2011-11746. Memorandum of Understanding Between the Food and Drug Administration and the International Anesthesia Research Society for the Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots Public-Private Partnership

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of an amendment to memorandum of understanding (MOU) 222-09-0014 between the International Anesthesia Research Society (IARS) and FDA. The purpose of this MOU is to establish the framework for collaboration between the parties and to support their shared interest of promoting the safe use of anesthetics and sedatives in children. This is an amendment to this MOU to rename the SAFEKIDS (Safety of Key Inhaled and Intravenous Drugs in Pediatrics) Public-Private Partnership (PPP) to SmartTots (Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots) PPP.

DATES:

The agreement became effective March 17, 2011.

FOR FURTHER INFORMATION CONTACT:

Wendy R. Sanhai, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4128, Rockville, MD 20857, 301-796-8518, Fax: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

In March 2009, FDA launched the SAFEKIDS Initiative to address major gaps in scientific information about the effects of anesthetics and sedatives on neurocognitive development of infants and young children. Under the framework of the SAFEKIDS Initiative, FDA and IARS entered into MOU 222-09-0014 to develop the SAFEKIDS PPP—a collaboration among multiple stakeholders to support shared interest of promoting the safe use of anesthetics and sedatives in children.

Per this announcement, the SAFEKIDS Initiative has been renamed the FDA Pediatric Anesthesia Safety Initiative (PASI). As such, all activities supported under the former SAFEKIDS Initiative, including existing projects funded by FDA, will now be supported under PASI.

The amended MOU is intended to revise MOU 222-09-0014 to reflect the official renaming of the FDA-IARS PPP to SmartTots PPP.

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: May 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.