[Federal Register: December 15, 2008 (Volume 73, Number 241)]
[Notices]
[Page 76031-76032]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de08-51]
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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 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,
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
mtondella@cdc.gov.
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 LBlake-
DiSpigna@cdc.gov.
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