[Federal Register Volume 77, Number 61 (Thursday, March 29, 2012)]
[Notices]
[Pages 19015-19016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7534]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12GO]
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 404-639-7570
and send comments to Kimberly S. Lane, at CDC 1600 Clifton Road, MS-
D74, Atlanta, GA 30333 or send an email 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 Control Program Indirect/Non-Medical Cost Study--
New--National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
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. Screening tests that may be used
alone or in combination include fecal occult blood testing (FOBT),
fecal immunochemical testing (FIT), flexible sigmoidoscopy, and/or
colonoscopy.
[[Page 19016]]
While screening rates have increased over the past decade,
screening prevalence is still lower than desirable, particularly among
individuals with low socioeconomic status. The indirect and non-medical
costs associated with CRC screening, such as travel costs, may act as
barriers to screening. Understanding these costs may provide insights
that can be used to reduce such barriers and increase participation.
In 2005, CDC established a four-year demonstration program at five
sites to screen low-income individuals aged 50-64 years who had no
health insurance or inadequate health insurance for CRC. In 2009, by
applying lessons learned from the demonstration program, CDC designed
and initiated the larger population-based Colorectal Cancer Control
Program (CRCCP) at 29 sites. The goals of the expanded program are to
reduce health disparities in CRC screening, incidence and mortality by
promoting CRC screening for the eligible population and providing CRC
screening to low-income adults over 50 years of age who have no health
insurance or inadequate health insurance for CRC screening.
To date there has been no comprehensive assessment of all the costs
associated with CRC screening, especially indirect and non-medical
costs, incurred by the low-income population served by the CRCCP. CDC
proposes to address this gap by collecting information from a subset of
patients enrolled in the program. Those who undergo screening by FIT or
colonoscopy will be asked to complete a specialized questionnaire about
the time and personal expense associated with their screening. Patients
who undergo fecal immunochemical testing will be asked to complete the
FIT questionnaire, which is estimated to take about 10 minutes.
Patients who undergo colonoscopy will be asked to complete the
Colonoscopy questionnaire, which includes additional questions about
the preparation and recovery associated with this procedure. The
estimated burden per response for the Colonoscopy questionnaire is 25
minutes. Demographic information will be collected from all patients
who participate in the study. Participation in the study is voluntary,
but patients will be offered an incentive in the form of a gift card.
CDC plans to conduct the information collection in partnership with
providers in five states (Alabama, Arizona, Colorado, New York, and
Pennsylvania). Each provider site will administer the survey until it
reaches a target number of responses. Targets for each site range
between 75 and 150 completed questionnaires, depending on the volume of
patients screened. Each participating provider will make patient
navigators available to assist patients with coordinating the screening
process and completing the questionnaires. Providers will be reimbursed
for patient navigator time and administrative expense associated with
data collection. Across the five participating sites, the estimated
cost of this data collection is approximately $50,000.
This information collection will be used to produce estimates of
the personal costs incurred by patients who undergo CRC screening by
FIT or colonoscopy, and to improve understanding of these costs as
potential barriers to participation. Study findings will be
disseminated through reports, presentations, and publications. Results
will also be used by participating sites, CDC, and other federal
agencies to improve delivery of CRC screening services and to increase
screening rates among low-income adults over 50 years of age who have
no health insurance or inadequate health insurance for CRC screening.
OMB approval is requested for one year. Each respondent will have
the option of completing a hardcopy questionnaire or an on-line
questionnaire. No identifiable information will be collected by CDC or
CDC's data collection contractor. There are no costs to respondents
other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form type respondents responses per response (in (in hours)
respondent hours)
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Patients Served by the FIT 300 1 10/60 50
Colorectal Cancer Control questionnaire.
Program.
Colonoscopy 315 1 25/60 131
questionnaire.
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Total..................... ................ .............. .............. .............. 181
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Dated: March 23, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012-7534 Filed 3-28-12; 8:45 am]
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