Synopsis SOLE SOURCE LHASA.docx

HHS OMAS

LHASA Software for Cosmetic Chemical Safety Assessment Support Package

Special Notice

7571TE26P00067

Special Notice / Notice of Intent to Sole Source

General Information

Contracting Office Address OMAS – Information Technology 5600 Fishers Lane Rockville, MD 20852

Description

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS.

The Food and Drug Administration, Office of Cosmetics and Colors (OCAC), under the Department of Health and Human Services, OMAS - Information Technology, intends to negotiate on a sole-source basis with Lhasa Ltd, 22-23 Blenheim Terrace, Leeds, United Kingdom, LS29HD (UEI: M9WQSCJPEY77), for Lhasa Predictor Software for Cosmetic Chemical Risk Assessment.

This acquisition is being conducted as a commercial acquisition in accordance with FAR Part 12, Commercial Products and Commercial Services, and applicable acquisition procedures. Lhasa Ltd. is the developer and proprietary provider of the Lhasa Software currently utilized by the FDA OCAC. The Government has determined that Lhasa Ltd is the only source capable of providing the required Lhasa Ltd Software, including software maintenance, software updates, installation assistance, and technical support necessary to ensure continued operation of the existing Lhasa implementation. No other source can meet the agency's requirements without substantial duplication of cost, unacceptable disruption to operations, compatibility concerns, and risk to the continuity of support for FDA OCAC data.

Evaluating the toxicity of cosmetic ingredients is challenging due to the complexity of their chemical structures and limited availability of experimental toxicity data. Most chemicals found in modern cosmetic products that are submitted to the Office of Cosmetics and Colors (OCAC) for safety review have very little or no toxicity data. It is, therefore, important for OCAC to have access to computational tools and databases that allow data-rich chemicals with similar chemical structures (or analogs) to the cosmetic ingredients to be identified and evaluated. The information from these analogs can then be used to infer the potential toxicity of the cosmetic ingredients.

LHASA is a commercial, knowledge-based computational system designed to support chemical safety assessment through expert rule-based and predictive modeling approaches. It integrates curated chemical databases with mechanistic toxicology knowledge derived from scientific literature and regulatory sources. LHASA software includes key modules such as Derek Nexus, Sarah Nexus, Meteor Nexus, and Vitic Nexus. Derek Nexus provides qualitative structure-activity relationship (QSAR) models for a wide range of toxicity endpoints (e.g., mutagenicity, carcinogenicity, skin sensitization, and reproductive toxicity) relevant to cosmetic safety evaluation. Sarah Nexus provides statistically based (machine learning-driven) predictions for mutagenicity, offering an independent and complementary approach to expert rule-based systems. Meteor Nexus supports the prediction of metabolic pathways and potential metabolites for chemicals. Vitic Nexus serves as a comprehensive toxicity database containing experimentally derived data and supporting information for chemical safety assessment.

Together, these tools support the safety evaluation of cosmetic ingredients. LHASA software can be used collectively to support the safety evaluation of ingredients used in cosmetic products.

The OCAC is requesting a one-year license for LHASA software for designated users. This license includes access to Derek Nexus, Sarah Nexux, Meteor Nexus, and Vitic Nexus modules. LHASA is proprietary, and no other software provides an equivalent combination of expert-reviewed knowledge bases, statistically derived models, and curated toxicity data for comprehensive chemical safety assessment. This justification supports a sole source acquisition.

This acquisition of ADMET Predictor Software for Cosmetic Chemical Risk Assessment will consist of one (1) 12-month base period and four (4) 12-month option periods.

Period of Performance

Base: July 31, 2026 – July 30, 2027 OY 1: July 31, 2027 – July 30, 2028 OY 2: July 31, 2028 – July 30, 2029 OY 3: July 31, 2029 – July 30, 2030 OY 4: July 31, 2030 – July 30, 2031

This notice of intent is not a solicitation or request for quotes. Notwithstanding, any responsible source that believes it is capable of meeting the Government's requirements may submit a capability statement. Responses to this posting must be submitted via email to, raja.seshadri@hhs.gov by July 23, 2026, at 5:00 PM EST.

A determination by the Government not to compete this contract action based upon responses to this notice is solely within the discretion of the Government. There is no solicitation package available. For any questions regarding this announcement, please contact Raja Seshadri at the above email address.