RFP 15DDHQ24R00000021 Eval of Abuse Potential of Hallucinogenic.pdf

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15DDHQ24R00000021

Darrell Gooodwin, darrell.goodwin@dea.gov

Drug Enforcement Administration Diversion Control Division

Not applicable.

This RFP is for the Evaluation of Abuse Potential of Hallucinogenic.

The proposals in response to this RFP shall on be due on May 6, 2024 at 1:00 PM EST.

Questions for this RFP shall be submitted no later than April 17, 2024 at 1:00 PM EST.

4/10/2024 4/10/2024

5/06/2024

1:00 PM, EST

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

04/10/2024Denise N. Scott

STOCK RECORD (S/R)

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U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

Evaluation of Abuse Potential of Hallucinogenic Substances Using In Vivo Pharmacological Studies

Diversion Control Division (DC)

REQUEST FOR PROPOSAL (RFP) NUMBER: 15DDHQ24R00000021

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Section 1: Schedule of Services

Unit cost estimates for different pharmacological tests Advance payments for costs incurred to conduct assays as specified in the Tables are not authorized. Contractor 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 1g 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

Drug Discrimination (initial training) - Drug 1

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 1

- Incidental Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Incidental Cost 4 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Incidental Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Incidental Cost 8 EA

Drug Discrimination of Test Drug - Assay Cost 16 EA

Drug Discrimination of Test Drug - Incidental Cost 16 EA

0011 Pharmacokinetic Assay - Assay Cost 10 EA 0012 Pharmacokinetic Assay - Incidental Cost 10 EA

Locomotor or another dose-finding assay (if applicable) - Assay Cost 16 EA

Locomotor or another dose-finding assay (if applicable) - Incidental Cost 16 EA

0015 Drug Cost Not to Exceed 16 EA

TOTAL COST ($)

$500.00 $8,000.00

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Ordering Period 2

CLIN

Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Drug Discrimination (initial training) - Drug 1

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 1

- Incidental Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Incidental Cost 4 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Incidental Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Incidental Cost 8 EA

Drug Discrimination of Test Drug - Assay Cost 16 EA

Drug Discrimination of Test Drug - Incidental Cost 16 EA

1011 Pharmacokinetic Assay - Assay Cost 10 EA 1012 Pharmacokinetic Assay - Incidental Cost 10 EA

Locomotor or another dose-finding assay (if applicable) - Assay Cost 16 EA

Locomotor or another dose-finding assay (if applicable) - Incidental Cost 16 EA

1015 Drug Cost Not to Exceed 16 EA

TOTAL COST ($)

Ordering Period 3

CLIN

Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Drug Discrimination (initial training) - Drug 1

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 1

- Incidental Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Incidental Cost 4 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Assay Cost 8 EA

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Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Incidental Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Incidental Cost 8 EA

Drug Discrimination of Test Drug - Assay Cost 16 EA

Drug Discrimination of Test Drug - Incidental Cost 16 EA

2011 Pharmacokinetic Assay - Assay Cost 10 EA 2012 Pharmacokinetic Assay - Incidental Cost 10 EA

Locomotor or another dose-finding assay (if applicable) - Assay Cost 16 EA

Locomotor or another dose-finding assay (if applicable) - Incidental Cost 16 EA

2015 Drug Cost Not to Exceed 16 EA

TOTAL COST ($)

Ordering Period 4

CLIN

Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Drug Discrimination (initial training) - Drug 1

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 1

- Incidental Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Incidental Cost 4 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Incidental Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Incidental Cost 8 EA

Drug Discrimination of Test Drug - Assay Cost 16 EA

Drug Discrimination of Test Drug - Incidental Cost 16 EA

3011 Pharmacokinetic Assay - Assay Cost 10 EA 3012 Pharmacokinetic Assay - Incidental Cost 10 EA

Locomotor or another dose-finding assay (if applicable) - Assay Cost 16 EA

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Locomotor or another dose-finding assay (if applicable) - Incidental Cost 16 EA

3015 Drug Cost Not to Exceed 16 EA

TOTAL COST ($)

Ordering Period 5

CLIN

Line Item Assay Quantity Unit Unit Price

Estimated Total Price

Drug Discrimination (initial training) - Drug 1

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 1

- Incidental Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Assay Cost 4 EA

Drug Discrimination (initial training) - Drug 2

- Incidental Cost 4 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 1 - Incidental Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Assay Cost 8 EA

Drug Discrimination (monthly maintenance of training drug) - Drug 2 - Incidental Cost 8 EA

Drug Discrimination of Test Drug - Assay Cost 16 EA

Drug Discrimination of Test Drug - Incidental Cost 16 EA

4011 Pharmacokinetic Assay - Assay Cost 10 EA 4012 Pharmacokinetic Assay - Incidental Cost 10 EA

Locomotor or another dose-finding assay (if applicable) - Assay Cost 16 EA

Locomotor or another dose-finding assay (if applicable) - Incidental Cost 16 EA

4015 Drug Cost Not to Exceed 16 EA

TOTAL COST ($)

Optional In Vivo Studies The DEA is open to the inclusion of other behavioral studies (e.g., locomotor activity, conditioned place preference, roto rod assays, self-administration studies, head twitch assay, etc.) 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 contractor mutually agree on all matters (i.e., feasibility, cost, etc.) regarding these optional in vivo studies, these studies 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).

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Section 2: Statement of Work

2.0 Background

The Drug and Chemical Evaluation Section (DOE) of the Drug Enforcement Administration’s (DEA) Diversion Control Division (DC) is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. Pharmacological, medical, epidemiological, and other scientific data for these drugs are needed to evaluate the abuse potential of these substances. DOE uses these evaluations 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 substances with hallucinogenic activity have been abused in the United States and pose a significant risk to the public safety. Law enforcement and forensic laboratory data have reported increased encounters of hallucinogenic substances. Abuse of some of these hallucinogenic substances has been associated with adverse health events. Due to the public health threat associated with the abuse of hallucinogenic substances, these substances may need to be controlled under the CSA. Pharmacological data is required for this evaluation.

Evaluating the discriminative stimulus properties of drugs of abuse including hallucinogens is highly important in determining their abuse potential. Studies on the discriminative stimulus effects of newer available hallucinogens in comparison to established hallucinogenic drugs such as d-lysergic acid (LSD), 2,5-dimethoxy-4-methylamphetamine (DOM), psilocybin, and phencyclidine (PCP) will help to determine hallucinogen-like effects and abuse potential of these substances. Additionally, since many newer hallucinogens are chemically similar to controlled ones, they may share the same metabolism pathways or are metabolized to an already controlled substance. As such, DEA would like the contractor to assess discriminative stimulus and pharmacokinetic (e.g., metabolism, metabolites) properties of selected hallucinogens. DEA is requesting that the pharmacological studies be initiated and completed in an expedited manner.

2.1 Brief Description of Work

For this project, DEA will provide the hallucinogenic test substances to the potential contractor. The reference standards for drug discrimination will be Schedule I or II substances. Therefore, the contractor should have a Schedule I and II-V researcher registration with DEA. The contractor shall conduct preclinical evaluation of discriminative stimulus effects of these substances in comparison to appropriate controls and reference standard hallucinogenic substances (i.e., LSD and PCP, or another controlled hallucinogen). The contractor will provide DEA with investigational study results and a description of the methodology used to conduct the investigation in the form of a formal study report as per the timelines specified in this Statement of Work, if not earlier. The contractor will evaluate a dose-response study of two training drugs, reference drugs, and up to 16 potential hallucinogenic test substances, in total, in the aforementioned studies. Here, separate groups of animals will be trained to discriminate the stimulus effects of LSD and PCP, or another controlled hallucinogen. Single dose administration will be used for each substance tested (i.e., 7 | P a g e training drug, reference drug, and test substances). Upon award of the contract, DEA will notify the contractor which substances will be trained as the reference drugs and the names of these test substances. DEA will provide the contractor sufficient quantities of the test substances needed to complete the proposed pharmacological studies. It is the contractor’s responsibility to purchase any necessary substances (such as reference drugs) that DEA does not provide for drug discrimination assays.

2.2 Security Requirements

All contractor personnel supporting this procurement are entrusted with a certain level of trust due to the nature of DEA's mission. The Government expects the contractor 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. The Diversion Control Division has agreed to accept all programmatic risk for the loss of any data as a result of the request to waive the U.S. citizenship requirement. The U.S.

citizenship requirement has been waived for this effort only.

3.0 Specific Tasks to be Performed

Task 1. Drug source, storage and record keeping.

Drug Source: DEA will provide the contractor the test substances only. The contractor is responsible for obtaining the training drug(s) (LSD, DOM, PCP, or another controlled hallucinogen), reference substances (e.g., PCE, psilocybin), and any other substances needed to complete the studies.

Record Keeping: The contractor 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) date of authorization for testing of the test substance;

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

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

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

(f) date of initiation of each study authorized by DEA;

(g) amount of test substance used for each authorized study;

(h) date of completion of each authorized study;

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

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

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

Task 2. Protocols of in vivo pharmacological studies (drug discrimination) in laboratory rodents.

The contractor’s proposal shall include the general protocols that are used for in vivo drug discrimination studies including a description of these studies (i.e., preferred methodology). Upon acceptance of the award and as specified in the deliverables, the contractor shall provide DEA the detailed study protocols. The study protocols shall contain a description of the methodology and apparatus used to conduct the experiments, maintenance of the animals to be used in the tests, data analysis including proposed statistical methods, and proposed presentations of the data and study results. Specifically, the study protocol should conform to the following standards:

The contractor shall provide a study protocol for drug discrimination.

The study protocols must be specifically written to meet the protocol preferences as listed in this Statement of Work under Tasks 3, 6, and 7.

The study protocol should closely follow the format of the materials and methods section of scientific journal articles. If the contractor has previously published these methods in a scientific journal, such information should be included as part of the study protocol and shall not be submitted as a separate file (i.e., submitting the example paper with the study protocol would not be considered acceptable). Details including the animal species and strain, number of animals, animal care, experimental design, data analysis including statistical methods and generation of results (e.g., ED50, 95% confidence limit values, standard error of the means, and repeated measures ANOVA, as appropriate) shall be included:

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

Signature lines shall be included on each study protocol. The protocol that is approved by both DEA and the contractor will be signed by the respective representatives. The original signed document will remain with DEA. A copy of the signed protocol will be provided to the contractor. The signed protocols will serve as an official record.

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Following receipt of the standard protocols by 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 contractor must be authorized by DEA. The contractor 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 DEA representative for review and approval. The DEA representative must approve the protocol 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 DEA shall be evaluated using the new modified method. For the most part, standard substances (known drugs of abuse such as LSD and PCP, or another controlled hallucinogen) shall be used. Special reports and data summaries shall adhere to the format determined by DEA.

Task 3. Evaluation of test substances in in vivo drug discrimination assay

I. Objective: The objective of this in vivo pharmacological study is to determine whether the test substances and/or standard reference substances are similar to known drugs of abuse with regard to their discriminative-stimulus effects.

II. Experimental Design: Drug discrimination studies shall be conducted in rats. The contractor shall maintain groups of rats trained to discriminate the stimulus effects of a given training drug (i.e., LSD and PCP, or another controlled hallucinogen) from its vehicle. It is expected that drug discrimination training for the animals commence within a week after the protocol is approved. The dose-response studies for training and reference drugs should be repeated periodically and the resulting dose-response curves should be included in the study reports (see Task 6). The contractor 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 complete the experiments in a timely manner. DEA may have in vitro serotonin, NMDA, or other receptor binding and functional data for some of the test substances and in such cases, DEA will share these data with the contractor. Such data may be of use in selecting the appropriate doses for this study. Antagonist studies conducted using the drug discrimination paradigm, with input from DEA, may be conducted in order to verify the behavioral effects of the test drugs (the antagonist drug can be selected by the contractor with input from DEA staff).

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 contractor shall immediately notify the DEA representative, in writing (email) with the issue and if the issue was resolved. Based

10 | P a g e on the issue noted by the contractor, 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. DEA may request that the contractor repeat testing of a substance using different testing conditions (e.g., change in drug pretreatment time or route of drug administration).

IV. Study Report: Following completion of the in vivo drug discrimination study for each test substance, the results in the form described in Task 4 (i.e., 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 contractor if there are any notable issues with the results.

Task 4. Protocols of in vivo pharmacological studies (pharmacokinetics) in laboratory rodents

The contractor’s proposal shall include the general protocols that are used for in vivo pharmacokinetic studies including a description of these studies (i.e., preferred methodology). Upon acceptance of the award and as specified in the deliverables, the contractor shall provide DEA the detailed study protocols. The study protocols shall contain a description of the methodology and apparatus used to conduct the experiments, maintenance of the animals to be used in the tests, data analysis including proposed statistical methods, and proposed presentations of the data and study results. Specifically, the study protocol should conform to the following standards:

I. The contractor shall provide a study protocol for the pharmacokinetic assay, indicating abilities to identify major metabolites of various substances (including non-hallucinogenic substances).

II. The study protocols must be specifically written to meet the protocol preferences as listed in this Statement of Work under Tasks 5, 6, and 7.

III. The study protocol should closely follow the format of the materials and methods section of scientific journal articles. If the contractor has previously published these methods in a scientific journal, such information should be included as part of the study protocol and shall not be submitted as a separate file (i.e., submitting the example paper with the study protocol would not be considered acceptable). Details including the animal species and strain, number of animals, animal care, experimental design, data analysis including statistical methods and generation of results (e.g., major metabolites identified, time of peak drug concentrations, standard error of the means, and repeated measures ANOVA, as appropriate) shall be included.

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

V. Signature lines shall be included on each study protocol. The protocol that is approved by both DEA and the contractor will be signed by the respective

11 | P a g e representatives. The original signed document will remain with DEA. A copy of the signed protocol will be provided to the contractor. The signed protocols will serve as an official record.

Following receipt of the standard protocols by 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 contractor must be authorized by DEA. The contractor 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 DEA representative for review and approval. The DEA representative must approve the protocol 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 DEA shall be evaluated using the new modified method. For the most part, standard substances (known drugs of abuse such as LSD and PCP, or another controlled hallucinogen) shall be used. Special reports and data summaries shall adhere to the format determined by DEA.

Task 5. Evaluation of test substances in in vivo pharmacokinetic assay

I. Objective: The objective of this in vivo pharmacological study is to determine whether the test substances and/or standard reference substances are similar to known drugs of abuse with regard to their pharmacokinetic properties, not limited to substances considered to be hallucinogenic.

II. Experimental Design: Pharmacokinetic studies shall be conducted in rodents. The contractor shall identify major metabolites, identify time of peak drug concentrations, among other agreed upon measures that may be similar to LSD, DOM, psilocybin, PCP, or other substances (hallucinogenic or non-hallucinogenic). Dosing may be similar to drug discrimination studies (outlined in task 2 and 3) or be based on dose that produced the greatest amount of substitution or full substitution of the test substance or elsewhere determined. It is expected that pharmacokinetic studies are able to commence within a week after the protocol is approved. The contractor shall have the equipment available for pharmacokinetic testing procedures such that the experiments can be conducted in a relatively expedient manner for this assay. Different test or references substances may be tested in the pharmacokinetic assay than the drug discrimination assay. DEA may have in vitro serotonin, NMDA, or other receptor binding and functional data for some of the test substances and in such cases, DEA may share these data with the contractor. Such data may be of use in selecting the appropriate doses for this study.

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

12 | P a g e constrains), the contractor 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 contractor, 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. DEA may request that the contractor repeat testing of a substance using different testing conditions (e.g., route of drug administration).

IV. Study Report: Following completion of the in vivo pharmacokinetic study for each test substance, the results in the form described in task 6 (e.g., major metabolites identified, time of peak drug concentrations, standard error of the means, and repeated measures ANOVA, as appropriate) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact contractor if there are any notable issues with the results.

Task 6. Final study report for each substance tested

Following completion of the experiments in Task 3 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 DEA.

(1) Study Reports: A final study report containing the complete methodology, data analysis, and study results for each compound/assay in comparison to reference standard drugs shall be provided to DEA. The study report should include dose-response curves for the test drug, the training, and reference drugs. The DEA representative will provide an example of a Final Study Report for the contractor 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. A drug by dose summary table and raw data should also be included in an appendix. The contractor 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:

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

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

ii. 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 by contractor and DEA representative.

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iii. Appendix: Summary table and raw data as agreed upon by the contractor and DEA representative.

Task 7. 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.

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

II. Study Reports: See task 6 for details on these reports.

III. Annual Progress Report: On or before the 5th working day following the end of the period of performance year, the contractor shall submit a report on activities during that year. One electronic copy in Microsoft Word or PDF format shall be sent to the DEA representative. In the report, contractor 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.

4.0 Period of Performance

Period of Performance POP Start POP End

Ordering Period 1 06/01/2024 05/31/2025

Ordering Period 2 06/01/2025 05/31/2026

Ordering Period 3 06/01/2026 05/31/2027

Ordering Period 4 06/01/2027 05/31/2028

Ordering Period 5 06/01/2028 05/31/2029

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5.0 Deliverables:

If a report on any of the requested studies cannot be provided by the specified timelines, the contractor must notify DEA immediately upon obtaining this knowledge. This notification shall be followed up by a letter to DEA stating the reason for the delay, the anticipated date of completion of investigations, and the anticipated delivery of the study. The DEA representative reserves the right to visit the location(s) 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 drug discrimination and pharmacokinetic assays

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.

4 Annual Progress Report 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.

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7 Meetings between DEA and contractor and supporting materials (as needed, may be waived)

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 contractor, developed or maintained by the contractor in the performance of this contract under this Statement of Work are deemed to be the property of DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release. None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the Statement of Work, without prior written approval of DEA. The contractor and DEA 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 contractor shall deliver (or otherwise dispose per DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or analyze data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).

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

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7.0 Retention of Information

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

7.1 DEA Representative (Scientific and Technical Contact):

Theresa Carbonaro, PhD Pharmacologist Drug and Chemical Evaluation Section

Drug Enforcement Administration

7.2 Level of Effort

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

8.0 Staffing Approach

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

NAICS 611310 - Colleges, Universities, and Professional Schools, Principal Investigator:

1. Principal Investigator:

a. Ph.D., and 10 years post degree 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:

a. Ph.D., and 10 years post degree 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.

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3. Research Technician assigned to analyze samples (Not Key Personnel)

4. Laboratory Manager (Not Key Personnel)

NAICS 621511 - Medical Laboratories

1. Principal Investigator (Study Director):

a. Ph.D., and 10 years post degree 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):

a. Ph.D. and 10 years post degree 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 (Not Key Personnel)

4. Research Technician assigned to analyze samples (Not Key Personnel)

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 will 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.

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

Resumes of 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

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A letter of commitment, signed by the person proposed for one of the key personnel labor categories. The letter must express their ability to work at the proposed labor category.

8.3 Staff 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.

9.0 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.

10.0 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 to 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.

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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: 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; sent electronically via 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:

15DDHQ24R00000021 are due no later than 1:00 PM EST on May 6, 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 April 17, 2024 at 1:00 PM EST. 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.

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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.

4. 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.

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5. 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:

Technic…