SOURCES SOUGHT
A -- Production, Analysis, and Distribution of Cannabis and Related Materials
- Notice Date
- 11/9/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- N01DA-20-8943
- Archive Date
- 12/25/2018
- Point of Contact
- Megan Nathan, Phone: (301) 443-6677, Andrew Hotaling, Phone: (301) 443-6677
- E-Mail Address
-
PADCRM@nih.gov, PADCRM@nih.gov
(PADCRM@nih.gov, PADCRM@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. 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, analysis, and distribution of cannabis and related materials for research purposes. Specifically, the project requires the contractor to perform the following tasks: (1)Grow, harvest, process, analyze, and store marijuana for research purposes or procure marijuana and marijuana products from existing commercial enterprises, including from qualified foreign sources, as required by the Contracting Officer's Representative (COR) to meet program needs. (2)Process marijuana to produce a range of standardized and pure extracts containing varying ratios (high, low and equal ratios) of tetrahydrocannabinol (THC) and cannabidiol (CBD) including pure (>99%) delta-9-THC, CBD, and other cannabinoids. (3)Store and maintain quality of products, including periodic analyses required to obtain and maintain Food and Drug Administration (FDA) quality requirements for Investigational New Drug (IND) research. (4)Develop new methods for growing marijuana plants containing high THC and low CBD; high CBD and low THC; equal ratios of CBD and THC; and placebos as directed by the COR. (5)Manufacture standardized marijuana cigarettes. (6)Manufacture Current Good Manufacturing Practice (CGMP) human-use marijuana extracts and dosage forms of marijuana extracts (including but not limited to oral solutions, oils, vaping fluids, capsules/tablets) within a range of varying concentrations of delta-9-THC and CBD, and analyze their strength and stability at various intervals. (7)Maintain a secure shipping facility, ship marijuana and marijuana products, and establish billing and accounting procedures to allow the collection of fees from product recipients 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. 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 research, manufacture, and distribution of Schedules I controlled substances including marijuana and its active and non-active constituents. 2.Offerors must demonstrate availability of secure indoor and outdoor growing facilities necessary to support production of up to 2000 kg of marijuana, as well as extraction/purification capabilities necessary to produce up to 500 kg of marijuana products per year, and facilities to store these materials under controlled conditions. 3.Offerors must demonstrate the ability to obtain and maintain a DEA-approved and secure storage facility to maintain an inventory of approximately 5000 kg of marijuana stock and active and inactive constituents under controlled conditions. 4.Offerors must demonstrate availability of laboratory facilities sufficient to perform extractions 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: 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 research, manufacture, and distribution of Schedule I controlled substances including marijuana and its active and non-active constituents. b.Possession of required growing facilities. c.Possession of required secure storage facilities. d.Availability of laboratory facilities to perform extractions of cannabis and related materials. 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 in PDF format to the primary point of contact at PADCRM@nih.gov in the form of a single PDF file with the subject line: "Capability Statement N01DA-20-8943." Written capability statements must be received NO LATER THAN 10 December 2018 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 23 November 2018 at 3:00 PM Eastern time. RFIs must be submitted by e-mail to PADCRM@nih.gov with the subject line "RFI - N01DA-20-8943." NIDA may not respond to RFIs made after 23 November 2018.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01DA-20-8943/listing.html)
- Record
- SN05148704-W 20181111/181109230427-b51d02536c551b4a47dd8b5dc2b03d00 (fbodaily.com)
- Source
-
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