[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53310-53311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21737]


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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 <a href="/cdn-cgi/l/email-protection#84ebe9e6c4e7e0e7aae3ebf2"><span class="__cf_email__" data-cfemail="82edefe0c2e1e6e1ace5edf4">[email protected]</span></a>.
    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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                      Forms                          Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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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
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[[Page 53311]]

    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


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