Document ID: FDA-2009-N-0667-0001
Agency: fda
Document Type: Notice
Title: Memorandum of Understanding With Baylor College of Medicine, University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, Texas A&m Health Center, The University of Texas Medical Branch at Galveston, and the Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative
Posted Date: 2009-03-13T04:00Z

[Federal Register: March 13, 2009 (Volume 74, Number 48)]
[Notices]               
[Page 10926-10944]
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

[FDA-2009-N-0667]
[FDA 225-07-8006]

 
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 Center, The University of Texas 
Medical Branch at Galveston, and The Methodist Hospital Research 
Institute for the FDA-ANH Nanotechnology Initiative

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) 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.
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[FR Doc. E9-5492 Filed 3-12-09; 8:45 am]

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