E7-2429. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Colorectal Cancer Screening Demonstration Program—New—National Center for Chronic Disease Prevention and Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) is seeking a 3-year Office of Management and Budget (OMB) approval to collect individual patient-level screening, diagnostic, and treatment data in association with a new colorectal cancer screening demonstration program. CDC funded 5 cooperative agreements in fiscal year (FY) 2005 to implement these new colorectal cancer (CRC) demonstration programs. These 3-year demonstration programs are designed to increase population-based CRC screening among persons 50 years and older in a geographically defined area, focusing screening efforts on persons age 50 years and older with low incomes and inadequate or no health insurance coverage for CRC screening (priority population).

Colorectal Cancer (CRC) is the second leading cause of cancer-related deaths in the United States, following lung cancer. Based on scientific evidence which indicates that regular screening is effective in reducing CRC incidence and mortality, regular CRC screening is now recommended for average-risk persons with one or a combination of the following tests: fecal occult blood testing (FOBT), flexible sigmoidoscopy, colonoscopy, and/or double-contrast barium enema (DCBE). Fecal immunochemical testing (FIT) is considered an acceptable alternative to FOBT. In the absence of evidence indicating a single most effective test, selected programs chose the screening test(s) they will use from the above list of recommended tests.

All funded programs are required to submit patient-level data to capture demographic information, CRC screening and diagnostic services provided through this program, and clinical results, and submit these data to Information Management Services (IMS) on a quarterly basis, so that CDC and the programs can evaluate immediate and long term (3 year) program effectiveness and assess the quality and appropriateness of the services delivered, including medical complications. While CDC funds will not be used for treatment, programs will need to monitor treatment and document that patients are receiving appropriate treatment services. Submitted data must contain no patient identifiers. CDC, the funded programs, and IMS worked together to define the key, standardized clinical data elements which are included in a codebook to be used by the programs and CDC known as the Colorectal Cancer Clinical Data Elements (CCDE). Data collection forms have been developed by staff at the programs to collect the standardized individual patient-level data. IMS will assist CDC by receiving the data from the programs, cleaning the data and producing standardized data reports.

All programs will additionally submit annual cost data to CDC to monitor cost and cost-effectiveness over the 3-year program period.

In developing the definition variable and data definitions to be reported in the CCDEs, CDC has consulted with representatives of the American Cancer Society, The National Cancer Institute, The Agency for Health Care Research and Quality, the Centers for Medicare and Medicaid Services, representatives from professional medical societies involved in colorectal cancer screening, representatives from managed care organizations, representatives from state health departments, and a variety of individuals with expertise and interest in this field.

There are no costs to the respondents other than their time. The total estimated annualized burden hours are 1270.

Estimated Annualized Burden Hours:

Respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Colorectal Cancer Demonstration Program Sites	Colorectal Cancer Data Elements for Colonoscopy Programs	2	240	1
	Colorectal Cancer Data Elements for Fecal Occult Blood Test Programs	3	1000	15/60
	Medical Complications Form	5	6	1
	Annual Aggregate Data on Medically Ineligible Clients	5	1	1
	Reimbursement Data Reporting Form	5	1	1
*Respondents include cooperative agreement recipients.

Dated: February 6, 2007.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.