[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Notices]
[Pages 44174-44176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0963]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send 
an email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
days of this notice.

Proposed Project

    Colorectal Cancer Control Program Indirect/Non-Medical Cost Study 
(OMB No. 0920-0963, exp. 4/30/2014)--Reinstatement with Change--
National Center for Chronic Disease Prevention and Health Promotion 
(NCCDPHP), Centers for Disease Control and Prevention (CDC).

[[Page 44175]]

Background and Brief Description

    In 2013 the Centers for Disease Control and Prevention (CDC) 
received Office of Management and Budget (OMB) approval to conduct a 
study to measure the time and costs incurred by patients screened for 
colorectal cancer (CRC) with colonoscopy or fecal immunochemical test 
(FIT) (OMB No. 0920-0963, exp. 4/30/2014). Information has been 
collected from patients screened through the Colorectal Cancer Control 
Program (CRCCP), however, the target number of respondents was not 
achieved during the initial approval period. CDC requests OMB approval 
to reinstate the information collection for one year in order to meet 
recruitment goals and complete the data analysis as outlined in the 
original approval.
    Changes described in this Reinstatement request include a reduction 
in the number of respondents and a corresponding reduction in the total 
estimated burden hours. There are minor modifications to the data 
collection instruments to clarify intent but these modifications do not 
change the estimated burden per response.
    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.
    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.
    CDC plans to conduct the information collection in partnership with 
providers in four states (Alabama, Arizona, Georgia, and Pennsylvania). 
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. The 
target number of responses for the overall study will result in 300 
completed Colonoscopy Questionnaires and 290 completed FIT 
Questionnaires. During the initial approval period CDC collected 
approximately 50% of the target number of completed questionnaires. To 
complete the study CDC plans to collect an additional 150 Colonoscopy 
Questionnaires and an additional 177 FIT Questionnaires.
    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. Participation is voluntary and there 
are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form type        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Patients Served by the          FIT                          177               1           10/60              30
 Colorectal Cancer Control       questionnaire.
 Program.
                                Colonoscopy                  150               1           25/60              63
                                 questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              93
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[[Page 44176]]

Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-17898 Filed 7-29-14; 8:45 am]
BILLING CODE 4163-18-P