[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33303-33304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14147]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-11GU]


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. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an 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 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 clarity 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 automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in 
Clinical Laboratories--New--the Office of Surveillance, Epidemiology, 
and Laboratory Services (OSELS), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The Survey of Rapid Influenza Diagnostic Testing Practices in 
Clinical Laboratories is a national systematic study investigating 
rapid influenza diagnostic testing practices in clinical

[[Page 33304]]

laboratories. The survey will be funded in full by the Office of 
Surveillance, Epidemiology, and Laboratory Services (OSELS) of the 
Centers for Disease Control and Prevention (CDC). Influenza epidemics 
usually cause an average more than 200,000 hospitalizations and 36,000 
deaths per year in the U.S. Respiratory illnesses caused by influenza 
viruses are not easily differentiated from other respiratory infections 
based solely on symptoms. Also influenza viruses may adversely affect 
different subpopulations. The effective use of rapid influenza 
diagnostic testing practices is an important component of the 
differential diagnosis of influenza-like-illness in both inpatient and 
outpatient treatment facilities. Test results are used for making 
decisions about antiviral vs. antibiotic use, and in making admission 
or discharge decisions. In many cases, rapid influenza tests are the 
only tests that can provide results while the patient is still present 
in the facility. Thus, the appropriate use of the tests, and 
interpretation of test results is critical to the treatment and control 
of influenza. More than a dozen rapid tests have been approved by the 
U.S. Food and Drug Administration and are in widespread use. The 
reliability of rapid influenza tests is influenced by the individual 
test product used and the setting. Reported sensitivities range from 
10-75%; while the median specificities reported are 90-95%. Other 
factors influencing accuracy are the stage (or duration) of illness 
when the diagnostic specimen is collected, type and adequacy of the 
specimen collected, variability in user technique for specimen 
collection or assay performance, and disease activity in the community. 
Given these and other collective findings, it is imperative for public 
health and for response planning that CDC develops sector-specific 
guidance and effective outreach to the clinicians on appropriate use of 
RIDT in their practices.
    Previous studies by CDC of outpatient facilities showed that 
clinical laboratories usually perform the rapid tests for emergency 
departments, and provide results for both inpatient and outpatient 
treatment. Thus, understanding the use of rapid influenza testing in 
clinical laboratories, how the laboratories report results to emergency 
departments and treatment facilities and health departments, and what 
quality assurance practices are used will guide future efforts of the 
CDC to develop appropriate influenza testing guidelines and sector-
specific training materials for clinicians and improve health outcomes 
of the American public.
    The survey covers basic laboratory demographic characteristics, 
specimen collection and processing, testing practices, reporting of 
results to emergency departments and other treatment facilities, 
reporting results to health departments, quality assurance practices, 
and methods of receiving updated influenza-related information. The 
majority of the questions request information about laboratory 
influenza testing practices.
    To date, no systematic study has been conducted to investigate how 
laboratories use these tests, how they report results, or how they 
interact with outpatient treatment facilities. The survey will be 
conducted on a national sample of clinical laboratories. There are no 
costs to respondents except their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                              No. of        Avg. burden
              Type of respondents                               Form name                     No. of       responses per   per response    Total burden
                                                                                            respondents     respondent       (in hrs)        (in hrs)
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Clinical Laboratory Supervisors................  Survey of Rapid Influenza Diagnostic                600               1           30/60             300
                                                  Test Practices in Clinical
                                                  Laboratories.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             300
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    Dated: June 1, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-14147 Filed 6-7-11; 8:45 am]
BILLING CODE 4163-18-P