Chemistry Support for the National Institute of Environmental Health Sciences (NIEHS) Division of Translational Toxicology (DTT)
ID: NIH-NIEHS-2024-CHEMType: Sources Sought
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; APPLIED RESEARCH (AJ12)

Original Source

https://sam.gov/opp/6ebfc77caf3f4ff3aec503c3194f6f8c/view
Timeline
    Description

    The National Institute of Environmental Health Sciences (NIEHS), part of the Department of Health and Human Services, is seeking small businesses to provide chemistry research and development (R&D) services for its Division of Translational Toxicology (DTT). The procurement aims to gather market research to inform acquisition strategies for well-characterized test articles and dose formulations used in toxicity testing, emphasizing the need for expertise in sophisticated analytical instrumentation. Interested parties must respond with company details, business size classification, and relevant capabilities by the specified deadlines, with the existing contract structure maintained for over 40 years and set to extend through 2027. For further inquiries, contact Mikel Outen at mikel.outen@nih.gov or Erica Kitzmiller at erica.kitzmiller@nih.gov.

    Point(s) of Contact
    Mikel Outen
    mikel.outen@nih.gov
    Erica Kitzmiller
    erica.kitzmiller@nih.gov
    Files
    Title
    Posted
    Draft Mandatory Qualification Criteria.pdf
    The document outlines mandatory qualification criteria for offerors responding to a contract with the Division of Translational Toxicology (DTT). It emphasizes four key requirements: 1. **GLP Compliance**: All work must adhere to FDA Good Laboratory Practices for Nonclinical Laboratory Studies, demonstrating compliance with 21 CFR 58. 2. **Animal Welfare**: Contract execution requires adherence to the Public Health Service (PHS) policy and the Animal Welfare Act, including accreditation from the Association for Assessment & Accreditation of Laboratory Animal Care International (AAALAC). 3. **PHS Assurance**: Offerors must have an approved animal welfare assurance statement from the NIH Office of Laboratory Animal Welfare at the time of contract award; funds cannot be used for animal work without this assurance. 4. **Integrated Pest Management Program**: Offerors need a proactive IPM program to safeguard animals within isolator/barrier facilities. These criteria ensure ethical and regulatory compliance in research that involves laboratory animals, reflecting the federal government's commitment to maintaining standards in public health and animal welfare. Offerors must provide documentation to prove their capability to meet these rigorous standards for consideration in the contract awarding process.
    Draft Statement of Work.pdf
    The document outlines the objectives and scope of a federal contract for chemistry services supporting DTT research, defining key terms and expected activities over a potential ten-year performance period. The contract includes multiple functional areas—Logistics and Handling, Characterization, Formulation, Biosample Analysis, Animal Studies, and Special Studies—that the contractor must address through qualified staff and facilities. Specific tasks involve procurement, handling of test articles, chemical characterization, formulation development, bioanalytical services, as well as safety and quality management compliant with FDA regulations. Optional extensions for advanced studies, such as omics analyses, in vitro assays, and high-throughput screening, can be included. The contractor is required to maintain communication with the DTT and provide timely reporting of financial and technical data, ensuring adherence to health and safety standards. Overall, the contract aims to facilitate cohesive and efficient chemical analyses within DTT’s toxicological evaluation processes while promoting regulatory compliance and research integrity.
    Small Business Sources Sought Notice.pdf
    The National Institute of Environmental Health Sciences (NIEHS) is seeking small businesses capable of providing chemistry research and development (R&D) services to support its Division of Translational Toxicology (DTT) as part of a Small Business Sources Sought Notice (SSN). This notice, which is not a solicitation, aims to gather market research to inform potential acquisition strategies for well-characterized test articles and dose formulations that will be used in toxicity testing. The document outlines the scope of required chemistry support, including chemical procurement, synthesis, characterization, and analysis. It emphasizes the importance of expertise in sophisticated analytical instrumentation for meaningful research outcomes. The SSN specifies that responses should include company details, business size classification based on NAICS code 541715, and a description of capabilities relevant to the attached draft Statement of Work (SOW). Interested parties must submit their responses and any questions by specified deadlines to NIEHS contact points. The existing contract structure is also detailed, noting that current requirements have been maintained for over 40 years with multiple contracts in place, set to be extended through 2027. The initiative highlights the governmental intention to engage small businesses as part of its operational strategy while ensuring the integrity of environmental health research.
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