[Federal Register: June 2, 2005 (Volume 70, Number 105)]
[Notices]
[Page 32339-32340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn05-71]
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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 omb@cdc.gov.
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
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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]
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