A29 - 15DDHQ21Q00000059 0001 SF30.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 0001 05-26-2021

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

DRUG ENFORCEMENT ADMINISTRATION

OFFICE OF ACQUISITION AND RELOCATION MGMT

8701 MORRISSETTE DRIVE

SPRINGFIELD, VA 22152

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, state and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

All interested offerors

15DDHQ21Q00000059

9B. DATED (SEE ITEM 11)

04-28-2021

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 11)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of amendment 0001 is to update the response date from June 1, 2021 at 10:00AM ET to July 1, 2021 at 10:00 AM ET. All changes are noted by a vertical line in the left margin.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR 15C.DATE SIGNED 16B. UNITED STATES OF AMERICA 16C.DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

Statement of Work

Evaluation of Benzodiazepine Substances using the Drug Discrimination Assay

I. Background

The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. These evaluations are used by DEA to support its domestic scheduling activities. In order for DEA to determine the abuse potential of drugs and chemicals, pharmacological, medical, epidemiological, and other scientific data for these drugs, when necessary, are needed to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances Act (CSA).

Recently, numerous designer substances with benzodiazepine-like activity have been abused in the United States and pose a significant risk to the public safety. Law enforcement and forensic laboratory databases have reported increased encounters of designer benzodiazepine substances. Severe consequences of designer benzodiazepine abuse include non-fatal overdoses and deaths. An increase in the likelihood of death occur especially when the designer benzodiazepines are combined with opioids. In the midst of the opioid epidemic, it is noteworthy that more than 30% of overdoses involving opioids also involve benzodiazepines according to the National Institutes of Health. Due to the immediate public health threat associated with these designer benzodiazepine substances, several of them have been placed under international control. In order to place designer benzodiazepine substances under national permanent control, pharmacological data is required.

Anxiolysis is a pharmacological property that is associated with benzodiazepine drugs.

The anxiolytic effects associated with benzodiazepines and related drugs have been reported to lead to abuse of this drug class. As such, DEA would like the vendor to assess the anxiolytic properties of the selected designer benzodiazepines in an in vivo pharmacological assay. Due to the time-sensitivity of this work, DEA is requesting that the pharmacological studies be initiated and completed in an expedient manner.

II. Brief Description of Work

For this project, DEA shall provide the designer benzodiazepine substances to the potential vendor. Therefore, the vendor should already have a Schedule II through V researcher registration (ideal) or be in the process of obtaining a Schedule II through V researcher registration. Researchers may obtain a schedule II through V research registration no later than 30 calendar days following notification of award. The vendor shall conduct preclinical anxiolytic evaluations of these substances in comparison to appropriate controls and reference standard benzodiazepine substances (e.g., midazolam, diazepam, alprazolam etc.). Each compound shall be assessed for benzodiazepine anxiolytic effects. The vendor shall provide DEA with investigational study results and a description of the methodology used to conduct the investigation in the form of a study report based on the timeline specified in this statement of work (SOW), if not earlier. The vendor shall evaluate up to 15 designer benzodiazepine substances. Upon award of the contract, the vendor shall be notified of the number of substances that shall be tested and the identity of these substances. The designer benzodiazepine substances shall be provided by DEA to the vendor in quantities sufficient for the proposed pharmacological studies. It is the vendor’s responsibility to purchase reference (control) compounds for the anxiolysis studies.

The drugs for conducting locomotor activity and drug discrimination studies on include but may not be limited to:

1. Flualprazolam Cayman 24481

2. Flubromazolam Cayman 16435

3. Clonazolam Cayman 18173

4. Metizolam Cayman 23111

5. Adinazolam Cayman 18205

6. Etizolam Cayman 12063

7. Brotizolam not at Cayman

8. Bromazolam Cayman 22665

9. Diclazepam Cayman 15554

10. Deschloroetizolam

NOTE: Substances in the above list may be differentially prioritized depending on the severity of their current trafficking. Additionally, substances may be exchanged for other substances not currently included in the above list due to changes in emerging trends with respect to trafficking.

III. Specific Tasks to be Performed For all seven tasks listed, the offeror must provide evidence that they have previously performed the task by submitting or indicating a citation for a publication in which they were primarily involved in conducting the protocol.

OR

The offeror must demonstrate their ability to formulate the protocol necessary to complete the task and also demonstrate that they physically possess all equipment necessary to complete the task as described in the protocol they formulated or cited.

Task 1. Drug source, storage and recordkeeping

I. Drug Source: DEA shall provide test substances to the vendor. The vendor is responsible for obtaining the training drug (midazolam or diazepam), reference substances (alprazolam), and any other substances needed to complete the studies.

II. Record Keeping: The vendor shall maintain electronic and paper copies of a chronological log of the test substance receipt and evaluation using a preformatted Microsoft Excel spreadsheet template provided by DEA. The preformatted template is not to be altered by the vendor in any way. If the vendor identifies the need to add further information not already included in the preformatted template, the vendor shall inform the DEA representative of such needs. When each substance is received, the following shall be recorded in the preformatted template:

a. test substance’s name;

b. date of authorization for testing of the test substance;

c. date of receipt of the test substance (if provided by DEA);

d. amount of test substance received (if provided by DEA);

e. pharmacological studies authorized by DEA for the test substance (e.g. drug discrimination);

f. date of initiation of each study authorized by DEA;

g. amount of test substance used for each authorized study;

h. date of completion of each authorized study;

i. date of the submission of each study report to DEA.

These records shall be kept up to date and forwarded to the DEA representative upon request.

III. Drug Storage and Schedule II-V Researcher Registration Requirement: Some of the reference and test substances may be in Schedule II-V of the CSA and shall be stored in accordance with the regulatory requirements as specified by the CSA. The vendor shall be registered with DEA as a Schedule II-V researcher. The vendor shall adhere to appropriate CSA regulatory requirements (i.e., appropriate registration, storage, etc.) related to such substances. In cases of non-controlled test substances, drug storage and handling shall be maintained as per the Good Laboratory Practices (GLP) or GLP-like conditions.

Task 2. Protocols of in vivo pharmacological studies (locomotor activity, drug discrimination studies) in laboratory animals

General protocols that are used for in vivo locomotor activity and drug discrimination studies and standard operating procedures (SOP) shall be provided by the vendor to DEA. The protocols shall contain a description of the methodology used to conduct the investigation, and description of the apparatuses that shall be used for conducting the studies, maintenance of the animals to be used in the tests, procedures for analysis of the data including proposed statistical methods, and proposed presentation of the data and study results. Specifically, the study protocol should conform to the following standards:

I. A study protocol shall be provided for each individual in vivo pharmacological study.

For example, one protocol should be provided for locomotor activity and one protocol for drug discrimination study.

II. The study protocols must be specifically written to meet the protocol preferences as listed in this SOW under Tasks 3 and 4.

III. The study protocol should closely follow the format of the materials and methods section that would be submitted for a peer-reviewed journal article. Details including the animal strain, number of animals, animal care, experimental design, data analysis including statistical methods and generation of results (e.g., ED50 and 95% confidence limit values, repeated measures ANOVA as appropriate) shall be included.

IV. The study protocol shall include examples of how data shall be presented. For example, representative dose-response curves, tables, and statistical analyses should be included.

This information can be taken from previously published studies. However, this information should be included in a section as part of the study protocol and shall not be submitted as a separate file, but the data should be cited (i.e. submitting the example paper with the study protocol would not be considered acceptable).

V. Signature lines shall be included on each study protocol. Upon approval of the protocol by DEA and the vendor, the protocol shall be signed by each representative. The original signed document shall remain with DEA. A copy of the signed protocol shall be provided to the vendor. The signed protocols shall serve as an official record.

Following receipt of the standard protocols by the DEA representative, a phone conversation may be scheduled to discuss the study protocols and SOPs. Any significant deviations or modifications from the protocol by the vendor must be authorized by DEA. The vendor must provide a modified protocol (e.g., change in time points, change in vehicle used, modification needed based on a specific test substance, etc.). The amended or modified protocol must be submitted in writing to the DEA representative for review and approval. The DEA representative must approve work with each new assay modification.

NOTE: The DEA representative must approve work with each new test method prior to its initiation. Only those test substances specified by DEA shall be evaluated in the new study under development. For the most part, standard substances (known drugs of abuse such as diazepam, midazolam, alprazolam, and others) shall be used. Special reports and data summaries shall adhere to a format determined by the DEA.

Task 3. Evaluation of test substances in the in vivo locomotor activity study

I. Objective: Using the general protocol and SOPs agreed to by the vendor and DEA in Task 2, the vendor shall, as specified by the DEA representative, evaluate standard

(reference) and/or test substances using the in vivo locomotor activity assay. The goal of the in vivo pharmacological study (locomotor activity study) is to determine whether the test substance can elicit changes in locomotor activity of the rodent. Further, this study can be used to identify parameters to include but not limited to onset of action, time to peak effect, duration of action, and dose effect response before conducting other behavioral tests for the test substances.

II. Experimental Design: Locomotor activity assays shall be conducted in rodents unless otherwise agreed upon by both DEA and the vendor. Briefly, the locomotor activity test shall be conducted in an automated activity monitoring chamber located in a sound-attenuating device that provides dim illumination. Prior to testing, rodents shall be injected via appropriate route with either vehicle, reference substances, or test substance and immediately placed in the chamber for locomotor activity monitoring. In all studies, horizontal activity (interruption of photocell beams) shall be measured. Testing shall be conducted with one rodent per activity chamber. Experimental groups for evaluating each test substance should consist of appropriate number of doses (three experimental doses at a minimum). Using a pharmacologically-effective dose range to generate a dose response curve, and statistically appropriate number of animals per group (at least 8 animals). Appropriate controls shall be used. For each test substance, ED50 (50% effective dose) and 95% confidence limit values shall be calculated. Data on dose-response curves shall also be presented and reported.

III. Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g., inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constraints), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if the issue was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email.

All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.

IV. Study Report: Following completion of the in vivo locomotor activity study for each test substance, the results in the form described in Task 5 (e.g., ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact the vendor if there are any notable issues with the results.

Task 4. Evaluation of test substances in in vivo drug discrimination assay

I. Objective: The goal of this in vivo pharmacological study is to understand whether the test substances can be substituted for the discriminative-stimulus effects produced by a known drug of abuse. Using the general protocol and SOPs agreed to by the vendor and DEA in Task 2, the vendor shall, as specified by the DEA representative, evaluate standard (reference) and/or test substances using the in vivo drug discrimination assay.

II. Experimental Design: Drug discrimination studies shall be conducted in rats unless otherwise agreed upon by both DEA and the vendor. The vendor and DEA shall agree on the strain of rodent to be used for each of the studies. The vendor shall maintain groups of animals (rats) trained to discriminate the stimulus effects of midazolam or diazepam from its vehicle. It is expected that drug discrimination training for the animals commence within a week after the protocol is approved. The reference drug shall be alprazolam unless otherwise directed by the DEA representative. The training and reference drugs should be tested periodically to establish a dose-effect reference standard in the rats. The vendor shall have the equipment available for drug discrimination testing procedures such that the experiments can be conducted in a relatively expedient manner for this assay. Additionally, it is encouraged to have multiple and/or automated apparatus for evaluating the discriminative stimulus effects in order to increase efficiency of completing the experiments.

III. Potential Experimental Issues and Reporting: In the even that any experimental issues arise (e.g., inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constraints), the vendor shall immediately notify the DEA representative in writing (email) with the issue and if the issue was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email.

All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.

IV. Study Report: Following completion of the in vivo locomotor activity study for each test substance, the results in the form described in Task 5 (e.g., ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact the vendor if there are any notable issues with the results.

Task 5. Final study report for each substance tested

Following completion of the experiments in Tasks 3 and 4, a final study report containing the complete methodology, data analysis, and study results for each test substance shall be provided in electronic format to DEA.

I. Study Reports: A final study report containing the complete methodology, data analysis, and study results for each compound/assay shall be provided to DEA. DEA representative shall provide an example of a Final Study Report for the vendor to use in preparation of the report. Raw data and final study results must be submitted in a preformatted template specified by DEA at scheduled time-points. Formatting of the specified template provided by DEA cannot be altered by the vendor in any way. If additional formatting is needed to accommodate data entry, the vendor shall notify DEA of their requirements and DEA shall provide a re-formatted template for data entry and aggregation. In addition to the pre-formatted template provided by DEA, where feasible, data shall be presented in tables and figures and the results shall be described in a textual format. Raw data should also be included in and appendix to the report. The vendor shall first submit a draft report using Microsoft word to the DEA representative. Upon review by the DEA representative, revisions may need to be made. Once revisions are completed or the draft is cleared by the DEA representative, final copies of the report shall be provided to the DEA representative in electronic MS Word version as well as a portable document file (pdf) format. Each report shall be due no later than thirty (30) calendar days after the study completion date. The format for the pdf document shall be as follows:

a. Front cover to contain: Date, title (to include compound name), researcher (name/address/phone number, email), contract number, DEA representative (name).

b. Main body to contain: (1) A brief (one or two paragraph) summary of the findings

(2) detailed methods, and (3) results organized as text, tables, and/or figures, as agreed upon with DEA representative.

Task 6. Reporting Requirements

All reports required herein shall be submitted in electronic format to the DEA representative as detailed in the following subsections. The preparation and submission of regularly recurring Technical Progress Reports shall be required for this agreement. These reports shall require descriptive information about the activities undertaken during the reporting period and shall require information about planned activities for future reporting periods. The frequency and specific content of these reports shall be determined by the DEA representative.

I. Monthly reports: On or before the 5th working day of each month, the vendor shall submit one electronic copy in PDF format of a report on activities during the month. In the report, vendor shall include: 1) all test study reports completed during the month; 2) a table, or set of tables, of all compounds tested in the contract, with the main results so far, and 3) entries for the compounds next in line for testing as specified above.

II. Study Reports: See Task 5 for details on these reports.

III. Progress Reports: On or before the 5th working day following the end of each period of performance year, the vendor shall submit a report on activities during the year. One electronic copy in Microsoft Word or PDF format, shall be sent to DEA representative. In the report, vendor shall include: section 1 – a summary of the overall results generated on standard compounds during the past 12 months; section 2 – a brief summary of any problems encountered while conducting the established experimental assays and, if applicable, a description of how those problems were resolved, as well as a brief summary of progress in any experimental assay development; section 3 – the log of all substances purchased; section 4 – any other information required. The summary of overall findings (section 1) should not be an all-inclusive summary of data generated on standard substances but, rather a summary of highlights.

Task 7. Level of Effort

The DEA representatives reserve the right to visit the laboratory where testing is being conducted.

I. Meetings between DEA and vendor:

a. Monthly conference calls: After submission of the monthly report, the vendor and the DEA representative shall have a teleconference meeting once a month. Other DEA and contract staff may participate if necessary. These meetings may be waived at the discretion of the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.

b. In-person meetings: DEA representatives may set-up a meeting with the vendor for the purpose of reviewing past, current, and/or proposed work under this agreement. These meetings may be waived at the discretion of DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.

c. Pre-Meeting Materials: Two weeks before each meeting, the vendor shall prepare "pre-meeting packets" summarizing all data on test compounds to be presented and describing relevant assay methods. This packet shall also include summaries of: (1) proposals for optimizing existing assays; (2) progress in ongoing assay development; (3) proposals for new assay development; (4) problems encountered in implementing tasks required in the agreement; and (5) proposed solutions to problems encountered. The vendor shall deliver this information to the DEA representative at least 2 weeks in advance of the meeting for approval, and after approval has been obtained, to each consultant at least 2 weeks prior to the meeting.

d. Post-Meeting Materials: After the meeting, the vendor shall prepare a post- Meeting report, summarizing the recommendations and comments of the attending consultants and DEA staff. The report shall include recommendations for optimizing specific assays and suggestions for incorporating new assays into the DEA testing program. The Post- Meeting Report shall be sent to the DEA representative within two (2) weeks of the meeting.

e. Meeting Location(s): The site of the meeting shall be either at the annual scientific meetings of professional associations such as the College on Problems of Drug Dependence and the Society for Neuroscience, DEA headquarters or other locations as specified by DEA. This agreement shall not be responsible for the payment of DEA consultants' expenses. Meetings via video teleconference to discuss status and other issues may be held, but could be cancelled at DEA’s discretion.

IV. Period of Performance

The period of performance for this agreement shall be for a 12 month duration with two six-month options. The exact dates of the period of performance are to be determined. If the agreement at the end of one year is terminated by one or both parties, the period of performance shall no longer extend to subsequent years. Prior to shortening the period of performance, a written notification shall be provided with 90-day notice.

V. Deliverables

If a report on any of the requested studies cannot be provided by the specified timelines, the vendor must notify DEA immediately upon obtaining this knowledge. This notification shall be followed up by a letter to DEA stating the reason for the delay, the anticipated date of completion of investigations, and the anticipated delivery of the study.

TASK

NUMBER

DELIVERABLE DELIVERY

SCHEDULE

1 Project kick-off meeting to discuss overall project expectations, timelines, and deliverables.

Agreed protocols of the in vivo locomotor activity and drug discrimination assays (with noted modifications, if necessary)

Within 2 working days following receipt of protocol.

Initial protocols to be provided to DEA within 30 calendar days after start of the agreement period.

Modified or revised protocols to be provided to DEA for review within 7 calendar days of discussion/notification by either party that the protocol must be modified or revised.

2 Monthly Status Reports 30 days from contract award date and monthly thereafter.

3 Study Report To DEA no later than 30 calendar days after study completion date.

5 Annual Progress Reports To DEA on or before the 5th working day following each year.

6 Final Report To DEA on or before the expiration of the agreement period.

7 Laboratory Records and Test Substances To DEA on or before the expiration of the agreement period.

VI. Use of Data

All documents, data, materials, records, and information sources provided to the vendor, developed or maintained by the vendor in the performance of this contract under this SOW are deemed to be the property of DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release. None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the Statement of Work, without prior written approval of DEA. DEA and the vendor shall mutually agree to discuss matters of Freedom of Information Act (FOIA) policy before each agency independently discloses requested information.

On or before the agreement year expiration, the vendor shall deliver (or otherwise dispose per DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or manipulate data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).

During or after the agreement, no data may be released, presented or published except upon prior approval of DEA. All requests which the vendor shall receive from third parties for access to the data must be referred to DEA.

VII. Retention of Information

The vendor shall retain, for 5 years beyond the duration of this agreement, all laboratory notebooks (which shall include paper copies of raw data) and electronic data files. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and paper copies of raw data. On or before the expiration date of this agreement, if so instructed by DEA, the vendor shall ship these items to the DEA representative in Arlington, VA.

VIII. Security Requirements

All contractor personnel supporting this procurement are entrusted with a certain level of trust due to the nature of DEA’s mission. The Government expects the vendor shall 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 shall be performed outside of DEA, all contractors must be escorted if entering a DEA facility. DEA reserves the right to modify the security requirements found in this contract at any time. The Diversion Control Division has agreed to accept all programmatic risk for the loss of any data as a result of the request to waive the U.S. citizenship requirement. The U.S. citizenship requirement has been waived for this effort only.

DEA representative (Scientific and Technical Contact): To be provided at award

IX. Instructions to Offerors

Questions /communications –

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 received by the FACD.Proposal.Submission@dea.usdoj.gov no later than May 11, 2021 at 10:00 am EST. All questions and answers will be provided to contractors as an amendment to the solicitation prior to the quote due date.

Time, date, and place for submission of quote

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 by July 1, 2021 at 10:00 AM EST via email at FACD.Proposal.Submission@dea.usdoj.gov. Please reference 15DDHQ21Q00000059 in the subject line of the email quote submission.

General Instructions mailto:FACD.Proposal.Submission@dea.usdoj.gov JBJordan Line

This will be a lowest price technically acceptable, all-or-none procurement based on the listed chemicals. 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.

Page limit

The Proposal shall not exceed 25 pages not including references or citation pages. The Proposal shall be written in plain English, in a concise, easy to read manner. Pages shall be standard 12 point (or larger) Times New Roman font. Legible, smaller font is allowed in graphics and tables.

Title page, table of contents, and index shall NOT be counted in the page count limitation.

DEA PROVISION & CLAUSE MATRIX – COMMERCIAL ITEMS

Updated through FAC 2021-01

October 2020 Page 1 of 22

SOLICITATION #: 15DDHQ21Q00000059

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:

[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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(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)

CONTINUED ON NEXT PAGE

October 2020 Page 3 of 22

SOLICITATION #: 15DDHQ21Q00000059

OFFERORS – COMPLETE THE REPRESENTATIONS BELOW AND RETURN THEM WITH YOUR OFFER OR QUOTE IF THE VERSION 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 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/

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SOLICITATION #: 15DDHQ21Q00000059

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

(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 (OCT 2020)

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…