2011-5919. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 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.

There is no cost to respondents to participate in this program. The total annualized burden for this data collection is 5,840 hours.

Estimate of Annualized Burden 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
CDI Surveillance Case Report Form—Partial	10	438	15/60
CDI Surveillance Health Interview	10	50	45/60

Dated: March 9, 2011.

Carol Walker,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.