Analysis 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: The availability and capability of qualified other-than-small business sources; and, 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 provide analysis of cannabis, cannabis products and other related materials of interest to the program (i.e. dispensary samples, etc.) to support research. The Contractor shall be required to furnish all necessary services, qualified personnel, materials, equipment, and facilities to perform the requirements specified below: Provide Analysis of Confiscated Marijuana Samples - The Contractor shall perform analysis of 150 confiscated marijuana samples/month submitted by the DEA, other law enforcement agencies, and/or by others as required by NIDA. Samples shall come from seizures of marijuana and marijuana-based products intended for sale and use (i.e. not immature plants or growing plants). Samples may also come from medical marijuana dispensaries. Provide Analysis of Cannabis Samples for the NIDA Drug Supply Program (NDSP) - The Contractor shall perform analysis on 200 samples/year of marijuana intended to support research projects as required by NIDA. The Contractor shall prepare a Certificate of Analysis (COA) in compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). The analyses will include those identified in Attachment 1. Provide Analysis of Other Samples for the NIDA Drug Supply Program (NDSP) - The Contractor shall perform analysis of 50 samples of other materials (ex. Botanicals, extracts, cannabis related products, etc.) intended to support research projects as identified by the COR. The Contractor shall prepare a Certificate of Analysis (COA) in compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Development and Validation of Analytical Methods - The Contractor shall develop and validate analytical methods if there are no established methods available. Stability Studies on Cannabis and Related Substances - The Contractor shall perform stability tests for cannabis and related products under accelerated and long-term storage conditions following the stability guidance of the FDA. This includes developing stability indicating assay methods and characterizing major degradation products. The accelerated stability tests for the drug products are carried out under stress conditions, such as temperature, moisture, light, etc. for recommendation of storage conditions and shelf life. The Contractor shall prepare a CMC section for FDA submission if needed. Disposal of Material - Upon NIDA authorization, the Contractor will dispose of contaminated and/or unusable cannabis plant materials, or any other related materials in accordance with appropriate DEA regulations. The main objectives of this contract are to: (1) analyze samples of marijuana provided by the DEA or other designated law enforcement agency and procure products not available through the program. (2) analyze samples of cannabis and produce a Certificate of Analysis (COA) to support research. (3) periodically analyze cannabis extracts, and isolated cannabinoids for authenticity, purity and stability; (4) prepare a quarterly Potency Monitoring Report on the results of the analysis of confiscated cannabis samples, and other samples of interest as authorized by NIDA. 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. In accordance with the Controlled Substances Act of 1970, any offerors must possess or demonstrate the capability to obtain Drug Enforcement Agency (DEA) Analytical Registration for Schedule I controlled substances including cannabis and its active and non-active constituents. Offerors must demonstrate availability of laboratory facilities sufficient to perform stability studies and analysis of cannabis and related materials. 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: Company Profile: A profile of the responding company including the following information: a. Company Name, Address, and UEI 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 Analytical registration for Schedules I controlled substances including cannabis and its active and non-active constituents. b. Availability of laboratory facilities to perform stability studies and analysis of cannabis and production of cannabis related products. 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: contact@example.gov in the form of a single PDF file with the subject line: - Capability Statement 75N95022R00062. Written capability statements must be received NO LATER THAN June 17th, 2022, at 3:00 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 June 7th at 3:00 PM Eastern time. RFIs must be submitted by e-mail to the POC identified below with the subject line - RFI - 75N95022R00062. NIDA may not respond to RFIs made after the deadline. 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 SAM.gov. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.