Safety of Key Inhaled and Intravenous Drugs in Pediatrics Support Services

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), intends to award a modification to contract HHSF223200810037C and increase the current capacity by an estimated additional $100,000. This contract was originally awarded to the Mayo Clinic 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 Mayo Clinic 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, its uniquely talented and dedicated personnel, as well as its comprehensive resources (i.e., extensive research facilities and capabilities; access to extensive medical databases), the Mayo Clinic is uniquely suited to complete the subject activities. Thus so far, the Mayo Clinic has completed, or is otherwise in the process of completing, each of the following tasks under contract: - Particiated 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 as detailed in the reporting requirements section of this document - Participated in two workshops to be held in the Maryland/Greater Washington, DC area - Published the findings of studies funded through this SOW in peer-reviewed scientific journals. Furthermore, the Mayo Clinic has designed and implemented a clinical study to perform each of the following: - Identified patients who received general anesthesia during infancy for procedures unrelated to CNS, cardiovascular issues, or others that may adversely affect cognitive development later in life. - Obtained standardized test records and medical background from the identified children with appropriate consent/assent - Compared test records against established population statistics to determine if there is a difference in median test scores for patients who were exposed to general anesthesia during infancy - Included in final report an analysis that explores confounding variables to produce hypotheses for at risk populations, alternative treatment options, and therapy options for future studies In furtherance and support of the SAFEKIDS Initiative, and in accordance with the proposed modification, it is expected that the Mayo Clinic shall complete the following activities: Design and implement a population-based retrospective study to perform the following: - Identify children who have been diagnosed with autism and determine the type, duration and frequency of anesthetic exposure among those identified - Obtain medical history from the identified children with appropriate consent/assent Design and implement a population-based retrospective study to perform the following: - Identify patients who received general anesthesia during infancy for procedures unrelated to CNS, cardiovascular issues, or others that may adversely affect cognitive development later in life. - Obtain standardized test records and medical background from the identified children with appropriate consent/assent - Identify children who have been diagnosed with various cognitive development impairments or learning disabilities and determine the type, duration and frequency of anesthetic exposure among those identified - Compare test records against established population statistics to determine if there is a difference in median test scores for patients who were exposed to general anesthesia during infancy - Include in final report an analysis that explores confounding variables to produce hypotheses for at risk populations, alternative treatment options, and therapy options for future studies - Publish results in a peer-reviewed journal citing FDA support for the study 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.