[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
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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.
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Total..................... ................ .............. .............. .............. 900
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[[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]
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