Proposed Data Collections Submitted for Public Comment and Recommendations

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

omb@cdc.gov.

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

Forms

Number of

respondents

Number of

responses per respondent

Average

burden per

response

(in hours)

Total burden

(in hours)

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

Total

5,840

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]

BILLING CODE 4163-18-P