[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Pages 76031-76032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Seeking To Evaluate Commercial Products, or Products in 
Development, for In Vitro Serological Diagnosis of Pertussis

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

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), National 
Center for Immunization and Respiratory Diseases (NCIRD), Division of 
Bacterial Diseases (DBD) through its component Branches have lead 
technical responsibility for research, development and evaluation of 
diagnostic tools for pertussis and application of these to 
epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, 
clinical, and biostatistical sciences to control and prevent vaccine 
preventable infectious diseases. CDC also conducts applied research in 
a variety of settings, and translates the findings of this research 
into public health practice.
    CDC is seeking to evaluate commercial products, or products in 
development, for in vitro serological diagnosis of pertussis. 
Specifically these should include tests to detect anti-pertussis toxin 
antibodies in infected and vaccinated individuals. The tests should be 
based on standardized reagents commonly used in the field (such as FDA 
Reference Serum Standard Lot 3 or equivalents). Products will 
be evaluated in CDC and collaborating laboratories and if appropriate, 
may be used in epidemiologic validation studies. Data obtained from 
this comparative analysis may be used by CDC in making recommendations 
and decisions for diagnosis of pertussis in the public health setting.
    Interested organizations that may have candidate products are 
invited to submit documentation for CDC to assess whether the offered 
product(s) are at a sufficient stage of development to be included in 
this comparative analysis. As a minimum, submitted information should 
be sufficient for CDC to

[[Page 76032]]

determine 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
    Organizations that have products selected by CDC for this 
comparative analysis will be required to enter into an appropriate 
agreement prior to the transfer of any material to CDC. Sample 
agreements may be viewed at the following Web site: http://www.cdc.gov/od/ads/techtran/forms.htm.
    All information submitted to 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). Only 
information submitted within thirty days of publication of this notice 
will be reviewed to determine if the offered product(s) will be 
acceptable for possible inclusion in this comparative analysis.
    Responses are preferred in electronic format and can be e-mailed to 
the attention of Jacqueline Goolsby [email protected]. Mailed responses 
can be sent to the following address: Jackie Goolsby, Branch Manager, 
Centers for Disease Control and Prevention, National Center for 
Immunization and Respiratory Diseases, Division of Bacterial Diseases, 
404-639-1319 (Phone), 404-639-3059 (Fax), 1600 Clifton Rd. NE., Mail 
Stop C-09, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical

    Dr. M. Lucia Tondella, Division of Bacterial Diseases, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop D-11, 
Atlanta, GA 30333. Telephone (404) 639-1239, E-Mail at 
[email protected].

Business

    Lisa Blake-DiSpigna, Technology Development Coordinator, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop A-42, 
Atlanta, GA 30333. Telephone (404) 639-2620, E-Mail at [email protected].

    Dated: December 3, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
 [FR Doc. E8-29580 Filed 12-12-08; 8:45 am]
BILLING CODE 4163-18-P