[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53310-53311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21737]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day 10-10GP]
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 [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 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 Emerging and Zoonotic Infectious Diseases, (NCEZID), 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.
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 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, and a description of the molecular characteristics of C. difficile
strains and the epidemiology of this infection among the population
under surveillance.
For this proposed data collection, there is no cost to respondents
other than their time. An estimated total of 8,750 CDI Surveillance
Case Report Forms (CRFs) will be completed during a one-year study
period. Approximately 4,370 cases will require a completed CRF taking
one hour; the remaining 4,380 cases will only require a partially
completed CRF taking 15 minutes. An estimated total of 500 CDI
Surveillance Health Interviews (HI) will need to be completed for the
same time period. The estimated time to complete the HI is 45 minutes.
Therefore, the total estimated annualized burden for this data
collection is 5,840 hours.
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.
Estimate of Annualized Burden Hours
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Number of Average burden
Forms Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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CDI Surveillance Case Report Form--Complete..... 10 437 1 4,370
CDI Surveillance Case Report Form--Partial...... 10 438 15/60 1,095
CDI Surveillance Health Interview............... 10 50 45/60 375
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Total....................................... .............. .............. .............. 5,840
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[[Page 53311]]
Dated: August 25, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-21737 Filed 8-30-10; 8:45 am]
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