Document ID: FDA-2010-N-0004-0007
Agency: fda
Document Type: Notice
Title: Memorandum of Understanding: Food and Drug Administration and the National Institutes of Health; et al.
Posted Date: 2010-07-20T04:00Z

[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]               
[Page 42105-42113]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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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, 
david.jacobsonkram@fda.hhs.gov.

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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