[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76736-76737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-12-11GU]


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 email to 
[email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this 
notice.

Proposed Project

    Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in 
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 
Laboratories is a national systematic study investigating rapid 
influenza diagnostic testing practices in clinical 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 of 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. The total estimated annual 
burden hours are 1020.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs)
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Clinical Laboratory Supervisors.......  Survey of Rapid                     2040               1           30/60
                                         Influenza Diagnostic
                                         Test Practices in
                                         Laboratories.
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[[Page 76737]]

    Dated: December 1, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-31561 Filed 12-7-11; 8:45 am]
BILLING CODE 4163-18-P