[Federal Register Volume 72, Number 29 (Tuesday, February 13, 2007)]
[Notices]
[Pages 6733-6734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2429]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-07-05CJ]


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 (404) 371-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
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

[[Page 6734]]

(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:

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


     Dated: February 6, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E7-2429 Filed 2-12-07; 8:45 am]
BILLING CODE 4163-18-P