[Federal Register Volume 70, Number 105 (Thursday, June 2, 2005)]
[Notices]
[Pages 32339-32340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-05-05CJ)


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 404-371-5983 
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 [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 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.

[[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
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                                                                                        Number of                       Average burden
                               Form                                    Number of      responses per   Number of times    per response     Total burden
                                                                      respondents*      respondent        per year        (in hours)       (in hours)
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Patient-level clinical data.......................................                3               70                4            25/60            350
Annual program-level data.........................................                3                1                1            25/60              1.25
                                                                   ------------------
    Total.........................................................  ...............  ...............  ...............  ...............            351.25 
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* Respondents are cooperative agreement recipients


    Dated: May 26, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-10950 Filed 6-1-05; 8:45 am]
BILLING CODE 4163-18-P