National Institute of Environmental Health Sciences (NIEHS) Assessment of Immunotoxicity – In Vitro and In Vivo Assessment of Immune Function
ID: 75N96025R00001Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTE OF HEALTH NIEHSMORRISVILLE, NC, 27560, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; BASIC RESEARCH (AJ11)
Timeline
    Description

    The National Institute of Environmental Health Sciences (NIEHS), part of the Department of Health and Human Services, is seeking proposals for a contract focused on the assessment of immunotoxicity through both in vitro and in vivo studies of immune function. The primary objective is to evaluate how selected chemical agents modify immune responses, utilizing established testing models to enhance understanding of immunotoxicity while aiming to reduce animal use in research. This initiative is critical for advancing toxicological assessments and ensuring compliance with federal standards in environmental health research. Interested contractors must submit their proposals by 4:00 PM EST on February 18, 2025, and can direct inquiries to Adam Muhsin at adam.muhsin@nih.gov or Erica Kitzmiller at erica.kitzmiller@nih.gov.

    Point(s) of Contact
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    The National Institute of Environmental Health Sciences (NIEHS) issued a Request for Proposals (RFP) for a contract aimed at assessing immunotoxicity through in vitro and in vivo studies of immune function. The solicitation, numbered 75N96025R00001, seeks to support the Division of Translational Toxicology (DTT) in evaluating the potential immune-modulating effects of chemical agents using established testing models. Contractors are expected to provide expertise, personnel, and resources to conduct these research studies, focusing on reducing animal use through in vitro methods. Key tasks include determining immune response modifications from chemical exposure, evaluating allergic reactions through established OECD tests, and conducting comprehensive in vivo testing in rodents. The contract covers a base period starting from 02/12/2026 to 02/11/2027, with the potential for multiple option periods extending up to nine additional years. Bids must be submitted by 4:00 PM EST on 2/18/2025, and offerors must comply with various regulations, including Section 508 compliance and animal welfare guidelines. The RFP emphasizes the importance of rigorous scientific methods and ongoing evaluation of research methodologies within the NIEHS framework.
    The document is a Proposal Intent Response Form associated with RFP No. 75N96025R00001, which pertains to the Assessment of Immunotoxicity for the National Institute of Environmental Health Sciences. It invites potential bidders to indicate their intention to either submit a proposal or not. The form emphasizes that responding is non-binding but aids in planning for proposal evaluation. Respondents are asked to provide their contact details, including their name, title, organization, and email. If they choose not to respond, they are prompted to furnish reasons for their decision. The document is structured to facilitate communication and planning for the procurement process, focusing on the assessment of immune function both in vitro and in vivo. The overall purpose is to gather preliminary indications of interest to assist in managing response evaluations efficiently.
    Attachment 11, titled "Historical Small Business Utilization," is a required form for all offerors responding to federal government RFPs. It aids in evaluating Factor 6, which focuses on small business participation. The form necessitates details regarding the offeror's contract history, including project specifics, performance type (prime, subcontractor, or joint venture), and subcontracting plans. Each project submitted under Factor 1 must include actual subcontract values and performance percentages, as well as established goals where applicable. Offerors must document achievements and explain any unmet goals or instances of zero subcontracting for small businesses. Specific sections are designated for inputting financial values related to various business categories, including small business concerns and disadvantageous classifications. The document emphasizes the need for clarity and completeness, rejecting any alternative format submissions. The focus is on promoting small business utilization within government contracting, ensuring accountability and transparency in how larger entities engage smaller firms. Overall, the form serves as a critical tool for fostering small business growth through federal contracts.
    The Small Business Participation Commitment Document (SBPCD) outlines the requirements for all offerors, including both large and small businesses, to detail their commitments to subcontracting with small businesses (SBs) in response to RFP No. 75N96025R00001. The document emphasizes the need to establish firm commitments through various agreements and includes sections for identifying the estimated total contract value, the funds designated for self-performance, and the proposed funds to be subcontracted. Offerors must meet a minimum small business participation requirement of 5% of the total contract value and detail the contributions from various small business socioeconomic categories, including Small Disadvantaged Business (SDB), Woman-Owned Small Business (WOSB), and others. Failure to meet the 5% requirement necessitates a detailed explanation. The SBPCD serves as a structured approach to ensure that small businesses have opportunities to participate in federal contracts, promoting equitable economic growth and business development within underrepresented sectors.
    The provided document outlines the structure and requirements for completing a government Request for Proposal (RFP) with a focus on financial estimates and administrative support for various research activities. It emphasizes the importance of populating yellow-highlighted cells across multiple tabs, ensuring accuracy in direct labor hours, rates, indirect costs, and overhead calculations without altering existing formulas, to maintain data integrity. Key sections detail base and optional work costs for administrative support, including direct labor, fringe benefits, overhead, and general administrative expenses. Specific research outlines such as In Vitro Screening Studies are included, highlighting the necessity for accurate labor and material cost estimates. It also covers travel costs associated with contractor activities and emphasizes the importance of detailed support for subcontractor and consultant costs. Overall, the document serves to guide the stakeholders in effectively compiling comprehensive and compliant proposals that align with federal grants and contracts by providing a structured method for financial documentation and transparency in cost estimation. This ensures adherence to regulatory standards and efficient management of federal resources throughout the project lifespan.
    This document is an attachment related to the Request for Proposals (RFP) 75N96025R00001, which requires respondents to provide detailed contact information for key personnel involved in the proposal submission. It highlights the necessity of including the business representative and proposed principal investigator's name, title, organization, street address (not a P.O. Box), and various contact methods (telephone, fax, email). This information is essential for ensuring effective communication throughout the proposal process. The clear structure mandates that this information be completed and submitted alongside the business proposal to facilitate swift and accurate contact with the involved parties.
    The document references a technical issue regarding the inability to display specific contents due to compatibility problems with the PDF viewer. It suggests the appropriate action of upgrading to the latest version of Adobe Reader for enhanced viewing capabilities. Additionally, it includes technical acknowledgments related to the trademarks of Windows, Mac, and Linux. However, without the proper contents, the document lacks substantive information to analyze regarding federal RFPs, grants, or state/local proposals. The main purpose appears to be to ensure users can access necessary documents smoothly by upgrading their software, which is critical for engaging with government contracting opportunities. It highlights the importance of maintaining updated software for compliance with modern technology standards in the context of government documentation.
    The document serves as guidance for completing Form NIH 2706, titled "Financial Report of Individual Project/Contract," primarily used by the NIH for monitoring financial and personnel resources in contracts. Its purpose includes providing contractors with relevant management data and identifying potential areas of financial discrepancies through comparisons of projections versus actual performance. Key reporting requirements include submitting an original and two copies of the report within 30 working days after the reporting period, detailing approved expenditure categories. Definitions for reporting categories such as personnel, travel, supplies, and overhead are specified, with instructions for entering data across multiple columns, including incurred costs, estimates, and variances. Contractors are required to provide detailed reports on any negotiated and non-negotiated expenditures if significant variances are detected. Overall, the document emphasizes structured fiscal reporting and analysis to facilitate efficient contract management, accountability, and transparency in federal projects, aligning with broader RFP, grant, and contract compliance frameworks in government operations.
    The document provided is the NIH Form 2706, which is part of a financial report required for individual projects or contracts under the National Institutes of Health. Its primary purpose is to track expenditures and manage the budget associated with specific contracts. The form includes sections for reporting the contractor’s name, reporting period, incurred costs, percentage of effort, estimated costs to complete the project, and any variances between negotiated contract amounts and actual costs reported. The structure of the form facilitates a comprehensive overview of financial performance by comparing cumulative costs and expenditures over specific periods, allowing for the identification of over or under-spending relative to the agreed budget. This form is crucial for federal grants, RFPs, and contracts, as it provides transparency in funding allocation and utilization, ensuring accountability within the NIH’s financial management practices. Use of this form is mandatory for contractors, reinforcing systematic reporting standards in accordance with federal regulatory requirements.
    The document outlines a Statement of Work (SOW) for a non-personal service contract between the National Institute of Environmental Health Sciences (NIEHS) and a contractor to assess immunotoxicity through in vitro and in vivo studies. The primary objective is to study how selected agents modify immune function by utilizing comprehensive testing models. The contractor must provide qualified personnel and possess the capability to execute specific immunotoxicity evaluations, employing both in vitro assays for humoral and cell-mediated immunity, as well as in vivo assessments in rodents. Research activities include the development of methodologies that predict immunotoxicity, and comprehensive reporting is required, including progress reports, study protocols, and final study reports. The contractor must comply with regulations regarding animal use and ensure that facilities are accredited. Essential to the project is the submission of a Quality Management Plan and adherence to ethical guidelines. This contract aims to address gaps in current toxicological assessments, contributing vital knowledge to the understanding of environmental health impacts and ensuring compliance with federal standards throughout the research.
    The document is a Proposal Summary and Data Record from the National Institutes of Health (NIH) for federal Request for Proposals (RFPs). It outlines key elements required for proposal submissions, including the project title, legal name and address of the offeror, place of performance, type of contract proposed (cost-reimbursement, fixed price, etc.), estimated completion time, starting date, and budgeted direct costs. It also includes questions regarding the involvement of subcontractors and human subjects or vertebrate animals in the research. Significant sections require details on principal and co-investigators, including their weekly hours and contact information, as well as those authorized to negotiate and execute contracts. Additionally, the document contains sections on IRB and IACUC approvals if the proposal involves human subjects or vertebrate animals. It concludes with administrative details such as the cognizant government audit agency, number of employees, business volume, and the offer's expiration date. This comprehensive structure aids in standardizing submissions and ensuring compliance with federal requirements regarding research proposals and funding.
    The document outlines the Annual Representations and Certifications required for offerors in government solicitations, emphasizing compliance with various federal acquisition regulations. It includes sections on identifying the North American Industry Classification System (NAICS) code, small business size standards, and certifications related to telecommunications equipment, cost accounting standards, and supply chain risks. Offerors must provide detailed information regarding their business practices, potential affiliations with foreign entities, and any legal or compliance issues that may impact contract eligibility. The text establishes specific representations that must be completed electronically through the System for Award Management (SAM), ensuring that offeror information is current and accurate. This comprehensive documentation is intended to ensure transparency and accountability in the contracting process, thereby safeguarding federal interests in various transactions, particularly those exceeding certain financial thresholds. The structure facilitates systematic collection of pertinent data necessary for evaluating an offeror's responsibility and suitability for contract awards in alignment with federal regulations.
    This document outlines the requirements for offerors participating in federal contracts, cooperative agreements, and grants. It specifically requests detailed information about key professional individuals involved in the proposal, including the Project Director and Principal Investigator. The file mandates that Offerors provide the total number of active federal contracts and commitments of effort for each key individual, alongside any outstanding proposals currently in anticipation. Each section necessitates clear identification of the individual’s name and title, agency affiliation, and total commitment effort. Furthermore, offerors must articulate the anticipated level of effort that these individuals will dedicate to the contract should it be awarded. The structure of the document involves a series of prompts aimed at ensuring comprehensive reporting on the capabilities and commitments of the involved professionals, essential for effective proposal evaluation in the context of government solicitations. The overarching goal is to assess qualifications and resource availability to inform decision-making in awarding contracts or grants.
    The document outlines a series of research proposals focused on immunotoxicity, specifically evaluating the effects of various agents, including lycopene, through in vitro and in vivo studies. The primary goal is to assess immune suppression and developmental immunotoxicity using established models such as human whole blood culture systems and various animal species, including Sprague Dawley rats and B6C3F1 mice. Each proposal emphasizes the importance of detailed project management strategies, including human and animal handling protocols, budgeting, and adherence to Good Laboratory Practice (GLP) standards. Key objectives include conducting evaluations of immune responses via specific assays for cytokine levels, leukocyte subpopulation analysis, and evaluating cell-mediated immunity. Government-furnished materials and required outputs are specified to ensure compliance and standardization. The proposals encourage innovation in toxicological assessments and aim to establish novel methodologies for future regulatory acceptance. Overall, the document serves as a framework for contractors to develop and submit comprehensive research proposals, aligning with the goals of the Division of Translational Toxicology at the National Institute of Environmental Health Sciences to improve immunotoxicity testing and minimize animal use in research.
    The document is an Experience Form used for government Requests for Proposals (RFPs) and contracts, aimed at gathering essential information about a firm's past project experience. It includes sections that ask for the firm's details, the nature of the work performed, project numbers, contract types, and award amounts. Key points include the need for detailed descriptions of the project’s relevancy to the RFP requirements, the specifics of work performed by the firm, and the project’s award dates and amounts. The structure is organized into numbered sections to ensure comprehensive and clear responses, prompting firms to provide both quantitative data and qualitative insights into their experience. This information is critical for evaluating the capability and qualifications of potential contractors and aligns with federal and state procurement processes, emphasizing transparency and accountability in government spending. Overall, the form serves as a foundational tool for assessing contractor experience and ensuring informed decision-making in government contracting.
    The document outlines the requirements for biographical sketches of senior/key personnel involved in a project assessing immunotoxicity, focusing on in vitro and in vivo immune function for the National Institute of Environmental Health Sciences (NIEHS). It specifies the structured format for presenting personal information, including degrees, work history, accomplishments, and contributions to science. The biographical sketch must encompass aspects of each individual's training, technical expertise, and significant research contributions within a maximum of five pages. Emphasis is placed on providing relevant peer-reviewed publications and detailing ongoing and completed research projects related to the proposed work, highlighting roles and goals. This document is part of a federal request for proposals (RFP) and aims to ensure that the project team has the necessary expertise and background to successfully carry out the research. Overall, it emphasizes the importance of detailed qualifications and relevant experience within the context of federal grants and RFPs.
    The NIEHS Past Performance Questionnaire (Form PPQ-0) is a structured document designed for contractors and clients to assess past project performance relevant to government contracts. Contractors fill in detailed information about the project, including contract specifics, the complexity of work performed, and outcomes, while clients evaluate the contractor's performance based on various criteria such as quality, timeliness, customer satisfaction, management, cost management, safety, and overall compliance. Ratings range from Exceptional (E) to Unsatisfactory (U), providing a systematic way to gauge contractor reliability and effectiveness. The form highlights the importance of direct client feedback, which can be submitted to NIEHS, ensuring that accurate performance evaluations contribute to future government RFPs and grants. This questionnaire serves as a critical tool in the procurement process, enabling informed decisions based on historical contractor performance.
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