Clinical and Immunological Investigation of Subtypes of Autism, Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders, and other PDN neurophysiology data

INTRODUCTION This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Consolidated Station Support and Simplified Acquisitions (CSS/SA) Branch intends to negotiate and award a purchase order to University of Vermont for clinical and immunological investigation of subtypes of autism, diagnosis and treatment of childhood-onset behavioral disorders, neuropsychiatric disorders and neurodevelopmental disorders, and other PDN neurophysiology data reimbursement without providing for full and open competition (including brand-name). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 622110. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-87 dated March 7, 2016. This acquisition is for a commercial item or service and is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures. This acquisition is NOT expected to exceed the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the authority of FAR Subpart 13.106-1. DESCRIPTION OF REQUIREMENT Background Information The Pediatrics and Developmental Neuroscience Branch (PDN) is in the process of analyzing data collected as part of a large phenomenological study of children with autism compared with children with other developmental disabilities and with typically developing children. As part of our medical and clinical evaluation, the children all had electroencephalograms and modified polysomnograms (without respiratory parameters). Our preliminary neurophysiologic data from our modified polysomnograms for the first 60 children with autism reveals that many of them have abnormal sleep architecture when compared to the other two groups. These differences in the organization of the sleeping bran likely reflect differences in underlying neural organization. Purpose and Objectives The contractor shall analyze polysomnographic and EEG data collected from participants from NIMH's PDN branch in the following manner: a) Power spectral analysis awake and asleep b) Paired electrode coherences c) The construction of network maps d) The quantification of epileptiform activity e) Analysis of changes in connectivity pre and post sleep manipulation with donepezil. f) Analysis of recordings will occur in a blinded fashion with only the patient's age available which will afford the best possible interpretation of data. Contractor Requirements The contractor shall provide maps of the neural networks of the subjects involved in the above protocols. The contractor will perform hierarchical clustering on a configured data matrix to determine the intrinsic groupings of networks within the study population. To further investigate the ability of correlation networks to classify children with autism and to extract defining structural features from these networks, the contractor shall use support vector machines (SVM). The analyses will consist of between-group comparison of all electrophysiological measures (power [absolute, relative, and ratios], spectral coherence/Pearson correlations, phase lag, and amplitude asymmetry). Coherence values will be subjected to Fisher-transformation for statistical analysis. The contractor will not have access to government facilities or government websites. The contractor will not be restricted from saving or printing data from their own network; however, the contractor is not required to save data to their network resources to evaluate it. All data analysis will be submitted to NIMH. None of the results will be published unless approved by NIMH. Period of Performance The period of performance shall be a 12 month period with two (2) 12 month option periods. A firm fixed price purchase order is contemplated. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, only the University of Vermont (UVM) is capable of meeting the needs of this requirement due to the extensive clinical experience in EEG sigma analysis both in animals and humans. UVM has a laboratory for Dr. Gregory Holmes which is involved in animal models of autism and epilepsy and utilizes state-of-the-art electrophysiological methods to understand neural networks in the developing brain. Analyses performed will allow researchers at NIMH to accomplish the goals of several clinical research protocols. The intended source is: The University of Vermont Medical Center, Inc. 111 Colchester Ave. Burlington, VT 05401 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Megan Ault, Contract Specialist, at megan.ault@nih.gov. US Mail and Fax responses will not be accepted.