75N95022R00058_PreSol_Notice.pdf

SOLICITATION NUMBER: 75N95022R00058

PRE-SOLICITATION NOTICE INFORMATION

Title: Production of Cannabis and Related Materials for Research.

Introduction:

This is a Pre-Solicitation Notice of Intent. This is NOT a solicitation for proposals, proposal abstracts, or quotations. A solicitation will be issued on a later date.

The purpose of this pre-solicitation notice is to notify potential offerors that the National Institute on Drug Abuse (NIDA) intends to solicit proposals for Production of Cannabis and Related Materials for Research from qualified contractors having the capability to perform the tasks identified in this pre-solicitation notice.

This acquisition is a re-competition of the similar requirement Production, Analysis, and Distribution of Cannabis and Related Materials contract (N01DA-15-7793) for the NIDA the Division of Therapeutics and Medical Consequences (DTMC) that was awarded in 2015 to the University of Mississippi.

Mandatory criteria:

The below mandatory criteria establish conditions that must be met to be considered for this project.

1. In accordance with the Controlled Substances Act of 1970, any offerors must possess or demonstrate the capability to obtain Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and non-active constituents.

2. Offerors must demonstrate availability of secure indoor and/or outdoor growing facilities necessary to support production of up to 2000 kg of marijuana, in a given year, as well as extraction/purification capabilities necessary to produce up to 500 kg of marijuana products in a given year.

3. Offerors must demonstrate availability of laboratory facilities sufficient to perform extractions and analysis of cannabis and related materials.

4. Offerors must demonstrate availability of laboratory facilities to perform extractions of cannabis and production of cannabis related materials products.

Project Tasks/Requirements:

The Contractor shall be required to furnish all necessary services, qualified personnel, materials, equipment, and facilities to perform the requirements specified below:

1) Produce or procure cannabis, cannabis extract and other cannabis-derived materials for basic and clinical research, and conduct quantitative and qualitative analysis, stability determination, and recommended storage conditions for these products for approved research.

2) Provide sufficient quantities of cannabis to meet anticipated needs as directed by the NIDA Contracting Officer's Representative (COR), followed by careful quantitative analysis prior to shipment to a DEA approved location (i.e. Research triangle Institute, Research Triangle Park, NC) as directed by the NIDA COR. NIDA supplies research investigators with cannabis and its main psychoactive component, delta-9-THC, and other components such as cannabinol (CBN), cannabidiol (CBD), cannabichromene (CBC), cannabigerol (CBG), other cannabinoids and components.

3) In order to meet present and anticipated needs for phytocannabinoids, the Contractor shall extract cannabis to isolate pure THC and other cannabinoids, obtain cannabis extract of known potencies, manufacture marijuana cigarettes of varying potencies, and provide purified materials and marijuana cigarettes for research and/or to the NIDA Drug Supply program, as directed by the COR.

4) Have the ability to irradiate (via Gamma or X-ray) all cannabis prior to shipment to the location authorized by the COR. This may be accomplished using a commercial firm or an in-house irradiator, similar to the RS 420-XL model available from Rad Source Technologies, Inc.

5) Analyze cannabis or cannabis products for cannabinoid contents and contaminants as designated by the COR. All pertinent Food and Drug Administration (FDA) and DEA requirements (e.g., cGMP) must be met for the cannabis preparations.

The NIDA DTMC requires the following tasks to be performed:

Task 1 – Provision of cGMP Cannabis (500 KG).

Task 2 – Provision of cGMP Cannabis (1000 KG) and Provision of cGMP Placebo Cannabis (500 KG).

Task 3 – Provision of cGMP Cannabis (2000 KG) and Provision of cGMP Placebo Cannabis (1000 KG).

Task 4 – Provision of cGMP Cannabinoid Extract.

Task 5 - Provision of GMP Cannabinoids.

Task 6 - Provision of Non-GMP Cannabinoids.

Task 7 - "End of Contract" Specific Task Requirement: Archival Maintenance of Records.

Set-Aside Status:

The services will be acquired through unrestricted full and open competitive procedures under NAICS Code 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Anticipated Period of Performance:

The anticipated period of performance is a period of five years.

Anticipated Contract Type:

The NIDA anticipates the award of one (1) contract. It is anticipated that the contract type shall be an Indefinite Delivery, Indefinite Quantity (IDIQ) using task orders.

Request for Proposal Release Information:

Request for Proposal (RFP) No. 75N95022R00058 will be available electronically on or about July 28, 2022. The RFP shall be accessible through sam.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days following RFP release. Offerors must submit a proposal for all Task Areas in order to be considered for award. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO SUBMIT A PROPOSAL

WHICH WILL BE CONSIDERED BY THE AGENCY.

Notes: It is the Offeror’s responsibility to monitor the above-mentioned site for the release of the solicitation and any amendments.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.