I. Background Information: The National Institute on Drug Abuse (NIDA) plans to solicit proposals from Offerors to provide materials to support research on marijuana (cannabis) and its constituents. Studies require a source of cannabis materials with consistent and predictable potency, free of contamination and in sufficient amounts to support a wide variety of research needs. Such production was established in the late 1960's by the Federal Government and this present procurement is a continuation of that effort. The National Institute on Drug Abuse (NIDA) has been providing the research community with standardized samples of cannabis, various cannabinoids and other drugs of abuse for basic and clinical research through its Drug Supply Program. II. Objective: NIDA intends to solicit proposals from offerors having the capability to perform the following tasks: (1) cultivate and harvest, or otherwise procure (i.e. import, etc.), 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), cannabidiol (CBD), and other constituents; (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; (7) supply cannabis, cannabis extract, other cannabinoids, and marijuana cigarettes to the NIDA Drug Supply program upon NIDA authorization; (8) analyze samples of marijuana provided by the DEA or other designated law enforcement agency and procure products not available through the program. MANDATORY CRITERIA: Listed below are mandatory qualification criteria. The qualification criteria establishes conditions that must be met at the time of receipt of Technical Proposals. The successful offeror must possess Drug Enforcement Administration (DEA) registration for Schedules II, III, IV or V, and demonstrate the capability to obtain, DEA registration for the Schedule I controlled substances included in this contract procurement, including marijuana and its active and non-active constituents. Discussion with DEA regarding capability to obtain DEA registration(s) may be documented with a letter or e-mail from DEA or a description of conversation with DEA personnel detailing the person contacted and what was relayed to the potential offeror regarding registration. In addition, the successful offeror must also possess separate DEA registrations for research, manufacture, and distribution of both Schedule I and as applicable, II, III, IV or V controlled substances at the time of award of this contract. The successful offeror must possess and maintain (1) a secure and video monitored outdoor facility of approximately 10-12 acres for growing and processing cannabis, and/or (2) an indoor growing facility for the purpose of growing, propagating, and sustaining cannabis plants under controlled conditions. The indoor facility (if applicable) must be at least approximately 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/or indoor facilities in case of emergency. The successful offeror must demonstrate the availability of a DEA-approved and secure storage (vault) facility to maintain an inventory of approximately 5000 kilograms of marijuana stock, marijuana cigarettes, and its active and inactive constituents under controlled conditions. In order to accommodate the analytical needs of this procurement, the successful offeror's laboratory and/or the successful offeror's subcontractor's laboratory must demonstrate the capability to perform stability analyses of cannabis and related materials in accordance with the Food and Drug Administration's - Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products (November 2003). The laboratory must also demonstrate the capability to perform extractions and analysis of cannabis and related materials. NIDA anticipates the award of one cost-reimbursement, level of effort-type contract for one 12-month base period and four 12-month option periods plus additional option quantities. RFP No. 75N95020R00011 will be available electronically on or about December 10, 2019. You will be able to access the RFP through SAM.gov (URL: https://beta.sam.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 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. III. Contracting Office Address: The official NIH address below must be used for US Postal Service (USPS) mail: NAME NATIONAL INSTITUTES OF HEALTH Office of Acquisitions, NIDA 3WFN - MSC 6012 301 NORTH STONESTREET AVE BETHESDA MD 20892 The official NIH address below must be used for FedEx and UPS packages: NAME NATIONAL INSTITUTES OF HEALTH Office of Acquisitions, NIDA 3WFN - MSC 6012 301 NORTH STONESTREET AVE ROCKVILLE MD 20850
