Notice Number: NOT-DA-15-038
Release Date: August 29, 2014
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following tasks: (1) cultivate and harvest, process, analyze, store, and distribute cannabis (marijuana) for research, (2) extract cannabis to produce pure and standardized (current Good Manufacturing Practices (cGMP)-grade) cannabis extracts containing varying concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), (3) isolate cGMP and research grade THC, CBD, and other cannabinoids, (4) periodically analyze cannabis extracts, and isolated cannabinoids for authenticity, purity and stability, (5) develop new methods for growing cannabis plants containing high THC, low CBD; high CBD, low THC; and equal strength of CBD and THC, (6) manufacture, analyze, determine stability, store, and supply marijuana cigarettes, and (7) supply cannabis, cannabis extract, other phyto-cannabinoids, and marijuana cigarettes to research investigators and/or to the NIDA Drug Supply program upon NIDA authorization.
Additional quantity options may include performance of one or more of the following tasks: (1) cultivation, growing, harvesting, analyzing, and storing of research grade cannabis in the amount of 1.5, 6.5, or 12 acres, (2) extraction of cannabis and production of cGMP-grade cannabis extract (high CBD, low THC; high THC, low CBD; and equal ratio of CBD and THC; or as required by NIDA) and performance of all necessary testing, (3) design, development, manufacturing, analysis, storing, and distribution of cGMP grade drug dosage form of cannabis extract of known cannabinoid strengths for clinical research, (4) manufacturing of cGMP-grade cannabis cigarettes, ascertaining physical and chemical specifications, checking purity and any other required specifications, creating data sheets, and storing and distributing the cigarettes as required by NIDA, and/or (5) analysis of confiscated marijuana samples submitted by the Drug Enforcement Administration (DEA), other law enforcement agencies, and/or by others as required by NIDA.
Listed below are mandatory qualification criteria. The qualification criteria establish conditions that must be met:
A. In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must possess a current DEA registration for Schedules II to V substances and demonstrate the capability to obtain DEA registration for Schedule I controlled substances including marijuana and its active and non-active constituents. In addition, any offeror must also possess DEA registration for research, manufacture, and distribution of Schedule I through V controlled substances before the award of this contract.
B. The successful offeror must possess, and maintain (1) a secure and video monitored outdoor facility of approximately 12 acres for growing and processing cannabis, and (2) an indoor growing facility for the purpose of growing, propagating, and sustaining cannabis plants under controlled conditions. The indoor facility must be at least 1000 square feet, having controls for light intensity, photo cycles, temperature, humidity, and carbon dioxide concentration. The successful offeror shall have provisions for back-up systems for the outdoor and indoor facilities in case of emergency.
C. The successful offeror must demonstrate the availability of a DEA and Food and Drug Administration (FDA) approved and secure storage (vault) facility to maintain an inventory of approximately 400 to 700 kilograms of marijuana stock, cannabis extract and its drug dosage form, marijuana cigarettes, and its active and inactive constituents under controlled conditions.
D. The successful offeror and/or the successful offeror's subcontractor responsible for the production/manufacture of cannabis extract drug dosage form, and marijuana cigarettes must be registered with the FDA as a pharmaceutical manufacturer for both sterile products and for drug dosage forms.
NIDA anticipates the award of one cost-reimbursement, level of effort-type contract for a base period of one year with four one-year options to extend performance and additional option quantities. RFP No. N01DA-15-7793 will be available electronically on or about September 10, 2014. You will be able to access the RFP through FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. NIDA will consider proposals submitted by any responsible offeror.
Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.
This advertisement does not commit the Government to award a contract.
Please direct all inquiries to: