[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8460-8461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03013]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-13AHB]
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 ICR--
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
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
[[Page 8461]]
both the adult and pediatric groups. There are no costs to respondents.
The total response burden for the study 201 hours.
Estimated Annualized Burden Hours
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Average
Type of respondents (adult and Number of Number of burden per
pediatric) Form name respondents responses per response (in
respondent hours)
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Case Subjects > 17 years of age....... Screening Process....... 129 1 5/60
Telephone interview..... 71 1 30/60
Control Subjects > 17 years of age.... Screening Process....... 142 1 5/60
Telephone interview..... 71 1 30/60
Case Subject <= 1-5 years of age...... Screening Process....... 141 1 5/60
Telephone interview..... 78 1 30/60
Control Subjects <= 1-5 years of age.. Screening Process....... 194 1 5/60
Telephone interview..... 78 1 30/60
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Total............................. ........................ .............. .............. ..............
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Leroy A. 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. 2014-03013 Filed 2-11-14; 8:45 am]
BILLING CODE 4163-18-P