15DDHQ19Q00000012_(1).pdf

U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT

ADMINISTRATION

Evaluation of Abuse Potential of Synthetic Opioids Using In Vivo

Pharmacological Studies

Diversion Control Division (DCD)

RFQ: 15DDHQ19Q00000012

I. Schedule of Services – Section 1

Unit cost estimates for different pharmacological tests.

Advance payments for costs incurred to conduct assays as specified in Table 1 or 2 are not authorized. Vendor will bill DEA on a monthly basis based on actual expenses (i.e., consumables, assay costs). Expense report will include total number of assays completed and the unit cost of each type of assay (e.g., 4 drug discrimination assays x specified unit cost = $). Drug costs will vary depending on amount needed. Any drug amount exceeding 1 g or a cost of $500 will need approval by DEA prior to ordering.

Table 1. Assay costs for Base Year

Assay1 Unit Cost2 ($) Drug Discrimination (monthly maintenance of training drug)

Drug Discrimination of test drug Locomotor Activity

Drug Cost – Not to Exceed $500.00 Incidentals

TOTAL COST ($)

Table 1. Assay costs for Option Year I

Assay Unit Cost ($)

Drug Cost Not to Exceed $500.00 Incidentals

TOTAL COST ($)

Table 1. Assay costs for Option Year II

Assay Unit Cost ($)

1 All studies should include statistically appropriate number of animals per group (at least 8 animals).

2 This can include lab consumables, overhead cost (if applicable), etc.). Please itemize.

Drug Cost Not to Exceed $500.00

Table 1. Assay costs for Option Year III

Drug Cost Not to Exceed $500.00

Table 1. Assay costs for Option Year IV

Drug Cost Not to Exceed $500.00

Statement of Work

Evaluation of Abuse Potential of Synthetic Opioids Using In Vivo Pharmacological Studies

II. Background

The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section (DPE) 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 synthetic opioids have emerged within the United States and poses significant risk to the public safety. Numerous synthetic opioids have been identified in samples submitted to federal, state and local forensic laboratories. There have been reports of overdoses, including fatalities, associated with the abuse of these substances. In response to the associated public health threat with the abuse of synthetic opioids, the Administrator of the DEA has placed several synthetic opioids in Schedule I of the CSA under a temporary scheduling order to avoid an imminent hazard to the public safety. Preliminary studies (in vitro) have shown that these substances share pharmacological similarities with other known drugs of abuse. However, detailed information on their biological and pharmacological activities is limited.

III. Brief description of work

For this project, unless otherwise specified by the DEA representative, the vendor shall purchase the reference drugs and all test substances3 approved by the DEA for testing. The DEA will provide the test substances otherwise not commercially available to the potential vendor for the requested testing. Most of these substances are Schedule I substances. Therefore, the vendor should already have a Schedule I researcher registration with DEA. The vendor shall conduct appropriate preclinical studies on these substances in comparison to appropriate controls and reference standard substances. The reference training drugs shall include, but not be limited to morphine, fentanyl and other drugs as directed by the DEA representative. Each substance shall be assessed for its abuse potential by using appropriate studies in rodents. The vendor will provide the 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. If a report on all requested studies cannot be provided by the specified timelines, a letter stating the anticipated date of completion of investigations and anticipated delivery of a study report will be required prior to that date. Final study conditions, including but not limited to the number of rodent, or the strain of rodent used, shall be subject to

3 The vendor shall provide adequate information on the purity of the test substance before conducting pharmacological testing. Also, should the drug cost exceed $500, the vendor shall contact DEA representative for approval.

approval of the DEA representative. The vendor shall be able to conduct all studies though not all assays might be requested

IV. Specific requirements

Task 1. Drug source, storage and recordkeeping.

I. Drug Source: Unless otherwise specified by the DEA representative (if it is determined that the test substance is not commercially available), the vendor shall purchase the reference and test drugs4. The cost of the drug should not exceed $500. If there is a deviation, DEA representative should be notified immediately. Actual cost of drug can be billed as an invoice. The vendor shall conduct a preclinical evaluation of these test substances (as specified in tasks listed below) in comparison to appropriate controls and the appropriate reference standard. Pharmacological evaluation of each test substance shall be done using appropriate in vivo assays as approved by DEA.

II. Record Keeping: The vendor shall maintain electronic and paper copies of a chronological log of the test substance receipt and evaluation using Microsoft Excel spreadsheet software. When each substance is received, the following shall be recorded :

a) test substance's name;

b) source of the test substance (if it is a purchased or a standard substance);

c) purity of the test substance (all test and reference drug should be ≥ 98%);

d) date testing of the test substance was authorized;

e) date the test substance was received (If provided by the DEA);

f) amount of test substance received (if provided by the DEA);

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

h) date when the study began for each authorized study;

i) amount of test substance used for each authorized study;

j) date when the study was completed for each authorized study;

k) date when the report was sent to the DEA.

This cumulative Receipt and Evaluation log shall be kept up to date and forwarded to the DEA representative upon request.

III. Drug Storage and Schedule I Researcher Registration Requirement: Some of the test substances maybe in Schedule I of the Controlled Substances Act (CSA). Under these circumstances, it is required that the test substances be stored under Schedule I requirements as specified by the CSA and that the vendor evaluating the test substances shall be registered with the DEA as a Schedule I researcher. Some reference drugs are in Schedule II of the CSA. Therefore appropriate DEA license and storage requirement shall be maintained. In cases where test substances are not Schedule I, drug storage

4 The vendor shall provide adequate information on the purity of the test substance before conducting pharmacological testing.

requirements shall be maintained under Good Laboratory Practices (GLP) or GLP-like conditions.

Task 2. Protocols of in vivo pharmacological studies (locomotor, analgesia, drug discrimination, and other optional studies) in laboratory rodent animals

General protocols that are used for in vivo analgesia, drug discrimination, and other optional studies shall be provided by the vendor to the DEA. The protocols shall contain a description of the methodology used to conduct the investigation, a description of the apparatuses that will 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 presentations 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 analgesia and one protocol for drug discrimination, etc.

II. The study protocols must be specifically written to meet the protocol preferences as listed in this SOW under Tasks 3, 4, 5, and 6.

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 animal, 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 will 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 will be signed by each representative. The original signed document will remain with DEA. A copy of the signed protocol will be provided to the vendor. The signed protocols will 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 modifications.

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

Task 3. Evaluation of test substances in in vivo analgesic effects

I. Objective: The goal of this in vivo pharmacological study is to understand whether administration of test substances can result in an analgesic effect. 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 agreed upon in vivo analgesia assays. Locomotor activity or other dose-finding assays can be conducted to achieve appropriate doses prior to the analgesia studies.

II. Experimental Design: Analgesia assays shall be conducted in mice or rats. If alternative rodent animal species or alternate species are selected, the vendor will provide to the DEA a comprehensive rationale for selecting a different animal species. The DEA and the vendor shall agree on the strain of rodent to be used for each of the studies. The vendor shall follow the DEA-approved in vivo analgesia protocol for conducting these studies. Briefly, analgesia study will be conducted using the warm-water tail withdrawal assay (this is the preferred method for the opioid drug class; however, other anti-nociceptive assays can be considered if a protocol and justification is made). Selection of the appropriate tests shall be agreed upon by both the DEA and vendor. Rodents will be injected via appropriate route (e.g., subcutaneous for opioid substance) with either vehicle or reference substances or test substance. To determine the receptor mediated effect, the analgesic effect of these compounds shall be evaluated in the presence of appropriate dose(s) of standard receptor antagonist(s) (e.g., naltrexone). Experimental groups for evaluating each test substance shall consist of appropriate number of doses and statistically appropriate number of animals per group (at least 8 animals). Data from the proposed experiments shall be summarized in terms of ED50 (median effective dose;

a dose producing the analgesic effect by 50%). Dose response curves from the studies shall also be included. Reference drugs shall be included in the proposed study. ED50 values may be presented as mean ± SEM. A 95% confidence interval or an equivalent data reporting measurement should be calculated from the dose-response curves. A statistical analysis of data collected from all tests for comparing different treatment groups with vehicle control should be performed and the resulting data should be presented.

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 constrains ), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if it 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.

Study Report: Following completion of the in vivo analgesia study for each test substance, the results in the form described in Task 7 (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 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. If alternative rodent animal species or alternate species are selected, the vendor will provide to the DEA a comprehensive rationale for selecting a different animal species. The DEA and the vendor 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 a given reference drug (from its vehicle during each year of the agreement. It is expected that drug discrimination training for the animals commence within a week after the protocol is approved. The reference training drugs shall include, but not be limited to, morphine and fentanyl or as 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 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 constrains ), 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 drug discrimination study for each test substance, the results in the form described in Task 7 (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 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 Task 3, 4, and 5 a final study report containing the complete methodology, data analysis, and study results for each test substance shall be provided in electronic format to the 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 the DEA.

The DEA representative will provide an example of a Final Study Report for the vendor to use in preparation of the report. 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 an appendix to the report. The vendor shall first submit a draft report in 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 shall be as follows:

ii.) Front cover to contain: Date, title (to include compound name), researcher

(name/address/phone number, email), contract number, DEA representative (name).

iii.) 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 will be required for this agreement. These reports shall require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined by the DEA Representative.

a. Monthly reports: On or before the 5th working day following the end of each period of performance year, 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 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.

b. Study Reports: See task 7 for details on these reports.

c. Annual 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 the DEA representative. In the report, vendor shall include: section 1 – a summary of the overall results generated on all substances 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.

a) Meetings between DEA and vendor:

i. 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.

ii. In-person meetings: At approximately 12-month intervals, 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 the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.

iii. Pre-Meeting Materials: Three 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 3 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.

iv. 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 three (3) weeks of the meeting.

v. 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, the DEA headquarters or other locations as specified by the 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 the DEA’s discretion.

V. Period of Performance

The period of performance for this agreement shall be for 12 month duration with the option to extend for four additional years and is subject to renewal by DEA and vendor after each performance year. 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 will no longer extend to subsequent years. Prior to shortening the period of performance, a written notification shall be provided with 90-day notice.

VI. Deliverables

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

ITEM DELIVERABLE DELIVERY SCHEDULE

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

Agreed protocols of the in vivo locomotor activity or other dose-finding studies, analgesia, drug discrimination assays studies

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 Reports 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.

VII. 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 the 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 the DEA. The DEA and the vendor will 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 the 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 the 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 the DEA. All requests which the vendor will receive from third parties for access to the data must be referred to the DEA.

VIII. 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 the DEA, the vendor shall ship these items to the DEA representative in Arlington, VA.

IX. Optional In Vivo Studies

The DEA is open to the inclusion of other behavioral studies (e.g., respiratory depression, conditioned place preference, rotorod assays) that can provide further information on the pharmacological properties of this class of substances. Please note that inability to perform any of the suggested optional studies will not exclude a researcher for consideration If the DEA representative and the vendor mutually agree on all matters (i.e., feasibility, cost, etc.) regarding these optional in vivo studies then these study can be added to the BPA. In the event additional behavioral studies are agreed upon a bilateral modification will be executed, incorporating a revised Statement of Work, Contract Line Items (CLINS).

DEA Representative (Scientific and Technical Contact): Will be provided at time of award

SECTION 3- INSTRUCTIONS TO OFFERORS

The U.S. Drug Enforcement Administration (DEA) intends to establish a firm fixed price Multi Award, Blanket Purchase Agreement (BPA) for Evaluation of Abuse Potential of NPS Using In Vivo Pharmacological Studies in accordance with FAR Part 13 to the responsive, responsible contractor who provides the best value to the Government. 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 including the Base Year and Option Periods (total of five years).

The services that will be issued under the BPA are described in Section 2 of the Request for Quotation (RFQ). The contractor shall furnish the services identified if and when requested by a Contracting Officer who is duly warranted by DEA to authorize the expenditure of funds during the period of performance of BPA.

DURATION OF THE BPA AGREEMENT

The anticipated period of performance for services described herein is established from 12 months after the award. If the DEA requires services for additional years, the period of performance will be:

Option Period I: 12 months after the Base Year

Option Period II: 12 months after Option Period I

Option Period III: 12 months after Option Period II

Option Period IV: 12 months after Option Period III

PRICING INFORMATION

The Contractor shall propose individual pricing for each contract line item on the Schedule of Services and include a total price for the quote.

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 13.303-5(b))

No single call placed under this Agreement shall exceed the simplified acquisition dollar threshold. Requirements shall not be split for the purpose of staying under the simplified acquisition threshold or individuals delegated limits of authority.

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

DEA Headquarters Contracting Officers

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

INVOICES

See DEA Provision and Clause Matrix, DEA clause DEA-2852.242-71 (Invoice Requirements (MAY 2012) on Page 19.

INSTRUCTIONS TO OFFERORS

This is an all-or-none procurement. The contractor, using the line item numbers included in Schedule of Services and Sample BPA Call Order, shall propose a rate for all years of the anticipated BPA including the Base Year and each BPA Option Period (total of five years).

OFFER ACCEPTANCE PERIOD – The contractor shall provide an offer acceptance period of not less than 90 calendar days.

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 Contract Specialist at Jacqueline.P.Schottler@usdoj.gov later than January 11, 2019 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 to Jacqueline Schottler by January 31, 2019 at 10:00 AM EST via email at Jacqueline.P.Schottler@usdoj.gov.

Please reference 15DDHQ19Q00000012 in the subject line of the email quote submission.

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, the date, and RFQ number.

mailto:Jacqueline.P.Schottler@usdoj.gov mailto:Jacqueline.P.Schottler@usdoj.gov

Proposal Volumes

I. Technical Proposal II. Past Performance

III. Business Proposal

Technical Proposal (Volume I)

The proposal shall be specific and complete in every detail. The 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.

The proposal shall be typed, single spaced, with one inch margins, using Time New Roman font, 12 point type (Or Equivalent), unreduced in size, on 8 ½” by 11” paper, not exceeding 15 pages for the Technical Proposal (Volume I). The first 15 pages of the Technical Proposal will be evaluated; pages in excess of this 15 page limit will not be considered. Title page, table of contents, and resumes, will not be counted in the page count limitation. Supporting Documents/Appendixes shall not exceed the 5 pages. Past performance references in Volume 2 shall not exceed 10 pages for Volume II and business proposal in Volume III shall not exceed 10 pages for the Business Proposal.

Evaluation Factor:

FACTOR 1: TECHNICAL CAPABILITY (Volume I):

The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how each TASK will be structured and executed.

The Offeror shall also provide:

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 1 Drug source, storage, and record keeping will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 2 Protocols of in vivo pharmacological studies (locomotor activity, drug discrimination studies, and other optional studies (e.g. conditioned place preference, rotorod assays)) in laboratory rodent animals will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 3 Evaluation of test substances in in vivo analgesic effects will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 4, Evaluation of test substances in in vivo drug discrimination assay will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 5 Final study report for each substance tested will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 6 Reporting Requirements will be structured and executed.

• The Offeror shall demonstrate the understanding of the requirement as stated in the Statement of Work by providing a narrative as to how Task 7 Level of Effort will be structured and executed.

Past Performance Proposal (Volume II)

Offerors (prime and subcontractor(s)) shall submit with its offer a minimum of three (3) contracts or task orders, performed during the past three (3) 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. The offeror shall provide Contracts or task orders listed and 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

In addition, the Offeror’s Past Performance Questionnaire (Attachment 1) should be completed by those contracting organizations listed above.

The Government will 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).

Business Proposal (Volume III)

BUSINESS INFORMATION TO BE FURNISHED – The contractor shall provide the following business information with their business proposal:

• Company Name, Address, Point of Contact

• DUNS number

• CAGE CODE number

• Business Size

• The Standard Form 18 fully executed. Include one (1) originally signed copy of the form and with blocks 13, 14 and 15 completed.

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

• Price Proposal – Contractors shall complete the worksheets in I. Section of Services (for base and all option periods to be considered on an all-or-non basis per the instructions in the solicitation. Failure to provide pricing for all CLINS may result in elimination from further consideration. The offeror shall complete Attachment 2 - 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 9.104-1. In the event a contractor is deemed not responsible, that contractor will be notified and removed from participation in this procurement.

EVALUATION

An Award will be made to the technically acceptable, legally eligible, responsible contractor, who proposes the lowest technically acceptable price and received a PASS rating for past performance. All proposals received will be subject to the technical and price evaluation by the technical proposal evaluation team. The Government reserves the right to award without discussions.

Three (3) Phase Evaluation:

1. If a contractor does not receive a PASS rating for Factors 1, the contractor shall not be further evaluated. If a contractor does receive a PASS rating for Factors 1, the contractor’s Past Performance shall be evaluated.

2. If a contractor does not receive a PASS rating for Past Performance, the contractor shall not be further evaluated. If a contractor does receive a PASS rating based on the ratings specified above, the contractor’s price shall be evaluated.

3. If a contractor received a PASS rating for Factors 1 and received a PASS rating for Past Performance, price will be the determining factor. (Attachment 2 - Sample Call Order)

Technical Evaluation Factor 1 and Past Performance shall be evaluated on a PASS/FAIL basis.

PASS – Proposal clearly meets the minimum requirements of the solicitation, and is technically acceptable. The offeror must receive a pass rating for all Tasks in order to be determined technically acceptable.

FAIL – Proposal does not clearly meet the requirements of the solicitation, and is technically unacceptable.

AWARD SELECTION

The following evaluation factors will be used in the source selection process:

a.) TECHNICAL CAPABILITY

Technical Proposals will be evaluated based upon:

The contractor’s ability to thoroughly address the technical criteria referenced in Section 2.

The government will evaluate the offeror’s;

• The government will evaluate the offeror’s ability to structure and execute TASK 1

• The government will evaluate the offeror’s ability to structure and execute TASK 2

• The government will evaluate the offeror’s ability to structure and execute TASK 3

• The government will evaluate the offeror’s ability to structure and execute TASK 4

• The government will evaluate the offeror’s ability to structure and execute TASK 5

• The government will evaluate the offeror’s ability to structure and execute TASK 6

• The government will evaluate the offeror’s ability to structure and execute TASK 7 b.) PAST PERFORMANCE

The Government will evaluate the contractor’s ability to thoroughly address the past performance referenced in Section V.

1. Up to three (3) contracts / task orders performed by the Offeror and for proposed subcontractor(s) 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).

2. The Offeror’s description of its resilience in the face of trouble, resourcefulness, and management determination to see that the organization lived up to commitments or standards.

3. The Offeror’s description of the similarities and differences between this proposed effort and the specifications of those contracts / task orders and description of the expectations and scopes of each of the contracts.

4. Completed Past Performance Questionnaire, Attachment 1

5. Reference checks, its own knowledge/experience, and/or information obtained from other sources which may include, but not necessarily be limited to, other Government contracting offices, the Contractor Performance Assessment Reporting System (CPARS), and the Past Performance Information Retrieval System (PPIRS).

c.) PRICE

Prices will be evaluated by summing the grand total Base and All Option Periods, in the Sample BPA Call Order, Attachment 2.

Important: Only the proposals that are deemed technically acceptable, legally eligible, and received a PASS rating for Factor 1: Technical Capability and Past performance will be forwarded for price analysis to determine lowest price. Price alone shall be the determining factor for the award. This is Lowest Price Technically Acceptable procurement. A proposal containing unreasonable or incomplete pricing may be rated as FAIL.

SELECTION OF CONTRACTOR

The Government reserves the right to make a single best value, Lowest Price Technically Acceptable (LPTA) award or no award as a result of this RFQ.

U.S. DRUG ENFORCEMENT ADMINISTRATION

PAST PERFORMANCE QUESTIONNAIRE

Attachment 1

Evaluation of Abuse Potential of Synthetic Opioids Using In Vivo Pharmacological Studies

RFQ- 15DDHQ19Q00000012

The purpose of this questionnaire is to obtain an evaluation of past performance on a contract that has been completed or is currently being performed by the Contractor listed above. You have received this questionnaire because the Contractor selected you to provide this evaluation in response to a request by the Drug Enforcement Administration (DEA) for past performance information. DEA will use the information you provide to assess the Contractor’s ability to perform the requirements of a contract. The information is to be provided directly to DEA. The information you provide may be released to the Contractor during debriefings; however, the source of the information will not be released.

It is requested that the Program Manager or the Contracting Officer Representative (COR) complete the evaluation. Please complete this past performance questionnaire, and submit your responses via email to jacqueline.p.schottler@usdoj.gov, no later than January 31, 2019 at 10:00 AM EST.

Thank you for your assistance in this Past Performance Evaluation process.

Jacqueline Schottler DEA Contract Support Specialist

Please rate the Contractor on the abilities listed in this questionnaire by circling the appropriate number to the right. The following definitions apply:

1 = Unacceptable Performance: Requirements were not achieved with significant consequences.

2 = Marginal Performance: Requirements were frequently not fully achieved, often with significant consequences.

3 = Satisfactory Performance: Requirements were generally achieved with occasional exceptions, and in most cases with minor consequences.

4 = Good Performance: Requirements were achieved with only rare exceptions, and the exceptions had minor consequences.

5 = Excellent Performance: Requirements were essentially always achieved or exceeded.

NA = Not Applicable: This does not apply to the work that was performed.

mailto:jacqueline

Studies

RFQ- 15DDHQ19Q00000012

CONTRACT & EVALUATOR INFORMATION

BLOCKS 1 THROUGH 7 TO BE COMPLETED BY THE OFFEROR

1. CONTRACTOR NAME & ADDRESS:

2. CONTRACT NO.:

3. CONTRACT AWARD DATE:

4. PERIOD OF PERFORMANCE/COMPLETION DATE:

5. CONTRACT VALUE (WITH OPTIONS):

6. TYPE OF CONTRACT:

7. TITLE OF CONTRACT AND DESCRIPTION OF CONTRACT REQUIREMENTS:

BLOCKS 8 AND 9 TO BE COMPLETED BY EVALUATION ORGANIZATION REPRESENTATIVE

8. EVALUATION: a. EVALUATOR’S NAME, POSITION (PM/COR/OTHER) AND ORGANIZATION:

b. EVALUATOR’S PHONE NUMBER: ______________________________________________________________

c. MONTHS CONTRACTOR PERFORMANCE MONITORED BY EVALUATOR: ________________________

d. RATINGS Please circle the response code which best reflects your evaluation of the contractor’s performance.

Studies RFQ- 15DDHQ19Q00000012

QUESTIONS

Demonstrated commitment to success of customer mission 1 2 3 4 5 NA Effectively manage resources and personnel. 1 2 3 4 5 NA Overall, risk management for the program. 1 2 3 4 5 NA Ability to manage daily operational and contractual tasks. 1 2 3 4 5 NA Overall, cost control (avoid overruns) of the program. 1 2 3 4 5 NA Timeliness in planning and meeting task schedules and performance including workload surges. 1 2 3 4 5 NA Ability to submit required reports and deliverables on schedule. 1 2 3 4 5 NA Quality assurance of products and services delivered. 1 2 3 4 5 NA Solving problems and resolution processes. 1 2 3 4 5 NA Employing of partnering and teaming strategies with government representatives and other contractors. 1 2 3 4 5 NA Ability to adapt to changing requirements to meet customer needs. 1 2 3 4 5 NA Sufficient certified/qualified personnel 1 2 3 4 5 NA Effectiveness of support in communicating efforts and results 1 2 3 4 5 NA Ability to prepare and submit accurate and timely invoices for completed work. 1 2 3 4 5 NA Overall timeliness of delivery. 1 2 3 4 5 NA Ability to effectively manage subcontractors, facilitate information exchanges and expedite work flows. 1 2 3 4 5 NA Overall commitment to customer satisfaction. 1 2 3 4 5 NA

Please provide any additional comments to describe the Contractor’s performance:

Would you hire this contractor again? (please check one) _____YES _____NO

If “no,” please explain why you would not hire this contractor again:

Thank you for completing this past performance survey.

ATTACHMENT 2: SAMPLE BPA CALL ORDER

The purpose of this BPA Call Order is to provide contractors DEA’s projected annual estimates to be ordered against the BPA.

(FOR PRICING EVALUATION PURPOSES ONLY)

The Sample BPA Call Order will be used for evaluating the contractor’s proposed price for each BPA year. The contractor shall enter its proposed unit price by contract line item number (CLIN) for the base period and each option period. The contractor shall enter the total price for each period and grand total for all periods combined. The contractor shall complete all calculations and fill in all spaces provided on the form.

Proposals that do not include pricing in the Sample BPA Call Order in its entirety (“all or none basis”) will not be evaluated by the government.

The completed Sample BPA Call Order shall be submitted with the contractor’s Proposal – the evaluation of which shall be considered for award of the resulting single BPA.