CRO Support for NCATS In Vitro and In Vivo Toxicology Studies

Added: May 02, 2016 2:25 pm

Contracting Office Address

NINDS R&D Contracts Management Branch
NCATS Section
6001 Executive Boulevard
Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531* 

*Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery

Description

This is not a Request for Proposals (RFP).  This is a Pre-solicitation Announcement only.  RFP No. N01TR-17-2002, titled “CRO Support for NCATS In Vitro and In Vivo Toxicology Studies,” will be issued via fedbizopps on or about May 17, 2016.

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. 

The overall goal of this project is to support safety evaluations that are of interest to NCATS by conducting various toxicology studies.  Specifically, to help identify, develop, and perform in-vitro and in-vivo IND/NDA/BLA-enabling safety studies for small and large molecules. In addition, in vitro tests and in-vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis.

To accomplish this goal, the Government plans to solicit proposals from offerors having in-house capability in one or more of the following technical areas: (1) Exploratory and Genetic Toxicology and (2) In-Vivo Toxicity Testing.

The Government anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this solicitation.

The ultimate goal of DPI and this planned project is to bring new drugs to market.  To this end, the Government will seek a Determination of Exceptional Circumstances (DEC) to deviate from the Federal Acquisition Regulation clauses at 52.227-11 Patent Rights and 52.227-14 Rights in Data.  The deviated language will enable DPI contributors to retain control of their intellectual property, will be included in the RFP, and incorporated in any resultant contract.  Prospective Offerors are advised that agreement to the terms of these FAR clauses deviations will be a condition for contract award. 

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.