Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences 75N96025R00004

This Solicitation is issued by the NICHD Office of Acquisitions on behalf of the National Institute of Environmental Health Sciences (NIEHS). This acquisition is being competed as a 100% Set-Aside for Small Business concerns whereby only Small Business concerns will be eligible for award. The small business size standard for the associated NAICS 541715, Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology and Nanotechnology) is 1,000 employees. A small business concern, as defined by FAR 19.001, means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc. "Concern" includes but is not limited to an individual, partnership, corporation, joint venture, association, or cooperative. For more information, see 13 CFR 121.105. Additionally, for acquisitions conducted under a 100% Small Business Set-Aside, per FAR 19.505(b)(1)(i), Limitations on Subcontracting , the concern [small business prime contractor] will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities [e.g. also small business concerns]. Any work that a similarly situated entity further subcontracts will count towards the concern's 50 percent subcontract amount that cannot be exceeded. In other words, for acquisitions conducted under 100% small business set-asides, the small business prime contractor cannot function as a pass-through entity where the majority of the contract expenditures are going to other than small business concerns. This acquisition represents a follow-on requirement to active contract HHSN273201500010C, with Integrated Laboratory Systems, LLC. The incumbent contractor is not currently a small business concern under applicable NAICS 541715. The National Institute of Environmental Health Sciences (NIEHS) anticipates awarding one (1) cost plus fixed fee cost-plus fixed fee, term, level of effort contract with a base period of 12 months and nine successive 12-month term options for a total possible period of performance of 10 years (anticipated period of performance 6/1/2026 through 5/31/2036 if all term options are exercised). The contract will also contain an Option to Extend Services up to an additional six months per FAR 52.217-8. This acquisition entitled Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences will support and assist the National Institute of Environmental Health Sciences (NIEHS) by conducting and evaluating toxicological testing using computational and/or alternative approaches, also referred to New Approach Methodologies (NAMs). NAMs broadly refers to any technology, methodology, approach, and/or combination of the three that can provide information on chemical hazard and risk assessment without the use of animals, such as in silico, in chemico, in vitro, and ex vivo approaches. The areas of focus for the research include but are not limited to population variability, susceptibility, developmental neurotoxicity, carcinogenicity, ecotoxicity, acute toxicity, etc. The outputs from this requirement will directly feed into the mission of the Department of Health & Human Services (HHS). This requirement would produce information to predict adverse human health effects from chemical exposures while also replacing, reducing, or refining the use of animals in toxicity testing. These services are necessary to support state of the art alternative toxicity testing at NIEHS. This acquisition is for continuing support services for alternative toxicological testing approaches that extend beyond the scope or capability of in-house staff. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM.GOV CONTRACT OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. Any responsible small business concern may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls or facsimile transmissions will be accepted. Proposals must be submitted via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile, e-mail or physical delivery are not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on How to Submit. See RFP Section L.3. Submitting Your Proposal for full details.

This Solicitation is amended to extend the due date for proposals to on or before December 5, 2025 4:30 PM EST due to the ongoing Government shutdown and related unavailability of staff to respond to questions. A future solicitation amendment will be issued to provide answers to questions posed once the Government re-opens. This may result in a further extension to the due date, if needed, to allow sufficient time for offerors to incorporate the information provided by the questions and answers in proposals. This Solicitation is issued by the NICHD Office of Acquisitions on behalf of the National Institute of Environmental Health Sciences (NIEHS). This acquisition is being competed as a 100% Set-Aside for Small Business concerns whereby only Small Business concerns will be eligible for award. The small business size standard for the associated NAICS 541715, Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology and Nanotechnology) is 1,000 employees. A small business concern, as defined by FAR 19.001, means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc. "Concern" includes but is not limited to an individual, partnership, corporation, joint venture, association, or cooperative. For more information, see 13 CFR 121.105. Additionally, for acquisitions conducted under a 100% Small Business Set-Aside, per FAR 19.505(b)(1)(i), Limitations on Subcontracting , the concern [small business prime contractor] will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities [e.g. also small business concerns]. Any work that a similarly situated entity further subcontracts will count towards the concern's 50 percent subcontract amount that cannot be exceeded. In other words, for acquisitions conducted under 100% small business set-asides, the small business prime contractor cannot function as a pass-through entity where the majority of the contract expenditures are going to other than small business concerns. This acquisition represents a follow-on requirement to active contract HHSN273201500010C, with Integrated Laboratory Systems, LLC. The incumbent contractor is not currently a small business concern under applicable NAICS 541715. The National Institute of Environmental Health Sciences (NIEHS) anticipates awarding one (1) cost plus fixed fee cost-plus fixed fee, term, level of effort contract with a base period of 12 months and nine successive 12-month term options for a total possible period of performance of 10 years (anticipated period of performance 6/1/2026 through 5/31/2036 if all term options are exercised). The contract will also contain an Option to Extend Services up to an additional six months per FAR 52.217-8. This acquisition entitled Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences will support and assist the National Institute of Environmental Health Sciences (NIEHS) by conducting and evaluating toxicological testing using computational and/or alternative approaches, also referred to New Approach Methodologies (NAMs). NAMs broadly refers to any technology, methodology, approach, and/or combination of the three that can provide information on chemical hazard and risk assessment without the use of animals, such as in silico, in chemico, in vitro, and ex vivo approaches. The areas of focus for the research include but are not limited to population variability, susceptibility, developmental neurotoxicity, carcinogenicity, ecotoxicity, acute toxicity, etc. The outputs from this requirement will directly feed into the mission of the Department of Health & Human Services (HHS). This requirement would produce information to predict adverse human health effects from chemical exposures while also replacing, reducing, or refining the use of animals in toxicity testing. These services are necessary to support state of the art alternative toxicity testing at NIEHS. This acquisition is for continuing support services for alternative toxicological testing approaches that extend beyond the scope or capability of in-house staff. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM.GOV CONTRACT OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. Any responsible small business concern may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls or facsimile transmissions will be accepted. Proposals must be submitted via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile, e-mail or physical delivery are not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on How to Submit. See RFP Section L.3. Submitting Your Proposal for full details.

This Solicitation is amended to extend the due date for proposals to on or before December 19, 2025 4:30 PM EST to allow sufficient time for offerors to review the list of Questions and Answers attached to the RFP Amendment 2 document and incorporate the information provided in proposals. Please note there is a REVISED ATTACHMENT 11 Budget Template (Excel) document provided with this solicitaiton Amendment 2 to correct spreadsheet formula inconsistencies and errors discovered in the original ATTACHMENT 11. Offerors should utilize this REVISED ATTACHMENT 11 in submitting their proposal budget spreadsheet. Any documents previously submitted to the NIH electronic Contract Proposal Receipt System (eCPS) will be automatically overwritten when submitting like-titled replacement documents up until the proposal due date and time indicated. Nov 3 2025 posting / Amendment 1: This Solicitation is amended to extend the due date for proposals to on or before December 5, 2025 4:30 PM EST due to the ongoing Government shutdown and related unavailability of staff to respond to questions. A future solicitation amendment will be issued to provide answers to questions posed once the Government re-opens. This may result in a further extension to the due date, if needed, to allow sufficient time for offerors to incorporate the information provided by the questions and answers in proposals. This Solicitation is issued by the NICHD Office of Acquisitions on behalf of the National Institute of Environmental Health Sciences (NIEHS). This acquisition is being competed as a 100% Set-Aside for Small Business concerns whereby only Small Business concerns will be eligible for award. The small business size standard for the associated NAICS 541715, Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology and Nanotechnology) is 1,000 employees. A small business concern, as defined by FAR 19.001, means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc. "Concern" includes but is not limited to an individual, partnership, corporation, joint venture, association, or cooperative. For more information, see 13 CFR 121.105. Additionally, for acquisitions conducted under a 100% Small Business Set-Aside, per FAR 19.505(b)(1)(i), Limitations on Subcontracting , the concern [small business prime contractor] will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities [e.g. also small business concerns]. Any work that a similarly situated entity further subcontracts will count towards the concern's 50 percent subcontract amount that cannot be exceeded. In other words, for acquisitions conducted under 100% small business set-asides, the small business prime contractor cannot function as a pass-through entity where the majority of the contract expenditures are going to other than small business concerns. This acquisition represents a follow-on requirement to active contract HHSN273201500010C, with Integrated Laboratory Systems, LLC. The incumbent contractor is not currently a small business concern under applicable NAICS 541715. The National Institute of Environmental Health Sciences (NIEHS) anticipates awarding one (1) cost plus fixed fee cost-plus fixed fee, term, level of effort contract with a base period of 12 months and nine successive 12-month term options for a total possible period of performance of 10 years (anticipated period of performance 6/1/2026 through 5/31/2036 if all term options are exercised). The contract will also contain an Option to Extend Services up to an additional six months per FAR 52.217-8. This acquisition entitled Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences will support and assist the National Institute of Environmental Health Sciences (NIEHS) by conducting and evaluating toxicological testing using computational and/or alternative approaches, also referred to New Approach Methodologies (NAMs). NAMs broadly refers to any technology, methodology, approach, and/or combination of the three that can provide information on chemical hazard and risk assessment without the use of animals, such as in silico, in chemico, in vitro, and ex vivo approaches. The areas of focus for the research include but are not limited to population variability, susceptibility, developmental neurotoxicity, carcinogenicity, ecotoxicity, acute toxicity, etc. The outputs from this requirement will directly feed into the mission of the Department of Health & Human Services (HHS). This requirement would produce information to predict adverse human health effects from chemical exposures while also replacing, reducing, or refining the use of animals in toxicity testing. These services are necessary to support state of the art alternative toxicity testing at NIEHS. This acquisition is for continuing support services for alternative toxicological testing approaches that extend beyond the scope or capability of in-house staff. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM.GOV CONTRACT OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. Any responsible small business concern may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls or facsimile transmissions will be accepted. Proposals must be submitted via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile, e-mail or physical delivery are not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on How to Submit. See RFP Section L.3. Submitting Your Proposal for full details.