This PDF is the current document as it appeared on Public Inspection on 01/02/2014 at 08:45 am.
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Clostridium difficile Infection (CDI) Surveillance (0920-0892, Expiration 07/31/2014)—Extension—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 to continue to monitor changes in CDI epidemiology, including changes in risk factors for disease, as well as increases in incidence and severity of illness related to this pathogen.
The title and the goals of the project have remained the same since the publication of the 60-day Federal Register Notice and there were no changes in burden estimates or data collection forms from what is shown in the current inventory.
The surveillance population will consist of persons residing in the catchment area of the participating Emerging Infections Program (EIP) sites who are 1 year of age or older. 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.Start Printed Page 396
A total of 600 individuals who develop CDI will be contacted for a telephone interview annually and, of those, it is estimated that 500 will meet study inclusion criteria. The interview screening is estimated to take 5 minutes and the full telephone interview is estimated to take 40 minutes. Therefore, the total estimated annualized burden for this data collection is estimated to be 383 hours.
There are no costs to the respondents other than their time.
|Type of respondents||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hrs.)|
|Persons in the community infected with C. difficile||Screening Form||600||1||5/60|
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. 2013-31478 Filed 1-2-14; 8:45 am]
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