E9-14989. 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 [e-mail].

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 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

Form name	Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
CDI Surveillance Case Report Form—Complete	EIP Surveillance Officer	10	383	1	3,830
CDI Surveillance Case Report Form—Partial	EIP Surveillance Officer	10	382	15/60	955
CDI Surveillance Health Interview	EIP Surveillance Officer	10	170	45/60	1,275
Total					6,060

Dated: June 17, 2009.

Maryam I. Daneshvar,

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