Opportunity

The National Institutes of Health, through the National Institute of Neurological Disorders and Stroke, issued solicitation 75N95022R00013 to secure current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical support services. This requirement supports the translational development of therapeutic biotechnology products, or Biologics, for NIH drug discovery and development programs, including the Blueprint Neurotherapeutics network, the Ultra-Rare Gene Therapy program, and the Helping to End Addiction Long-term Pain Therapeutics Development Program. The opportunity is classified under NAICS 541714 Research and Development in Biotechnology (except Nanobiotechnology) and PSC AN12 Health R&D Services; Health Care Services; Applied Research.

Contractors must provide Biologics cGMP manufacturing and GLP nonclinical services, which include executing studies and completing the documentation necessary for regulatory filing and clinical trial evaluation. These services may be delivered through internally executed studies or subcontracted work. The government intends to award indefinite delivery, indefinite quantity (IDIQ) contracts and will issue specific task orders for work supporting various NIH biologics programs.

The response deadline for this solicitation is March 14, 2022, and all proposals must be submitted through the NIH electronic Contract Proposal Submission system. Evan Feely serves as the point of contact for this notice, which includes 33 attachments such as budget templates, wage rate determinations, electronic invoicing instructions, and two amendments containing questions and answers and revised section documentation. Offerors must maintain an active registration in the System for Award Management at the time of proposal submission.