Notice Number: NOT-NS-06-006

Key Dates
Release Date: March 27, 2006

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement to study basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic medical countermeasures against chemical threat agents and their movement through the regulatory process.  The overall goal of this research program is to enhance our diagnostic and treatment response capabilities during an emergency.  The NIH requires a nontraditional, proactive, and product development oriented program to provide preclinical development support for promising therapeutic candidates.  The Preclinical Development Facility will be part of a comprehensive research network and is designed to support a centralized facility for the advanced preclinical development of promising candidate pharmaceutical preparations.  Any resultant Contractor will be required to conduct safety, toxicology, pharmacokinetic/dynamic, biodistribution, and chemistry and manufacturing studies with candidate drugs that prevent or mitigate the harmful effects of chemical threat agents.  The facility shall not conduct efficacy studies with drugs; nor shall they conduct studies with the chemical agents themselves.  Candidate drugs that will be tested in this facility shall have been previously shown to be efficacious by studies conducted within the CounterACT Research Network that utilize models for, or actual, chemical agents.

This facility would provide several functions:  1) conduct cGLP absorption, distribution, metabolism, and excretion, including PK/PD studies, in a range of animal species for candidate drugs; 2) conduct cGLP toxicology safety studies for candidate drugs; 3) conduct cGMP optimization and control studies including synthesis, composition, formulation and packaging, and stability; and 4) prepare study reports and recommendations for countermeasure modification, if necessary. 

It is anticipated that one cost-reimbursement type contract will be awarded for a period of five (5) years beginning September, 2006.  This is not a Request for Proposals (RFP).  Request for Proposals (RFP) No. NIH-NINDS-06-04 will be available electronically and may be accessed through the FedBizOpps (URL:  http://www.fedbizopps.gov) or through the NINDS website at the following URL address:  (http://www.ninds.nih.gov/funding/currentrfps.htm) 15 or more calendar days after the issuance of this synopsis.  THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY.  OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED.  NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED.  All responsible sources may submit a proposal, which shall be considered by the agency.

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NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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