Pediatric Anesthesia Neuro-Development Assessment (PANDA) Study

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), intends to award a modification to contract HHSF223200810036C and increase the current capacity by an estimated additional $249,000. The prospective contract action will thereby increase the overall contract value to an estimated $657,000. This contract was originally awarded to Columbia University 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 Columbia University has gained throughout the development of the Pediatric Anesthesia and Neuro-Development Assessment (PANDA) Study over the past two years, its uniquely talented and dedicated personnel, as well as its comprehensive resources (i.e., information technology infrastructure; neuro-developmental assessment and neuropsychological testing abilities), Columbia University is uniquely suited to complete the subject activities. Thus so far, Columbia University has completed, or is otherwise in the process of completing, each of the following tasks under contract: * Participated in FDA's Safety of Key Inhaled and Intravenous Drugs in Pediatrics (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. * Published the findings of studies conducted under contract in peer-reviewed, scientific journals. * Identified children who were exposed to general anesthesia within the first three years of life. * Determined the study eligibility criteria. * Developed methods to quantify anesthesia exposure. * Obtained a complete medical history (with appropriate consent), including significant perinatal events and social history. * Established an infrastructure for database management. * Within the study population, documented the dose, types and use duration of all anesthetic agents, including but not limited to, agents that exhibit GABA agonists/NMDA antagonist properties, opioids and other hypnotics. In furtherance and support of the PANDA Study, and in accordance with the proposed modification, it is expected that Columbia University shall complete the following activities: * Initiate new clinical sites to recruit, enroll, and study subjects to help facilitate the timely completion of the PANDA Study; * Coordinate the feasibility phase of the PANDA Study amongst US sites; and * Perform study assessment for eligible subjects at sites other than the coordinating site to provide a better understanding for the feasibility and associated time line of the full trial. 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.