E9-5492. Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with The Alliance for NanoHealth (ANH), a collaboration among: Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute. This MOU identifies the terms of collaboration between FDA and ANH in the area of nanotechnology. Specifically, this MOU establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public-private partnership dedicated to the identification of scientific and translational gaps in moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization, all with immediate benefit to public health. The activities are aligned with the mutual interests and respective missions of the Parties, including the FDA's Critical Path Initiative which seeks to modernize the product development and regulatory sciences needed to reduce uncertainties about product performance throughout the product life cycle. Thus, a key goal for the Parties is to improve the safety and efficacy of nanoengineered products and speed their delivery to the patients who need them and the consumers who use them.

DATES:

The agreement became effective February 11, 2009.

FOR FURTHER INFORMATION CONTACT:

Wendy R. Sanhai, Office of the Commissioner (HZ-1), Food and Drug Administration, 5600 Fishers Lane, suite 6A-08, Rockville, MD 20857, 301-827-7867.

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: March 4, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.