[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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