SCREENING FOR CARDIOTOXICITY AND NEUROTOXICITY COMBINED WITH HEPTATOTOXICITY IN ZEBRAFISH
Added: Aug 26, 2015 4:35 pm This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) availability of competition; (2) the capability of qualified small business concerns; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.BACKGROUND: The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina, is one (1) of the 27 Institutes and Centers composing the National Institutes of Health. The NIEHS is home to the National Toxicology Program (NTP), a Health & Human Services (HHS) interagency program dedicated to testing and evaluating substances in our environment. The National Toxicology Program Laboratory (NTPL) exists within the Division of the NTP to provide state-of-the-art laboratory research support that complements and extends the NTP's scientific capabilities and contributes to the identification and understanding of potential health related issues related to environmental/chemical exposures.The NTP has been interested in exploring effects of toxicants during early developmental life stages since they are often uniquely sensitive to environmental insults, due in part to the enormous changes in cellular differentiation, proliferation and migration required to form the required cell types, tissues and organs. As part of this, there has been recent interest across the NTP in exploring the utility of zebrafish as a potential model to be incorporated into screening efforts since it offers many practical advantages, including rapid external development, ease of maintenance, high fecundity, transparent embryos, and homology to mammals. While there are other ongoing efforts to assess teratogenicity and molecular end-points following early exposure, there are currently no studies in place to assess cardiotoxicity in conjunction with neurobehavior and hepatotoxicity by multiplexing assays in a Good Laboratory Practice (GLP) environment. To address this, the NIEHS has identified BioBide Biophenix due to its extensive experience conducting studies multiplexing various assays to provide composite information on systemic toxicity. Assays will be conducted for screening cardiotoxicity, and a combination of behavioral alterations to assess neurotoxicity and hepatotoxicity. These studies will provide valuable information in different target organs, and will be useful in identifying relative toxicity of compounds for further prioritization for in vivo hazard characterization.Early developmental exposure can cause a large spectrum of health impairments affecting various biological systems. Toxicant screening with high toughput in vitro assays can provide important information concerning the immediate effects on cellular function. Intermediate models like zebrafish, are important since they reduce the time and cost required for toxicology testing, thereby increasing the success rate of rapidly identifying potential target organs for environmental toxicants and help with prioritizing which chemicals should be then followed up with studies in mammalian models. This project will serve to demonstrate the usefulness of the zebrafish model for providing key information concerning cardiotoxicity, hepatotoxicity and neurotoxicity following developmental exposures.PURPOSE AND OBJECTIVES: The Contractor shall reduce the time required to perform mammalian toxicity testing, and shall be able to screen a larger number of compounds more rapidly. The Contractor shall utilize an innovative method in which several assays shall be multiplexed using automation to conduct medium toughput high-content screening in zebrafish. The Contractor shall provide zebrafish based services in the preclinical area, mainly toxicology, as well as safety and efficacy.The Contractor shall assess the impact of exposure during development on cardiotoxicity and neurotoxicity combined with heptatotoxicity of 30 compounds with unknown toxicological potential in zebrafish embryos.ANTICIPATED PERIOD OF PERFORMANCE: The anticipated period of performance is for a base of 12 months with one (1) 1-year option period. Studies shall be completed within 75 days following receipt of compounds.NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement will be classified under the NAICS code 541380, "Testing Laboratories" with a size standard of $15.0M.ANTICIPATED CONTRACT TYPE: The anticipated contract type will be a firm-fixed price contract type.DELIVERY LOCATION: National Institute of Environmental Health Sciences, Building 101, 111 T.W. Alexander Drive, Research Triangle Park, North Carolina 27709CAPABILITY STATEMENT/INFORMATION SOUGHT: Capability statements should include the following information:- Company name and address; - Clear and convincing documentation of their capability of providing and ability to provide the services specified in this notice;- Examples of prior completed Government contracts, references, and other related information; respondents' DUNS number, organization name, address, point of contact, size and type of business (e.g., HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses); - Point of contact, including telephone number and email address for representative from interested business;- Do you have a GSA vehicle that could be utilized for these services? If yes, please provide the contract number and point of contact informationCONFIDENTIALITY: 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).DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.Interested parties may identify their interest and capability to respond to the requirement. The Government shall consider all responses received within seven (7) days of this posting. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish their capability to fulfill this requirement. NIEHS will not be responsible for any costs incurred by interested parties in responding to this notice. Please email, with the sources sought notice number in the subject line to the Contracting Officer listed below. NIHES2015063 Department of Health and Human Services National Institutes of Health
8/26/15, 4:35 PM SCREENING FOR CARDIOTOXICITY AND NEUROTOXICITY COMBINED WITH HEPTATOTOXICITY IN ZEBRAFISH
Added: Sep 16, 2015 9:54 am This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 in conjunction with FAR 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.(1) This solicitation document, NIHES2015063, is issued as a Request for Quotation (RFQ) to provide screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish for the National Institutes of Environmental Health Sciences (NIEHS), Research Triangle Park, NC.(2) This solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Regulation (FAR); HHS Acquisition Regulation (HHSAR); Federal Acquisition Circular (FAC) 2005-82 effective May 7, 2015.(3) Notice of Set-Aside, Associated NAICS Code, and Size Standard: This solicitation competed on a full and open competitive basis. The associated NAICS code is 541380, "Testing Laboratories" with a size standard of $15.0M.(4) List of Contract Line Item Number(s) and items, quantities and units of measure, (including option(s): See document titled RFQ, NIHES2015063, screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish.(5) Description of Requirements for the Items to be acquired: The National Toxicology Program (NTP) has been interested in exploring effects of toxicants during early developmental life stages since they are often uniquely sensitive to environmental insults, due in part to the enormous changes in cellular differentiation, proliferation and migration required to form the required cell types, tissues and organs. As part of this, there has been recent interest across the NTP in exploring the utility of zebrafish as a potential model to be incorporated into screening efforts since it offers many practical advantages, including rapid external development, ease of maintenance, high fecundity, transparent embryos, and homology to mammals. While there are other ongoing efforts to assess teratogenicity and molecular end-points following early exposure, there are currently no studies in place to assess cardiotoxicity in conjunction with neurobehavior and hepatotoxicity by multiplexing assays in a Good Laboratory Practice (GLP) environment. The Contractor shall have extensive experience conducting studies multiplexing various assays to provide composite information on systemic toxicity. Assays shall be conducted for screening cardiotoxicity, and a combination of behavioral alterations to assess neurotoxicity and hepatotoxicity. These studies will provide valuable information in different target organs, and will be useful in identifying relative toxicity of compounds for further prioritization for in vivo hazard characterization.Early developmental exposure can cause a large spectrum of health impairments affecting various biological systems. Toxicant screening with high toughput in vitro assays can provide important information concerning the immediate effects on cellular function. Intermediate models like zebrafish, are important since they reduce the time and cost required for toxicology testing, thereby increasing the success rate of rapidly identifying potential target organs for environmental toxicants and help with prioritizing which chemicals should be then followed up with studies in mammalian models. This project will serve to demonstrate the usefulness of the zebrafish model for providing key information concerning cardiotoxicity, hepatotoxicity and neurotoxicity following developmental exposures.The Contractor shall reduce the time required to perform mammalian toxicity testing, and shall be able to screen a larger number of compounds more rapidly. The Contractor shall utilize an innovative method in which several assays shall be multiplexed using automation to conduct medium toughput high-content screening in zebrafish. The Contractor shall provide zebrafish based services in the preclinical area, mainly toxicology, as well as safety and efficacy. The Contractor shall assess the impact of exposure during development on cardiotoxicity and neurotoxicity combined with heptatotoxicity of 30 compounds with unknown toxicological potential in zebrafish embryos.(6) Date(s) and place(s) of performance and acceptance and FOB point: A base of 12 months with one (1) 1-year option period. Studies shall be completed within 75 days following receipt of compounds. The opportunities for sample degradation and compromising the quality of data are greater with the continued movement of samples to various sites for analysis, therefore; analysis shall take place in a single facility located within the contiguous United States (CONUS).(7) The provision at FAR 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition. See document titled RFQ, NIHES2015063, screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish.(8) Applicability of the provision at FAR 52.212-2, Evaluation -- Commercial Items. See document titled RFQ, NIHES2015063, screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish.(9) FAR 52.212-3, applies to this acquisition: Representation, Certifications, and Other Statements of Offerors - In accordance with provisions FAR 52.212-3, Offeror Representations and Certifications--Commercial Items, IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST: (1) Go to the Online Representations and Certifications Application (ORCA) and complete the Representations and Certifications. Offerors must access ORCA tough the System for Award Management (SAM) at http:// www.sam.gov; and (2). Complete, and INCLUDE as part of your price proposal.(10) FAR 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. See document titled RFQ, NIHES2015063, screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish.(11) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items. See document titled RFQ, NIHES2015063, screening for cardiotoxicity and neurotoxicity combined with heptatotoxicity in zebrafish.(12) The Date, Time and Place Offers are Due: The Quoter shall submit dated quote to the following e-mail address: uche.washington@nih.gov at or before Monday, 21 September 2015 at 12:00 PM EST.(13) The point of contact (POC) for this acquisition is Ms. Onyenauche Washington at (919) 541-0423/uche.washington@nih.gov. NIHES2015063 Department of Health and Human Services National Institutes of Health
9/16/15, 9:54 AM