Production, Analysis, and Distribution of Cannabis and Related Materials

This is a notice of intent to award a sole source modification under current Contract No. HHSN271201500023C (NIDA Ref. No. N01DA-15-7793) with The University of Mississippi of University, MS, to add Option Quantity 10 to the contract and to exercise it once in the Base Period (Contract Year 1). Upon exercise of the Option Quantity under the proposed modification, the Contractor shall produce up to 50 kilograms (kg) of placebo marijuana under current Good Manufacturing Practices (cGMP) procedures and enter it into the NIDA Drug Supply Program inventory. The placebo marijuana shall contain <0.01% delta-9-tetrahydrocannabinol (THC) and <0.01% cannabidiol (CBD). The Contractor shall add the information on the production, analysis, and storage of the placebo marijuana into the Food and Drug Administration (FDA) Drug Master File upon completion. NIDA may exercise this Option Quantity as and when warranted during the performance of this contract multiple times during the life of the contract. This notice is being published by NIH/NIDA in accordance with Federal Acquisition Regulation (FAR) 5.201. The statutory authority for this sole source modification is FAR 6.302-1, Only One Responsible Source. This notice of intent is not a request for competitive proposals. However, the Government shall consider all responses received within fifteen days of this posting. Interested parties may identify their interest and capability to respond to the requirement. A determination not to compete this requirement, based upon responses to this notice, is solely at the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish a bona fide capability to fulfill this requirement. NIDA will not be responsible for any costs incurred by interested parties responding to this notice.