Inactive Total Small Business Set-Aside (FAR 19.5)

Amendment 2: Two questions and answers added to Q&A document; two-page limit removed for Key Personnel Narrative, and minor adjustment made to Information/Physical Access Security document. Amendment ... Amendment 2: Two questions and answers added to Q&A document; two-page limit removed for Key Personnel Narrative, and minor adjustment made to Information/Physical Access Security document. Amendment 1: Consolidated Q&A document posted in response to questions submitted by 11/5 deadline. Revised documents also posted for Combined Synopsis/Solicitation (pgs 3-4), Statement of Work (pgs 9-10), Tech Eval Criteria (pgs 4-5), and Information/Physical Access Security (pgs 8-12). Description: The National Institute of Neurological Disorders and Stroke (NINDS) has a need for biological therapeutics development subject matter expert (SME) consulting services. SME consultants will be required to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. Several such programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders. These include the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH programs. The SMEs will support these biologics development programs by providing consulting services related to candidate biologics therapeutics development, current Good Manufacturing Practices (cGMP) manufacturing, and evaluation of the biologics in Phase 1 clinical trials. Please review the attachments for additional information.