# Special Project Method Development and Method Validation Analytical Track

> **NIH FDA U19** · OHIO STATE DEPARTMENT OF AGRICULTURE · 2020 · $13,350

## Abstract

Increasing the Capability and Capacity of 
Microbiological and Chemical Testing to Support an 
Integrated Food Defense and Food Safety System 
Special Projects Discipline, Method Development and Method Validation 
Analytical Track 
Project Summary / Abstract 
Method development and method validation are vital to the production of new testing assays 
and providing defensible methods to support any corresponding regulatory action, respectively. 
Common prohibitors of successful single laboratory validation (SLV) and multi-laboratory 
validation (MLV) studies are that of poor design of experiment leading to unusable validation 
data or the high cost of coordinating multiple laboratories and standardizing the method across 
national or even international lines. In both cases these studies require a large investment of 
time for each participating laboratory. Nevertheless, the benefits of a validated study are worth 
the costs involved. The Ohio Department of Agriculture (ODA) Consumer Protection 
Laboratory (CPL) thus proposes in the first project period to participate in a multi-laboratory 
validation (MLV) study for the FDA Elemental Analysis Manual method EAM 4.12, “Mass 
Spectrometric Determination of 18 Elements in Bottled Water.” ODA-CPL will supply all 
necessary reagents, experienced personnel and logistical support to ensure their laboratory 
portion of work is complete. ODA-CPL will participate in any communications related to the 
MLV. In future project periods, ODA-CPL intends to continue method development and 
method validation activities and applying to perform studies for microbiological or chemical 
methods depending on FDA’s priorities so long as ODA-CPL’s assets and workflow are 
compatible.

## Key facts

- **NIH application ID:** 10173201
- **Project number:** 1U19FD007087-01
- **Recipient organization:** OHIO STATE DEPARTMENT OF AGRICULTURE
- **Principal Investigator:** Jason Siu Kong
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $13,350
- **Award type:** 1
- **Project period:** 2020-09-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10173201

## Citation

> US National Institutes of Health, RePORTER application 10173201, Special Project Method Development and Method Validation Analytical Track (1U19FD007087-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10173201. Licensed CC0.

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