Examining the Effects of General Anesthesia

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), intends to award a modification to contract HHSF223200810033C and increase the current capacity by an estimated additional $250,000. This contract was originally awarded to the International Anesthesia Research Society under full-and-open competitive procedures. The Government intends to award the modification to this contract consistent with the terms identified within this announcement upon the basis of the authority provided in 10 U.S.C 2304(c)(1) and implemented by FAR 6.302-1, only one responsible source and no other services will satisfy requirement. Due to the vast institutional knowledge which the International Anesthesia Research Society has gained throughout the development of the FDA's Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative over the past two years and its progress examining the effects of general anesthesia during the first year of life on chronic cognitive development, its uniquely talented and dedicated personnel, as well as its comprehensive resources and established relationships throughout the scientific community, the International Anesthesia Research Society is uniquely suited to complete the subject activities. Thus so far, the International Anesthesia Research Society has completed, or is otherwise in the process of completing, each of the following tasks under contract: * Participated in FDA's SAFEKIDS Initiative scientific workshops * Identified an appropriate study sample size that will allow for demonstration of a clinically and statistically significant effect with scientifically appropriate power * Presented reports required under contract * Participated in at least one workshop related to the SAFEKIDS Initiative in the Maryland/Greater Washington, DC area * Published the findings of studies in peer-reviewed scientific journals. In furtherance and support of the SAFEKIDS Initiative, and in accordance with the proposed modification, it is expected that the International Anesthesia Research Society shall complete the following activities: * Continue pre-existing work in furtherance of the SAFEKIDS Initiative * Complete the initial phase of the administrative infrastructure for the multi-phased public-private partnership (PPP) to sustain the SAFEKIDS PPP; and Any other entity would incur substantial start-up costs and a significant amount of time in order to obtain the requisite resources and specialized knowledge required to successfully complete all work required under the subject requirement. Furthermore, with the public health at stake, there remains a pressing need to foster current progress and limit undue risk of project failure. There from, it is hereby determined that the subject services may not be competed without undue delay, duplication of previous efforts, and substantial duplication of cost. The Government will support the proposed actions by written justification, as well as obtain all requisite approvals. The Government will post the respective justification on www.fbo.gov. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is NOT a request for competitive proposals. However, all capability statements received within fifteen days after date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Capability Statements submitted should demonstrate the offerors experience and expertise to provide the services identified above within the time frame required and without substantial duplication of cost to the Government. The statement shall include business size; ability to self-perform work; layers of subcontracting; and any other information indicating a legitimate ability to meet these specific requirements. Statements should not exceed five (5) pages in length. Written inquiries may be directed to Terry Frederick at Terry.Frederick@fda.hhs.gov.