[Federal Register: June 26, 2006 (Volume 71, Number 122)]
[Notices]
[Page 36344-36345]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn06-51]
-----------------------------------------------------------------------
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 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
[[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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form type Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Quarterly patient-level clinical data....... 5 280 25/60 583
Annual cost data............................ 5 1 25/60 2
-------------------------------------------------------------------
Total................................... ............... ............... ............... 585
----------------------------------------------------------------------------------------------------------------
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