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. This requirement facilitates the translational development of therapeutic biotechnology products, or biologics, for various drug discovery and development programs. These initiatives include 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 reports and documentation necessary for regulatory filing and the clinical evaluation of biological therapeutics for neurological-related disorders.

This solicitation, identified by number 75N95022R00013, is categorized under NAICS 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 work assigned through subsequent task orders. Performance may be achieved through a combination of internally executed studies and subcontracted work. Proposals are due by March 14, 2022, and must be submitted through the NIH electronic Contract Proposal Submission (eCPS) system.

The solicitation was published on January 25, 2022, and last updated on March 1, 2022. Administrative documentation includes 33 attachments, such as multiple amendments containing questions and answers, electronic invoicing instructions, business proposal budget templates, and wage rate determinations. Evan Feely serves as the primary point of contact for this requirement. All offerors are required to maintain an active registration in the System for Award Management (SAM) at the time of proposal submission.