Requirements Document Customs Standards.pdf

STATEMENT OF WORK

Mixed Custom Standards

Background

Denver Human and Animal Food Laboratory (DENHAFL) is one of the servicing laboratories of the Human and Animal Food (HFP), Office of Regulatory Testing and Surveillance (ORTS) network, responsible for conducting laboratory analyses of human and animal food samples to assess compliance with FDA laws and regulations. HFP laboratories detect harmful chemicals, pathogens, and contaminants in food, protecting public health by preventing exposure to harmful contaminants that may result in serious adverse health consequences, including death. This mission is supported through outbreak response, for-cause testing, and comprehensive surveillance of the food supply.

Within HFP, DENHAFL performs analysis of veterinary drug residues in aquaculture, dairy, and game meat products. Each year, Denver laboratory analyzes 500 aquaculture samples, 600 raw milk samples, 165 retail milk samples, and 50 game meat samples for the presence of more than 50 chemical residues.

To support screening and confirmatory analyses, each batch of analyzed samples must be matrix matched to the sample specimen and contain a continuous calibration verification standard (CCV) and an initial calibration verification standard (ICV). In accordance with the Office of Regulatory Science (ORS) SOP- 000583, standards may be purchased as a custom mixture from two different vendors or from the same vendor with different lots. These multi-residue veterinary drug analyses are expected to continue for up to five (5) years and require consistent preparation of standards at the specified amounts.

Purpose/Scope

Denver Human and Animal Food Laboratory (DENHAFL) require custom prepared ISO 17034 analytical reference standards for use in regulatory analysis to protect public health. Purchasing custom prepared multi-component standards improves analytical reliability and accuracy of results, reduces variability, saves time, and can be more cost effective than individually purchasing neat materials and preparing separate mixes and/or separate standards. The anticipated period of performance is one (1) year.

The multi-component standards shall have a minimum expiration or retest date of 12 months at the time of shipment. Compounds shall be grouped according to stability and shelf-life requirements, as specified in the tables below. The contractor shall provide a total of ten (10) 1mL ampules of each premade drug class mixture containing two separate lots. One lot (Lot A) shall be designated for ICV use and a second lot (Lot B) shall be designated for CCV use; five (5) 1mL vials of Lot A shall be provided for the ICV and five (5) 1mL vials of Lot B shall be provided for the CCV. The contractor shall honor the delivery schedule as outlined in the deliverables section of this contract.

Technical Specifications/Requirements

The contractor shall be accredited and certified to ISO 17034.

All standards shall be prepared and verified in accordance with ISO 17034 requirements.

If an ISO 17034 accredited reference standard is not commercially available for a specified standard, the contractor may request exclusion of the standard from the mixture provided that the exclusion is supported by appropriate documentation and technical justification.

Documentation shall include evidence of commercial unavailability and reasonable attempts made to obtain the required ISO 17034 reference material. Proposed exclusions shall be subject to Government review and approval prior to preparation of the standard mixtures.

Unless approved by the Government, no more than five (5) total standards listed within the tables below may be excluded under this provision.

The contractor shall prepare all reference standards at the target concentrations specified in the Government-provided tables whenever feasible. The contractor shall not intentionally formulate or routinely default to the minimum acceptance concentration levels in lieu of the specified target concentrations for convenience, cost reduction, or other internal operational purposes when target levels are scientifically achievable. Any proposed deviation from the specified target concentration due to documented technical limitations, including insolubility, instability, degradation, or other scientifically justified constraints, shall require Government review and approval prior to preparation and shipment of the standards.

If the standards within the Government-provided tables are determined to be chemically incompatible, unstable, or otherwise unsuitable for preparation within a combined mixture, the contractor shall separate the affected reference materials and prepare them as individual mixtures or standalone standards, as necessary, to maintain analyte integrity, stability, and certified concentration requirements.

When multiple concentrations are specified within a mixture, the contractor shall maintain the relative concentration ratios identified in the Government-provided tables. If required concentration ratios cannot be maintained due to chemical incompatibility, solubility limitations, stability concerns, or other technical constraints, the affected standards shall be separated and prepared as individual mixtures or standalone standards while maintaining the specified target concentrations to the maximum extent practicable.

For standards with a certified shelf-life of less than twelve (12) months from the date of shipment, the contractor shall provide replacement ampules at no additional cost to the Government to ensure continuous availability of in-date reference standards throughout the contract performance period. Replacement ampules shall be shipped prior to expiration of the existing materials or approximately one hundred and sixty-five (165) calendar days after the first shipment. All replacement materials shall meet the same concentration, preparation, certification, packaging, and analytical verification requirements specified in this Statement of Work.

The standards shall be sent to the shipping destination, using priority shipping. The contractor shall preserve the integrity of the standards during shipment, i.e., in appropriate protective packaging on cold packs or dry ice.

Standards shall be dissolved in appropriate liquid chromatography mass spectrometry

(LCMS) grade solvents and sealed in volumes of 1mL in glass ampules.

The contractor shall provide two (2) separate lots for each set of standards for a total of ten

(10) 1mL ampules. Five (5) 1mL vials of Lot A and five (5) 1mL vials of Lot B.

A certificate of analysis (COA) shall accompany or be available online for all compounds. At a minimum, the COA shall contain/provide the component name, lot number, chemical abstract service number (CAS), uncertainty level, expiration date, solvent used to prepare the standard material, certified value, how the certified value was obtained (i.e., GC/MS, HPLC), and the ISO17034 seal or certificate number.

All compounds prepared from salt forms, tartrate salts, benzoate salts, or hydrochloride salts shall have final concentrations calculated and reported as the equivalent free base concentration or free acid concentration.

Compounds prepared from monohydrates or dihydrates shall have final concentrations calculated and reported as the equivalent anhydrous concentration.

For Abamectin and Ivermectin standards prepared from multi-component neat materials, final concentrations shall be calculated and reported as Abamectin B1a and Ivermectin B1a equivalent concentrations. Emamectin standards prepared from Emamectin benzoate, final concentrations shall be corrected for the benzoate salt contribution and calculated and reported as Emamectin B1a equivalent concentrations.

The required groups of compounds, concentration levels, Chemical Abstracts Service (CAS) number, and minimum shelf-life requirements are listed in the tables below:

NSAIDs (1) (Nonsteroidal Anti-Inflammatory Drugs)

CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Carprofen 53716-49-7 500 µg/mL 12 months Methanol Mefenamic Acid 61-68-7 500 µg/mL 12 months Meloxicam 71125-38-7 500 µg/mL 12 months Tolfenamic Acid 13710-19-5 500 µg/mL 12 months

NSAIDs (2) (Nonsteroidal Anti-Inflammatory Drugs)

CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Ketoprofen 22071-15-4 500 µg/mL 12 months Methanol Etodolac 41340-25-4 500 µg/mL 12 months Flunixin 38677-85-9 500 µg/mL 12 months

NSAIDs (3) (Nonsteroidal Anti-Inflammatory Drugs)

CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Diclofenac (from Diclofenac sodium)

15307-79-6 500 µg/mL 12 months Methanol

Naproxen 22204-53-1 500 µg/mL 12 months Niflumic Acid 4394-00-7 500 µg/mL 12 months Suxibuzone 27470-51-5 500 µg/mL 12 months Phenylbutazone 50-33-9 500 µg/mL 12 months

Macrolides (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Tripelennamine (from Triplennamine HCl)

154-69-8 100 µg/mL 12 months Methanol

Tilmicosin 108050-54-0 100 µg/mL 12 months Erythromycin A 114-07-8 500 µg/mL 12 months

Tylosin (acceptable to be prepared from Tylosin tartrate)

1401-69-0 500 µg/mL 12 months

Bacitracin 1405-87-4 5000 µg/mL 12 months Thiabendazole 148-79-8 100 µg/mL 12 months Tulathromycin A 217500-96-4 100 µg/mL 12 months

Macrolides (2) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Virginiamycin M1 (Ostreogrycin A)

2141153-0 5000 µg/mL 12 months Methanol

Amphenicols (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Chloramphenicol 56-75-7 50 µg/mL 12 months Methanol Florfenicol 73231-34-2 50 µg/mL 12 months Thiamphenicol 15318-45-3 50 µg/mL 12 months

Avermectins (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Abamectin 71751-41-2 500 µg/mL 12 months Methanol Doramectin 117704-25-3 500 µg/mL 12 months Emamectin 155569-91-8 500 µg/mL 12 months Eprinomectin 123997-26-2 500 µg/mL 12 months Ivermectin 70288-86-7 500 µg/mL 12 months Selamectin 220119-17-5 500 µg/mL 12 months

Avermectins (2) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Moxidectin 113507-06-5 500 µg/mL 12 months Methanol

Nitroimidazole (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Metronidazole 443-48-1 500 µg/mL 12 months Methanol

Nitroimidazole (2) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Ketoconazole 65277-42-1 500 µg/mL 12 months Methanol Dimetridazole 551-92-8 500 µg/mL 12 months Ornidazole 16773-42-5 500 µg/mL 12 months Ronidazole 7681-76-7 500 µg/mL 12 months Tinidazole 19387-91-8 500 µg/mL 12 months

Quinolones (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Flumequine 42835-25-6 500 µg/mL 12 months Methanol: DMSO (9:1) Nalidixic acid 389-08-2 500 µg/mL 12 months

Oxolinic acid 14698-29-4 500 µg/mL 12 months Fluoroquinolones (1) CAS Concentration of

Stock (µg/mL) Shelf-Life Solvent

Enrofloxacin 93106-60-6 500 µg/mL 12 months Methanol Ciprofloxacin 85721-33-1 500 µg/mL 12 months

Fluoroquinolones (2) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Danofloxacin 112398-08-0 500 µg/mL 12 months Methanol Difloxacin (from Difloxacin hydrochloride)

98106-17-3 500 µg/mL 12 months

Marbofloxacin 115550-35-1 500 µg/mL 12 months Norfloxacin 70458-96-7 500 µg/mL 12 months Ofloxacin 82419-36-1 500 µg/mL 12 months Orbifloxacin 113617-63-3 500 µg/mL 12 months Sarafloxacin (from Sarafloxacin hydrochloride hydrate)

91296-87-6 500 µg/mL 12 months

Sulfonamides (1) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

17a-Methyltestosterone 58-18-4 40 µg/mL 12 months Methanol Sulfacetamide 144-80-6 500 µg/mL 12 months Sulfachloropryidazine 80-32-0 500 µg/mL 12 months Sulfadiazine 68-35-9 500 µg/mL 12 months Sulfadimethoxine 122-11-2 500 µg/mL 12 months Sulfamethazine 57-68-1 500 µg/mL 12 months Sulfamethoxazole 723-46-6 500 µg/mL 12 months Sulfadoxine 2447-57-6 500 µg/mL 12 months Sulfaethoxypyridazine 963-14-4 500 µg/mL 12 months Sulfamerazine 127-79-7 500 µg/mL 12 months Sulfamethoxypyridazine 80-35-3 500 µg/mL 12 months Sulfapyridine 144-83-2 500 µg/mL 12 months Sulfaquinoxaline 59-40-5 500 µg/mL 12 months Sulfathiazole 72-14-0 500 µg/mL 12 months Sulfamonomethoxine 1220-83-3 500 µg/mL 12 months Trimethoprim 738-70-5 500 µg/mL 12 months

Sulfonamides (2) CAS Concentration of Stock (µg/mL)

Shelf-Life Solvent

Sulfaclozine (from Sulfaclozine sodium monohydrate)

1392129-96-2 500 µg/mL 12 months Methanol

Sulfisoxazole 127-69-5 500 µg/mL 12 months Ormetoprim 6981-18-6 500 µg/mL 12 months Sulfamethizole 144-82-1 500 µg/mL 12 months Sulfanitran 122-16-7 500 µg/mL 12 months

Deliverables / Schedule

Deliverable Quantity Per Delivery

Date Location

Multi-Component NSAIDs (1) Standard Solution Lot A (ICV) 5 x 1mL ampules

12/01/2026 DENHAFL

Multi-Component NSAIDs (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component NSAIDs (2) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component NSAIDs (2) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component NSAIDs (3) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component NSAIDs (3) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Macrolides (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Macrolides (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Macrolides (2) Virginiamycin M1 Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Macrolides (2) Virginiamycin M1 Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Amphenicols (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Amphenicols (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Avermectins (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Avermectins (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Avermectins (2) Moxidectin Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Avermectins (2) Moxidectin Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Nitroimidazole (1) Metronidazole Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Nitroimidazole (1) Metronidazole Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL

Multi-Component Nitroimidazole (2) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Nitroimidazole (2) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Quinolones (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Quinolones (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Fluoroquinolones (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Fluoroquinolones (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Fluoroquinolones (2) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Fluoroquinolones (2) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Sulfonamides (1) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Sulfonamides (1) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Sulfonamides (2) Standard Solution Lot A (ICV) 5 x 1mL ampules 12/01/2026 DENHAFL Multi-Component Sulfonamides (2) Standard Solution Lot B (CCV) 5 x 1mL ampules 12/01/2026 DENHAFL

Delivery shall occur (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding Federal holidays or Federal closures. Federal holidays are listed below, and specific dates can be found at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

New Year’s Day Independence Day Veterans Day Martin Luther King, Jr. Day Labor Day Thanksgiving Day Presidents Day Juneteenth Day Christmas Day Memorial Day Columbus Day

Shipping Destination

FDA Denver Laboratory 6th Avenue & Kipling St, Bldg. 20, Door W10 Denver, Colorado, 80225

Point of Contact (POC)

Will be identified at the time of award.

Period of Performance

The Period of Performance will begin the date of contract award execution for one (1) year.