[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
----------------------------------------------------------------------------------------------------------------
                                                                     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.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             900
----------------------------------------------------------------------------------------------------------------


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