SOW_TCC Membership 1-7-26.docx

STATEMENT OF WORK

Tissue Chip Testing Research Services

1. Background This Statement of Work (SOW) is issued on behalf of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), a component of the National Institutes of Health (NIH), Office of Director (OD), located at 9000 Rockville Pike, Bethesda, MD 20892. DPCPSI supports NIH-wide coordination and planning by:

· Identifying emerging scientific opportunities, public health challenges, and knowledge gaps

· Developing and implementing tools, methodologies, and resources to support research portfolio analysis and priority setting

· Supporting effective responses to evolving public health and scientific needs

· Planning and conducting evaluations of NIH programs and projects, including those required under the Government Performance and Results Act (GPRA) and other federal performance initiatives

The NIH Office of Research Innovation, Validation, and Application (ORIVA), housed within DPCPSI, leads efforts to promote, develop, validate, and apply human-relevant, non-animal methodologies (NAMs) across biomedical and regulatory science. NAMs broadly refer to any technology, methodology, approach, and/or combination thereof—such as in silico, in chemico, in vitro, and ex vivo approaches—that can provide information on chemical hazard and risk assessment while supporting the 3Rs (replacement, reduction, and refinement of animal studies). ORIVA serves as the hub for coordinating NIH-wide, interagency, and international initiatives that advance NAMs for human-centered research, reduce reliance on animal models, and enhance scientific rigor, reproducibility, and translational relevance of biomedical research. The office provides strategic advice to NIH leadership and the U.S. Department of Health and Human Services (HHS) on matters relating to the development and implementation of alternative methods, and collaborates with NIH Institutes and Centers (ICs) to integrate NAMs into intramural research, strategic planning, and extramural funding portfolios. ORIVA also tracks and reports progress toward broader adoption of human-biology based approaches and facilitates partnerships with government agencies, academia, industry, and NGOs to expand awareness, training, and translational success of these methodologies.

Human-relevant complex in vitro modeling systems, often referred to as “tissue chips” or “organ-on a-chip” are a rapidly developing area of technology that holds great promise for advancing NAMs. It is critical that ORIVA establishes effective partnership with an entity that has the capability to evaluate the functionality and reproducibility of tissue chips, thereby advancing scientific understanding of this technology, reducing reliance on animal models, and improving translation to humans.

2. Objective The objective of this acquisition is to obtain services that provide processed scientific data and summary reports regarding the functionality, reproducibility, robustness and reliability of tissue chip models through a research consortium.

3. Requirement

· The Contractor shall include two (2) ORIVA employees designated by the Government as Participant Representative and Alternate Participant Representative in the steering committee, which will determine the specific platforms, types of testing are required for testing by the Contractor, and what type(s) of testing is/are required to increase confidence in the function and fit for purpose of a particular platform.

· The Contractor shall perform testing of tissue chip platforms selected by the Steering Committee using standard laboratory practices. The Contractor shall provide research staff, equipment and facilities required to execute the research program. The Contractor shall designate a Principal Investigator (PI) to oversee the activities. The Principal Investigator shall assist with coordinating steering committee meetings, communications and other needs. If for any reason, the PI cannot continue to fulfill his duties as the Principal Investigator, Contractor shall appoint a replacement Principal Investigator, to be approved by the Steering committee.

· The Contractor shall coordinate legal and/or material transfer agreements with tissue chip manufacturers.

· The Contractor shall prepare processed data, reports and communicate the results of the research program to the scientific community through means such as presentations, consultations, and peer reviewed publications.

· The Contractor shall maintain records of all work performed under the research program. The Contractor shall prepare a written agenda prior to each Consortium steering committee meeting and keep accurate and complete minutes of each meeting’s discussion and decisions; minutes shall be subject to review and approval by the Government.

· If requested by the Government, Contractor shall provide technical consultations and/or training on the use of various tissue chip platforms to the Government, as a member organization, upon request.

4. Deliverables