05-18514. Memorandum of Understanding Between the Food and Drug Administration, Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Neurological Disorders and Stroke

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 the Food and Drug Administration, Center for Biologics Evaluation and Research (FDA/CBER), and the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/NINDS). The purpose of this MOU is to provide a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CBER and NIH/NINDS units shall take place.

DATES:

The agreement became effective February 12, 2002.

FOR FURTHER INFORMATION CONTACT:

For FDA/CBER: Kimberly Benton, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, WOC1/rm. 209N, Rockville, MD 20852, 301-827-5102.

For NIH/NINDS: Robert Finkelstein, Extramural Research, Neuroscience Center, National Institutes of Health, 6001 Executive Blvd., rm. 2143, Bethesda, MD 20892, 301-496-9248.

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: September 8, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.