[Federal Register Volume 71, Number 122 (Monday, June 26, 2006)]
[Notices]
[Pages 36344-36345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-06-05CJ]


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 Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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

[[Page 36345]]

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, DCPC is requesting approval to collect individual patient-
level screening, diagnostic, and treatment data in association with a 
new colorectal cancer screening demonstration program. DCPC is funding 
5 cooperative agreements from fiscal year (FY) 2005-2008 for 
implementation of 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 with 
low income and inadequate or no health insurance coverage in a 
geographically defined area.
    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 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. This information 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, clinical services and outcomes, and 
submit these data to CDC on a quarterly basis. 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 cost data to CDC to be 
used to monitor cost and cost-effectiveness over the 3-year program 
period.
    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 cost data will 
continue over the 3 years of the demonstration programs.
    In the burden table below, two data collection forms will be used: 
Patient-level clinical data collection forms and cost data collection 
forms. The data will be collected from the 5 cooperative agreement 
recipients, i.e., the respondents. The estimated number of responses 
represents the number of patients receiving clinical services per 
recipient program, one report per patient per quarterly reporting 
period (estimated at 70 patients per program per quarter). This would 
result in an estimated annualized burden for the quarterly reports of 
583 hours. Additionally, respondents will report annual cost data. For 
reporting the annual cost data, the respondents will submit only one 
report each for the entire year.
    There is no cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                  Number of     Average  burden
                  Form type                      Number of      responses per    per  response     Total burden
                                                respondents       respondent       (in hours)         hours
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Quarterly patient-level clinical data.......               5              280            25/60              583
Annual cost data............................               5                1            25/60                2
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    Total...................................  ...............  ...............  ...............             585
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    Dated: June 20, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E6-10024 Filed 6-23-06; 8:45 am]
BILLING CODE 4163-18-P