RFP 15DDHQR00000028 Synthetic Cathinones - signed.pdf

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15DDHQ24R00000028

Darrell Gooodwin, darrell.goodwin@dea.gov

Drug Enforcement Administration Diversion Control Division

Not applicable.

This RFP is for the Evaluation of Abuse Potential of Synthetic Cathinones and Other Substances

The proposals in response to this RFP shall be submitted by May 31, 2024 at 1:00 PM EST.

Questions for this RFP are due no later than May 14, 2024 at 1:00 AM EST.

5/08/2024

5/31/2024

1:00 PM, EST

Drug Enforcement Administration 8701 Morrissette Drive Springfield, VA 22152-1080

05/08/2024Denise N. Scott

STOCK RECORD (S/R)

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U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

DEA Diversion Control Division

Evaluation of Abuse Potential of Synthetic Cathinones and Other Substances that have Stimulant Effects Using In Vivo Pharmacological Studies

REQUEST FOR PROPOSAL (RFP)

15DDHQ24R00000028

DEA/DC/DPE 2

I. Schedule of Services

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 = $). The unit cost for each assay is the assay cost plus the incidental 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.

The contractor shall propose a single loaded rate per Contract Line Item Number (CLIN) that includes direct labor, overhead, fringe, general and administrative expenses (G&A), and profit.

The contractor must verify the calculated totals per labor category, by year, and the grand total for all years.

Ordering Period 1

CLIN

Line Item Assay

Quantity Unit Unit Price

Estimated Total Price

0001 Drug Discrimination for Initial training - Methamphetamine

4 Lot

0002 Drug Discrimination for Initial training - Methamphetamine - Incidental Cost

4 Lot

0003 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board

8 Lot

0004 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board - Incidental cost

8 Lot

0005 Drug Discrimination of Test drug - Assay Cost - Methamphetamine

15 Lot

0006 Locomotor Activity Assay Cost 20 Lot 0007 Locomotor Activity Assay Incidental Cost 20 Lot 0008 Drug Discrimination for Initial training - Drug 2 4 Lot 0009 Drug Discrimination for Initial training - Drug 2

Incidental Cost 4 Lot

0010 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board

8 Lot

0011 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board - Incidental Cost

8 Lot

0012 Drug Discrimination of Test drug - Assay Cost - Drug 2

15 Lot

0013 Self-Administration Assay Cost 2 Lot 0014 Self-Administration Incidental Cost 2 Lot 0015 Drug Cost - Not to Exceed Unless Approved 20 Lot $500.00 $10,000.00

TOTAL COST ($)

DEA/DC/DPE 3

Ordering Period 2

CLIN

Line Item Assay

Quantity Unit Unit Price

Estimated Total Price

1001 Drug Discrimination for Initial training - Methamphetamine

4 Lot

1002 Drug Discrimination for Initial training - Methamphetamine - Incidental Cost

4 Lot

1003 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board

8 Lot

1004 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board - Incidental cost

8 Lot

1005 Drug Discrimination of Test drug - Assay Cost - Methamphetamine

15 Lot

1006 Locomotor Activity Assay Cost 20 Lot 1007 Locomotor Activity Assay Incidental Cost 20 Lot 1008 Drug Discrimination for Initial training - Drug 2 4 Lot 1009 Drug Discrimination for Initial training - Drug 2

Incidental Cost 4 Lot

1010 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board

8 Lot

1011 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board - Incidental Cost

8 Lot

1012 Drug Discrimination of Test drug - Assay Cost - Drug 2

15 Lot

1013 Self-Administration Assay Cost 2 Lot 1014 Self-Administration Incidental Cost 2 Lot 1015 Drug Cost - Not to Exceed Unless Approved 20 Lot $500.00 $10,000.00

Ordering Period 3

CLIN

Line Item Assay

Quantity Unit Unit Price

Estimated Total Price

2001 Drug Discrimination for Initial training - Methamphetamine

4 Lot

2002 Drug Discrimination for Initial training - Methamphetamine - Incidental Cost

4 Lot

2003 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board

8 Lot

2004 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board - Incidental cost

8 Lot

2005 Drug Discrimination of Test drug - Assay Cost - Methamphetamine

15 Lot

2006 Locomotor Activity Assay Cost 20 Lot

DEA/DC/DPE 4

2007 Locomotor Activity Assay Incidental Cost 20 Lot 2008 Drug Discrimination for Initial training - Drug 2 4 Lot 2009 Drug Discrimination for Initial training - Drug 2

Incidental Cost 4 Lot

2010 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board

8 Lot

2011 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board - Incidental Cost

8 Lot

2012 Drug Discrimination of Test drug - Assay Cost - Drug 2

15 Lot

2013 Self-Administration Assay Cost 2 Lot 2014 Self-Administration Incidental Cost 2 Lot 2015 Drug Cost - Not to Exceed Unless Approved 20 Lot $500.00 $10,000.00

Ordering Period 4

Line Item Assay

Quantity Unit Unit Price

Estimated Total Price

3001 Drug Discrimination for Initial training - Methamphetamine

4 Lot

3002 Drug Discrimination for Initial training - Methamphetamine - Incidental Cost

4 Lot

3003 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board

8 Lot

3004 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board - Incidental cost

8 Lot

3005 Drug Discrimination of Test drug - Assay Cost - Methamphetamine

15 Lot

3006 Locomotor Activity Assay Cost 20 Lot 3007 Locomotor Activity Assay Incidental Cost 20 Lot 3008 Drug Discrimination for Initial training - Drug 2 4 Lot 3009 Drug Discrimination for Initial training - Drug 2

Incidental Cost 4 Lot

3010 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board

8 Lot

3011 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board - Incidental Cost

8 Lot

3012 Drug Discrimination of Test drug - Assay Cost - Drug 2

15 Lot

3013 Self-Administration Assay Cost 2 Lot 3014 Self-Administration Incidental Cost 2 Lot 3015 Drug Cost - Not to Exceed Unless Approved 20 Lot $500.00 $10,000.00

Ordering Period 5

DEA/DC/DPE 5

Line Item Assay

Quantity Unit Unit Price

Estimated Total Price

4001 Drug Discrimination for Initial training - Methamphetamine

4 Lot

4002 Drug Discrimination for Initial training - Methamphetamine - Incidental Cost

4 Lot

4003 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board

8 Lot

4004 Drug Discrimination for Monthly maintenance (Methamphetamine), Test drug on board - Incidental cost

8 Lot

4005 Drug Discrimination of Test drug - Assay Cost - Methamphetamine

15 Lot

4006 Locomotor Activity Assay Cost 20 Lot 4007 Locomotor Activity Assay Incidental Cost 20 Lot 4008 Drug Discrimination for Initial training - Drug 2 4 Lot 4009 Drug Discrimination for Initial training - Drug 2

Incidental Cost 4 Lot

4010 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board

8 Lot

4011 Drug Discrimination -Monthly maintenance (Drug 2), Test drug on board - Incidental Cost

8 Lot

4012 Drug Discrimination of Test drug - Assay Cost - Drug 2

15 Lot

4013 Self-Administration Assay Cost 2 Lot 4014 Self-Administration Incidental Cost 2 Lot 4015 Drug Cost - Not to Exceed Unless Approved 20 Lot $500.00 $10,000.00

Section 2: Statement of Work

2.0 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, synthetic cathinones, have emerged within the United States and pose significant risk to the public safety. Numerous synthetic cathinones 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. There have also been reports of other substances that have stimulant effects besides cathinones that have emerged in the illicit drug markets or caused harm. In response to the associated public health threat with the abuse of synthetic cathinones, the Administrator of the DEA has placed several synthetic cathinones 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.

2.1 Scope of Work

For this project, unless otherwise specified by the DEA representative, the vendor shall purchase the reference drugs and all test substances1 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. Some 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 such as locomotor activity study and drug discrimination study on these substances in comparison to appropriate controls and reference standard substances. The type of study requested is dependent upon the class of substance. The reference training drugs shall include, but not be limited to, methamphetamine, methcathinone, MDMA (3,4-methylenedioxymethamphetamine), cocaine, 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 rodents, or the strain of rodent used, shall be subject to approval of the DEA representative. The vendor shall be able to conduct all studies though not all assays might be requested during.

3.0 Specific Tasks

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 drugs2. 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. The vendor shall provide adequate information on the purity of the test substance before conducting pharmacological testing.

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 such test substances be stored under Schedule I requirements as specified by the CSA and that vendor evaluating the test substances shall be registered with the DEA as a Schedule I researcher. All 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 requirements shall be maintained under Good Laboratory Practices (GLP) or GLP-like conditions.

Task 2. Protocols of in vivo pharmacological studies (locomotor activity, drug discrimination studies, self-administration and other optional studies (e.g. conditioned place preference, rotorod assays) in laboratory rodent 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 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 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, 4 and 5.

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 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 substances 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

MDMA, methamphetamine, cocaine, 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 this 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 mice unless otherwise agreed upon by both the DEA and vendor. Briefly, locomotor activity test will be conducted in an automated activity monitoring chamber located in a sound-attenuating device that provides dim illumination. Prior to testing, mice will be injected via appropriate route with either vehicle or reference substances or test substance and immediately placed in the chamber for locomotor activity monitoring. In all studies, horizontal activity (interruption of photocell beams) will be measured. Testing shall be conducted with one mouse 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 a 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 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 locomotor activity 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 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 the DEA and vendor. 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, methamphetamine, MDMA (3,4-methylenedioxymethamphetamine), cocaine, and other drugs 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.

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 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

Task 5. Evaluation of test substances in in vivo intravenous self-administration studies

I. Objective: The goal is to understand whether the test compounds can be self-administered intravenously by animals. Using the general protocol and SOPs with agreement of the vendor and DEA in Task 2, the investigators shall, as specified by the DEA representative, evaluate standard (reference) and/or test substances using the in vivo self-administration assay.

II. Experimental Design and Results: Self-administration studies shall be conducted in rats unless otherwise agreed upon by both the DEA and vendor. Selection of the positive (e.g. another stimulant) and/or negative controls (e.g. extinction test with vehicle) for each self-administration assay shall be agreed upon by both the DEA and vendor.

Experimental groups for evaluating each test substance should consist of the appropriate number of doses and the statistically appropriate number of animals per group. Unless otherwise instructed by the DEA representative, separate groups of animals (rats) trained to self-administer a given reference drug of abuse (e.g. amphetamine, methamphetamine, cocaine, MDPV, etc.,) from its vehicle using well established methodology as approved by the DEA representative, will be maintained upon request.

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 self-administration study for each test 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

Task 6. Optional In Vivo Studies

The DEA is open to the inclusion of other behavioral studies (e.g., 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 agree on all matters (i.e., feasibility, cost, etc.) regarding these optional in vivo studies then these study can be added to the contract.

Task 7. 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 8. 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 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.

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 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.

4.0 Period of Performance

Period of Performance POP Start POP End

Ordering Period 1 07/01/2024 07/29/2025

Ordering Period 2 07/01/2025 07/28/2026

Ordering Period 3 07/01/2026 07/28/2027

Ordering Period 4 07/01/2027 07/28/2028

Ordering Period 5 07/01/2028 07/28/2029

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

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, drug discrimination assays, self-administration study and other optional studies, if applicable

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.

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

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

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

7 Meetings between DEA and Contractor (as needed, may be waived at the discretion of the DEA representative)

To or with DEA:

i. Monthly conference calls:

once a month after submission of monthly report

ii. In-person meetings (as needed)

iii. Pre-Meeting Materials:

three weeks before each meeting for approval; two weeks before each meeting for dissemination

iv. Post-Meeting Materials:

within three weeks after each meeting

v. Meeting Location(s): to be determined as specified by DEA (may include video conferencing, scientific meetings, DEA headquarters, etc.)

6.0 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.

7.0 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.

7.1 DEA Representative (Scientific and Technical Contact):

Cassandra Prioleau, Ph.D.

Drug and Chemical Evaluation Section Drug Enforcement Administration

7.2 Security Requirement

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 will employ persons of integrity and trustworthiness. To ensure this, DEA reserves the right to conduct background screening or a full background investigation on all employees if a need arises. While all services provided on this contract will be performed outside of DEA, all contractors must be escorted if entering a DEA facility. DEA reserves the right to modify the security requirements found in this contract at any time.

8.0 Staffing/Key Personnel

8.1 Key personnel associated with this acquisition shall include, but are not limited to the following:

I. NAICS 611310 - Colleges, Universities, and Professional Schools

1. Principal Investigator (Key Personnel):

a. Ph.D., and 3 years’ experience in an academic research laboratory setting; detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

2. Co-Principal Investigator (Key Personnel):

a. Ph.D., and 3 years’ experience in an academic research laboratory setting; detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

3. Research Technician assigned to conduct locomotor activity testing (Non-Key

Personnel)

4. Laboratory Manager (Non-Key Personnel)

5. Research Technician assigned to conduct drug discrimination testing (Non-Key Personnel)

It is assumed that multiple technicians may be necessary to conduct any one of the tasks associated with this acquisition.

II. NAICS 621511 - Medical Laboratories

1. Principal Investigator [Study Director] (Key Personnel):

a. Ph.D., and 3 years’ experience in an academic research laboratory setting;

detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

2. Co-Principal Investigator [Project Director] (Key Personnel):

a. Ph.D., and 3 years’ experience in an academic research laboratory setting;

detail relevant professional training; certifications, and verifiable previous successful program experience/expertise.

b. Resumes shall include start and end dates, company/ agency name and a detailed description of each work experience, clearly referencing the experience required in the SOW, education and qualifications.

3. Laboratory Manager (Non-Key Personnel)

4. Research Technician assigned to conduct locomotor activity testing (Non-Key

Personnel)

5. Research Technician assigned to conduct drug discrimination testing (Non-Key Personnel)

It is assumed that multiple technicians may be necessary to conduct any one of the tasks associated with this acquisition.

8.2 Management Plan:

The management plan must include:

A proposed approach for managing unforeseen personnel shortages.

A description of the Offeror’s quality control process and how the staffing plan supports managing the quality of services provided.

A description of how the Offeror shall overcome the challenges, mitigate the risks and deliver the performance outcomes and deliverables described in the SOW.

Include the proposed approach to utilizing and managing subcontractors if they will be utilized.

8.3 Staff Recruitment/Retention:

The contractor shall explain current employee benefits and commitments that will ensure retention of personnel hired to work under the contract for 5 years beyond the duration of the contract agreement period of performance.

8.4 Past Performance:

The contractor shall provide past performance examples relevant to the 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.

9.0 Transition Plan [Phase-In & Phase-Out]

The Contractor shall submit a transition phase-in/out plan that will not affect the operations of the program during the transition periods during the contract performance. The Contractor shall transition in accordance with its timeline to complete all phase-in activities within 60 days of the effective date of the contract. The transition plan of the successful Contractor will be incorporated into the contract after award.

A. Transition Phase-In Transition is an integral part of contract startup. The plan for transition-in shall include, but is not limited to:

1. Management of Phase-In Activities.

2. Initial staffing levels and timeline to achieve and perform tasks stated in the

SOW.

3. Management of Knowledge Transfer Activities

4. Development and Dissemination of Operational Instructions, Procedures, and

Control Directives.

5. Ensuring No Disruption of Work and Maintaining Continuity of Operations.

6. Transfer of Government Furnished Property, Material, Equipment and Data, if applicable.

7. Monitoring and Reporting of Transition Progress.

B. Transition Phase-Out

The Contractor shall submit a transition-out plan. The plan shall include, but is not limited to:

1. Management of Knowledge Transfer

2. Transfer and/or return of Government Data, Material, Equipment, and

Furnished Property.

3. Provides any data/documentation/task completed in performance of contract includes final version, drafts, and research and analysis report.

4. Ensuring no disruption of work and maintaining continuity of operations.

5. Hiring and retention personnel.

6. Monitoring and Reporting of Transition Progress.

Section 3: Basis of Award:

The government intends to award a Firm Fixed Price, single award BPA in accordance with FAR Part 13. The basis of award will be best value trade-off approach. All Non- Cost evaluation factors when combined are significantly more important than Cost (Factor 4). In the event proposals are evaluated as technically equal in quality, cost will become a major consideration in selecting the successful Offeror. The government will utilize the Confidence Adjectival ratings– Low, Some, and High and may or may not award to the lowest cost offer and highest technically rated Offeror.

An award will be made to the Offeror offering the “best value to the government based on the evaluation of all non-cost factors and review of cost, along with the proposal(s) demonstrating an understanding of the contract requirements and their ability to satisfy those requirements based on the required SOW. The Government will make an award without discussions based on initial offer received. Therefore, all submitted Proposals should be best and final.

Section 4: RFP Instructions to Offerors

Submittal Requirements: Proposals shall be submitted electronically to Darrell Goodwin, Contract Specialist at darrell.goodwin@dea.gov and Denise Scott, Contracting Officer at Denise.N.Scott@dea.gov. Submittal shall be on Offeror’s letterhead clearly labeled with company name, address, phone number, Cage Number, Unique Entity ID, business size/socio economic category, and point of contact(s) and email address(s). The Offeror’s executive summary must include the name and signature of an official authorized to bind the submitting organization. Proposals must be received by the published due date and time; electronic email. Be advised that late proposals will not be considered.

Time, Date, and Place for Submission: The proposal submitted in response to this RFP No:

15DDHQ24R00000028 are due no later than 1:00 PM EST on May 31, 2024.

Questions in regard to the RFP are to be submitted to Darrell Goodwin, Contract Specialist at darrell.goodwin@dea.gov and Denise Scott, Contracting Officer at Denise.N.Scott@dea.gov.by 1:00 PM EST on May 14 , 2024. Any question received after this due date will not be addressed. Offerors shall submit their question in the format shown below.

Page, Section and Paragraph # and/or Attachment

Questions Comments

Note, Offeror’s questions and DEA responses may result in the form of an amendment to the RFP. Responses to questions will not reveal the Offerors who proposed the questions.

1. Basis for Award: The basis of award will be best value trade-off approach. The government intends to issue a competitive firm fixed price single award BPA in accordance with FAR 13; in the best interest of the Government. The basis of award will be best value trade-off approach

2. Proposal Period: The Vendor’s proposals shall be good for not less than 90 calendar days.

3. Expenses Related to Vendor Submission: The Government will not pay any cost incurred in the preparation and submission of any proposal.

Determination of Vendor Responsibility: Separate and independent of this evaluation, the Contracting Officer will decide of responsibility using the standards listed in FAR 9.104-1. In the event a Vendor is deemed not responsible, that Vendor will be notified and removed from participation in this procurement.

RFP Response - The proposal shall conform DEA provisions and clauses included in the RFP. To aid its evaluation:

The proposal shall be clearly and concisely written as well as being neat, indexed, and logically assembled.

The proposal shall be specific and complete in every detail.

The proposal shall be practical, straightforward with concise delineation of what it is the

Offeror 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. The Statement of Work (SOW) reflects the objectives of the program, therefore merely stating or affirming that the Vendor will execute the performance requirements without sufficient elaboration will not be acceptable.

All pages shall be appropriately numbered and identified with the name of the Vendor, the date, and RFP number.

a. 52.215-1 Instructions to Offerors—Competitive Acquisition. (JAN 2017) North American Industry Classification System (NAICS) code.

b. As a result of the solicitation, the Government intends to issue a competitive firm fixed price single award BPA to the responsible Offeror’s whose proposal(s) are conforming to the solicitation and represents the best value to the Government.

c. NAICS 611310 - Colleges, Universities, and Professional Schools, 621511 - Medical

Laboratories, 541715 - Research and Development, and 541380 - Testing Laboratories and Services with fixed priced CLINS for five (5) ordering periods.

d. An official authorized to by your organization must sign the RFP responses. Proposals shall provide convincing rationale to address how the Offeror intends to meet these requirements. Offeror are reminded that Government reserves the right to award this effort based on the initial proposal, as received, without discussions. Proposals must be clear, coherent, and prepared in sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposals shall not simply rephrase or restate the Department’s requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. Each volume shall be written on a stand-alone basis so that its contents may be evaluated without seeking information from other volumes of the proposal. Information required for evaluation, which is not found in its designated volume, will be assumed to have been omitted from the proposal.

Proposal Format and Content:

All proposals shall contain the two separate volumes (and sections) identified in the chart below and be submitted as two (2) separate PDF files, subject to the quantities and page limits as specified below:

Table 3.0

Volume Title Document Format Maximum Page Limit* I Factor 1: Technical

Capability

Subfactor 1:

Transition Plan (Phase-In/Phase- Out)

1 Original – Electronic Version

Page Limit: 20 pages (Table of contents and Executive Summary are excluded from page count).

I Factor 2: Staffing Approach

Subfactor 1:

Recruitment/Retention:

Subfactor 2:

Management Plan:

1 Original – Electronic Version Page Limit: 20 pages (Resumes pages are excluded from total page limits).

I Factor 3:

Past Performance

1 Original – Electronic Version

Page Limit: 3 pages.

II Factor 4: Business Proposal/Cost

1 Original – Electronic Version

No Page Limit

Pricing Spreadsheet

Sample BPA-Call Order

Pages submitted in excess of the page limitations described above will not be evaluated.

Paper, Page Size and Markings: Each volume shall have a Table of Contents for easy reference.

The proposals shall be formatted such that, if printed, they fit within 8 ½ x 11- inch paper, in a commercially standard font size (no smaller than 11-point).