[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Page 4725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Influenza Diagnostic Testing and Reporting

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: General notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) located 
within the Department of Health and Human Services (HHS) is seeking to 
assess new technologies that improve rapid influenza diagnostic testing 
and supplement national laboratory-based surveillance for human 
influenza infections. In particular, the Influenza Division within the 
National Center for Immunization and Respiratory Diseases (NCIRD) at 
HHS/CDC proposes to evaluate new or improved point of care diagnostic 
tests for influenza virus detection that incorporate the capability to 
transmit influenza diagnostic test results electronically, such as 
through wireless communication technology, for more timely diagnosis of 
human influenza and/or other respiratory pathogen infections in 
outpatient/ambulatory and emergency room healthcare practices.

DATES: HHS/CDC will accept inquiries/proposals until December 31, 2015.

ADDRESSES: You may submit your inquiry/proposal by email: 
[email protected].
    All information submitted to HHS/CDC will be kept confidential as 
allowed by relevant federal law, including the Freedom of Information 
Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905). 
Responses are preferred in electronic format. CDC does not intend to 
publish the results of these evaluations.

FOR FURTHER INFORMATION CONTACT: Influenza Division, Centers for 
Disease Control and Prevention. Email: [email protected].

SUPPLEMENTARY INFORMATION: HHS/CDC uses epidemiologic, laboratory, 
clinical, and biostatistical sciences to prevent and control vaccine 
preventable infectious diseases. HHS/CDC also conducts applied research 
in a variety of settings, and translates the findings of this research 
into public health practice. HHS/CDC/NCIRD Influenza Division has lead 
technical responsibility for research, development, and evaluation of 
diagnostic tools for influenza and application of these to national 
surveillance and epidemiologic studies of influenza. Improving 
influenza diagnostic testing is part of HHS/CDC/NCIRD Influenza 
Division's strategic plan and includes support of the development of 
expanded respiratory pathogen tests on existing test platforms; 
development of advanced sequence detection methods for identifying 
novel influenza strains with pandemic potential; rapid identification 
of antiviral resistant influenza strains; rapid identification of 
influenza immunological response to determine the presence or absence 
of circulating antibodies specific for influenza viruses; and the 
development and characterization of stable diagnostic reagents or 
reference material and controls, for application with existing 
diagnostic test systems on established platforms.
    HHS/CDC/NCIRD Influenza Division seeks to collaborate on 
evaluations of any new or improved diagnostic tests for the detection 
of human influenza viruses. The tests may range from high complexity 
molecular assays providing genetic sequence information to point of 
care type tests that facilitate more timely diagnosis of human 
influenza infections and/or other respiratory pathogen infections in 
ambulatory and emergency room healthcare practices. Assays should 
present sensitivity and specificity higher than currently available 
products.
    For commercial products with approval for use by the US Food and 
Drug Administration (FDA), HHS/CDC/NCIRD Influenza Division is seeking 
to evaluate the potential supplementation of current national 
laboratory-based influenza surveillance data with influenza test result 
data that can be transmitted directly to a public health entity (state, 
local, or CDC) from the test platform electronically, such as through 
wireless technology. Direct test platform-based reporting capability 
has been newly established. Current surveillance incorporates data from 
healthcare provider offices and laboratories through manual or 
automated reporting functions; however, most of the current testing 
platforms do not have the capacity to directly transmit reports. Such 
reports represent a new data source and thus require evaluation and 
determination of appropriate data use agreements.
    HHS/CDC/NCIRD Influenza Division is also interested in 
collaborating with organizations working on validation of novel and 
improved respiratory specimen collection materials and methods that can 
enable reliable and consistent self-collection or collection by non-
expert personnel. Data obtained from the evaluation can be compared 
through analytical assessments and be used by HHS/CDC in making 
recommendations and decisions for diagnosis of influenza in the health 
setting. Products may be evaluated at HHS/CDC and/or at collaborating 
laboratories and if appropriate, may be used in epidemiologic 
validation studies.
    Interested organizations that have candidate products are invited 
to approach the HHS/CDC/NCIRD Influenza Division to assess whether the 
available product(s) are at a sufficient stage of development and how 
HHS/CDC can collaborate on evaluations and comparative analysis.

Information To Submit

    At a minimum, submitted information should include the following 
for each candidate product: (a) Product package insert or detailed 
instructions for use; (b) Detailed information to determine if the 
product is calibrated to a recognized standard; (c) Preliminary data 
demonstrating suitability for validation studies and clinical trial 
data on sensitivity and specificity; (d) Whether the product is FDA 
approved; and (e) Statement of how HHS/CDC/NCIRD Influenza Division 
could collaborate on product evaluation or further development.

    Dated: January 22, 2014.
Stacey Hoffman,
Acting Director, Division of Executive Secretariat Centers for Disease 
Control and Prevention.
[FR Doc. 2014-01670 Filed 1-28-14; 8:45 am]
BILLING CODE 4163-18-P