Notice of Intent to Sole Source.pdf

Sole Source Notice

Description: NOTICE OF INTENT TO SOLE SOURCE

The Office of Acquisitions and Grants Services (OAGS) intends to sole source using the authority of FAR 6.302-1(b)(1)(i), unique supplies or services available from only one source or only one supplier with unique capabilities. Only the prospective contractor, CERTARA USA INC. (located at 100 Overlook Ctr., Ste 101, Princeton, NJ 08540), can provide software (i.e. Phoenix Quantum) to allow Office of Clinical Pharmacology drug reviewers to complete the review of INDs, NDAs, BLAs, ANDAs, and other submissions from sponsors, the primary role of the Office, which were purchased by Food and Drug Administration under 75F40121P00361, 75F40119P10423, and 75F40120P00371.

The requirement is to acquire hundreds of Phoenix Quantum software licenses and IVIVC Toolkits. The FDA receives Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions from sponsors.

Within these submissions sponsors include clinical pharmacology and pharmacometric data (PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation) output from Phoenix Quantum. These data must be independently analyzed and verified by Office of Clinical Pharmacology reviewers and pharmacometricians. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses. This software is essential to the review of sponsor submissions. These reviews are on strict schedules with timelines that must be met per the various user fee acts governing such work (Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Mission-critical functions. These activities have a direct impact on public health.

The North American Industry Classification System (NAICS) code for this requirement is 511210 with the size standard of $41.5 million. This notice of intent is not a request for quotes; however, all responsible sources may submit a quote within 15 days of issuance of this notice of intent. All responses must be submitted to the Government point of contact at the email address shown below. A determination by the Government not to open the requirement to competition based upon the responses to this notice is solely within the discretion of the Government.

Contracting Office Address:

Office of Acquisitions and Grants Services, 4041 Powder Mill Road, Beltsville, MD 20705.

Government Points of Contact: Lilibeth Deato, Contracting Officer, Email: Lilibeth.Deato@fda.hhs.gov;

Terry Zeng, Contract Specialist, minjie.zeng@fda.hhs.gov.