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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.
There is no cost to respondents to participate in this program. The total annualized burden for this data collection is 5,840 hours.
|Respondent||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|CDI Surveillance Case Report Form—Complete||10||437||1|
|Start Printed Page 14022|
|CDI Surveillance Case Report Form—Partial||10||438||15/60|
|CDI Surveillance Health Interview||10||50||45/60|
Dated: March 9, 2011.
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-5919 Filed 3-14-11; 8:45 am]
BILLING CODE 4163-18-P