[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54472-54473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13AHB]


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 LeRoy Richardson, 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

    Risk Factors for Community-Associated Clostridium difficile 
Infection through the Emerging Infections Program (EIP)--New--National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The epidemiology of C. difficile has changed dramatically during 
recent years, with increases in incidence and severity of disease being 
reported across several countries. In addition, populations previously 
thought to be at low risk, such as young, healthy individuals residing 
in the community, are now being identified with severe C. difficile 
infection (CDI). Community-associated CDI is estimated to represent 32% 
of all CDI based on population-based CDI surveillance data, with an 
incidence of 30-40 per 100,000 population in the United States. 
Previous reports have shown that approximately 40% of patients 
acquiring community-associated CDI (CA-CDI) were not exposed to 
antibiotics, which is a well-recognized risk factor for CDI; suggesting 
that additional factors may contribute to infections. Other factors 
such as proton pump inhibitors have been raised as a risk factor for 
CDI in the community and on February 8, 2012, the U.S. Food and Drug 
Administration issued a communication advising physicians to consider 
the diagnosis of CDI among patients taking proton pump inhibitors. 
However, the data on the association of CDI with proton pump inhibitors 
are still controversial and studies to quantify this association are 
needed. In addition to the understanding of the factors that predispose 
patients to CDI, further evaluation of potential C. difficile exposure 
sources in the community is necessary to guide prevention efforts.
    The sources of C. difficile and the risks for developing CDI in 
previously thought to be low-risk community populations are not well 
defined. Although initial evaluation of CA-CDI cases identified several 
potential risk factors (e.g., outpatient healthcare exposures, infants 
in the home, and proton pump inhibitor use), the magnitude of 
association of these risks with disease development using a control 
population has not been evaluated to date. This proposed case-control 
study will enable investigators to evaluate these associations and 
focus future investigations and prevention strategies on those factors 
identified as significantly associated with disease development.
    CDC requests OMB approval to collect information from the public 
using a standardized questionnaire over a three-year period. The study 
will have a pediatric and an adult component given that C. difficile 
exposure sources in the community may vary by age. For example, C. 
difficile has been isolated from daycare centers' environment which may 
be a potential source for C. difficile acquisition in pediatric 
population, but less likely to be a source for adults.
    For this project, we estimate that 129 persons >=18 years of age 
with C. difficile infection (case-patients) will be contacted for the 
CDI study interview annually. Of those, 71 will agree and be eligible 
to participate in the study and will proceed to the full telephone 
interview. A total of 142 persons >= 18 years of age without C. 
difficile infection (control-patients) will be contacted for the 
interview annually. Of those, 71 will agree and be eligible to 
participate in the study and will complete the full interview. Among 
the pediatric group, we estimate that 141 and 194 parents of children 
between 1 and 5 years of age with and without C. difficile infection 
will be contacted for the interview, respectively. Among the case- and

[[Page 54473]]

control-patients, we estimate that 78 in each group will agree and be 
eligible to participate in the study and will proceed to the full 
interview. We anticipate the screening questions to take about 5 
minutes and the telephone interview 30 minutes per respondent in both 
the adult and pediatric groups.
    There are no costs to respondents. The total response burden for 
the study is estimated as follows:

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
Type of respondents (adult and                       Number of       Number of      burden per     Total burden
          pediatric)                Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Case subjects >17 years of age  Screening                    129               1            5/60              11
                                 Process.
                                Telephone                     71               1           30/60              36
                                 interview.
Control Subjects >17 years of   Screening                    142               1            5/60              12
 age.                            Process.
                                Telephone                     71               1           30/60              36
                                 interview.
Case Subject <=1-5 years of     Screening                    141               1            5/60              12
 age.                            Process.
                                Telephone                     78               1           30/60              39
                                 interview.
Control Subjects <=1-5 years    Screening                    194               1            5/60              16
 of age.                         Process.
                                Telephone                     78               1           30/60              39
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             201
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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. 2013-21468 Filed 9-3-13; 8:45 am]
BILLING CODE 4163-18-P