[Federal Register Volume 74, Number 121 (Thursday, June 25, 2009)]
[Notices]
[Pages 30297-30298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-09BX]


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 [email protected].
    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

[[Page 30298]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name               Respondents       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
CDI Surveillance Case Report    EIP Surveillance              10             383               1           3,830
 Form--Complete.                 Officer.
CDI Surveillance Case Report    EIP Surveillance              10             382           15/60             955
 Form--Partial.                  Officer.
CDI Surveillance Health         EIP Surveillance              10             170           45/60           1,275
 Interview.                      Officer.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,060
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    Dated: June 17, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-14989 Filed 6-24-09; 8:45 am]
BILLING CODE 4163-18-P