Inactive
Notice ID:75N96021Q00002
REQUEST FOR INFORMATION “NIEHS Division of the National Toxicology Program Human Neurosphere Assay Services” This exchange is being issued in accordance with Federal Acquisition Regulation (FAR) 15.20...
REQUEST FOR INFORMATION “NIEHS Division of the National Toxicology Program Human Neurosphere Assay Services” This exchange is being issued in accordance with Federal Acquisition Regulation (FAR) 15.201(e) as a Request for Information (RFI). The purpose of this RFI is for the National Institute of Environmental Health Sciences (NIEHS) to gain both subject-matter knowledge and industry feedback concerning the subject requirement. This RFI may also be used to identify qualified and interested business concerns. This exchange is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this exchange is to obtain information regarding: (1) the availability and capability of qualified business sources, (2) socioeconomic status of those qualified business sources, and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the subject effort. Responses to this request will assist NIEHS in determining the appropriate acquisition strategy and method, including whether a socioeconomic based set-aside is optimal. Respondents are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party's expense. I. BACKGROUND: The Division of the National Toxicology Program (DNTP) is part of an interagency program whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. The program maintains an objective, science-based approach in dealing with critical issues in toxicology and is committed to using the best science available to prioritize, design, conduct, and interpret its studies. To that end, DNTP is continually evolving to remain at the cutting edge of scientific research and to develop, validate and apply new technologies II. REQUIREMENT DESCRIPTION: Scope. The DNTP is exploring testing methods to identify environmental compounds with the potential for developmental neurotoxicity (DNT). For the purposes of this request for information (RFI), developmental neurotoxicity means adverse outcomes to the developing nervous system resulting from chemical exposure. The developing nervous system is more vulnerable to chemical exposure than the adult nervous system. This vulnerability may be due to perturbations in key neurodevelopmental processes including: proliferation, migration, differentiation, synaptogenesis and apoptosis of neural progenitor cells (NPCs). Over the last decade, scientists have evaluated NPCs in in vitro models from various species following chemical exposure. Of those evaluated, models derived from human stem/progenitor cells are most promising for informing human health as they model more physiologically relevant cell types found in the developing human brain. Requirements. The technical requirements anticipated for this effort are as follows: The DNTP has a requirement to investigate environmental chemicals with unknown DNT potential in a battery of human-derived cell-based assays that cover the ontogeny of key neurodevelopmental events that may cause adverse effects in a dose and/or time-dependent manner. NTP requires a human NPC-derived 3D neurosphere assay (NSA) that allows for the assessment of multiple neurodevelopmental endpoints in a multiplexed format. This assay will be required to capture proliferation, apoptosis, migration, differentiation, and neurite outgrowth in the same human NPCs. Examination of these processes in the 3D neurospheres will allow for complex interactions of multiple cell types (e.g. neurons, astrocytes, oligodendrocytes, oligodendrocyte progenitors and radial glia) not captured in other 2D assays that are involved in these key neurodevelopmental processes. DNTP requires a high throughput NSA for evaluation of developmental neurotoxicity to allow for the batch screening of compounds evaluated that might be used to prioritize compounds for targeted in vitro and in vivo DNT testing. Special emphasis is placed on an assay system that has been previously validated and tested in at least 100 environmental compounds. The laboratory should have demonstrated proficiency with reporting out large sets of data (>100 compounds). The DNTP envisions the use of an assay that is widely accepted globally based on 1) biological plausibility, 2) implementation of the assay for regulatory purposes, and 3) scalability for and demonstration of high throughput screening. Qualifications and Capabilities. The DNTP requires contractor support of a laboratory comprised of experts in the DNT field, with a wealth of experience screening >100 environmental compounds with unknown DNT potential in the human NSA. A qualified procurement source should possess years of experience establishing experimental conditions optimizing a high-content image analysis (HCA) approach for DNT screening of the NSAs. Specifically, a qualified procurement source should have experience using human NSA which allows for a human-relevant model system demonstrated to predict the DNT of environmental compounds with high sensitivity and high specificity. A qualified procurement source should offer a solution that yields an optimized workflow that provides a high degree of reproducibility of the following technical endpoints: Proliferation Viability Cytotoxicity Radial glia Migration Astrocyte Differentiation Neuronal Differentiation Neuronal Migration Neurite morphology Oligodendrocyte Differentiation Oligodendrocyte Migration From these endpoints, a qualified procurement source should possess the following capabilities: Produce a concentration response curve suitable for defining the potency and efficacy of a response, which has been demonstrated to be both reliable and relevant. Produce data that shows the activity of a compound on a molecular initiating event or key event within a developmental neurotoxicity adverse outcome pathway. Provide information (i.e., expert knowledge) on the best molecular or cellular targets that accurately characterize the activity of a compound within a specific pathway resulting in an adverse developmental neurotoxic outcome Provide information (i.e., expert knowledge) on assays, technologies, or methods that will aid in identifying developmentally neurotoxic compounds, which are activated or deactivated by metabolic activity. Period of Performance. Anticipated procurement date December 2020 with an estimated base period of one year and two option year periods. III. INFORMATION SOUGHT: Interested organizations are requested to submit their capability statements, which should not exceed ten (10) pages in length, that clearly details the ability to perform the aspects of the work described above and should be tailored to the work requirements as concisely as possible, as well as a standard product brochure, if available. Each response should also include the following business information: DUNS Number Organization Name Company Address Point of Contact (Including name, title, addresses, telephone number, fax number and email address) Business Size Socio-economic Status Teaming Agreements if necessary NIEHS requests that the following information be addressed with submissions: Capabilities, approaches, and experience in providing information germane to the above requirement description, with emphasis on the “Qualifications and Capabilities” section. Unique value proposition (if any) as it pertains to new and/or innovative technologies and methods, germane to the scope of this effort. Ability to support projects and service customers that are located in Raleigh-Durham Metropolitan area in North Carolina, USA. Recommendations and/or commentary on the current market environmental factors and/or conditions relevant to this effort. IV. RESPONSE INSTRUCTIONS: The descriptive literature provided in response to this RFI should not exceed 10 pages, not including a standard product brochure, if available. Disclaimer and Important Notes. This notice does not obligate the government to award a contract or otherwise pay for the information provided in response to this request. The government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Respondents are advised that the government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
