A30 - 15DDHQ21Q00000083.pdf

Procurement Sensitive

Contract Synthesis of Chemical Substances - SOW

U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

Synthesis of Chemical Substances

Diversion Control Division (DC)

REQUEST FOR QUOTE

15DDHQ21Q00000083

REQUEST FOR QUOTATIONS This RFQ is is not a Small Business-Small PAGE OF PAGES (THIS IS NOT AN ORDER) Purchase Set Aside 1

1. REQUEST NO. 2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

15DDHQ21Q00000083

5A. ISSUED BY 6. DELIVER BY (Date)

DEA

Office of Acquisition and Relocation Management 8701 Morrissette Drive Springfield VA 22152 7. DELIVERY

FOB

DESTINATION OTHER

(See Schedule)5B. FOR INFORMATION CALL: (No collect calls)

NAME TELEPHONE NUMBER 9. DESTINATIONAREA CODE & NUMBER

Jennifer Jordan jennifer.b.jordan@usdoj.gov DEA 8701 Morrissette Drive Springfield VA 22152

8. TO:

To all prospective Small Business Offerors.

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5A ON OR

BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5A. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State, and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

Please provide a quote in accordance with the attached Request for Quote

0.00

0.00

0.00

0.00

GRAND TOTAL $0.00

12. DISCOUNT FOR PROMPT PAYMENT - -

a. 10 CALENDAR DAYS b. 20 CALENDAR DAYS c. 30 CALENDAR DAYS d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF QUOTATION

All interested offerors shall include the following:

DUNS Number:

Cage Code:

16. SIGNER

a. NAME (Type or Print) b. TELEPHONE

AREA CODE & NUMBER

c. TITLE (Type or Print)

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 18 (REV. O6-95)

Prescribed by GSA FAR (48 CFR) 53.215-1(a)

Aug 3, 2021 at 1:00PM ET

1.0 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.

This BPA is intended for use for all DOJ components, but it is anticipated DEA will be the primary component issuing call orders.

2.0 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.

3.0 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.

4.0 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.

Class Quantity Price Opioids- Benzimidazole class

0.1 mg – 100 mg >100 mg – 500 mg

>500 mg – 999 mg 1g – 3g >3g – 5g

Opioids- Fentanyl class 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Opioids-Other structural class

0.1 mg – 100 mg

>100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Benzodiazepines 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

PCP-like 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Barbituates 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Tryptamines 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Amphetamines 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Synthetic Cannabinoids 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g

>3g – 5g Phenethylamines 0.1 mg – 100 mg

>100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Lysergamides 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Synthetic Cathinones 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Piperazines 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Aminoindanes 0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Non-specified structural class

0.1 mg – 100 mg >100 mg – 500 mg >500 mg – 999 mg 1g – 3g >3g – 5g

Other1 Per substance, if applicable

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

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 DOJ technical representative before synthesis may begin. Contractor shall immediately notify the DOJ 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 DOJ 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 DOJ 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 Pharmacological Classes Examples of general classes Examples of substances in each class

Depressants Opioids (varying structural classes)

Fentanyl, AH-7921, isotonitazene

Benzodiazepines Alprazolam, temazepam, bromazolam PCP-like Methoxetamine (MXE) Barbituates Phenobarbital, Secobarbital

Hallucinogens Tryptamines alpha-methyltryptamine (AMT), 5- MeO-DMT

Amphetamines Methamphetamine, MDMA Synthetic Cannabinoids APINACA, JWH-018, 5F-ADB Phenethylamines 2C-E, 25H-NBOMe PCP-like Methoxetamine (MXE) Lysergamides LSD, 1B-LSD

Stimulants Synthetic cathinones 4-methylethcathinone (4- MEC), alpha-pyrrolidinovalerophenone (α-PVP)

Piperazines benzylpiperazine (BZP), 1-(3-chloro)piperazine (mCPP)

Aminoindanes 5,6-methylenedioxy-2-aminoindane (MDAI)

PCP-like Methoxetamine (MXE) Phenethylamines 2C-E, 25H-NBOMe

Non--speficied structural class

Any substance that is not captured in the above categories

1.3-dimethylamylamine (DMMA)

2. Delivery: Upon completion of synthesis and purification, the contractor shall notify (email) the DOJ technical representative when the substance(s) will be ready to be shipped. DOJ 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 DOJ technical representative. Each CoA shall include analytical data that confirms the substance’s identity, physical characteristics (color, form, etc.), purity2, and any other pertinent analytical information. Examples of acceptable analytical methods to confirm identity include: GC-MS, 2 Purity level will be approved by DEA technical representative prior to beginning of synthesis.

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 releveant analytical spectra with response to this request.

5.4 Task 4. Reporting requirements

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

A. Weekly Progress Reports: Contractor shall provide weekly progress reports to the DOJ technical representative in writing. One electronic copy in Microsoft Word or PDF format shall be sent to the DOJ 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 DOJ 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).

6.0 PERIOD OF PERFORMANCE

Ordering Period There is a 60-month period for this BPA. Each BPA Call awarded under this Blanket Purchase Agreement (BPA) will have its own POP. BPA Calls may be awarded off of this BPA up to and including October 1, 2026. Each DOJ Component will issue their own BPA Calls.

7.0 PLACE OF PERFORMANCE

The contract will be carried out at the laboratory facility of the contractor. The DOJ technical representative reserves the right to visit the laboratory where synthesis occurs.

8.0 SECURITY - Applicable to DEA

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

Contract Synthesis of Chemical Substances - SOW a DEA facility.

9.0 DELIVERY/DELIVERABLES

A report on the status of the requested substances shall be provided to the DOJ 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 DOJ representative in writing.

Deliverable Description Quantity/Media Delivery Schedule

1. Lead time estimate and purity statement Written statement At least one week prior to synthesis

2. Synthesis Requested quantity of each substance

Based on approved lead time estimate and purity

3. Delivery Email notification 1-2 days after completion of synthesis and purification

4. Certificate of Analysis Written report confirming identity and purity

Upon completion of synthesis and purification; delivered with substance(s) and a copy to the DOJ technical representative

5. Weekly progress reports Written status update Weekly

6. Annual progress reports Written status update To DOJ on or before the 1 year date of each year of the award.

DEA ONLY

Requested substances will be delivered to the below address:

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

Dulles, VA 20166

If other DOJ components order from the BPA, they will provide the delivery address for substances.

10.0 RATING METHODOLOGY

Offerors shall provide sufficient information for the government to determine its level of confidence in the ability of the Offeror to perform the requirements of the RFQ base on as assessment of relevant experience from the contractor. The Government will assess it's level of confidence that the contractor will successfully perform the requirements based on their experience.

The following confidence levels will be used and illustrates to what degree the Offerors proposal meets the evaluation standards.

Table T-1 - (add in evalution factors)

Confidence Level Definitions

High Confidence The Government has high confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with little or no Government intervention.

Some Confidence The Government has some confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with some Government intervention.

Low Confidence

The Government has low confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract even with Government intervention.

DEA Technical Representative (Scientific and Technical Contact): TBD

INSTRUCTIONS TO OFFERORS

The Government anticipates a multiple award Blanket Purchase Agreement (BPA). All offerors shall submit a technical proposal, business proposal and quotation based on a sample BPA call in accordance with the SOW referenced in Section 2. All timely proposals received in response to this RFQ may be fully evaluated by the DEA. Items shall be quoted on an all or none basis.

Partial quotes will not be accepted. The contractor shall propose a quote for all years of the anticipated BPA. The Government reserves the right to make award based on initial offers without discussions. Therefore, the offeror is requested to submit its best proposal to the Government on the most favorable terms both from a technical and cost/price standpoint.

DURATION OF THE BPA AGREEMENT

The anticipated period of performance for services described herein is for 60 months after the date of award.

DELIVERY AND DESTINATION

Delivery and destination requirements will be clearly defined at the time individual call orders are placed. Deliveries shall be accompanied by a delivery ticket that shall contain the following information: name of supplier, BPA number, date of order; order number; itemized list of items;

quantity and price of each item; and date of delivery.

CALL LIMITATIONS (FAR 13.5)

No single call placed under this Agreement shall exceed $50,000.

INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THIS BPA

The individuals authorized to place calls under this Blanket Purchase Agreement, and the limits of their purchase authority are shown below:

UNLIMITED

DOJ Contracting Officers All call orders shall be placed prior to the start of the service period of performance.

INVOICES - DEA ONLY

See DEA Provision and Clause Matrix, DEA clause DEA-2852.242-71 (Invoice Requirements

(MAY 2012)

OFFER ACCEPTANCE PERIOD – The contractor shall provide an offer acceptance period of no less than 180 calendar days.

TIME, DATE, AND PLACE FOR SUBMISSION OF QUOTE

All communications concerning the solicitation, including any of a technical nature, shall be made through the Contract Specialist. All questions, technical or otherwise, shall be in writing and sent to FACD.Proposal.Submission@usdoj.gov and Jennifer.b.jordan@usdoj.gov no later than July 20, 2021 at 1:00PM EST. All questions and answers will be provided to contractors as an amendment to the solicitation prior to the quote due date.

mailto:FACD.Proposal.Submission@dea.usdoj.gov

The Government may reject all offers received in response to this solicitation, if doing so is in the best interest of the Government. Late submissions will not be accepted. No telephone or fax requests will be accepted. This solicitation does not commit the Government to pay any costs incurred in the submission of a quotation. Quotes shall be submitted electronically to Jennifer Jordan by Aug 3, 2021 at 1:00PM EST via email at FACD.Proposal.Submission@usdoj.gov and Jennifer.b.jordan@usdoj.gov and please reference 15DDHQ21Q00000083 in the subject line of the email quote submission.

PROPOSAL FORMAT/PAGE LIMITATIONS

The proposal shall be split into two separate volumes: Technical Proposal and Business Proposal.

The Technical Proposal and Business Proposal will be evaluated independently and shall not be combined into a single document. The following instructions establish the acceptable minimum requirements for the format and content. The Technical Proposal shall not exceed 20 pages and shall be single-spaced, 8.5 X 11-inch paper containing text no smaller than 12-point font not applicable to graphics, tables or resumes/CV’s. Each page shall be numbered accordingly.

The Business Proposal shall not exceed 5 pages and shall be single-spaced, 8.5 X 11-inch paper containing text no smaller than 12-point font. The Business Proposal shall contain a completed copy of Schedule of Services and Sample BPA Call.

COMPLIANCE WITH INSTRUCTIONS

When evaluating a contractor’s capability to perform the prospective BPA, the DEA will also consider compliance with these instructions. The Government will consider a contractor’s noncompliance with these instructions, or any attempt to evade the requirements imposed by these instructions, as indicative of the conduct the Government may expect from the contractor during BPA performance. The Government reserves the right to treat noncompliance with these instructions as a risk, and may treat such risk as grounds to eliminate any contractor from award consideration.

EXPENSES RELATED TO CONTRACTORS SUBMISSION

The Government will not pay any cost incurred in the preparation and submission of any proposals.

DETERMINATION OF CONTRACTOR RESPONSIBILITY

Separate and independent of this evaluation, the Contracting Officer will make a determination of responsibility using the standards listed in FAR 13.303. In the event a contractor is deemed not responsible, that contractor will be notified and removed from participation in this procurement.

GENERAL INSTRUCTIONS

To aid its evaluation, the proposal shall be clearly and concisely written as well as being neat, indexed, and logically assembled addressing each factor in the order specified by the solicitation.

All pages of each part shall be appropriately numbered and identified with the name of the contractor, and RFQ number. The proposal shall be specific and complete in every detail. The mailto:FACD.Proposal.Submission@dea.usdoj.gov mailto:Jennifer.b.jordan@usdoj.gov proposal shall be practical, straightforward with concise delineation of what it is the contractor will do to satisfy the requirements of the Statement of Work.

The proposal shall not merely offer to perform work in accordance with the scope of the work. It shall outline the actual work proposed as specifically as practical. Statement of Work reflects the objectives of the program, therefore merely stating or affirming that the contractor will execute the performance requirements without sufficient elaboration will not be acceptable.

Proposal Volumes I. Technical Proposal II. Business Proposal

VOLUME I:

FACTOR 1: TECHNICAL CAPABILITY

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

b. DEA Registration: This Factor assesses the Offeror’s ability to manufacture controlled substances. The Offeror must demonstrate that it has a DEA manufacture’s registration (must contain Schedule I and II) and is familiar with, and has been in compliance with, the requirements necessary for the handling of controlled substances. The proposal shall discuss the Offeror’s procedure for the synthesis, purification, and shipment of controlled substances.

c. Administration Services: This Factor assesses the Offeror’s ability to provide effective administrative services throughout the life of the BPA. Proposals must demonstrate that the Offeror has a clear understanding of the Government requirements as outlined in the BPA -Statement of Work.

d. Ability to perform tasks listed in SOW

FACTOR 2: PERSONNEL

The Offeror must demonstrate that its proposed personnel are optimally suited for the effort. Offeror shall send resumes to support their determination. Preferential background includes: Chemistry background/degree(s) of people in lab, lab staff structure (lead scientist, scientific staff, etc.), years of experience doing synthesis, number of people who will potentially work on different BPA calls.

FACTOR 3: COMPANY EXPERIENCE:

Offerors (prime and subcontractor(s)) shall submit with its offer a minimum of three (3) contracts or task orders, performed during the past five (5) years that are representative of the Offeror’s capability to provide services with similar scope, magnitude, and complexity of prior performance, similar to that stated in the Statement of Work (SOW).

The Offeror shall also specifically address its resilience in the face of trouble, resourcefulness, and management determination to see that the organization lived up to commitments or standards. Contracts or task/call orders listed may include those entered into by the Federal Government, agencies of state and local Governments and commercial customers. Include the following information for each contract:

• Project title

• Whether the contractor performed as the prime or subcontractor

• Agency Managing Project

• Client/Agency Point of Contact (POC) to include name, phone number, and email address

• Project Agency Contract / Order Number

• Period of Performance

• Value by year of contract/order

• Discuss in detail their performance

The Government may supplement the information provided by the offeror with information the Government obtains through reference checks, its own knowledge/ experience, and/or from other sources. These sources may include, but are not necessarily limited to, other Government contracting offices, the Contractor Performance Assessment Reporting System (CPARS), and the Past Performance Information Retrieval System

(PPIRS).

VOLUME II: BUSINESS PROPOSAL:

The contractor shall provide the following business information with their business proposal:

• Sample BPA Call – The Offeror shall propose individual pricing for each contract line item of the Schedule of Services. The Offeror shall complete Attachment 1 Sample BPA Call Order and provide the price per milligram (mg) or gram (g), respectively, in the Schedule of Services. The Schedule of Services table or the Sample BPA Call Order cannot be modified or edited in any capacity. In the event that the Schedule of Services or Sample BPA Call Order is modified, the vendor may be removed from consideration of award. Failure to provide pricing for all CLINS may result in elimination from further consideration.

• Company Name, Address, Point of Contact

• DUNS Number, Cage Code

• Business Size

• Completion of DEA-2852.209-70 – Organizational Conflicts of Interest (MAY 2012) – The Contractor shall refer to clause DEA-2852.209-70 located in attached clause matrix.

• Any changes or updates to the representations and certifications on file in the System for Award Management as required by paragraph (b) of Federal Acquisition Regulation provision 52.212-3 Contractor Representations and Certifications – Commercial Items.

• Completion of DEA-2852.242-74 – Contract Administration Points of Contact.

• Completion of Standard Form 18 (Rev. 06-95)

EVALUATION OF OFFERORS

The Government anticipates a multiple award BPA resulting from this solicitation to offeror(s) that provide best value to the Government.

The following factors shall be used to evaluate Offerors:

VOLUME I:

FACTOR 1: TECHNICAL CAPABILITY

The Government will assess whether the prime contractor or major subcontractor will successfully perform the BPA requirements based on their ability to demonstrate:

a. Quality/Purity:

i. The Offeror’s ability to provide high purity synthetic substances throughout the life of the BPA.

ii. Offeror has a clear understanding of the Government requirements as outlined in the BPA Statement of Work.

iii. Offeror ability to have appropriate chemical and analytical equipment necessary to produce the best quality product possible.

b. DEA Registration:

i. Offeror’s ability to manufacture controlled substances.

ii. Offeror has a DEA manufacture’s registration (must contain Schedule I and II) and is familiar with, and has been in compliance with, the requirements necessary for the handling of controlled substances.

iii. The Offeror’s procedure for the synthesis, purification, and shipment of controlled substances.

c. Administration Services:

i. Offeror’s ability to provide effective administrative services throughout the life of the BPA.

ii. The Offeror has a clear understanding of the Government requirements as outlined in the BPA -Statement of Work.

d. Ability to perform tasks listed in SOW

FACTOR 2: STAFFING PLAN

The Government will assess whether the prime contractor or major subcontractor will successfully perform the BPA requirements based on their ability to demonstrate proposed personnel are optimally suited for the effort.

FACTOR 3: COMPANY EXPERIENCE:

The Government will assess its level of confidence that the prime contractor or major subcontractor will successfully perform the BPA requirements based on its corporate experience, considering matters such as:

a. Capability to provide services with similar scope, magnitude, and complexity of prior performance, similar to that stated in the Statement of Work (SOW).

b. Resilience in the face of trouble, resourcefulness, and management determination to see that the organization lived up to commitments or standards.

The Government may supplement the information provided by the offeror with information the Government obtains through reference checks, its own knowledge/ experience, and/or from other sources. These sources may include, but are not necessarily limited to, other Government contracting offices, the Contractor Performance Assessment Reporting System (CPARS), and the Past Performance Information Retrieval System

(PPIRS).

VOLUME II: BUSINESS PROPOSAL:

The Government will evaluate the pricing based on the Sample Call Order. The Sample Call Order is for evaluation purposes only, but does reflect a sample or estimate of work anticipated under this BPA. The Government will also determine price reasonableness of the pricing provided in the Schedule of Supplies.

BASIS OF AWARD

The Government intends to award multiple blanket purchase agreements (BPAs) on a best value basis to the Quoters that are determined to be the most advantageous to the government. Quoters are cautioned that an award may not necessarily be made to the lowest priced Quoters. However, if non-price factors are evaluated as comparatively equal between two or more Quoters, price may become a determinative factor.

DEA PROVISION & CLAUSE MATRIX – COMMERCIAL ITEMS

Updated through FAC 2021-04

April 2021 Page 1 of 21

SOLICITATION #: 15DDHQ21Q00000083

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address:

https://www.acquisition.gov/far-smart-matrix.

(End of provision)

CONTRACTING OFFICER: Check the corresponding box for the provisions and clauses applicable to this procurement.

52.204-6 UNIQUE ENTITY IDENTIFIER (OCT 2016)

52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

52.204-7 ALT I SYSTEM FOR AWARD MANAGEMENT (OCT 2018) WITH ALTERNATE I OCT 2018)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

52.209-12 CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

52.211-6 BRAND NAME OR EQUAL (AUG 1999)

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)

52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical Capability Past Performance Price

[Contracting Officer shall insert the significant evaluation factors, such as (i) technical capability of the item offered to meet the Government requirement; (ii) price; (iii) past performance (see FAR 15.304); and include them in the relative order of importance of the evaluation factors, such as in descending order of importance.]

Technical and past performance, when combined, are [Contracting Officer state, in accordance with FAR 12.602]

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

52.225-7 WAIVER OF BUY AMERICAN STATUTE FOR CIVIL AIRCRAFT AND RELATED ARTICLES (FEB 2016)

DEA-2852.209-75 NATIONAL SECURITY RISK ASSESSMENT (JUN 2014)

(a) Any offeror responding to this solicitation acknowledges that before acquiring information technology equipment or software, the U.S. Department of Justice and its component entities will assess the supply chain risk of cyber-espionage or sabotage associated with the acquisition of such equipment or software, including any risk associated with such equipment or software being produced, manufactured, or assembled by one or more entities identified as posing a cyber-threat, including but not limited to, those that may be owned, directed, or subsidized by the People’s Republic of China.

(b) By submitting an offer to this solicitation, the Offeror understands and agrees that the Government retains the right to reject any offer or response to this solicitation made by the Offeror, without any further recourse by, or explanation to, the Offeror, if the Government determines the Offeror or the equipment or software offered by the Offeror, in whole or in part, presents an unacceptable risk to national security.

(c) To assist the Government in assessing whether the acquisition poses a national security risk, offerors are required to complete and submit with its offer or quotation the National Security Acquisition Risk Assessment Questions, which are attached to this solicitation. Offerors must answer all questions completely and accurately to the best of their knowledge and belief. All answers are to be reflective of the parent and subsidiary levels of an organization.

https://www.acquisition.gov/far-smart-matrix https://www.acquisition.gov/content/52204-6-unique-entity-identifier https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52209-7-information-regarding-responsibility-matters https://www.acquisition.gov/content/52209-12-certification-regarding-tax-matters https://www.acquisition.gov/content/52211-6-brand-name-or-equal https://www.acquisition.gov/content/52212-1-instructions-offerors-commercial-items https://www.acquisition.gov/content/52212-2-evaluation-commercial-items https://www.acquisition.gov/content/15304-evaluation-factors-and-significant-subfactors#i1108563 https://www.acquisition.gov/content/part-12-acquisition-commercial-items#i1112620 https://www.acquisition.gov/content/52225-7-waiver-buy-american-statute-civil-aircraft-and-related-articles

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SOLICITATION #: 15DDHQ21Q00000083

(d) Offerors are also required to request, collect, and forward with its offer or quotation completed National Security Acquisition Risk Assessment Questions from all subcontractors that will provide any equipment or software in performance of the contract or order. Offerors are responsible for the thoroughness and completeness of each subcontractor's submission.

(e) Failure to provide any such requested information may render a proposal unacceptable.

(End of provision)

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April 2021 Page 3 of 21

SOLICITATION #: 15DDHQ21Q00000083

OFFERORS – COMPLETE THE REPRESENTATIONS BELOW AND RETURN THEM WITH YOUR OFFER OR QUOTE IF THE VERSIONS OF THESE PROVISIONS IN YOUR ANNUAL REPRESENTATIONS AND CERTIFICATIONS IN THE SYSTEM FOR AWARD MANAGEMENT ARE EARLIER THAN OCT 2020.

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision— Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(d) Representation. The Offeror represents that—

(1) It will, will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that— It does, does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained:

Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.sam.gov/

April 2021 Page 4 of 21

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained:

Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021)

Attention is drawn to paragraph (b) of provision 52.212-3, which requests offeror-provided fill-in information in (b)(2), when applicable:

(b)(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM.

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (u) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

***** Paragraph (i) Contracting Officer fill-in information: Paragraph (i)(1): The end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor are listed by Schedule of Supplies/Services Item Number as follows: [when applicable, enter item numbers with country of origin in parentheses and separated by commas]

***** Paragraph (k) Contracting Officer fill-in information: select applicable item when an exemption to the Service Contract Labor Standards statute applies.

Paragraph k(1) is applicable. Paragraph k(2) is applicable.

(v) (2) The Offeror represents that—

(i) It does, does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(ii) After conducting a reasonable inquiry* for purposes of this representation, that it does, does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

* Reasonable inquiry has the meaning provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

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https://www.acquisition.gov/content/52212-3-offeror-representations-and-certifications-commercial-items http://www.sam.gov/ https://www.acquisition.gov/content/52212-3-offeror-representations-and-certifications-commercial-items https://www.acquisition.gov/content/part-4-administrative-matters#i1121876 https://www.acquisition.gov/far/52.204-25

April 2021 Page 5 of 21

SOLICITATION #: 15DDHQ21Q00000083

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/far-smart-matrix.

(End of clause)

CONTRACTING OFFICER: Check the appropriate box only for clauses that are applicable to this procurement.

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (JUN 2020)

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (JUN 2020)

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

52.204-12 UNIQUE ENTITY IDENTIFIER MAINTENANCE (OCT 2016)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020)

52.204-19 INCORPORATION BY REFERENCE…