cGMP Mitragynine HCl Supplemental Stability & Analytical Activities

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 75N95024Q00480 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Curia Global, Inc., 26 Corporate Circle Albany, New York 12203 for cGMP Mitragynine HCl Supplemental Stability & Analytical Activities.

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS) is conducting a preclinical development of Mitragynine (MG) to support its clinical evaluation, as part of the Helping to End Addiction Long-term initiative (HEAL).

The Contractor shall provide long term stability studies on two cGMP batches of Mitragynine HCl and requalify cGMP reference standard of Mitragynine HCl annually for up to 3 years. See Attachment 1 - Statement of Work.