[Federal Register Volume 79, Number 162 (Thursday, August 21, 2014)]
[Notices]
[Pages 49516-49517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-14-0924]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort to reduce public burden, invites the general
public and other Federal agencies to take this opportunity to comment
on proposed and/or continuing information collections, as required by
the Paperwork Reduction Act of 1995. To request more information on the
below proposed project or to obtain a copy of the information
collection plan and instruments, call 404-639-7570 or send comments to
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or
send an email to [email protected].
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. 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; (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; and (e)
estimates of capital or start-up costs and costs of operation,
maintenance, and purchase of services to provide information. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, disclose or provide information
to or for a Federal agency. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information; and to transmit or otherwise
disclose the information. Written comments should be received within 60
days of this notice.
Proposed Project
Survey of Rapid Influenza Diagnostic Testing (RIDT) Practices in
Clinical Laboratories and Evaluation of Laboratory Course (OMB Control
No. 0920-0924, expired 02/28/2013)--Reinstatement with Change -- Center
for Surveillance, Epidemiology, and Laboratory Services, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to obtain Office of Management and
Budget (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, 2013. 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 Testing (RIDT) Practices in Laboratories and Evaluation of
RIDT 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 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 Center for Surveillance, Epidemiology, and Laboratory Services
of the Centers for Disease Control and Prevention.
[[Page 49517]]
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 Testing in Ambulatory Settings,'' with
continuing education credits that is available to clinicians and
laboratorians free of charge. We would like to ask survey respondents
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
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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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
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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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-19828 Filed 8-20-14; 8:45 am]
BILLING CODE 4163-18-P