Attachment 2 SOW Final.pdf
PDF 269 KB Posted
- Attached to
- Analyzation of Samples for Emergent Screwworm
- Solicitation number
- 1232SA26Q0102
About this file
This is a Statement of Work from the US Department of Agriculture (USDA) for analytical services supporting an emergent screwworm research study conducted in collaboration with the Food and Drug Administration (FDA). The contractor shall perform specialized toxicological analysis on 50-100 samples of experimental molasses-based cattle feed supplements using validated high-performance liquid chromatography (HPLC) and mass spectrometry protocols. The scope includes three primary technical assessments: Quantitative Potency Verification to measure ivermectin and doramectin active pharmaceutical ingredients (APIs) and confirm concentration thresholds; Batch Homogeneity Testing with multi-point sampling across production runs to ensure uniform macrocyclic lactone distribution; and Clinical Stability Profiling to assess API degradation under simulated field conditions and determine shelf-life and environmental durability. The sample range of 50-100 blocks is provided to allow accurate pricing and resource planning under a Firm Fixed Price (FFP) contract structure, with historical data suggesting similar studies require between 50 and 65 samples.
Deliverables shall include a comprehensive analytical report summarizing findings for each sample, raw and processed data in electronic format compliant with ISO 17025 standards, and submission of reports within 15 business days following completion of analyses for each batch. The contractor must provide qualified analytical chemists with expertise in complex organic and inorganic analyses, toxin and xenobiotic residue identification, and specialized technical proficiency in advanced mass spectrometry platforms (LC-MS/MS, GC/MS, HRMS), elemental analysis using ICP-MS, and sample preparation techniques including solid-phase extraction and liquid-liquid extraction. The contractor must maintain strict adherence to ISO 17025 standards and Standard Operating Procedures to ensure data accuracy and legal defensibility. No government-furnished materials, travel, security requirements, data rights restrictions, or Section 508 compliance needs are specified for this effort.
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US Department of Agriculture (USDA)
Statement of Work
Contents Project General Information
1.0 Scope of Work
2.0 Background
Contractor Requirements
3.0 Technical Requirements / Tasks
4.0 Government Furnished
5.0 Deliverables / Schedule
6.0 Travel
7.0 Contractor’s Key Personnel
8.0 Security Requirements
9.0 Data Rights
10.0 Section 508 – Electronic and Information Technology Standards Attachment
Project Analyzation of samples for emergent screwworm
General Information
1.0 Scope of Work
Analyzation of samples for emergent screwworm research study in collaboration with the Food and Drug Administration (FDA).
2.0 Background
The United States Department of Agricultural Research Services In collaboration with the Food and Drug Administration (FDA), requires specialized toxicological analysis of experimental molasses-based cattle feed supplements for an emergent New World screwworm (Cochliomyia hominivorax) research study.
Contractor Requirements
3.0 Technical Requirements / Tasks
Using validated, proprietary high-performance liquid chromatography (HPLC) and mass spectrometry protocols, CAHFS will provide the following technical assessments for approximately 50-100 samples from cooked molasses cattle supplement blocks:
• Quantitative Potency Verification: Precise quantification of ivermectin and doramectin active pharmaceutical ingredients (APIs) to ensure the manufactured blocks meet the pre-defined insecticide concentration thresholds required for the study's efficacy parameters.
• Batch Homogeneity Testing: Multi-point sampling across production runs to confirm that the macrocyclic lactones are uniformly distributed throughout the molasses matrix, preventing "hot spots" or sub-therapeutic dosing zones.
• Clinical Stability Profiling: Longitudinal assessment of API degradation under simulated field conditions to determine the shelf-life and environmental durability of the blocks.
Scope of Analyses:
The contractor shall perform these assessments on 50-100 block samples. This range is provided to allow accurate pricing and resource planning under a Firm Fixed Price (FFP) contract structure. Historical data suggests similar studies have required between 50 and 65 samples, and this estimate reflects anticipated project needs.
The data generated from these assessments are time-critical; they will serve as the primary "go/no-go" criteria for the study timeline. These results will confirm whether the feed supplements meet the stringent regulatory requirements for insecticide consistency and stability before the New World screwworm study officially commences.
4.0 Government Furnished
N/A
5.0 Deliverables / Schedule
The contractor shall provide analytical results for all required assessments—Quantitative Potency Verification, Batch Homogeneity Testing, and Clinical Stability Profiling—covering 50-100 samples>Deliverables shall include:
- Comprehensive Analytical Report: Summarizing findings for each sample, including potency verification, homogeneity data, and stability profiles.
- Data Tables and Supporting Documentation: Raw and processed data in electronic format, compliant with ISO 17025 standards.
- Submission Timeline: Reports shall be delivered within 15 business days following completion of analyses for each batch or as otherwise agreed upon in the project schedule.
6.0 Travel
N/A
7.0 Contractor’s Key Personnel
The Contractor shall provide a qualified analytical chemists capable of servicing and detecting quantifying chemical compounds in biological and environmental samples. The qualified analytical chemists must possess the expertise required to perform complex organic and inorganic analyses to identify toxins, xenobiotic residues, and essential nutrients like vitamins and minerals in animal tissues, blood, feed, and water.
• Analytical Testing: Performing complex organic and inorganic analyses to identify toxins, xenobiotic residues, and essential nutrients like vitamins and minerals in animal tissues, blood, feed, and water.
• Method Development: Designing and validating new diagnostic assays and procedures to meet emerging animal health threats and improve detection sensitivity.
• Quality Control: Maintaining strict adherence to ISO 17025 standards and Standard Operating
Procedures (SOPs) to ensure data accuracy and legal defensibility.
• Laboratory Management: Overseeing the maintenance, calibration, and troubleshooting of high-end analytical instrumentation
Specialized Technical Expertise
• Mass Spectrometry: Expertise in advanced platforms such as Liquid Chromatography-Mass Spectrometry (LC-MS/MS), Gas Chromatography-Mass Spectrometry (GC/MS), and High-Resolution Mass Spectrometry (HRMS) like Thermo Orbitrap.
• Elemental Analysis: Using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to measure minerals and toxic heavy metals.
• Sample Preparation: Proficiency in techniques such as solid-phase extraction, liquid-liquid extraction, and matrix matching to isolate compounds from complex biological matrices.
8.0 Security Requirements
N/A
9.0 Data Rights
N/A
10.0 Section 508 – Electronic and Information Technology Standards N/A
Attachment N/A
| Project |
| General Information |
| 1.0 Scope of Work |
| 2.0 Background |
| Contractor Requirements |
| 3.0 Technical Requirements / Tasks |
| 4.0 Government Furnished |
| 5.0 Deliverables / Schedule |
| 6.0 Travel |
| 7.0 Contractor’s Key Personnel |
| 8.0 Security Requirements |
| 9.0 Data Rights |
| 10.0 Section 508 – Electronic and Information Technology Standards |
| Attachment |
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