Sources Sought Notice_Production of Cannabis and Related Materials for Research.pdf

Sources Sought Number: 75N95022R00058

Title: “Production of Cannabis and Related Materials for Research”.

This is a Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS.

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement or otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked.

The purpose of this notice is to obtain information regarding:

1. The availability and capability of qualified other-than-small business sources; and,

2. The availability and capability of qualified small business sources;

a. Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and

b. Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

The applicable NAICS code for this acquisition is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Responses to this notice will be accepted from all businesses under this NAICS code. Responses should clearly state whether the respondent is considered a small or other-than-small business under this NAICS code.

PROJECT REQUIREMENTS

The National Institute on Drug Abuse (NIDA) seeks capability statements from all businesses having the in-house capability to act as a centralized source for acquisition and/or production of cannabis and related materials for research purposes. 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 main objectives of this contract are to:

(1) cultivate and harvest cannabis (marijuana) for the NIDA Drug Supply Program (NDSP);

(2) extract cannabis to produce pure and standardized (current Good Manufacturing Practices (cGMP)-grade) cannabis extracts containing varying concentrations of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and other constituents (e.g., other cannabinoids and/or other plant components) as directed by the COR;

(3) isolate cGMP and research grade THC, CBD, and other cannabinoids as directed by the COR;

(4) analyze cannabis, cannabis extracts, and/or other cannabis products (i.e. isolated cannabinoids, etc.)

for authenticity, purity and stability;

(5) maintain Chemistry Manufacturing and Controls information to support the use of the cannabis, provided under this task, under an Investigational New Drug (IND) application to FDA. This can also be accomplished through the establishment and maintenance of a Drug Master File (DMF) filed with FDA.

(6) Provide the CMC information or a Letter of Authorization (LOA) for FDA to reference the Drug Master File (DMF), to researchers using the cannabis under an IND as identified by the COR.

(7) supply cannabis, cannabis extract and/or other cannabis products to the NIDA Drug Supply program upon COR authorization.

MANDATORY CRITERIA:

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

Respondents should provide a clear summary of their ability to meet these requirements.

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 as identified in Attachment 1.

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

CAPABILITY STATEMENT/INFORMATION SOUGHT:

The established NAICS code is 541715. Information sent should be relevant and specific in the technical area under consideration and include the following sections:

1. Company Profile: A profile of the responding company including the following information:

a. Company Name, Address, and DUNS Number

b. Point of Contact

c. Phone, email, and fax

d. Registered NAICS codes

e. Business size and status (e.g. large or small business, HUBZone, SDVOSB, etc.)

2. Experience: An outline of previous similar projects in the areas specified above and work in the field of drug abuse;

3. Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions;

4. Mandatory Qualifications: A clear outline of the offeror’s ability to meet the mandatory criteria detailed above and summarized below:

a. Possession of or demonstration of capability to obtain DEA registrations for manufacture and distribution of Schedules I controlled substances including cannabis and its active and non-active constituents.

b. Possession of required growing facilities.

c. Availability of laboratory facilities to perform extractions of cannabis and production of cannabis related products.

d. Availability of laboratory facilities sufficient to perform analysis of cannabis and related materials as identified in Attachment 1.

5. Facilities: Availability and description of facilities and equipment required to conduct this type of work.

Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable.

Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner.

Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

Capability statements should be submitted electronically to the following e-mail address:

mjcontract@mail.nih.gov in the form of a single PDF file with the subject line: “Capability Statement 75N95022R00058.” Written capability statements must be received NO LATER THAN June 6th, 2022, at 12:00 PM Eastern time.

Requests for Information (RFIs)

Requests for clarification or additional information must be made in writing to the Contracting Officer.

RFIs must be submitted on or before May 26th at 6:00 PM Eastern time. RFIs must be submitted by e-mail to the POC identified below with the subject line “RFI – 75N95022R00058.” NIDA may not respond to RFIs made after the deadline.

Primary Point of Contact:

Polina Klimenkova Contract Specialist mjcontract@mail.nih.gov

Secondary Point of Contact:

KJ Shaikh Contracting Officer mjcontract@mail.nih.gov

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). 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.

After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.

mailto:mjcontract@mail.nih.gov mailto:PADCRM@nih.gov

Attachment 1

Information needed related to the production of cannabis. It can be provided directly to NIDA or submitted to a Drug Master File (DMF) and Letter of Authorization (LOA) to cross reference provided to

NIDA.

Cannabis Biomass Batch Identification

Date of Harvest

U Miss Barrel ID

Species

Irradiated? Yes ___ No ___ Date Irradiated __/__/____

Attributes Methods Acceptance criterion Duration of indoor light (light on/off cycle) (if grown inside)

Provide the light cycle and RH% for plants grown indoors

Leaves, stems, roots, etc. that are harvested.

At what age and the minimum and maximum height of the plants at harvest (height range would be acceptable)

Humidity (if grown inside)

Part of the plant harvested Age of the plant at harvest

Height of the plant Mode of plant propagation

(seed vs graft) (Graft: Female or male)

WHO Good Agricultural and Collection Practices (GACP) for Medicinal Plants

(2003, Section 2.2) Water determination USP <921> <561>

Foreign organic matter USP <561>

Stem (3 mm or more in diameter) at harvest

Method XXXX

Information needed related to the harvested cannabis. It can be provided directly to NIDA or submitted to a Drug Master File (DMF) and Letter of Authorization (LOA) to cross reference provided to NIDA.

Cannabis Biomass (for use in Drug Products for Inhalation): in cigarettes and vaporizer

Botanical identification1 NDSP Lot Number

Harvest Batch ID

Date Harvested

Irradiated? Yes ___ No ___ Date Irradiated __/__/____ Tests Methods Acceptance criterion

Species WHO Good Agricultural and Collection Practices (GACP) for Medicinal Plants (2003, Section 2.1)

Verified and recorded by a botanist Cultivar (s)/Variety

Microscopic and Macroscopic identification AHPA or USP <563>

Water determination USP <921> <561>

Chemical profile1, 2

∆8-THC

Method # XXXX

HPLC/GC-FID

∆9-THC

∆9-THC Acid A ∆9-THC Acid B

CBD (Cannabidiol) CBG (Cannabigerol)

THCV (Tetrahydrocannabivarin) CBDV (Cannabidivarin) CBC (Cannabichromene)

Total ∆9-THC Total CBD

Other terpenes Degradation products of THC/CBD and other terpenes e.g. CBN (Cannabinol)

Adventitious agents Pesticides/Herbicides/Insecticides1 USP <561> Tested and No chemicals are used and/or found.

Aflatoxins1 USP <561>

Elemental impurities

USP <561>, USP <232> (table 1) for inhalational daily dose PDE (mcg/day)

Microbial Enumeration Tests1,2,3

Total Aerobic Microbial Count (TAMC) Total Combined Yeasts/Mold Count (TYMC)

USP <61>

102 CFU/g or CFU/mL 101 CFU/g or CFU/mL

Tests for Specified microorganisms1,2,3 Pseudomonas aeruginosa Absent

Staphylococcus aureus Bile-tolerant Gram-negative bacteria

USP <62> Absent Absent

Escherichia coli Absent Salmonella ssp. Absent

Water activity1,2 USP <1112>