[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3430-3431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-0745]


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 or 
send comments to Ron Otten, 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 Screening Program (OMB No. 0920-0745, exp. 6/30/
2013)--Extension--National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Of cancers affecting both men and women, Colorectal Cancer (CRC) is 
the second leading cause of cancer-related deaths in the United States. 
Based on scientific evidence which indicates that regular screening is 
effective in reducing CRC incidence and mortality, regular CRC 
screening is now recommended for adults starting at age 50 and 
continuing until age 75 years. Screening tests that are recommended by 
the United States Preventive Services Task Force, and that may be used 
alone or in combination, include fecal occult blood testing (FOBT), 
fecal immunochemical testing (FIT), flexible sigmoidoscopy, and 
colonoscopy.
    In 2005, CDC established a three-year demonstration program, 
subsequently extended to four years, to screen low-income individuals 
50 years of age and older who have no health insurance or inadequate 
health insurance for CRC. The five demonstration sites reported 
information to CDC including de-identified, patient-level demographic, 
screening, diagnostic, treatment, outcome and cost reimbursement data 
(Colorectal Cancer Screening Demonstration Program, OMB No. 0920-0745, 
exp. 7/31/2010). The information was used to assess the feasibility and 
cost effectiveness of a publicly funded screening program, describe key 
outcomes, and guide program expansion.
    In 2009, CDC received additional funding from Congress and 
established the expanded Colorectal Cancer Control Program (CRCCP) to 
increase screening rates in the general population through evidence-
based screening provision and screening promotion activities. All 
funded sites provide CRC screening and follow-up services to low-income 
men and women who are underinsured or uninsured for CRC screening. 
Funded sites also plan and implement program activities that promote 
CRC screening in the general population through policy, systems, 
community and individual level interventions. With expanded CRCCP 
support, the number of sites funded to provide CRC screening services 
increased from five to 26 and the original information collection was 
revised. Changes incorporated through the revision process included an 
increase in the number of respondents; simplification of the clinical 
data collection based on experience with the five demonstration program 
sites;

[[Page 3431]]

discontinuation of the cost reimbursement data collection; addition of 
an activity-based economic data collection; and deletion of the term 
``Demonstration'' from the title. Information currently reported to CDC 
includes program-level activity cost data, and de-identified patient-
level demographic, screening, diagnostic, treatment and outcome data 
(Colorectal Cancer Screening Program, OMB No. 0920-0745, exp. 6/30/
2013).
    CDC plans to request a three-year extension of the current 
approval. No changes are proposed to the content of the information 
collection, reporting procedures for awardees, or the estimated burden 
per respondent. However, the number of funded CRC screening sites will 
increase from 26 to 29.
    Program awardees will continue to implement evidence-based 
interventions to increase population-level screening rates and to 
address disparities in access to CRC screening services.
    Through this program, funded awardees will provide CRC screening 
services to low-income individuals 50 years of age and older who have 
no health insurance or inadequate health insurance for CRC. On average, 
each program awardee is expected to provide services to 375 individuals 
per year. De-identified clinical data elements will be reported to CDC 
electronically. In addition, each awardee will collect and report 
program-level activity-based cost data to CDC through an electronic 
Cost Assessment Tool (CAT). The activity-based cost information allows 
CDC to monitor individual awardees and compare activity-based costs 
across multiple sites and programs. A similar approach has been 
employed for a number of CDC-funded cancer programs (see Economic 
Analysis of the National Breast and Cervical Cancer Early Detection 
Program, OMB No. 0920-0776, exp. 3/31/2011, and Economic Analysis of 
the National Program of Cancer Registries, OMB No. 0920-0812, exp. 6/
30/2012).
    CDC will use the information collected from Colorectal Cancer 
Screening Program awardees to monitor and evaluate the CRC screening 
program and funded sites; improve the quality of screening and 
diagnostic services for underserved individuals; develop outreach 
strategies to increase screening; and report program results to 
Congress and other legislative authorities. Participation is required 
for all CRCCP awardees. 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 respondents           Form type       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Colorectal Cancer Control       Clinical Data                 29             375           15/60           2,719
 Program Awardees.               Elements.
                                Cost Assessment               29               1              22             638
                                 Tool.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,357
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    Dated: January 8, 2013.
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. 2013-00755 Filed 1-15-13; 8:45 am]
BILLING CODE 4163-18-P