Added: Jul 23, 2008 12:30 pm
Modified: Aug 07, 2008 3:00 pm
Track Changes
The FDA is issuing the subject Request for Proposals (RFP) to provide non-clinical and clinical studies to assess the effects of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children, as well as overarching coordination and program management activities, in furtherance of the Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative.
FDA s mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by fostering innovations that make medical products more safe, effective, and affordable. As part of its goal of fostering innovation, FDA seeks to identify and address those scientific and technical obstacles to the optimum development of safe and therapeutically important medical products. A key aspect of the Agency s mission is to identify, and help address, potential safety concerns associated with all products under its jurisdiction and this includes the use of anesthetics and sedatives in pediatric patients.
Non-clinical studies in juvenile animal models have shown that exposure to some anesthetics and sedatives is associated with neurodegenerative changes in the central nervous system, as well as memory and learning deficits. Anesthetic agents that have been specifically implicated are NMDA receptor antagonists, such as ketamine, and GABA agonists, such as sevoflurane. The anesthesia community and the FDA acknowledge that there are insufficient human data to either support or refute the clinical relevance of these findings for pediatric patients. Therefore, additional non-clinical and clinical studies will be needed to assess the effect of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children.
The SAFEKIDS Initiative is a new requirement and will be a multi-phased, multi-year effort; however, the subject synopsis is expected to encompass only the initial phase of the overall initiative. FDA is soliciting proposals from entities capable of completing one or more of the following tasks/studies:
(1) Assessment of long-term neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants;
(2) Assessment of the pharmacokinetics, pharmacodynamics, and short- and long-term neurotoxic effects of an anesthetic in infants undergoing various surgical procedures;
(3) Assessment of the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes;
(4) Assessment of long-term cognitive development following general anesthesia as an infant;
(5) Evaluation of mechanisms of and potential prevention of neurotoxicity after administration of an inhalation anesthetic in an animal model; and
(6) Development of an administrative and scientific infrastructure to support the creation and execution of a series of projects under the SAFEKIDS Initiative
The period of performance for each individual task order listed above will be approximately 26 months from date of award. Planning and performing studies to address the aforementioned issues will involve enormous challenges in terms of design, assurance of validity and reliability of the outcome measures, and ethical considerations. The services will be provided under a Firm-Fixed-Price (FFP) Contract. There is no predetermined number of awardees: More than one individual project may be awarded to a single deserving entity.
This is a Full and Open competitive requirement: Not as a set-aside for any specific class of business concern and (2) utilizing the procurement methods proscribed in FAR Part 15 Contracting by Negotiation. The primary location of performance is anticipated to be at the contractor s preferred location; however, the contractor will be required to travel to the Washington, DC/Maryland geographical area.
The designated North American Industry Classification System (NAICS) code is: 541690 Other Scientific and Technical Consulting Services (Small Business Size: $6.5M). This industry comprises establishments primarily engaged in providing advice and assistance to businesses and other organizations on scientific and technical issues (except environmental).
This announcement is an active RFP. The proposal due date is September 8, 2008, at 1:00PM, Eastern Time. The anticipated award date for this effort is expected to be on or around September 19, 2008.
