SOW.pdf

STATEMENT OF WORK (SOW)

Contract Synthesis of Chemical Substances

Study of Precursors, Chemicals, and Synthetic Pathways used in the Chemical Synthesis of Drug Substances

Diversion Control Division (DC)

Background

The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section is responsible for the evaluation of drugs and chemicals to determine if these substances are being abused or used in the illicit manufacture of controlled substances, respectively. These evaluations are then used by DEA to develop appropriate drug and chemical controls. In order for DEA to determine the appropriate controls for new drugs and chemicals, scientific and medical data for these drugs are needed to initiate the administrative procedure to place these substances under regulatory control of the Controlled Substances Act (CSA).

There are numerous novel psychoactive substances (NPS) being abused in the United States and they pose a significant risk to the public safety. The volume of substances being marketed illicitly is rapidly increasing due to small changes to the chemical structures of known substances of abuse. To best protect the public from the dangers of these new drugs, the DEA needs to be able to not only obtain and study these emerging substances, but also study and evaluate the precursors and methodologies used to make these substances. As such, the synthesis and methodological study of selected substances will be used in the initial collection of information, or to further enhance what is already known about various controlled substances. The information gathered from the procurement, and study of the methodological pathways used to produce these substances, will support the goals of the Diversion Control Program.

Brief Description of work

The DEA is seeking the services of a contractor that can custom synthesize a variety of chemical substances that span a wide selection of substances or substance classes, such as fentanyl, methamphetamine, amphetamines, cathinones, benzodiazepines, etc. Specifically, synthesis using precursors of interest, pre-determined pathways with detailed information on feasibility, impurity profiles, intermediates, reagents and solvents used, reaction conditions, yields and associated ratios, observed using each specified synthetic pathway. Synthesis and purification should yield varying quantities ranging from milligram- to gram-scale production. The contractor should also be familiar with current methodologies to minimize the lead time for synthesis of the requested substances. Synthesis should be completed in the shortest amount of time practical.

For this agreement, the DEA will require that the contractor be able to provide the following:

1. Proof of DEA registration: Contractor will need show that they are registered with DEA to manufacture controlled substances (Schedule I-V) and Listed I chemicals prior to the award of the contract and be familiar with the appropriate security, storage, and record-keeping requirements to handle controlled substances. Contractor will need to have the relevant drug and chemical codes for substances requested (if controlled). Registration is required prior to the beginning of agreement start date.

2. Sta experience: Contractor will provide information about the education and experience of each person’s proposed role (Lab director, manager, scientist, technician, etc.).

Response should be no more than four pages.

3. Any additional information that a vendor would like to submit in support of their chemical synthesis and analytical capabilities as related to this request.

Cost estimate for synthesis of di erent substances and quantities of substances.

The contractor should provide a breakdown of the cost for synthesis of the final substance and the corresponding quantities. Cost will be inclusive of work required to provide detailed information on: methodology feasibility, intermediates, impurity profiles, and yields using a specified starting material and synthetic pathway that may be requested. Contractor will bill the DEA once synthesis is complete, compilation and delivery of methodological and analytical information, and the requested substances have been delivered.

Table 1. Pricing list to be filled in by contractor

Chemical Class Quantity Price

Opioids e.g. fentanyl’s 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Benzodiazepines 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

PCP-like 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Tryptamines 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Amphetamines, e.g.

methamphetamine

0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Cannabinoids 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Phenethylamines 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Cathinones 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Piperazines 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Ad Hoc Request 0.1 mg – 100 mg

>100 mg – 500 mg

>500 mg - 1g

>1g – 3g

>3g – 5g

Other1 Per substance, if applicable

Specific Requirements

Task 1. Lead time estimation and methodology profiling

Contractor will provide an estimate of the time for synthesis and methodology profiling. Contractor will also provide a statement of the expected purity at least one week prior to the start of synthesis, followed by determination of actual purity of each final substance upon completion of synthesis.

1. Lead time estimation: Contractor will provide a written (email) estimate of the total time for synthesis of requested substances using the requested synthetic pathways. Estimate should state the shortest time possible for synthesis. The DEA considers the “standard” lead-time to be 10 weeks. Under certain circumstances, the contractor will need to provide requested substances as a “rush” synthesis. The DEA considers a “rush” synthesis to be from two to four weeks.

The lead-time estimate will be provided prior to the beginning of synthesis and approved by the DEA technical representative before synthesis may begin. Contractor will immediately notify the DEA technical representative if there are any changes in the lead time.

2. Methodology Profiling: Contractor will provide a written (email) statement of the expected methods that will be used to document the following for each substance prior to synthesis:

a. Determination of requested synthetic pathway feasibility,

b. Impurity profiling,

c. Yield calculations and corresponding product ratios,

d. Detailed listing of utilized reaction mechanisms with reagents, reactants, and elucidated intermediates. Synthetic schema should also be provided.

Task 2. Synthesis and delivery

Substances will be synthesized in the timeframe stated in the lead-time estimate.

1. Synthesis: Substances will be synthesized using a specified synthetic pathway or by ad hoc reaction mechanisms, as agreed upon by DEA and the contractor.

1 May include any additional cost associated with processing, shipment, delivery, etc. (if applicable). Please itemize.

2. Delivery: Upon completion of synthesis, the contractor will notify (email) the DEA technical representative when the requested profiling and requested information for each substance(s) will be ready. Contractor will deliver requested data within 2 weeks from completion of syntheses and if necessary, the final product quantities, within 1-2 business days after synthesis and purification are complete. The use of a shipping company (i.e.

FedEx) that utilizes delivery confirmation will allow for confirmation of delivery by contractor. Substance must be shipped using appropriate storage conditions (ex. dry ice, refrigerated container, etc.) to ensure best quality product is delivered. Vendor will submit invoice for payment once delivery is complete.

Task 3. Analytical Reporting

A detailed listing of the analytics that will be used to determine the parameters detailed in the methodological profiling description (ex. GC-MS, NMR, HPLC, etc.). Contractor will provide a sample of the spectra(s) used to document the methodology profile from previous syntheses (of any substance) with response to this request. Also, a Certificate of Analysis (CoA) will be sent with each final substance shipped and an electronic copy will be sent to the DEA technical representative. Each CoA will include analytical data that confirms the substance’s identity, physical characteristics, purity2, and any other pertinent analytical information. Examples of acceptable analytical methods to show purity include GC-MS, NMR, HPLC, etc. Information provided should be specific to the batch shipped.

Task 4. Reporting requirements+

All reports required herein shall be submitted in electronic format to the DEA technical representative as detailed in the following subsections.

A. Monthly Progress Reports: Contractor will provide monthly progress reports to the DEA technical representative in writing. One electronic copy in Microsoft Word or PDF format shall be sent to the DEA technical representative. The progress reports shall contain, but not be limited to: (1) a listing of newly requested substances/methodologies, (2) listing of substances already being processed, (3) cost for each substance, (4) expected synthesis completion date for each substance, (5) expected delivery date or methodology information and final substances, and (6) documentation of problems and their resolution (if applicable).

B. Annual Progress Reports: At the end of each performance year, the contractor will submit a report on activities during the year. One electronic copy in Microsoft Word or PDF format shall be sent to the DEA technical representative. In the report, vendor shall include: (1) listing of substances synthesized, (2) compilation of information from methodology profiling from each substance and pathway evaluated, (3) itemized listing of cost per substance, and

(4) summary of total cost for all substances synthesized and associated fees (if applicable).

2 Purity level will be approved by DEA technical representative prior to beginning of synthesis.

Period Of Performance

Ordering Period

There is a one-year base ordering period of performance (POP) with four one-year option periods for the master SOAPS contract. Each Task Order (TO) awarded under this Blanket Purchase Agreement (BPA) will have its own POP. Should a TO be awarded towards the end of the BPA POP, the fewer option years the TO will have. TOs may be awarded o of this BPA up to and including April 30, 2025, with four (4) possible exercisable option periods.

SOAPS BPA Ordering Periods

Base Period TBD TBD

Option Year 1 TBD TBD

Option Year 2 TBD TBD

Option Year 3 TBD TBD

Option Year 4 TBD TBD

Task Order Period of Performance

The period of performance for this task order shall be a 12-month base year with the option to extend for four additional years. If the agreement at the end of one year is terminated by one or both parties, the period of performance will no longer extend to subsequent years. Prior to shortening the period of performance, a written notification shall be provided with 90-day notice.

From: TBD To: April 30, 2025, or Acceptance Date of Last Deliverable

Place Of Performance

The contract will be carried out at the laboratory facility of the contractor. The DEA technical representative reserves the right to visit the laboratory where work under this agreement occurs.

Security

Not Applicable

Delivery/Deliverables

A report on the status of the requested substances will be provided to the DEA technical representative within the specified timeline. Delivery of the requested substances and the accompanying certificate of analysis should occur within the agreed-upon timeline for synthesis. If there are any delays in synthesis/delivery of the requested substances, or submission of the progress report, the contractor should immediately notify the DEA representative in writing.

Deliverable Description Quantity/Media Delivery Schedule

1. Lead time estimate and methodology profiling description

Written statement At least one week prior to synthesis

2. Synthesis Listing/schema of requested precursors and pathways used, and the a listing of the analytical methods used to determine each requirement in the methodology profile.

Based on approved lead time estimate

3. Delivery Email notification prior to delivery of final products and precursors.

Actual delivery of requested substances and requested quantitites using previously specified delivery service.

1-2 days after completion of synthesis and purification

4. Analytical Reporting Written report detailing spectral data and findings on methodology feasibility, impurity profiling, Upon completion of synthesis and determination of required methodology reagents and reactants used, yields and corresponding ratios, intermediates profiling information;

email a copy to the DEA technical representative

5. Monthly progress reports Written status update

Monthly

6. Annual progress reports Written status update

To DEA on or before the expiration of the agreement period.

Requested substances will be delivered to the below address:

Reference Materials Program

Special Testing and Research Lab

22624 Dulles Summit Ct.

Dulles, VA 20166

Government Furnished Property

Travel

Not Applicable

SPECIAL REQUIREMENTS

Key Personnel / Continuity of Operations (COOP)

Not applicable

Performance Required Beyond Standard Workday

Special Clauses

TBD

INCUMBENT & Transition Plan

TBD

Evaluation Criteria

The Government intends to select an O eror for contract award based on a best value, tradeo approach. The following Factors may be or not limited to:

1. Technical Approach

2. DEA registration

3. Past Performance

4. Cost/Price

5. Sta ing Plan

6. Administrative Services

Quality/Purity: This Factor assesses the O eror’s ability to provide high purity synthetic substances throughout the life of the TO. Proposals must demonstrate that the O eror has a clear understanding of the Government requirements as outlined in the Task Order Statement of Work (TOSOW). O eror should also demonstrate that they have appropriate chemical and analytical equipment necessary to produce the best quality product possible.

DEA Registration: This Factor assesses the O eror’s ability to manufacture controlled substances.

The O eror must demonstrate that it has a DEA manufacture’s registration and is familiar with, and has been in compliance with, the requirements necessary for the handling of controlled substances. The proposal shall discuss the O eror’s procedure for the synthesis and shipment of controlled substances.

Cost/Price: The Government will evaluate the total proposed cost/price of the base year and all option years. In addition, this evaluation will include an assessment of the O eror's proposal for completeness, realism, reasonableness, and overall risk.

Past Performance: This Factor assesses the O eror’s experience providing chemical synthesis services of a similar size and scope as compared to the TOSOW. The Government shall consider the O eror's record of providing services to commercial and government customers. Experience with government customers, however, shall be considered more significant. The contractor shall only use contracts, task orders, or other contracting vehicles issued within the last five years of a similar scope.

Sta ing Plan: The O eror must demonstrate that its proposed personnel are optimally suited for the e ort.

Administrative Services: This Factor assesses the O eror’s ability to provide e ective administrative services throughout the life of the TO. Proposals must demonstrate that the O eror has a clear understanding of the Government requirements as outlined in the TO -Statement of Work (TO- SOW)

Rating Methodology

The Government will evaluate all “Non-Cost” Factors based on a confidence rating system. The rating system will allow the evaluation board to identify strengths, weaknesses, and risks associated with each proposal.

DEA Technical Representative (Scientific and Technical Contact):

Trudy Amin, Ph.D.

Chemist

Drug and Chemical Evaluation Section

Drug Enforcement Administration