[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42105-42113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17634]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0004]
[FDA-225-10-0015]
Memorandum of Understanding: Food and Drug Administration and the
National Institutes of Health, National Institutes of Environmental
Health Sciences, National Toxicology Program; and the National
Institutes of Health, National Human Genome Research Institute,
National Institutes of Health, Chemical Genomics Center; and the
Environmental Protection Agency, Office of Research and Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the National
Institutes of Health (NIH), National Institutes of Environmental Health
Sciences (NIEHS), National Toxicology Program (NTP); and the NIH,
National Human Genome Research Institute (NHGRI), NIH Chemical Genomics
Center (NCGC); and the Environmental Protection Agency, Office of
Research and Development.
This four-party Memorandum of Understanding (MOU) sets in place
mechanisms to strengthen the existing collaborations that utilize the
complementary expertise and capabilities of the NIEHS/NTP, the NCGC of
the NHGRI, the Office of Research and Development (ORD) of the EPA, and
the FDA in the research, development, validation, and translation of
new and innovative test methods that characterize key steps in toxicity
pathways. This MOU amends and supersedes an MOU between the first three
named parties for the same purposes. A central component of this MOU is
the exploration of high throughput screening (HTS) assays and tests
using phylogenetically lower animal species (e.g., fish, worms), as
well as high throughput whole genome analytical methods, to evaluate
mechanisms of toxicity. Ultimately, the data generated by these new
tools is to be provided to risk assessors to use in the protection of
human health and the environment. The goals of this MOU are to
investigate the use of these new tools to: (1) Identify mechanisms of
chemically induced biological activity, (2) prioritize chemicals for
more extensive toxicological evaluation, and (3) develop more
predictive models of in vivo biological response. Success in achieving
these goals is expected to result in test methods for toxicity testing
that are more scientifically and economically efficient and models for
risk assessment that are more biologically based. As a consequence, a
reduction or replacement of animals in regulatory testing is
anticipated to occur in parallel with an increased ability to evaluate
the large numbers of chemicals that currently lack adequate
toxicological evaluation.
DATES: The agreement became effective June 4, 2010.
FOR FURTHER INFORMATION CONTACT: David Jacobson-Kram, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, rm. 6488,
Food and Drug Administration, Silver Spring, MD 20993, 301-796-0175,
[email protected].
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: July 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[FR Doc. 2010-17634 Filed 7-19-10; 8:45 am]
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