Tuesday, September 16, 2025 9/16/2025

Nitrosamines Forum to Advance Critical Translational Science (NA FACTS)

Award Number: U01FD008279
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2024
PERIOD OF PERFORMANCE END DATE: 07/31/2026

Group Awards By:

View Award Description

Nitrosamines Forum to Advance Critical Translational Science (NA FACTS) - Title: Nitrosamines Forum for Advancing Critical Translational Science (NA FACTS) FOA Title & Number: Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01), RFA-FD-24-020 Project Summary 1 The Health and Environmental Sciences Institute (HESI) will address the need to implement feasible and 2 sustainable safety assessment methods that protect public health from nitrosamine (NA) risks while ensuring 3 uninterrupted access to essential medications by establishing the Nitrosamines Forum for Advancing Critical 4 Translational Science (NA FACTS). NA FACTS will form two multi-stakeholder advisory teams, each with 5 distinct tasks. One advisory team will be tasked with identifying, prioritizing and preparing a report with 6 recommendations on in vivo and in vitro research priorities for assessment of NA impurities in drugs (Specific 7 Aim 1). This advisory team may identify and initiate a select number of new projects within the existing HESI 8 Genetic Toxicology Testing Committee (GTTC) Nitrosamines Research Program (NRP) and establish a 9 competitive seed funding mechanism to catalyze a limited number of additional new programs (Specific Aim 10 3). A second advisory team will be tasked with designing and convening a workshop to assess the feasibility of 11 establishing a public-facing (Q)SAR database that builds on NA classification (Specific Aim 2). The NA FACTS 12 Principal Investigator (PI) and Key/Senior Persons will provide FDA with a report synthesizing the 13 recommendations from the prioritization exercise and the outcomes of this workshop. The summary reports 14 for Aims 1 and 2 will be publicly posted with FDA approval. Specific Aim 4 (assessment of opportunities to 15 ensure that research and practices identified in Aims 1-3 can continue following closure of the cooperative 16 agreement) will be fulfilled as a component of Aims 1-3 above. Specifically, HESI personnel will utilize the 17 networks and topical areas developed in Aims 1-3 to focus this effort. HESI personnel will also apply their 18 decades of expertise to assess and evaluate stakeholders’ interest in supporting or leading continued work 19 related to Aims 1-3 at the close of this cooperative agreement. HESI personnel will work with the NA FACTS 20 team and existing GTTC NRP to facilitate discussion of possible resource models and program mechanisms 21 that could support sustained activity (e.g., stakeholder contributions of funding or expertise/data/studies, 22 grants, etc.). HESI foresees ongoing success advancing this important work given the organization’s 35 years of 23 designing innovative scientific, resource sharing collaborations, which includes the establishment and growth 24 the GTTC NRP.


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: 2025 ( Subtotal = $0 )
2025	2024	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	7/23/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $350,000 )
2024	2024	HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE	740 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	7/31/2024	NEW	$350,000
														Subtotal = $350,000

Grand Total All Awards = $350,000

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Nitrosamines Forum to Advance Critical Translational Science (NA FACTS)

Award Number: U01FD008279

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2024

PERIOD OF PERFORMANCE END DATE: 07/31/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer