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Proposed Data Collections Submitted for Public Comment and Recommendations

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Information about this document as published in the Federal Register.

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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 404-371-5983 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to

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 Demonstration Program “ New ” 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

The CDC is requesting approval to collect individual patient-level screening, diagnostic, and treatment data in association with a new colorectal cancer screening demonstration program. CDC is planning to fund 3-5 cooperative agreements in fiscal year (FY) 2005 to implement 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 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 will be able to choose which screening test(s) they will use from the above list of recommended tests.

All funded programs will be required to submit patient-level data on CRC screening and diagnostic services provided as part of this demonstration project, which will be used to assess the quality and appropriateness of the services delivered.

Programs that receive CDC funding to provide screening and diagnostic services will collect individual patient-level data to capture demographic information and clinical services and outcomes, and submit these data to CDC on a quarterly basis. Some of the cooperative agreement recipients may receive funding for program components other than the provision of screening and diagnostic services. Programs that do not receive CDC funding to provide screening and diagnostic follow up services will still collect individual patient-level data but will only submit the data in aggregate to CDC, on a quarterly basis. Grantees may be asked by CDC to submit individualized data if aggregate data do not meet quality indicator standards. 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.

All programs will additionally submit annual program-level data to CDC to be used to evaluate program effectiveness and monitor cost, funding sources, and an increase in population-based screening over the 3-year program period. Start Printed Page 32340

The additional burden to these respondents will be small, since CDC will only select programs that are already performing some CRC screening, and will therefore already be collecting these types of data. Data collection for both patient-level and program-level data will continue over the 3 years of the demonstration programs. There is no cost to respondents other than their time.

Estimated Annualized Burden Table

FormNumber of respondents*Number of responses per respondentNumber of times per yearAverage burden per response (in hours)Total burden (in hours)
Patient-level clinical data370425/60350
Annual program-level data31125/601.25
* Respondents are cooperative agreement recipients
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Dated: May 26, 2005.

Betsey Dunaway,

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

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[FR Doc. 05-10950 Filed 6-1-05; 8:45 am]