[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70782-70783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-12-12GO]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-7570 or send an email to 
[email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

[[Page 70783]]

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 with fecal 
occult blood testing (FOBT), fecal immunochemical testing (FIT), 
flexible sigmoidoscopy, and/or colonoscopy is effective in reducing CRC 
incidence and mortality, regular CRC screening is now recommended for 
average-risk persons. In 2009, by applying lessons learned from a four-
year e demonstration program, CDC designed and initiated the larger 
population-based Colorectal Cancer Control Program (CRCCP) at 29 sites 
with the goals of reducing health disparities in CRC screening, 
incidence and mortality.
    To date there has been no comprehensive assessment of all the costs 
associated with CRC screening, especially indirect and non-medical 
costs that may act as barriers to screening, 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. 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 to patients who 
undergo screening by FIT or colonoscopy 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. 
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. 
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.
    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 (in English or 
Spanish) 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. The total estimated 
annualized burden hours are 181.

                                        Estimated Annualized Burden Hours
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                                                                                  Number of      Average burden
        Type of  respondents               Form name            Number of       responses per     per response
                                                               respondents       respondent          (in hr)
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Patients Served by the Colorectal    FIT Questionnaire....               300                 1             10/60
 Cancer Control Program.
                                     Colonoscopy                         315                 1             25/60
                                      Questionnaire.
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    Dated: November 19, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-28727 Filed 11-26-12; 8:45 am]
BILLING CODE 4163-18-P