[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14021-14022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day 11-10GP]


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 (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
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
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                                                                                Number of        Average burden
                       Respondent                            Number of        responses per    per response  (in
                                                            respondents         respondent           hours)
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CDI Surveillance Case Report Form--Complete............                 10                437                  1

[[Page 14022]]

 
CDI Surveillance Case Report Form--Partial.............                 10                438              15/60
CDI Surveillance Health Interview......................                 10                 50              45/60
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    Dated: March 9, 2011.
Carol Walker,
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