[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20112-20114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-0924]


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 or 
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email 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 and Evaluation of Laboratory Course--
Reinstatement (OMB Control No. 0920-0924) with change--the Office of 
Surveillance, Epidemiology, and Laboratory Services (OSELS), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The purpose of this request is to obtain Office of Budget and 
Management (OMB) approval to reinstate with change, the data collection 
for the Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in 
Clinical Laboratories (OMB Control No. 0920-0924). OMB approval for the 
2012 RIDT project expired February 28, 2012. CDC seeks a three-year 
approval to conduct the RIDT project. Changes incorporated into this 
reinstatement request include changing the name of the collection to 
``Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in 
Clinical Laboratories and Evaluation of Laboratory Course'' and adding 
a question about whether or not the participants have taken the free 
CDC rapid influenza testing course, Strategies for Improving Rapid 
Influenza Testing

[[Page 20113]]

in Ambulatory Settings, and to rate the usefulness of the course in 
their clinical setting. The Survey of Rapid Influenza Diagnostic 
Testing Practices in Clinical Laboratories and Evaluation of Laboratory 
Course 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 of the Centers for Disease Control and Prevention.
    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 versus 
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 in both hospitals and outpatient settings, how 
the results are reported to emergency departments, treatment facilities 
and health departments, and what quality assurance practices are used 
will guide future efforts of the CDC to continue to develop and update 
appropriate influenza testing guidelines and sector-specific training 
materials for clinicians and improve health outcomes of the American 
public. In fact, CDC has developed a rapid testing course, ``Strategies 
for Improving Rapid Influenza Diagnostic Testing'', with continuing 
education credits that is available to clinicians and laboratorians 
free of charge. We would like to ask respondents to the survey if they 
have taken the course, and ask them to rate its usefulness.
    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 
respondents would be clinical laboratory supervisors, nurses, and other 
clinicians. The majority of the questions request information about 
laboratory influenza testing practices. For this request, we have also 
added a question about whether or not the participants have taken the 
free CDC rapid influenza testing course and to rate its usefulness in 
their clinical setting.
    No updated systematic study has been conducted to investigate how 
laboratories now use these tests, how they report results, or how they 
interact with outpatient treatment facilities, whether they have taken 
the free rapid influenza testing course, or how they rate the course. 
The survey will be conducted on a national sample of laboratories and 
clinical facilities, including those in outpatient facilities that 
perform rapid influenza diagnostic tests. There are no costs to 
respondents except their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs)
                                                                    respondent         hrs)
----------------------------------------------------------------------------------------------------------------
Clinical Laboratory             Survey of Rapid              600               1           30/60             300
 Supervisors.                    Influenza
                                 Diagnostic Test
                                 Practices in
                                 Clinical
                                 Laboratories.
Nurses........................  Survey of Rapid              600               1           30/60             300
                                 Influenza
                                 Diagnostic Test
                                 Practices in
                                 Clinical
                                 Laboratories.
Other Clinicians..............  Survey of Rapid              600               1           30/60             300
                                 Influenza
                                 Diagnostic Test
                                 Practices in
                                 Clinical
                                 Laboratories.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             900
----------------------------------------------------------------------------------------------------------------



[[Page 20114]]

    Dated: March 28, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-07742 Filed 4-2-13; 8:45 am]
BILLING CODE 4163-18-P