2013-07041. 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 email 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 Program (OMB No. 0920-0745, exp. 6/30/2013)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Of cancers affecting both men and women, colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Based on scientific evidence which indicates that regular screening is effective in reducing CRC incidence and mortality, regular CRC screening is now recommended for adults starting at age 50 and continuing until age 75 years.

In 2005, CDC established a three-year demonstration program, subsequently extended to four years, to screen low-income individuals 50 years of age and older who have no health insurance or inadequate health insurance for CRC. The five demonstration sites reported information to CDC including de-identified, patient-level demographic, screening, diagnostic, treatment, outcome and cost reimbursement data (OMB No. 0920-0745, exp. 7/31/2010). The information has been used to assess the feasibility and cost effectiveness of a publically funded screening program, describe key outcomes, and guide the expansion of the program. In 2009, with the conclusion of the demonstration program and increased Congressional funding to continue support of a colorectal cancer screening program, CDC established the Colorectal Cancer Control Program (CRCCP) to fund 26 sites for a five-year program period to increase population-based CRC screening and reduce health disparities in CRC screening, incidence and mortality. Funded sites implement evidence-based interventions to increase population-level screening rates. To address disparities in access to screening, funded sites screen low-income individuals 50 years of age and older who have no health insurance or inadequate health insurance for CRC. The funded sites report information to CDC including programmatic-level activity cost data, and de-identified patient-level demographic, screening, diagnostic, treatment and outcome data (OMB No. 0920-0745, exp. 6/30/2013).

CDC is requesting OMB approval to continue the information collection for an additional three years. CDC will collect de-identified Colorectal Clinical Data Elements (CCDE) on services provided to low-income individuals age 50 and older with inadequate or no health insurance. CDC will use the information to monitor and evaluate the program and funded sites; improve the quality of screening and diagnostic services for underserved individuals; develop outreach strategies to increase screening; and report program results to Congress and other legislative authorities. Each site will screen an estimated 375 individuals per year (186 semiannually).

The program will also collect program-level activity-based cost data utilizing a Cost Assessment Tool (CAT) previously used by other CDC-funded cancer programs. The information to be collected through the CAT will allow CDC to compare activity-based costs across multiple sites and programs, and will provide a more effective means of monitoring and improving the performance and cost-effectiveness of the CRC screening program.

Summary CCDE information will be transmitted to CDC electronically twice per year. Information collected through the Cost Assessment Tool will be transmitted electronically to CDC once per year. Participation is required for all sites funded through the CRC screening program. The number of funded sites will increase from 26 to 29 and this will result in an increase in the number of respondents and total burden. There are no changes to the content of the information collection or the estimated burden per response.

There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,357.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hours)
Colorectal Cancer Screening Programs	Clinical Data Elements	29	375	15/60
	Cost Assessment Tool	29	1	22

Dated: March 21, 2013.

Ron A. Otten,

Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention.