Federal Register: December 15, 2008 (Volume 73, Number 241)
DOCID: fr15de08-51 FR Doc E8-29580
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
NOTICE: NOTICES
DOCID: fr15de08-51
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis
DOCUMENT 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 antipertussis 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
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
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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 emailed to the attention of Jacqueline Goolsby jgoolsby@cdc.gov. 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, 4046391319 (Phone), 4046393059 (Fax), 1600 Clifton Rd. NE., Mail Stop C09, Atlanta, GA 30333.
SUMMARY:
Seeking To Evaluate Commercial Products, or Products in Development, for In Vitro Serological Diagnosis of Pertussis,
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 D11, Atlanta, GA 30333. Telephone (404) 6391239, EMail at
mtondella@cdc.gov.
Business
Lisa BlakeDiSpigna, Technology Development Coordinator, National
Center for Immunization and Respiratory Diseases, Centers for Disease
Control and Prevention (CDC), 1600 Clifton Road NE., Mail Stop A42,
Atlanta, GA 30333. Telephone (404) 6392620, EMail at LBlake DiSpigna@cdc.gov.
Dated: December 3, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E829580 Filed 121208; 8:45 am]
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