[Federal Register: June 17, 2003 (Volume 68, Number 116)]
[Notices]
[Page 35891-35892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn03-62]
[[Page 35891]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Cooperative Research and Development Agreement
AGENCY: Centers for Disease Control and Prevention (CDC), Health and
Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Division of Bacterial and Mycotic Diseases (in the
National Center for Infectious Disease, Centers for Disease Control and
Prevention) is seeking to explore possible partnerships in applied
research to improve public health preparedness and response to
bioterrorism associated with use of bacterial and fungal agents. The
Division of Bacterial and Mycotic Diseases (DBMD) through its component
Branches has lead CDC 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 conducts
applied research in a variety of settings, and translates the findings
of this research into public health practice.
The division works in partnership with a variety of public,
academic, and for-profit and not-for-profit private sector
organizations to achieve public health goals.
Broad categories of bioterrorism-related research of interest to
the DBMD include:
1. Rapid evaluation of powder, food, water, and other potential
vehicles for presence of bioterrorism agents, and their associated
toxins;
2. Epidemiologic investigation of suspected and confirmed
bioterrorism events;
3. Pre-, during, and post-bioterrorism event surveillance;
4. Diagnosis of suspect and confirmed bioterrorism-related illness;
5. Treatment of suspect and confirmed bioterrorism-related illness;
6. Post-exposure prophylaxis for prevention of bioterrorism-related
illness among exposed persons;
7. Remediation of health risks in environments contaminated or
potentially contaminated as a result of BT events.
DBMD is currently involved in a number of bioterrorism-related
research activities including, but not limited to:
1. Development and revision of agent-(and toxin-) specific National
Bioterrorism Response Plans;
2. Anthrax vaccines;
3. Immunotherapy for anthrax and botulism;
4. Anthrax diagnostics;
5. Antimicrobial susceptibility testing;
6. Epidemiologic and clinical research;
7. Building representative stain collections;
8. Molecular subtyping (and electronic networks for sharing
associated data);
9. Identification of virulence factors;
10. Methods for rapid detection of foodborne agents in food and
water;
11. Evaluation of unexplained deaths and critical illnesses.
Because CRADA's are designed to facilitate the development of
scientific and technological knowledge into useful, marketable
products, a great deal of freedom is given to Federal agencies in
implementing collaborative research. The CDC may accept staff,
facilities, equipment, supplies, and money from the other participants
in a CRADA; CDC may provide staff, facilities, equipment, and supplies
to the project. CDC MAY NOT PROVIDE FUNDS to the other participants in
a CRADA. Responses will be accepted through one year after publication
of this notice.
FOR FURTHER INFORMATION CONTACT:
Technical
Bradley Perkins, MD, Division of Bacterial and Mycotic Diseases,
National Center for Infectious Diseases, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Rd. NE., Mail stop C-09, Atlanta, GA
30333. Telephone (404) 639-4721, E-Mail at BPerkins@CDC.GOV.
Business
Lisa Blake-DiSpigna, Technology Development Coordinator, National
Center for Infectious Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton R. NE., Mail stop E-51, Atlanta, GA
30333. Telephone (404) 498-3262, E-Mail at LCBS3@CDC.GOV.
SUPPLEMENTARY INFORMATION:
DBMD is seeking to identify organizations that are interested in a
partnership for the common goal of improving the Nation's preparedness
and ability to respond to bioterrorism based on mutually agreed rule
and principles. Partnerships may be based on existing products--systems
or tests, development of new products--systems or tests, evaluation of
specific issues, communications strategies, or other exchange of
knowledge. Partnerships must be constructed in a way that does not
create a real or perceived conflict of interest for CDC, the Department
of Health and Human Services, or the Federal Government. DBMD will not
engage in partnerships which benefit a partner but provide no clear
benefit to the Nation's preparedness and ability to respond to
bioterrorism.
Respondents should provide evidence of expertise in the conduct of
research that focuses on accomplishments and current capabilities, with
supporting documentation (e.g., publications, certifications, resumes,
etc.), along with qualifications for the principal investigator who
would be involved in the CRADA. A proposed research plan outline should
be included with sufficient detail to allow for its merit to be judged
on the criteria below. Respondents selected for a CRADA will develop
the final research plan in collaboration with CDC.
The key criteria by which CDC will judge a potential partnership
are whether:
(1) The partnership leads to significant gains in the Nation's
preparedness and ability to respond to bioterrorism.
(2) These gains are worth the effort involved in establishing and
maintaining the partnership.
With respect to Government Intellectual Property (IP) rights to any
invention not made solely by a CRADA partner's employees for which a
patent or other IP application is filed, CDC has the authority to grant
to the CRADA partner an exclusive option to elect an exclusive or
nonexclusive commercialization license. This option does not apply to
inventions conceived prior to the effective date of a CRADA that are
reduced to practice under the CRADA, if prior to that reduction to
practice, CDC has filed a patent application on the invention and has
licensed it or offered to licensed it to a third party. The terms of
the license will fairly reflect the nature of the invention, the
relative contributions of the Parties to the invention and the CRADA ,
the risks incurred by the CRADA partner and the costs of subsequent
research and development needed to bring the invention to the
marketplace. The field of use of the license will be commensurate with
the scope of the research plan.
This CRADA(s) is proposed and implemented under the 1986 Federal
Technology Transfer Act: Public Law 99-502, as amended.
[[Page 35892]]
Projects that involve the collection of information from 10 or more
individuals may be subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act.
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.
Dated: June 11, 2003.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease
Control and Prevention.
[FR Doc. 03-15218 Filed 6-16-03; 8:45 am]
BILLING CODE 4163-18-P