Preparation and Distribution of Research Drug Products

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), seeks capability statements from qualified Small Business organizations (NAICS code 541715, small business size standard is 1000 employees. For details of Small Business Size Standards, see http://www.sba.gov). This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, Historically Underutilized Business Zone (HUBZone) small businesses, Small Disadvantaged Businesses (SDB), women-owned small businesses, and other small businesses) to fulfill the needs of NIH and NIDA for this future requirement. Under the upcoming solicitation, NIDA seeks qualified organizations having capability to analyze and characterize various drugs of abuse including cannabinoids and other research chemicals. Organizations will be able to produce drug dosage forms, such as delta-9-tetrahydrocannabinol (delta-9-THC), methadone, morphine, and naltrexone pellets. Furthermore, they will acquire, develop, and produce marijuana and nicotine research cigarettes of varying strengths and specifications and maintain an inventory and supply of various DEA scheduled and unscheduled chemicals and drugs. The contractor must possess extensive experience in carrying out the project tasks and must demonstrate the availability of adequate facilities and equipment. The contractor must indicate possession of a current Schedule I and II manufacturer license, Schedule I and II researcher license, Schedule I and II distributor license, and Schedule I and II exporter and importer license. Contractors must possess these required licenses or demonstrate their ability to obtain them at the time of contract award (estimated at July 2019). Award will not be made to any contractor who has not obtained the specified licenses. Contractors must have the capacity to complete the following tasks: - Acquire hard-to-find controlled and uncontrolled drug compounds and/or drug dosage forms and analyze purity, authenticity, and stability of these compounds while storing them in a secure and DEA-approved facility and having the capability to ship these compounds to research investigators. - Manufacture standardized marijuana cigarettes within a range of varying concentrations of delta-9-THC and analyze strength and stability of them at various intervals while having the capability to maintain a secure shipping facility and to ship marijuana cigarettes to research investigators. - Manufacture nicotine research cigarettes and analyze them for required chemical constituents at various intervals while having the capability to store and ship securely these nicotine research cigarettes to research investigators. If you are interested in responding to this notice, you must demonstrate and document in any capability statement you submit 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 is not limited to, current or past contracts with the Government and/or commercial organizations, references, (i.e., names, titles, telephone numbers), and any other information serving to document the organization's capability (e.g., awards, commendations, etc.). The information you send should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects; (2) Personnel: Name, professional qualifications and specific experience of scientists and technical personnel who may be assigned as principal investigator and/or project director; (3) Facilities: Availability and description of facilities to perform the tasks mentioned above; and (4) Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for informational 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 the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contact; 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) capability information in response to the requirements and qualifications identified in this notice; and 7) type(s) of business, if any (e.g., 8(a), Veteran-owned, service-disabled Veteran-owned, HUBZone, SDB, women-owned, or other small business). Written capability statements must be submitted to Lisa Bielen, whose contact information is included, NO LATER THAN 5 pm Eastern time November 8, 2018. Paper or electronic capability statements will be accepted.