH US grantee organizations may be small businesses or small entities or they may work closely with small businesses or small entities to fulfill the work of their individual cooperative agreements.  Every effort was made during the design and development of the REACH MIS to minimize the effort and burden on the respondent.  These efforts stem from the design principles of never asking for data inputs that will not be used, and if a specific datum is used as input, it is only asked for once.  The absolute minimum amount of information input from the respondent is provided for in the system, and where ever appropriate and possible data is retrieved automatically for the user from previous data entries.  REACH US grantees’ use of the system increases their efficiency to meet reporting requirements, and therefore, represent a reduction in burden.

6.  Consequences of Collecting the Information Less Frequently

The consequences of not using the REACH MIS semi-annually would be an increased burden on the respondents to produce their semi-annual progress reports as required by their cooperative agreements with CDC.  Further, the consequences of using the REACH MIS less frequently or not using such a system would include a reduced capacity of each grantee to systematically record ephemeral knowledge related to the implementation of project interventions.  This can reduce the accuracy in recording barriers and successes related to reducing racial and ethnic health disparities.  In turn, less frequent data collection would reduce the amount, validity, and reliability of information available to resource and policy decision makers from the community and government, including CDC.  There are no legal obstacles to reducing the burden.

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

The REACH MIS fully complies with the regulation.

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

A.  A copy of the Federal Register Notice required by 5 CFR 1320.8(d) was published in the Federal Register on February 27,2007(volume 72, number 38, page 8738; See Attachment 4a).  One public comment were received in response to this notice (see Attachment 4b).  

B.  No effort was made to consult with persons outside the agency. However, the following individuals were consulted during the initial development of the system:
		Ms. Patricia Brindley
		PHHS Block Grant Program Consultant
	Centers for Disease Control and Prevention
	National Center for Chronic Disease Prevention and Health Promotion
	4770 Buford Highway, NE, MS K-30
	Atlanta, GA 30341
	770-488-5282;
PBrindleycdc.gov

		Mr. Marian Anandappa 
		Developer
	CDC, NCCDPHP
	4770 Buford Highway, NE, MS K-30
	Atlanta, GA 30341
	770-488-5155
		MAnandappa@cdc.gov

9.  Explanation of Any Payment or Gift to Respondents

There is no payment to respondents, understanding that respondents are members of grantee organization staff or subcontractors who will use REACH MIS to document their grant efforts.

10.  Assurance of Confidentiality Provided to Respondents

The CDC Privacy Act Officer has reviewed this Request for OMB Clearance and determined that the Privacy Act is not applicable because personally identifiable information is not being collected through the REACH MIS.

The REACH MIS is designed to receive and process data from CDC’s REACH US grantees, and does not specify data collection activities from individual respondents or ask questions of a sensitive nature.  The program allows grantees to perform remote data entry and retrieval of data on the grantees’ programmatic activities related to the elimination of health disparities. The system may be used to meet the reporting requirement of their cooperative agreements with CDC.  Users are allowed to enter contact information to facilitate communication within and between grantee organizations and project officers.  This contact information includes the individual’s name, title, role, mailing address, email address, telephone number, and fax number.  The user’s password and a hint question and answer are recorded for access purposes.  Several questions asked within the MIS require a response, and this is notated by an asterisk. All other information are optional.  

For the purpose of identifying users, a login name and password is required for each user.  This information is not available to anyone other than the user.  Users can only access information specific to their own project.  The system will allow users to voluntarily share their project deliverables.  REACH MIS follows applicable governmental security guidance in the DHHS Automated Information Systems Security Program Handbook.  Data submitted by grantees will be encrypted during transit.  Grantees are advised to not submit and store personal data on the REACH MIS Web site and the site is audited for such information.  The REACH MIS site does not itself collect personal information.  

The REACH MIS is processed on a stand-alone network protected by a firewall, entirely separate from local area networks (LAN), and will be processed on dedicated servers.  Access to the server is restricted.  There are no direct electronic connections between project data and other business information systems.  Electronic access to the REACH MIS is password protected.  The Web site servers are housed in a secure data network (SDN) which is required by CDC.

11.  Justification for Sensitive Questions

REACH MIS does not specify data collection activities from individual respondents, and does not ask questions of a sensitive nature.  

12.  Estimates of Annualized Burden Hours and Costs

A.  The total burden is estimated to be 120 hours, with the assumption of 40 respondent/grantee organizations, and 2 instances of using the system each year.  The estimated burden table is provided below (Table A.12-1).  This burden estimate was determined through experience developing and managing a similar system and through experience gained while pilot testing the REACH IN system.

Table A.12-1 Estimates of Annualized Burden to Respondents	
Respondents	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden
(in hours)	
REACH US Grantees	40	2	90/60	120	
Total				120	

B.  The estimate of annualized cost to respondents is $945.00, as presented in the table below (Table A.12-2).  This estimate is based on the assumption of respondents holding positions similar to the Bureau of Labor Statistics occupation title of Data Entry Keyers, with a mean hourly rate rounded up to $11.81.

Table A.12-2 Estimates of Annualized Costs to Respondents	
Type of
Respondents	No. of Respondents	Frequency of Responses	Hourly Wage Rate	Respondent Cost	
Data Entry Keyers	40	2	$11.81	$945.00	
Total				$945.00	

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

There are no additional costs to respondents.

14.  Estimates of Annualized Cost to the Federal Government

Development, Implementation, and Maintenance
Major cost factors for the progress reporting system include application design and development costs, and system modification costs based on pilot testing and feedback from REACH IN system users. Ongoing costs will include system maintenance and training costs. For the purposes of calculating the estimated annualized cost to the government, the progress reporting system  project has been divided into two phases: 1) development of the application; and 2) implementation, and system maintenance. Table 1 provides a detailed breakdown of the estimated cost for phases 1 and 2.  The total cost in Table A.14-1 is not an annualized cost. It represents the total cost for development and implementation of the system and is a one-time expenditure. 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 A.14-1. Total Cost to the Federal Government for System Development, Implementation, and Maintenance in Project Phases 1 and 2
Phase	Estimated Cost	
Planning	$7,000	
Analysis	$77,000	
Design	$21,000	
Development	$140,000	
Testing	$31,500	
Deployment	$5,600	
Documentation	$14,000	
Training	$14,000	
Maintenance	$7,000	
Total	$317,100	

The total costs itemized in Table A.14-1, annualized over the three years of this clearance request, result in an annualized cost of $105,700.

15.  Explanation for Program Changes or Adjustments

A centralized system of similar capability to the REACH MIS is currently available to REACH 2010 grantees (called REACH IN).  However, the cooperative agreement for REACH 2010 will expire in 2007, and a new program announcement will begin for the REACH US Program.  Upon receipt of OMB approval for the new REACH U.S. MIS, the Information Network (REACH IN) clearance will be discontinued.  The OMB control number for Information Network (REACH IN) is 0920-0603.

16.  Plans for Tabulation and Publication and Project Time Schedule

This project does not use a statistical method, and there is no statistical analysis plan.  

A.16-1 Project Time Schedule	
Activity	Time Schedule	
REACH MIS available for data entry	Upon OMB approval	
Respondent data entry	Quarterly, beginning four months after OMB approval	
Respondent reports due	Semi-annually	
Publication	12 to 18 months after OMB approval	

17.  Reason(s) Display of OMB Expiration Date is Inappropriate
	
The OMB expiration date is displayed prominently on the website as required.  

18.  Exceptions to Certification for Paperwork Reduction Act Submissions

No exemptions from the certification statement are being sought.

B.  Collections of Information Employing Statistical Methods

There are no applicable statistical methods involved in this project.

1.  Respondent Universe and Sampling Methods

The respondent universe includes all REACH US grantees using REACH MIS.  All are being provided secure access to the system for the purposes of quarterly data entry and semi-annual report creation.  No sampling from this universe will be undertaken.

2.  Procedures for the Collection of Information

Upon receipt of OMB approval, each respondent is notified of the availability of the system and each will enter data into the system at their own discretion.  The staff is available to meet with or otherwise consult with each respondent to ensure the proper and most efficient use of the system.

3.  Methods to Maximize Response Rates and Deal with Nonresponse

Response rate is maximized through the design and development of an inviting web-based application that is easy to use, and the use of which will ease the burden of grantees to fulfill their evaluation reporting requirements.  Further, ongoing technical assistance by electronic mail, telephone, and in-person site visits encourage grantees to use the system.  Nonresponse is addressed through regular system audits, which indicate the quantity of data being entered into the system by respondent while preserving the private nature of the data itself.  Grantee organizations not using the system to an adequate level are contacted to encourage their use of the system and to provide input on ways to improve it. 

4.  Tests of Procedures or Methods to be Undertaken

Procedures for the collection of information are the same as those approved previously in REACH In.  REACH IN has been in use by 42 respondents since its initial approval. The use of REACH IN has decreased the burden on the respondents in that it is a means to produce their semi-annual evaluation report as required by their cooperative agreements with CDC.  In addition, a single data collection system reduces error in the amount, validity, and reliability of information available to resource and policy decision makers from the community and government, including CDC.  

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

No statistical analysis is undertaken for this effort and therefore individuals were not consulted on the statistical aspects of the project.

The following individuals will oversee data collection:

Youlian Liao, MD
Division of Adult and Community Health (DACH)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
Centers for Disease Control and Prevention (CDC)
Atlanta, GA  30341
Telephone:  (770) 488-5299
Fax:  (770) 488-5974
Email:  Youlian.Liao@cdc.hhs.gov

List of Attachments

Attachment 1.	Authorizing Legislation, Title 42 USC Sec. 241
Attachment 2. Authorizing Legislation, Title 42 USC Sec. 247b.
Attachment 3.	REACH Management Information System Design Document 
Attachment 4a.  Published 60 Day Federal Register Notice
Attachment 4b.  Public Comment and CDC Response