DOCUMENT
Q -- Biomarkers and PTSD - Attachment
- Notice Date
- 3/1/2018
- Notice Type
- Attachment
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- U.S. Department of Veterans Affairs;OPAL | Strategic Acquisition Center;10300 Spotsylvania Ave | STE 400;Fredericksburg VA 22408-2697
- ZIP Code
- 22408-2697
- Solicitation Number
- 36C10G18Q9068
- Response Due
- 3/15/2018
- Archive Date
- 4/14/2018
- Point of Contact
- KEVIN HERSHEY
- Small Business Set-Aside
- N/A
- Description
- ***** Begin Word Document - 'RFI-DESCRIPTION' ***** Subject: Request for Information RFI/Sources Sought, Synopsis State-of-the-art immunoassays with high sensitivity, high specificity, and quality control will be used to measure neuropeptide Y (NPY) and its processing enzyme Dipeptidyl-Peptidase 4 (DPP-4), corticotropin releasing factor (CRF), cortisol, estradiol, nociceptin, and cytokines (interleukin-6, IL6; interleukin-10, IL10; tumor necrosis factor-alpha, TNFa) in plasma and cerebrospinal fluid samples. The contractor will supervise the performance of these 9 immunoassays in the laboratory, perform data reduction after the immunoassays are completed to calculate plasma and CSF levels of each analyte, and interact with researchers at the National Center for PTSD to analyze, present, and publish the research findings. The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work, except as otherwise specified. This procurement action is being taken on behalf of the Department of Veterans Affairs, National Center for Post-Traumatic Stress Disorder (NCPTSD) Executive Division. The Department of Veterans Affairs; Office of Acquisition Operations, Strategic Acquisition Center (SAC) is issuing this Request for Information (RFI) in accordance with Federal Acquisition Regulations (FAR) 15.201(e) for market research purposes. The Strategic Acquisition Center is requesting responses from qualified businesses capable of providing complete assays of PTSD-relevant stress neuropeptides, hormones, cytokines, and other biomarkers in plasma and cerebrospinal fluid of trauma-exposed men with and without PTSD who completed the National Institute of Mental Health R21 study (MH31113) and the National Center for PTSD-supported lumbar puncture study entitled GABAergic Neurotransmission in PTSD for the Department of Veterans Affairs. This notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, or request for proposals. This Sources Sought effort is intended to gain knowledge of potential qualified sources and solicit feedback for acquisition planning purposes. Potential vendors are encouraged to submit a minimum two, no more than four page non-binding statement of interest that includes the requested responses demonstrating their capabilities. Responses to this Sources Sought are not considered adequate responses to a solicitation announcement. The applicable qualifying NAICS code for this effort is 622110 General Medical and Surgical Hospitals, Federal Supply Classification is Q301 Medical Laboratory Testing Services. Small Business size standard for the specified NAICS code is $38.5 M. REQUESTED INFORMATION: If your business can provide the required services, please submit a non-binding statement of no more than four pages providing the following information. Company Name as registered in The System For Award Management (SAM): Capability Statement. Provide a tailored capability statement, specific to this RFI. The response should clearly describe business capabilities to deliver required service Socio-economic status and business size. Specifically, indicate whether your business is a certified Service Disabled Veteran Owned Small Business (SDVOSB) and registered in VetBiz Registry at http://www.vetbiz.gov, or a Veteran Owned Small Business (VOSB) If Small Business (SB), indicate if your firm qualifies as a (a) small, emerging business, or small disadvantage business, (b) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act Provide the DUNS number of your business: State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov State explicitly whether or not the required services are on your GSA Federal Supply Schedule and that they meet the requirements of Statement of Objectives. (FSS Holders only) Provide the link to the General Services Administration (GSA) schedule information including schedule/contract number and schedule listing the specified labor categories required to complete tasks. (FSS Holders only) Please answer all of the following additional questions: What unique equipment would you use ot accomplish the SOW tasks What are the performance metrics you would use to measure successful accomplishment? Responses are due by 3:00 PM EST, March 14, 2018. Please submit email responses to Contract Specialist, Kevin Hershey, at Kevin.Hershey@va.gov. Please include in the subject line of your email the following: Attention: NCPTSD LAB SERVICES. This notice is to assist the VA in market research identifying potential sources only. Issuance of this notice does not constitute an obligation on the part of the Government to procure these commodities or to issue a solicitation nor to notify respondents of the results of this notice. No solicitation document exists at this time. The VA is neither seeking proposals nor accepting unsolicited proposals, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The Government will not pay for any information or administrative costs incurred in response to this Sources Sought Notice. Attachment: Statement of Work (SOW) Title of Projects: Project #1: PTSD-Relevant Biomarkers in the CSF of Trauma-Exposed Men with and without PTSD Project #2: Longitudinal Plasma Biomarker Predictors of PTSD and Comorbid Conditions in the TRACTS Cohort Scope of Work: Contract will perform State-of-the-art immunoassays with high sensitivity, high specificity, and quality control will be used to measure neuropeptide Y (NPY) and its processing enzyme Dipeptidyl-Peptidase 4 (DPP-4), corticotropin releasing factor (CRF), cortisol, estradiol, nociceptin, and cytokines (interleukin-6, IL6; interleukin-10, IL10; tumor necrosis factor-alpha, TNFa) in plasma and cerebrospinal fluid samples. The contractor will supervise the performance of these 9 immunoassays in the laboratory, perform data reduction after the immunoassays are completed to calculate plasma and CSF levels of each analyte, and interact with researchers at the National Center for PTSD to analyze, present, and publish the research findings. The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work, except as otherwise specified. Background: Major Goals for Project #1: Project #1 will be used to complete assays of PTSD-relevant stress neuropeptides, hormones, cytokines, and other biomarkers in plasma and cerebrospinal fluid of trauma-exposed men with and without PTSD who completed the National Institute of Mental Health R21 study (MH31113) and the National Center for PTSD-supported lumbar puncture study entitled GABAergic Neurotransmission in PTSD. The major goal is to provide further insight into the neuroendocrine and neuroimmune pathophysiological mechanisms and the neurobiological profiles contributing to PTSD risk and increasing PTSD severity. This research will advance development of Precision Medicine interventions for the prevention and treatment of PTSD. Major Goals for Project #2: Funding for Project #2 will be used to complete assays of multiple stress neuropeptides, hormones, cytokines, and other biomarkers in plasma samples related to the pathophysiology of PTSD and TBI. This research will provide a fully translational, longitudinal, systems biology characterization of TRACTS participants across time. The plasma biomarker results will be integrated with the following TRACTS data to predict PTSD risk and recovery, as well as evolution of other trauma-related psychiatric, substance abuse, and medical conditions: (a) lifetime trauma history, (b) lifetime blunt and blast brain trauma, (c) lifetime, post-deployment, current and follow-up PTSD symptoms, (d) other DSM-IV disorders, (e) pain and other medical conditions, (f) neuropsychological test profiles, (g) structural, DTI and resting state MRI data, (h) fasting blood CBC, chemistries and metabolic/lipid profiles, (i) genotyping and gene methylation profiles. Period of performance: Commencing 15 days after contract award for 12 months. Type of contract: This is an indefinite delivery contract with a period of performance of 12 months plus up to 4 (12) month option periods. Description of Tasks and Associated Deliverables: Task One: Task One is divided into two components: (a) Immunoassay measurements and analyses of plasma levels of NPY, DPP-4, cortisol, estradiol, nociception, and three cytokines (IL6, IL10, TNFa) in 30 plasma samples. (b) Immunoassay measurements and analyses of CSF levels of NPY, DPP-4, CRF, cortisol, estradiol, nociception, and three cytokines (IL6, IL10, TNFa) in 30 plasma samples. The contractor shall prepare a data sharing agreement and provide a detailed work plan for completing the task order. The contractor will conduct the requested immunoassays, perform data reduction, interpret the data and research findings, and assist in the preparation of academic products. Deliverable One: A data sharing agreement and detailed immunoassay work plan will be established. NPY, DPP-4, CRF, cortisol, estradiol, nociception, IL6, IL10, and TNFa will be measured in plasma and CSF samples using state-of-the-art immunoassays with high sensitivity, specificity, and quality control in the contractor s lab. Detailed spreadsheets with the neuroendocrine, hormone, cytokine, and biomarker results will be transmitted securely from the contractor to the National Center for PTSD at the Boston VA Healthcare System. Task Two: Task Two involves immunoassay measurements and analyses of plasma levels of NPY, DPP-4, cortisol, estradiol, nociception, and three cytokines (IL6, IL10, TNFa) in 360 plasma samples. The contractor shall prepare a data sharing agreement and provide a detailed work plan for completing the task order. The contractor will conduct the requested immunoassays, perform data reduction, interpret the data and research findings, and assist in the preparation of academic products. Deliverable Two: A data sharing agreement and detailed immunoassay work plan will be established. NPY, DPP-4, cortisol, estradiol, nociception, IL6, IL10, and TNFa will be measured in plasma samples using state-of-the-art immunoassays with high sensitivity, specificity, and quality control in the contractor s lab. Detailed spreadsheets with the neuroendocrine, hormone, cytokine, and biomarker results will be transmitted securely from the contractor to the National Center for PTSD at the Boston VA Healthcare System. Task Three: Data interpretation and preparation of academic products. Deliverable Three: The contractor will have teleconferences and meetings with the study team at the National Center for PTSD as needed once the immunoassays and data analyses have been completed to provide interpretation of the results obtained. In addition, the contractor will contribute, as appropriate, to academic products generated from this work. CONTRACTOR EXPERIENCE REQUIREMENTS The contractor must have extensive experience and expertise in conducting neuroendocrine, cytokine, and biomarker research. The contractor s lab personnel must be highly skilled in developing, characterizing, and optimizing immunoassay methods when methods are not yet perfected or available. Laboratory must be a well-equipped neuroendocrine, molecular biology, and cell culture lab with state-of-the-art immunoassay and other analytical equipment required to perform the specific measurements as stated above. ***** End Word Document - 'RFI-DESCRIPTION' ***** DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
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