SAFEKIDS Initiative

Synopsis: This posting is to announce the Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Contracts Operations Team (COT) forth coming solicitation for "the Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative". Objective: The objective of this project is to conduct non-clinical and clinical studies to assess the effect of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children. 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. Two (2) potential functional categories shall be addressed as listed below: Functional Category 1 - Administrative Tasks: This Functional Category will require a qualified entity to create and/or maintain the administrative infrastructure, called the SAFEKIDS Public-Private Partnership (SAFEKIDS PPP), with FDA and with sufficient staff to support overarching activities, to include but not be limited to scientific studies, outreach/education, publications/reports, funding of future projects and the administration of a Scientific Advisory Board (SAB) to identify, prioritize, implement and fund a series of studies under the SAFEKIDS PPP and as mandated by FDA's SAFEKIDS Initiative. Functional Category 2 - Scientific Tasks: Tasks issued under this Functional Category will relate to the development and execution of scientific projects related to a better understanding of the effects of anesthetics and sedatives on the developing human brain. These tasks may include design and implementation of prospective clinical trials, retrospective studies, additional follow-up for patients enrolled in previous trials, and preclinical studies. Competition Type: 100% Full and Open Competition NACIS code: 813920 Procurement Solicitation Number: 10-223-SOL-00124 It is anticipated that and IDIQ contract will be awarded utilizing task orders. Individual task orders shall be define by the Contracting Officer as Firm Fixed Price, Labor Hour, Time and Material or a Combination of contract types listed. The period of performance will consist of a base and Four (4) One (1) year option periods. The solicitation and any documentation relating to this requirement will only be available through the internet at: www.fedbizopps.gov. Notifications will not be sent to offerors regarding the issuance of the solicitation nor any of its amendments. It is the offeror's responsibility to monitor FedBizOpps for release of this acquisition and any associated amendments. The RFP is anticipated to be released on or about May 18, 2010. Interested parties must respond to the RFP in order to be considered for award of any resultant contract. All qualified sources may submit proposals which shall be considered by the agency however, QUESTIONS WILL NOT BE ENTERNATINED AT THIS TIME. Once the solicitation is released, offerors will be given an opportunity to present questions via e-mail only and answers will be posted to www.fedbizopps.gov. Offeror's response to the request for Proposal (RFP) will be due approximately 30 days following the issuance date of the RFP. Award of this requirement is anticipated on or about September 8, 2010. Interested offeror's must be registered in the Central Contract Registration (CCR) database before an award can be made to them. If the offeror is not registered in the CCR, they may do so through the CCR website at http://www.ccr.gov.