[Federal Register Volume 68, Number 116 (Tuesday, June 17, 2003)]
[Notices]
[Pages 35891-35892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15218]



[[Page 35891]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 [email protected].

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 [email protected].

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 [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.

    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