[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 <a href="/cdn-cgi/l/email-protection#117e7c73517275723f767e67"><span class="__cf_email__" data-cfemail="9bf4f6f9dbf8fff8b5fcf4ed">[email protected]</span></a>.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form type       respondents   responses  per   response  (in    (in hours)
                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Patients Served by the          FIT                          300               1           10/60              50
 Colorectal Cancer Control       questionnaire.
 Program.
                                Colonoscopy                  315               1           25/60             131
                                 questionnaire.
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P


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