A15 - Sole Source Documentation over SAT FAR PART 13_redacted.pdf

SOLE SOURCE FOR CONDUCTING ACQUISITIONS USING SIMPLIFIED ACQUISITION PROCEDURES AUTHORIZED BY

FAR 13.501 WITHOUT PROMOTING COMPETITION TO THE MAXIMUM EXTENT PRACTICABLE

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Identification Number (purchase request/solicitation number): D-25-DO-0010

1. Identification of the agency and contracting activity.

A. Agency: Drug Enforcement Administration (DEA)

B. Contracting activity: Office of Acquisition and Relocation Management (FA)

C. Requiring activity: Drug Control Unit (DOEP)

2. Nature and/or description of the action being approved. (e.g., new contract award or modification expanding the scope of an existing contract)

DEA needs pharmacological studies to be initiated and completed in an expedited manner. The vendor is an incumbent contractor with trained animals.

3. A description of the supplies or services required to meet the agency’s needs, including the estimated value.

(inclusive of all options)

DEA-Diversion Control Division (DC), Drug and Chemical Evaluation Section (DOE) is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. In order to make this determination, pharmacological and other scientific data are needed to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances ACT (CSA). Evaluating the discriminative stimulus properties of cannabinoids will help establish the THC-like property of the drugs and allow classification of these new drugs under the CSA. As such, DEA-DOE wants the vendor to conduct behavioral pharmacology studies of selected cannabinoids in an in vivo drug discrimination assay.

Period of performance or Total estimated value: $ final delivery date: 07/01/2025 - 06/30/2026

4. An identification of the statutory authority permitting other than competition to the maximum extent practicable.

The simplified acquisition threshold is defined in FAR 2.101. Per FAR 6.001, acquisitions of certain commercial items exceeding the simplified acquisition threshold and conducted using simplified acquisition procedures as authorized by FAR 13.501 are exempt from the requirement to promote full and open competition. Such acquisitions must promote competition to the maximum extent practicable as required by 41 U.S.C. 1901 and FAR 13.104. Because this acquisition will be conducted without promoting competition to the maximum extent practicable, this justification is prepared for review and approval in accordance with FAR 13.106-1(b)(2) and 13.501(a).

Select the Authority that applies:

41 U.S.C. 1901, FAR 13.501(a) exceeding the simplified acquisition threshold; or 41 U.S.C. 1903, FAR 13.501(a) emergency procurement (up to $750K within the United States and up to

$1.5Million outside the United States)

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

DEA requires pharmacological data to evaluate abuse potentials of substances before they can be placed in a schedule within the controlled substances act (CSA). Data obtained through pharmacological research contract https://www.acquisition.gov/far/part-2#FAR_2_101 https://www.acquisition.gov/far/part-6#FAR_6_001 https://www.acquisition.gov/far/part-13#FAR_13_501 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section1901&num=0&edition=prelim https://www.acquisition.gov/far/part-13#FAR_13_104 https://www.acquisition.gov/far/part-13#FAR_13_106_1 https://www.acquisition.gov/far/part-13#FAR_13_501 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section1901&num=0&edition=prelim https://www.acquisition.gov/far/part-13#FAR_13_501 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section1903&num=0&edition=prelim https://www.acquisition.gov/far/part-13#FAR_13_501

November 2022 2 will provide scientific and technical support for court cases involving such substances. RTI has performed pharmacological evaluation of pytocannabinoids for DEA in the last six yeas (06/2019-04/2025). RTI has a well equipped laboratory with animals already trained to discriminate THC stimulus properties and can readily generate the necessary in vivo behavioral data using drug discrimination studies. Because RTI has the capability is of high significance because the process of training rodents for this specific behavior is a time consuming process and requires many months- rats have to learn a behavior that is specific to a trained drug cue. The pharmacological property of novel drugs are required to delinate and understand their mechanism of action. This information is needed to make decision on abuse potential of a novel subgstance. This data are the basis of DEA’s regulatory control of controlled substances.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Based on previous solicitation that was recently published ( REQ No: 5DDHQ25Q00000010) only two vendors (University of North Texas and RTI) provided response to the solicitation. Both vendors have the technical capability to complete the work. However, one of the vendors (RTI) has the trained rats ready to complete the required work in an expedited manner. Training of rodents to acquire the specific behavior required for the assay is time consuming, which requires months to complete. DEA-DOE believes only RTI can complete the studies ina timely manner without requiring additional time for training the rodents.

As such, DEA believes there are no other sources that has trained rats ready. All other sources would need time to complete rodent training.

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Only one source is reasonably available

8. A description (summary) of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

RTI is the incumbent and has rats trained to complete work. Desired data are time-sensitive in nature.

9. Any other facts supporting the use of other than competition to the maximum extent practicable, such as:

i. Explanation of why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available.

Because of the urgency and the compelling need to obtain additional in vivo behaviroal pharmacological data on cannabinoids in a timely manner, a pharmacology laboratory that have animals already trained for THC discriminative stimulus effect need to be identified to meet DEA’s current need.

ii. When the acquisition is result in a follow-on contract for the continued development or production of a major system or highly specialized equipment, an estimate of the cost to the Government that would be duplicated and how the estimate was derived.

RTI has a well developed laboratory and have completed similar requirement for DEA in the past several years.

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10

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iii. When the justification is based on an urgent and compelling requirement, cite data, estimated cost, or other rationale as to the extent and nature of the harm to the Government.

Based on the time-sensitive nature of the requirement, RTI has already trained rats that can be used to complete the studies without needing extra time for training.

iv. When the justification is for brand name, explain why the particular brand is the only brand that can satisfy the Government’s need. Include in the explanation why other brands do not meet the Government’s requirement.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

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CERTIFICATIONS

I hereby certify that I have no financial interests of the sort addressed in subpart D of 5 CFR § 2635 that may give the appearance of a conflict of interest in regards to this Justification.

I hereby certify that I have no personal or business relationships or interests of the sort addressed in 5 CFR §

2635.502 that may give the appearance of a conflict of interest in regards to this Justification.

Requesting Official _____________ Date __06/04/2025__

Signature & Title

“I hereby certify that the description of the requirement meets the Government’s minimum needs and that the technical data and supporting information, which form the basis for this Justification for Other than Full and Open Competition, are accurate and complete to the best of my knowledge and belief".”

I hereby certify that I have no financial interests of the sort addressed in subpart D of 5 CFR § 2635 that may give the appearance of a conflict of interest in regards to this Justification.

I hereby certify that I have no personal or business relationships or interests of the sort addressed in 5 CFR §

2635.502 that may give the appearance of a conflict of interest in regards to this Justification.

Requesting Office Technical Point of Contact ____________________________________ Date _______________ Signature & Title

“I hereby certify that this Justification for Other than Full and Open Competition is accurate and complete to the best of my knowledge and belief.”

Contract Specialist ____________________________________ Date __6/5/2025_____ Signature

Contracting Officer ____________________________________ Date __6/5/2025_____ Signature

“I have reviewed the subject contract action and find it legally sufficient for award.

CC Legal Counsel ____________________________________ Date _______________ (if over $750,000) Signature https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635/subpart-D?toc=1 https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635/subpart-E/section-2635.502 https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635/subpart-E/section-2635.502 https://www.ecfr.gov/current/title-5/chapter-XVI/subchapter-B/part-2635/subpart-D?toc=1

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REVIEWS AND APPROVALS

Competition Advocate ____________________________________ Date _______________

Chief, FAC ____________________________________ Date _______________

Bureau Procurement Chief (if over $750,000 ____________________________________ Date _______________ per JAR 2806.304) Signature

Head of the Contracting ____________________________________ Date _______________ Activity (if over $15M) Signature

Senior Procurement Executive (if over $75M) ____________________________________ Date _______________ Signature http://www.ecfr.gov/cgi-bin/text-idx?SID=3fda8408419c81be5c700dc54ca7e51f&node=se48.6.2806_1304&rgn=div8