[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Page 77398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Public Notice

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 Infectious Disease (NCID), Division of Bacterial and Mycotic 
Diseases (DBMD) and the National Immunization Program, Epidemiology and 
Surveillance Division 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 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; and (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 Michael J. Detmer at [email protected]. Mailed responses 
can be sent to the following address: Michael J. Detmer, Division of 
Bacterial and Mycotic Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., 
NE., Mail Stop C-09, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT: Technical: Dr. Patty Wilkins, Division 
of Bacterial and Mycotic Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention (CDC), 1600 
Clifton Rd., NE., Mail Stop D-11, Atlanta, GA 30333. Telephone (404) 
639-3297, E-Mail at [email protected].
    Business: Lisa Blake-DiSpigna, Technology Development Coordinator, 
National Center for Infectious Diseases, Centers for Disease Control 
and Prevention (CDC), 1600 Clifton Rd., NE., Mail Stop A-42, Atlanta, 
GA 30333. Telephone (404) 639-2620, E-Mail at [email protected].

    Dated: December 21, 2005.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention.
[FR Doc. E5-8103 Filed 12-29-05; 8:45 am]
BILLING CODE 4163-18-P