[Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
[Notices]
[Pages 1938-1939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-950]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[CRADA 96-001]


National Institute for Occupational Safety and Health Cooperative 
Research and Development Agreement

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC), announces 
the opportunity for potential collaborators to enter into a Cooperative 
Research and Development Agreement (CRADA) to develop a direct reading 
immunoassay device for monitoring human urinary metabolites of the 
herbicide, alachlor. Humans metabolize alachlor in such a way as to 
produce a set of chemically altered compounds (metabolites) that are 
more easily excreted, primarily in urine. By determining the level of 
these metabolites in urine of workers who are at risk for exposure to 
alachlor, an assessment of exposure can be made. The device that CDC 
wants to have developed would allow rapid and easy determination of 
urinary metabolite levels, thus allowing intervention procedures to be 
implemented.
    It is anticipated that all inventions which may arise from the 
CRADA will be jointly owned. The collaborator with whom the CRADA is 
made will have an option to negotiate an exclusive or non-exclusive 
royalty-bearing license. The CRADA will be executed for a 2-year period 
with the possibility of renewal for another 2-year period.
    Because CRADAs are designed to facilitate the development of 
scientific and technological knowledge into useful, marketable 
products, much 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. There is a single restriction in this exchange: CDC MAY NOT 
PROVIDE FUNDS to the other participants in a CRADA.
    This opportunity is available until February 23, 1996. Respondents 
may be provided a longer period of time to furnish additional 
information if CDC finds this necessary.

FOR FURTHER INFORMATION:
    Technical: R. DeLon Hull, Ph.D. or J. Patrick Mastin, Ph.D., 
Division of Biomedical and Behavioral Sciences, National Institute for 
Occupational Safety and Health, CDC, 4676 Columbia Parkway, Mailstop C-
26, Cincinnati, Ohio 45226, Telephone 513-533-8122 and 513-533-8399, 
Fax 513-533-8510.
    Business: Theodore F. Schoenborn, Technology Transfer Coordinator, 
National Institute for Occupational Safety and Health, CDC, 4676 
Columbia Parkway, Mailstop R-2, Cincinnati, Ohio 45226, Telephone 513-
841-4305, Fax 513-841-4500.

SUPPLEMENTARY INFORMATION: The direct reading device should be similar 
to home pregnancy test kits and suitable for use by the worker or a 
local health care professional. For instance a test strip made of an 
absorbent material such as chromatography paper would be held in the 
urine stream or dipped in a sample of urine and the urine allowed to 
wick up the strip. The presence and approximate concentration of the 
metabolite would be visualized as, for instance, a color change (as 
with pH test paper) or the appearance of a color band at a height 
indicative of the concentration of the metabolite. The concentration of 
metabolite could then be estimated, for example, from a gradient scale 
imprinted on the device or by comparison to a visual standard. Urine 
from herbicide applicators being screened during NIOSH field studies 
will be used to test the strips as they are being developed.
    The device should meet the following requirements: 
    
[[Page 1939]]

    Requires no special expertise to use, so that workers or their 
local health professionals can use the device.
    Be immunoassay-based, in order to get sufficient sensitivity and 
selectivity.
    Be self-contained, i.e., does not require any instrumentation for 
analysis.
    Be produced easily and inexpensively and be readily available to 
workers.
    Applicants will be judged according to the following criteria:

    1. Adequacy and technical capabilities to develop the desired 
technologies and product;
    2. Ability to develop, produce, market, and support the device; and
    3. Ability to complete the CRADA in a timely fashion.

    This CRADA is proposed and implemented under the 1986 Federal 
Technology Transfer Act: Public Law 99-502.
    The response must be made to: Theodore F. Schoenborn, Technology 
Transfer Coordinator, National Institute for Occupational Safety and 
Health, CDC, 4676 Columbia Parkway, Mailstop R-2, Cincinnati, Ohio 
45226 Telephone 513-841-4305, Fax 513-841-4500.

    Dated: January 17, 1996.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-950 Filed 1-23-96; 8:45 am]
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