Trichuris Trichiura

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate on an other than full and open competition basis with the George Washington University, 1918 F Street, N.W., Washington, DC 20052 to obtain the generation, inventory and storage of two to six million Good Manufacturing Practice (cGMP) grade nematode parasite Trichuris trichiura that has been isolated from healthy donors for use in a Controlled Human Trichuris Infection (CHTI) with fecal samples received form the George Washington University.  See the attached Statement of Work. 

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.501(a)(1).

Only one award will be made as a result of this solicitation.  This will be awarded as a firm-fixed price type of contract.

Delivery to Bethesda, Maryland 20892 with a period of performance for full performance of a base year that includes four (4) one-year option periods from date and acceptance of award. 

The task and functions associated will encompass the initiation, implementation, conduct, analysis, completion, and closeout of cGMP production of the Trichuris trichiura inoculum that will be used by the Laboratory of Parasitic Diseases (LPD).  In addition, this is to prepare an Investigation New Drug (IND) application for controlled Human Trichuris Infection with the U.S. Food and Drug Administration (US-FDA).  This is a continuation to generate, ship, and store the Trichuris trichiura for cGMP compliance and research reproducibility.  Without these worms, the LPD will not be able to perform their established clinical trial.  There are protocols are already established, and work has been ongoing to get the worms to the point of cGMP.  The data collected from the eggs created by this requirement must be submitted as an IND to the US-FDA.  Two (2) years of contract data, and funds will be lost if this project doesn’t continue.  The US-FDA regulations are very specific.  Protocols, sources and the trichiura cannot be changed, or the US-FDA will demand a restart of the entire project, causing great loss of government resources.  George Washington University is the only known vendor capable of creating cGMP grade Trichuris trichiura.  For cGMP compliance and research reproducibility, the same vendor must be used.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 6.302-1 only one source available, no substitutions possible.  THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS.  All responsible sources that could provide cGMP grade nematode parasite Trichuris trichiura submit a capability statement that will be considered by email (subject line to reference NIAID-NOI-22-2117352) to Tonia Alexander at talexander@niaid.nih.gov, by 11:00 am eastern daylight time (EDT) July 8, 2022.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.  Any responses received by NIAID after this date and exact time specified is late and will not be considered.