AN41--ATTN TARA DOSSIEMA Define behavioral deficits associated with TBI and PTSD

Pre-Solicitation Notice for a sole source. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a requirement with the Mary Hitchcock Memorial Hospital on behalf of Dartmouth-Hitchcock Clinic (MHMH/DHC). The applicable NAICS code is 541715. The PSC is AN41. The authority for this action is FAR 13.106-1(b)(2): Only one Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Interested persons may contact the Contracting Specialist via email at contact@example.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. PERFORMANCE WORK STATEMENT Biomarker Development to Guide Personalized Interventions for Traumatic Brain Injury and Posttraumatic Stress Disorder (PTSD) INTRODUCTION: The mission of VA s National Center for PTSD (NCPTSD) is to advance the clinical care and social welfare of America's Veterans and others who have experienced trauma, or who suffer from PTSD, through research, education, and training in the science, diagnosis, and treatment of PTSD and stress-related disorders. We generate, collate, synthesize, disseminate, and promote implementation of the best information about PTSD. SCOPE: Traumatic brain injury (TBI) and PTSD are significant problems for military personnel and Veterans. These conditions can impose extensive quality of life burdens on affected individuals. Brain injury and PTSD are characterized by disrupted communication between brain regions that can result in neuropsychiatric symptoms, including depression, anxiety, hyperarousal, social avoidance, impaired fear, and maladaptive decision making. There is a growing interest in utilizing targeted brain stimulation to improve TBI and PTSD, however, prior to widespread application, there is a critical need to define biomarkers associated with specific domains of impairment. It has been proposed that this knowledge will help guide personalized interventions that are tailored according to symptomatology. The overarching goal of the current project is to define the utility of clinically-relevant biomarkers to guide treatment. The project will focus on systems-level brain activity as a neural biomarker and blood proteins as a peripheral biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. The project will utilize a subject model of TBI with and without PTSD. Following experimental injuries, subjects will undergo treatment which will include targeted brain stimulation and psychedelic agents. The proposed work supports ongoing collaborative research currently conducted by investigators at the White River Junction VA. Key activities to be performed include: 1) Define behavioral deficits, 2) Define treatment effects, and 2) Develop biomarkers to guide personalized treatment. PERIOD AND PLACE OF PERFORMANCE: The place of performance will be at both the White River Junction VA Healthcare System (WRJ-VAHS) and the contractor location, Mary Hitchcock Memorial Hospital for itself and on behalf of Dartmouth-Hitchcock Clinic (MHMH/DHC). Approximately 25% of the work will be performed in the Neuro-Immune Laboratory at WRJ-VAHS, and the other 75% of work will be performed in a laboratory at MHMH/DHC. The contract location should be located within a 30-minute drive of the WRJ facility to ease transportation of the subjects. It has been determined that transportation can be feasibility performed, due to shared veterinary resource agreement between locations. BACKGROUND: The WRJ Translational Neuroscience Research Group aims to identify and evaluate novel, interventions for TBI and PTSD. As part of this work, the group aims to define clinically-relevant biomarkers to guide treatment implementation. The current study will employ subject models of TBI and/or PTSD where animals will receive experimental injuries and will receive brain stimulation with and without psychedelic agents. The current project will employ validated pre-clinical behavioral assays to assess multiple domains of impairment, including hyperarousal, social interactions, appetitive behaviors, and executive function. Animals will be assessed at various time points post-injury. Neural and blood-based biomarkers will be collected to assess how systems-level brain activity and hypothalamic-pituitary-adrenal (HPA) axis activity, respectively, relate to behavioral deficits and response to treatment. PERFORMANCE OBJECTIVES/DELIVERY SCHEDULE: Define behavioral deficits associated with TBI and PTSD (deliver data set and report within 6 months of contract start date). Determine the utility of neural activity and/or blood-based biomarkers to identify animals with behavioral deficits (deliver data set and report within 6 months of contract start date). Determine the utility of treatment to improve behavioral deficits (deliver data set and report defining proof-of-concept data within 12 months of contract start date). Determine the utility of neural and/or blood-based biomarkers to personalize treatment (deliver data set and report within 12 months of contract start date). Acceptable completion of deliverables will be determined through receipt of complete data sets that include details of all procedures, behavioral outcomes, and statistical comparisons. All deliverables include estimated personnel and supply costs associated with planned studies. PUBLICATION/COLLABORATION ON RESULTS: The VA and MHMH/DHC will maintain joint ownership of work product and intellectual property rights. OTHER REQUIREMENTS: Prior to commencement of work described, all personnel will be required to obtain and maintain all appropriate certifications for performing preclinical research at the VA and MHMH/DHC, including CITI and Bioraft training, IACUC approval, and VA-Without Compensation (WOC) research affiliate designation. B.3 PRICE/COST SCHEDULE ITEM INFORMATION ITEM DESCRIPTION OF QUANTITY UNIT NUMBER SUPPLIES/SERVICES 0001 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1.00 - - - - - - - - JB - - - - - - - - - - Define behavioral deficits associated with TBI and PTSD Estimated Invoice: 6 months 0002 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1.00 - - - - - - - - JB - - - - - - - - - - Determine the utility of neural biomarkers to identify animals with behavioral deficits. Estimated Invoice: 6 months 0003 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1.00 - - - - - - - - JB - - - - - - - - - - Determine the utility of treatment to improve behavioral deficits. Estimated Invoice: 12 months 0004 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1.00 - - - - - - - - JB - - - - - - - - - - Determine the utility of neural biomarkers to personalize treatment. Estimated Invoice: 12 months Records Management: The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.