NOI.pdf

PRESOLICITATION NOTICE: INTENT TO AWARD A SOLE-SOURCE CONTRACT

INTENDED SOURCE: The Critical Path Institute – 1840 E River Road Suite 100 Tuscan, AZ 85718-5893

ANTICIPATED PERIOD of PERFORMANCE: 2 years from date of award

DESCRIPTION OF REQUIREMENT:

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) intends to award a sole source contract to The Critical Path Institute. FDA has a need to to collect multicenter, retrospective patient-level data regarding BK virus (BKV) management practices and clinical outcomes. These data will be summarized to fill in knowledge gaps, identify possible surrogate endpoints, and develop a model for predicting BK virus nephropathy (BKVN). It is hoped that the information garnered from this project will help establish a regulatory pathway to approval for BKV therapeutics and spur interest in developing drugs for this indication.

The applicable North American Industry Classification System (NAICS) code for this acquisition is 541720, Research and Development in the Social Science and Humanities.

The Government intends to solicit and negotiate directly with The Critical Path Institute and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government.

All interested parties must express their interest and capabilities in writing via email to Telisha.Wilson@fda.hhs.gov within eleven (11) calendar days after the date of publication of this notice. No faxed documents will be accepted. If no responsive statements are received within eleven (11) calendar days, an award will subsequently be made to The Critical Path Institute.

This is a Federal contract opportunity; FDA-NOI-115746 for services at Food and Drug Administration Office of Acquisitions and Grants Services – Rockville, MD.

Response Date: January 20, 2023 by 10AM EST

Please email responses to Telisha Wilson at Telisha.wilson@fda.hhs.gov. No phone calls or faxes will be accepted.

mailto:Telisha.wilson@fda.hhs.gov