Inactive

This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this Notice is to obtain information regarding the availabil... This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this Notice is to obtain information regarding the availability and capability of all qualified small business sources to perform a potential requirement. This Notice is issued to help determine the availability of qualified small business sources technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or award a contract. Responses will not be considered as proposals or quotations. No award will be made as a result of this Notice. The Government will NOT be responsible for any costs incurred by the respondents to this Notice. This Notice is for research and information purposes only. Background: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts research into the causes, treatments, and preventions of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease. The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts. The NINDS intends to issue a solicitation seeking three, part-time Regulatory Affairs Consultants to provide technical recommendations to support the translational development of neurological and pain therapeutics for NIH’s Blueprint Neurotherapeutics Network (BPN) drug discovery and development programs. Several such programs are being launched or expanded to provide support for investigators developing medicinal interventions for neurological disorders. The Regulatory Affairs Consultants will support the NIH Blueprint Neurotherapeutics program [BPN], the NIH HEAL [Help End Addiction Long term] PTDP [Pain Therapeutics Development Program] and other NIH neuroscience-focused drug discovery and development programs.