[Federal Register Volume 69, Number 19 (Thursday, January 29, 2004)]
[Notices]
[Page 4302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1906]


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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), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: This is a request for information only. It is not a request 
for proposal and does not commit the government to issue a 
solicitation, make an award, or pay any costs associated with 
responding to this announcement. All submitted information shall remain 
with the government and will not be returned.
    The Centers for Disease Control and Prevention (CDC), National 
Center for Infectious Disease (NCID), Division of Bacterial and Mycotic 
Diseases (DBMD) through its component Branches has lead technical 
responsibility for a number of Category A, B and C bioterrorism agents 
and their associated toxins (Bacillus anthracis, Clostridium botulinum, 
Brucella sps., Burkholderia sps., Staphylococcus entertoxin B, other 
food- or waterborne bacterial pathogens, and other bacterial agents). 
DBMD uses epidemiologic, laboratory, clinical, and biostatistical 
sciences to control and prevent bacterial and mycotic infectious 
disease. The Division also conducts applied research in a variety of 
settings, and translates the findings of this research into public 
health practice.
    DBMD is seeking to evaluate commercial products, or products in 
development, for in vitro comparison of immunotherapeutic and 
immunoprophylactic antibody treatments for anthrax. Specifically these 
may include monoclonal and polyclonal antibody toxin inhibitors and 
inhibitors of intracellular anthrax toxin function. CDC will coordinate 
the evaluation of products in a range of in vitro and in vivo models. 
Data obtained from this comparative analysis will be used by CDC and 
DHHS in making recommendations and decisions on development of an 
appropriate procurement strategy to meet the nation's bioterrorism 
defense needs.
    Interested organizations that 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 assess the following for each candidate 
product:
    a. Pre-clinical animal efficacy studies.
    b. Pre-clinical pharmacokinetic studies.
    c. Biochemical analysis to include:

Binding affinity measurements for monoclonal antibodies.
Animal species (if applicable).
Epitope or domain binding targets (if available).
Mass value assignment for antigen-specific antibody levels (e.g. Anti-
PA specific IgG concentration).

    Organizations that have products selected by CDC for this 
comparative analysis will be required to submit data packages with as 
much detail as possible for the pre-clinical studies, and 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 by February 1, 2004, 
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. Conrad Quinn, 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) 
639-2858, 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 E-51, Atlanta, 
GA 30333. Telephone (404) 498-3262, e-mail at [email protected].

    Dated: January 22, 2004.
Joseph R. Carter,
Deputy Chief Operating Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 04-1906 Filed 1-28-04; 8:45 am]
BILLING CODE 4163-18-P