[Federal Register: June 25, 2009 (Volume 74, Number 121)]
[Notices]
[Page 30297-30298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn09-44]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-09-09BX]
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.
Alternatively, to obtain a copy of the data collection plans and
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta,
Georgia 30333; comments may also be sent by e-mail to omb@cdc.gov.
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 a 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 clarify 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 information technology. Written comments
should be received within 60 days of this notice.
Proposed Project
Clostridium difficile Infection (CDI) Surveillance--New--National
Center for Preparedness, Detection, and Control of Infectious Diseases
(NCPDCID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Steady increases in the rate and severity of Clostridium difficile
infection (CDI) indicate a clear need to conduct longitudinal
assessments of the impact of CDI in the United States. C. difficile is
an anaerobic, spore-forming, gram positive bacillus that produces two
pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea
to fulminant colitis and death. Transmission of C. difficile occurs
primarily in healthcare facilities, where environmental contamination
by C. difficile spores and exposure to antimicrobial drugs are common.
No longer limited to healthcare environments, community-associated CDI
is the focus of increasing attention. Recently, several cases of
serious CDI have been reported in what have been considered low-risk
populations, including healthy persons living in the community and
peri-partum women.
For this proposed data collection, the surveillance population will
consist of persons residing in the catchment area of the participating
Emerging Infections Program (EIP) sites. This surveillance poses no
more than minimal risk to the study participants as there will be no
interventions or modifications to the care study participants receive.
EIP surveillance personnel will perform active case finding from
laboratory reports of stool specimens testing
[[Page 30298]]
positive for C. difficile toxin and abstract data on cases using a
standardized case report form. For a subset of cases (e.g., community-
associated C. difficile cases) sites will administer a health
interview. Remnant stool specimens from cases testing positive for C.
difficile toxin will be submitted to reference laboratories for
culturing, and isolates will be sent to CDC for confirmation and
molecular typing. Outcomes of this surveillance project will include
the population-based incidence of community- and healthcare-associated
CDI among participating EIP sites, characterization of C. difficile
strains that are responsible for CDI in the population under
surveillance with a focus on strains from community-associated cases, a
description of the epidemiology of community- and healthcare-associated
CDI, and hypothesis-generation for future activities using EIP CDI
surveillance infrastructure.
The proposed surveillance for CDI through the Emerging Infections
Program will expand CDC capacity to monitor incidence of C. difficile
in community and healthcare settings as well as to monitor and detect
antimicrobial resistance. This activity supports the HHS Action Plan
for elimination of healthcare-associated infections.
CDC estimates that a total of 7,650 CDI Surveillance Case Report
Forms (CRFs) will be completed during a one-year study period on
incident CDI cases within the EIP catchment area. Approximately 3,825
cases will require a completed CRF; the remaining 3,825 cases will only
require a partially completed CRF. CDC estimates that 1,700 CDI
Surveillance Health Interviews (HI) will be completed during a one-year
study period. Surveillance Officers at the EIP sites will complete and
submit the case report forms and health interviews. There are no costs
to respondents.
Estimates of Annualized Burden
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Number of Average burden
Form name Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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CDI Surveillance Case Report EIP Surveillance 10 383 1 3,830
Form--Complete. Officer.
CDI Surveillance Case Report EIP Surveillance 10 382 15/60 955
Form--Partial. Officer.
CDI Surveillance Health EIP Surveillance 10 170 45/60 1,275
Interview. Officer.
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Total..................... ................ .............. .............. .............. 6,060
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Dated: June 17, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-14989 Filed 6-24-09; 8:45 am]
BILLING CODE 4163-18-P