Document ID: FDA-2011-N-0005-0001
Agency: fda
Document Type: Notice
Title: Memorandums Of Understanding: International Anesthesia Research Society for Strategies for Mitigating Anesthesia Related Neuro-Toxicity, etc.
Posted Date: 2011-05-13T04:00Z

[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Pages 28046-28052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11746]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0005; FDA 225-09-0014]

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.

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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: 301-827-
5891, Wendy.sanhai@fda.hhs.gov.

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.
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[FR Doc. 2011-11746 Filed 5-12-11; 8:45 am]
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