E8-29580. 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.

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 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 [e-mail]. 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 [phone], E-Mail at [e-mail].

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 [phone], E-Mail at [e-mail].

Dated: December 3, 2008.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention.