2010-17634. 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 ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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, [e-mail].

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.