Comment from Chris V

I write in support of the FDA's proposed rule to exempt certain class II clinical toxicology test system devices from premarket notification 510(k) requirements when intended for federal drug testing programs. In May 2023, DOT authorized oral fluid drug testing as an alternative to urine collection under 49 CFR Part 40. Three years later, no laboratories have been certified to perform that testing, in significant part because the assays needed for commonly screened substances have not been cleared under the existing framework. DOT itself characterized this gap as an "inadvertent factual impossibility" in its May 11, 2026 final rule (91 FR 25507). This regulatory gap has real consequences for workers. Paruresis, commonly known as shy bladder syndrome, is an anxiety disorder that affects an estimated 7% of adults. In severe cases, it prevents individuals from urinating when others are present or when they feel observed. For employees in safety-sensitive transportation positions who have paruresis, compliance with federally required urine collection is not a matter of willingness. Their bodies physically will not let them, no matter how much they would like to. The proposed rule will not, by itself, solve this. But it will remove a meaningful regulatory barrier that has functioned as a chokepoint, and it will help close the gap between what federal regulations promise and what affected workers can actually access. It is a necessary step toward making available a testing alternative that the program has already authorized, and I urge the agency to finalize it.