[Federal Register: January 29, 2004 (Volume 69, Number 19)]
[Notices]
[Page 4302]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja04-49]
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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 MDetmer@cdc.gov. 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 cquinn@cdc.gov.
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 lblake-dispigna@cdc.gov.
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