Biosafety Level-4 Positive Protection Suits

Waiver Rationale Summary

NIH performed extensive market research to find a domestic supplier for suits suitable for a BSL-4 environment that will provide researchers with superior protection against the pathogens they study and has been unable to find a suitable domestic source. NIH has been buying positive pressure suits that are foreign made for over ten (10) years and in that time, has not identified a source that can provide domestically manufactured suits at the safety levels necessary. To ensure mission critical IRF research continues without interruption, NIH intends to procure positive pressure suits that are not domestically manufactured. Failure to acquire suits that meet safety requirements, would jeopardize NIH’s ability to conduct research to advance the understanding, diagnosis, and treatment of life-threatening diseases which impact humans worldwide. Following the Make PPE in America Act requirements, NIH has made a nonavailability determination that BSL-4 positive pressure suits are not mined, produced, or manufactured in the United Status insufficient and reasonably available commercial quantities and of a satisfactory quality.