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EpiIntestinal TM Organotypic Tissue Model

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RFQ-RT-16-00097Federal

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The U.S. Environmental Protection Agency intends to negotiate a sole source procurement with MatTek Corporation for the EpiIntestinal Organotypic Tissue Model, which is essential for studying the gastrointestinal uptake and toxicity of engineered nanomaterials (ENMs). ENMs are increasingly used in consumer and industrial products, but their unique properties and limited toxicity data present regulatory challenges. This tissue model, composed of primary human intestinal cells forming a three-dimensional structure similar to the human intestine, offers a scientifically valid alternative to animal and human clinical testing. It allows the EPA to generate critical data necessary for assessing human exposure risks to ENMs, supporting science-driven regulatory decisions. MatTek is the exclusive manufacturer and distributor of this product, which is produced under proprietary processes protected by intellectual property rights, justifying the sole source procurement under FAR 6.302-1. The EPA has previously used this model in research and plans to continue generating comparable data using it. While this contract is recommended to proceed without full and open competition, the agency is soliciting any potential competitors to submit their capabilities and itemized pricing within 10 days to assess whether competition is feasible. Responses should be directed to Marsha Johnson at the EPA’s Research Triangle Park office, with strict instructions against telephone or fax inquiries.

General Info

EPA to negotiate sole source contract with MatTek for proprietary 3D intestinal tissue model.

NAICS

541380 - Testing Laboratories and Services

Place of Performance

NC

Set-Aside

NONE

Documents

0

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Organization & Contact Information

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AgencyEnvironmental Protection Agency → Information Technology Acq Division (ita
ContactsNo contacts available
OfficeDurham, NC, 27709, USA
Office AddressDurham, NC, 27709, USA
ContactsNo contact information available

Full Description

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EpiIntestinal¿ Organotypic Tissue Model RFQ-RT-16-00097 Notice of Intent The U.S Environmental Protection Agency (EPA) intends to negotiate on a sole source basis with MatTek Corporation to procure an EpiIntestinal¿ Organotypic Tissue Model. This procurement is recommended to be processed without full and open competition. Engineered nanomaterials (ENMs) are a technological advancement in materials science and their production and use are expected to have an enormous impact on future global economies. ENMs are now being used in many consumer and industrial products (e.g., sunscreens, catalysts, conductors, drug delivery) and there is a great potential for their use in other products. A critical issue for the Agency is how to regulate ENMs, as these materials are fairly recent and data on exposure and toxicity is limited. In addition, because of their size (one dimension less than 100 nanometers), the chemical and physical properties of ENMs are unlike most regulated chemicals. Because of the use of ENMs in many products, human exposure by ingestion, inhalation and dermal contact to these materials is a concern to the Agency. The goal of this project is to investigate the gastrointestinal tract uptake and toxicity of ENMs using reconstructed intestinal tissue containing primary human intestinal cells. These cells which form a three dimensional highly differentiated tissue has many of the same properties as the human intestine and is a good alternative to animal and human clinical testing. Data generated from these types of studies will aid the Agency in making science-based decisions on the risk to exposure to ENMs. EPA¿s laboratory has tested ENMs with MatTek¿s EpiIntestinal¿ tissue model under previous experiments. Future experiments will generate data to be compared with existing experimental data that has already been developed with this product. Additionally, this organotypic product is manufactured under proprietary processes which are protected by patent rights, trademarks and/or trade secrets. MatTek is the sole manufacturer and distributor of this product. The circumstance permitting is FAR 6.302-1 ¿Only one responsible source and no other supplies or services will satisfy agency requirements¿. All interested parties who believe they can provide the required product should fully explain their capabilities and qualifications in writing within 10 days from the date of this announcement and provide itemized pricing that is sufficient to make a determination that competition is feasible. The intent of this notice is to determine if any other source(s) exist, and therefore, no solicitation is available. Consequently, anyone failing to provide the aforementioned and instead chooses to merely submit a routine letter requesting a copy of the statement of work or more information about the project will be ignored. The information received to this notice will be considered solely for the purpose of determining whether or not to conduct a competitive procurement. Please submit response to Marsha Johnson at contact@example.gov or to the U.S. EPA, Attn: Marsha Johnson (AA-005), RTP Procurement Operations Division, 109 Alexander Drive, Research Triangle Park, NC 27709. No telephone or faxed requests will be honored.

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