2010-2059. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Colorectal Cancer Screening Program (OMB Number 0920-0745, exp. 7/31/2010)—Revision—Division of Cancer Prevention and Control (DCPC), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

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. Screening tests that are recommended by the United States Preventive Services Task Force, and that may be used alone or in combination, include fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), flexible sigmoidoscopy, colonoscopy, and/or double-contrast barium enema (DCBE).

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 report 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 is being used to assess the feasibility and cost effectiveness of a publicly funded screening program and describe key outcomes, and has been critical in guiding the expansion of the program.

CDC will request OMB approval to continue the information collection for three years, with changes. First, the number of funded sites will increase from 5 to 26, and the term “Demonstration” will be deleted from the title of the program. Second, there will be a reduction in the burden per respondent associated with the collection of clinical information. Reporting forms for medical complications and medically ineligible clients will be discontinued, and reporting forms for colorectal cancer clinical data elements (CCDE) will be streamlined. Data elements that were underused in analysis of the demonstration program data, or difficult to standardize across programs, will be removed, and the level of detail collected from endoscopy and pathology reports will be reduced. As a result, the reporting burden per CCDE form will be similar regardless of primary test provided. Third, the collection of patient-level reimbursement cost data will be discontinued and will be replaced by the collection of program-level activity-based cost data. The revised information collection will utilize a Cost Assessment Tool (CAT) currently in use by another CDC-funded cancer program (OMB No. 0920-0812, exp. 6/30/2012). 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.

The goals of the expanded CRC screening program are to increase population-based screening and to reduce health disparities in CRC screening, incidence and mortality. The program will continue to provide services to low-income individuals age 50 and older with inadequate or no health insurance. Each site will screen an estimated 375 patients per year (186 semiannually). The increase in the number of funded sites and the proposed changes will result in an overall increase in burden to respondents.

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. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form type	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Colorectal Cancer Screening Programs	Clinical Data Elements	26	375	15/60	2,438
	Cost Assessment Tool	26	1	22	572
Total					3,010

Dated: January 26, 2010.

Maryam I. Daneshvar,

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