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

The National Institute of Neurological Disorders and Stroke (NINDS), an organization within the National Institutes of Health, requires current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical support services. This solicitation, identified by number 75N95022R00013, focuses on the translational development of therapeutic biotechnology products (Biologics) for neurological disorders. These services support several NIH 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).

Selected contractors must execute studies and complete study reports and documentation to enable regulatory filing and clinical trial evaluation for biological therapeutics. The scope of work encompasses both Biologics cGMP manufacturing and GLP nonclinical services, which may be fulfilled through a combination of internal execution and subcontracted efforts. All work is conducted under NAICS code 541714 for Research and Development in Biotechnology (except Nanobiotechnology) and PSC AN12 for Health R&D Services; Health Care Services; Applied Research.

The government intends to award indefinite delivery, indefinite quantity (IDIQ) contracts, with specific activities authorized through individual task orders. Responses to this solicitation are due by March 14, 2022, and must be submitted through the NIH electronic Contract Proposal Submission (eCPS) system. The notice includes 33 attachments, such as wage rate determinations, electronic invoicing instructions, and various budget templates. Point of contact Evan Feely manages this requirement on behalf of the National Institutes of Health NIDA office.