# NH PHL Discipline D Special Project Track 3 Development and Validation

> **NIH FDA U19** · NH STATE DEPT/HLTH STATISTICS/DATA MGMT · 2020 · $35,000

## Abstract

Discipline D: Special Projects 
Track 3: Method Development and Method Validation 
The NH PHL proposes to take part in a short-term multi-laboratory validation of Elemental 
Analysis Manual method EAM 4.12: analysis of bottled water by ICP-MS during Year 1 of this 
funding agreement. NH PHL has assisted in previous studies involving the U.S. FDA's Guidelines 
for the Validation of Chemical Methods in Food, Feed, Cosmetics, and Veterinary Products, and 
is well aware of the procedures required to take part in this validation study. The NH PHL will 
incorporate the reference method onto or testing platform, and prepare method blanks, matrix 
blanks and matrix spikes of known concentrations to show the robustness, precision, accuracy, 
selectivity, limit of detection, limit of quantitation, linearity, range, measurement uncertainty, 
ruggedness, confirmation of identity and spike recovery of the data generated by the NH PHL. 
False positive and negative rates will be determined using samples shared by other validating 
laboratories. All performance characteristics will be shared with other partners assisting in this 
validation study to provide robust statistics on the method overall. 
NH PHL will attend conference calls relating to this project and monthly FERN calls, and maintain 
facilities and personnel necessary to complete the work proposed. The NH PHL will maintain a 
valid 20.88 agreement with the FDA. This work would finally be presented at the LFFM Face-to- 
Face meeting, and NH PHL would assist with publication of the final study.

## Key facts

- **NIH application ID:** 10173082
- **Project number:** 1U19FD007070-01
- **Recipient organization:** NH STATE DEPT/HLTH STATISTICS/DATA MGMT
- **Principal Investigator:** Christine Louise Bean
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $35,000
- **Award type:** 1
- **Project period:** 2020-09-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10173082

## Citation

> US National Institutes of Health, RePORTER application 10173082, NH PHL Discipline D Special Project Track 3 Development and Validation (1U19FD007070-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10173082. Licensed CC0.

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