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Design Phase for Validation and Qualification Network (VQN) Public-Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs)

Award Number: OT2OD039875
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: OTHER
PERIOD OF PERFORMANCE START DATE: 03/14/2025
PERIOD OF PERFORMANCE END DATE: 06/13/2026

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Design Phase for Validation and Qualification Network (VQN) Public-Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs) - NAMs VQN PPP Design Phase Abstract for FNIH OT Proposal January 17, 2025 The National Institutes of Health (NIH) Common Fund has launched a new program, Complement-ARIE. The overarching goal of the Complement-ARIE Program is to catalyze the development, standardization, validation, and use of human-based New Approach Methodologies (NAMs) that will transform the way basic, translational, and clinical sciences are done. Specific program goals include: • Develop better models and understand human health and disease outcomes across diverse populations. • Develop NAMs that provide insight into specific biological processes or disease states. • Validate mature NAMs to support standardization and clinical use. • Complement traditional models and make biomedical research more efficient and effective. In the initial Design Phase, the NIH seeks input from the Foundation for the National Institutes of Health (FNIH) - and in alignment with the executed Request for Collaboration - to develop a public-private partnership (PPP) that enables new, impactful, and timely synergies with other relevant stakeholders as part of establishing common data elements and standardized reporting, applying validation/qualification frameworks, and accelerating deployment and regulatory implementation of NAMs. The PPP will seek to develop a Validation and Qualification Network (VQN) to establish common data elements and standardized reporting, apply validation/qualification frameworks, and accelerate deployment and regulatory implementation of NAMs. This VQN will interact with other aspects of the Complement-ARIE program as needed, but also recruit partners and projects from other ongoing efforts within the NAMs field. The Design Phase (FY25) will produce a white paper with a detailed plan to build and launch a PPP, focusing on the key primary processes of building the NAMs VQN with multiple stakeholders across academia, industry, NGOs, government, and international groups. It is anticipated that if the Design Phase is successful that two Implementation Phases to build and utilize the NAMs VQN created will follow. OTA-25-003 Abstract


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH, INC	11400 ROCKVILLE PIKE STE 600	NORTH BETHESDA	MD	20852	MONTGOMERY	USA	Trans-NIH Research Support	000	1	1/28/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $299,995 )
2025	2025	FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH, INC	11400 ROCKVILLE PIKE STE 600	NORTH BETHESDA	MD	20852	MONTGOMERY	USA	Trans-NIH Research Support	000	1	3/11/2025	NEW	$299,995
														Subtotal = $299,995

Grand Total All Awards = $299,995

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Design Phase for Validation and Qualification Network (VQN) Public-Private Partnerships for Adoption and Implementation of New Approach Methodologies (NAMs)

Award Number: OT2OD039875

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: OTHER

PERIOD OF PERFORMANCE START DATE: 03/14/2025

PERIOD OF PERFORMANCE END DATE: 06/13/2026

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