[Federal Register: February 13, 2007 (Volume 72, Number 29)]
[Notices]
[Page 6733-6734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe07-52]
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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 omb@cdc.gov. 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:
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Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
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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.
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*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