A23 - RFI_Chemical Substances.docx

REQUEST FOR INFORMATION

Drug Enforcement Administration Diversion Control Division

THIS IS A REQUEST FOR INFORMATION ANNOUNCEMENT ONLY. This is not a solicitation and is issued solely for information, planning purposes and market research only. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP. This RFI does not commit the Government to contract for any supply or service. The Drug Enforcement Administration (DEA) is not at this time seeking proposals. The purpose of this RFI is to seek information about existing contractors that can provide the service stated in the Statement of Work (SOW).

The DEA consistently seeks to obtain information and comments from public, private or other entities that will provide the agency with insight into market conditions and/or scientific advances that will aid in the refinements of requirements and the formation of an acquisition strategy to determine a laboratory capable of performing the requested services.

This RFI is designed to conduct market research to determine the current level of availability in the current market. The DEA is interested in obtaining information from contractors that can meet the requirements in the SOW. Small businesses and academic laboratories are encouraged to respond to this RFI in order to assist the DEA in determining the potential level of interest, adequate competition, and technical capability of the Small Business community to fulfill this requirement. However, responses to this RFI are solicited from all interested parties.

Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on the Federal Business Opportunities (FedBizOpps) website. It is the responsibility of the potential offers’ to monitor these sites for additional information pertaining to this requirement.

Responses

Interested parties are requested to respond to this RFI with a white paper of no more than five pages.

Section 1:

Section 1 of the white paper shall provide administrative information, and shall include the following as a minimum:

Company name; mailing address; physical address; point of contact(s); telephone number, fax number; email address; Federal Tax Identification Number, DUNS number; NAICS code; company business size (if small indicate type); and GSA schedule number (if applicable), and must be registered in Systems for Award Management (www.SAM.gov) to be considered for this requirement.

A corporate or company capability statement between one and five pages that includes relevant experience within the last three years. Relevant experience is defined as possessing the experience described in the SOW. The capability statement should include a detailed description of similar tests/studies performed with other government agencies.

A representative sample of contracts your firm was awarded to provide the requirements as described in this notice within the past three years. For each contract listed include the type of contract; total estimated value; contract period of performance (e.g., base and number of option periods); customer (i.e. federal agency) and respective point of contact (e.g., point of contact’s name, phone number, and email address).

The Government encourages creativity and innovation in responses to the RFI. The North American Industry Classification System (NAICS) code applicable to this requirement is 621511. Interested parties are requested to submit the above requested information (Capabilities Statements and White Page) via email directly to Jennifer Jordan at jennifer.b.jordan@usdoj.gov no later than May 5, 2021, 10:00 a.m. local Eastern Daylight Time. Any responses received after the closing date will not be considered. No literature will be returned to responding sources and each source is solely responsible for all expenses associated with submitting their literature. All information will be kept confidential and will not be disseminated to the public. This sources sought synopsis neither constitutes a Request for Proposal (RFP), nor does it restrict the Government to an ultimate acquisition approach. This synopsis should not be construed as a commitment by the Government for any purpose. Request for a solicitation will not receive a response.

Section 2:

Section 2 of the white paper shall address the requirements listed in ‘Specific Requirements to be Performed’ in the SOW. Responses should include a narrative as to how each task is to be structured and executed. The vendor is able to provide comments on the Statement of Work.

U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

Synthesis of Chemical Substances

Diversion Control Division (DC)

REQUEST FOR INFORMATION

Table of Contents

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. These evaluations are then used by DEA to develop appropriate drug controls and determine the status of controlled, excluded, or exempted drugs and drug products. In order for DEA to determine the abuse potential of 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. These substances span a wide range of pharmacological classes (i.e. hallucinogens, stimulants, depressants, etc.) and pose a significant risk to the public safety. Additionally, there is an expansive range of chemical structures that make-up the substances in each pharmacological class. 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 expeditiously obtain and study these emerging substances. As such, the synthesis of requested substances will be used in the initial collection of information, or to further enhance what is already known about those substances. The information gathered from the procurement, and further study of these substances, will support the goals of the Diversion Control Program.

Brief Description of work Contractor shall custom synthesize a large variety of chemical substances. Substances span a wide selection of chemical classes, such as cannabinoids, cathinones, opioids, etc. Synthesis and purification should yield varying quantities ranging from milligram- to gram-scale production. The contractor shall be familiar with current methodologies to minimize the lead time for synthesis and delivery of the requested substances. Synthesis shall be completed in the shortest amount of time practical.

Staffing Contractor shall provide qualified staff for the proposed roles, such as: Lab director, manager, scientist, and technician. Other roles requested shall be reviewed by the Government.

SCHEDULE OF SUPPLIES

Table 1 is the cost for synthesis of each class of substance that may be requested. Examples of each class of substance are shown in Table 2, under Task 2.

Table 1.

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

>100 mg – 500 mg

>500 mg – 999 mg

1g – 3g

>3g – 5g

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

Per substance, if applicable

Specific Requirements

5.1 Task 1. Lead time estimation and purity statement

Contractor shall provide a written (email) estimate of the time for synthesis of each substance at least 1 week prior to the beginning of synthesis. Contractor shall also provide a statement of the expected purity of each substance at least one week prior to the start of synthesis.

1. Lead time estimation: Contractor shall provide a written (email) estimate of the total time for synthesis and purification of requested substances. Estimate should state the shortest time possible for synthesis and purification. The DEA considers the “standard” lead time to be from in-stock to 10 weeks. Under certain circumstances, the contractor shall provide requested substances as a “rush” synthesis. The DEA considers a “rush” synthesis to be from two to four weeks, if the substance(s) is not in-stock.

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

a. In the event the Contractor fails to meet the requisite delivery time and fails to provide sufficient notice the Contracting Officer will request an additional discount for the products that were not delivered in accordance with the terms and conditions.

2. Statement of purity: Contractor shall provide a written (email) statement of the expected purity for each substance prior to synthesis. Final purity should be ≥98%, unless approved by the DEA technical representative. . TLC is not an acceptable method to determine purity of the final product. Acceptable methods to determine purity include, NMR, HPLC, etc.

In the event that the Contractor provides a substance that does not meet the agreed upon purity, the Contractor shall provide a replacement substance at no additional cost to the government. A quote may be requested before each call and should include: substance name(s), lead time, purity estimation, quantity, price, and shipping/handling cost (if applicable) for each substance requested.

5.2 Task 2. Synthesis and delivery

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

1. Classes of substances: Contractor shall synthesize substances from the following classes of substances including, but not limited to, hallucinogens, stimulants, and depressants (Table 2). For the purposes of this Statement of Work (SOW), metabolites and plant-based substances (THC-THCA, ect) are not included. However, if these substances are needed in the future, a quote will be requested for synthesis. Examples of each class of substances (non-exhaustive descriptions) are shown below.

Table 2. List of substance classes

2. Delivery: Upon completion of synthesis and purification, the contractor shall notify (email) the DEA technical representative when the substance(s) will be ready to be shipped. DEA technical representative shall approve final purity before shipment of substances. Contractor shall deliver requested items and 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 shall be shipped using appropriate storage conditions (ex. dry ice, refrigerated container, etc.) to ensure best quality product is delivered. Vendor shall submit invoice for payment once delivery is complete.

5.3 Task 3. Certificate of Analysis

A Certificate of Analysis (CoA) shall be sent with each substance shipped and an electronic copy shall be sent to the DEA technical representative. Each CoA shall include analytical data that confirms the substance’s identity, physical characteristics (color, form, etc.), purity[footnoteRef:2], and any other pertinent analytical information. Examples of acceptable analytical methods to confirm identity include: GC-MS, NMR, HPLC, etc. Information provided shall be specific to the batch shipped. Analytical spectra used (not just results) shall be provided with CoA. Contractor will provide a sample CoA and relevant analytical spectra with response to this request. [2: Purity level will be approved by DEA technical representative prior to beginning of synthesis.]

5.4 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. Weekly Progress Reports: Contractor shall provide weekly 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, (2) listing of substances already being processed, (3) cost for each substance, (4) expected synthesis completion date for each substance, (5) expected delivery date, and (6) documentation of problems and their resolution (if applicable).

B. Annual Progress Reports: At the end of each performance year, the contractor shall 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) itemized listing of cost per substance, and (3) summary of total cost for all substances synthesized and associated fees (if applicable).

period of performance

There is a 60-month period for this BPA. Each BPA Call awarded under this Blanket Purchase Agreement (BPA) will have its own POP.

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 synthesis occurs.

Security

The personnel security access level for this contract is Low Risk. The U.S. citizenship requirement for this effort has been waived. The program office accepts full responsibility for any loss of information as a result of setting aside the citizenship requirement. The Government expects the vendor will employ persons of integrity and trustworthiness. To ensure this, DEA reserves the right to conduct background screening or a full background investigation on all employees if a need arises. While all services provided on this contract will be performed outside of DEA, all contractors must be escorted if entering a DEA facility.

Delivery/Deliverables

A report on the status of the requested substances shall 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 shall immediately notify the DEA representative in writing.

Requested substances shall be delivered to the below address:

Reference Materials Program Special Testing and Research Lab 22624 Dulles Summit Ct.

Dulles, VA 20166 image1.emf