Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

The National Institutes of Health, specifically the National Institute of Neurological Disorders and Stroke (NINDS), requires current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical support services. These services facilitate the translational development of therapeutic biotechnology products (biologics) for various drug discovery and development programs, including the NIH Blueprint Neurotherapeutics (BPN) network, the NINDS Ultra-Rare Gene Therapy (URGenT) program, and the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP). Contractors are responsible for executing studies and completing the necessary reports and documentation to enable regulatory filing and clinical trial evaluation for biological therapeutics.

This requirement falls under NAICS code 541714 for Research and Development in Biotechnology (except Nanobiotechnology) and PSC AN12 for Health R&D Services, Health Care Services, and Applied Research. All work is conducted through task orders issued against indefinite delivery, indefinite quantity (IDIQ) contracts. The services may be fulfilled through a combination of internally executed studies and subcontracted work. Evan Feely serves as the primary point of contact for this solicitation.

The response deadline for solicitation 75N95022R00013 is March 14, 2022. Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) system, and offerors are required to maintain an active registration in the System for Award Management (SAM). The solicitation includes 33 attachments, including wage rate determinations, business proposal templates, and electronic invoicing instructions. Recent amendments to the notice provided responses to questions and a revised Section M.