Comment from Pam B.

AnonymousSupportIndividual
Summary: The commenter, a workplace substance abuse testing program administrator, supports the proposal to exempt certain Class II medical devices from premarket notification. They argue that the current regulatory process is overly bureaucratic and that the FDA should allow for easier adoption of saliva testing to improve workplace safety and efficiency.
To: Food and Drug Administration, Department of Health and Human Services From: Pam B. RE: Docket FDA-2026-N-4268 Date: 6/25/2026 I have served various roles in workplace substance abuse testing programs for over 35 years. My current status is DER for an employer with approximately 5,000 employees subject to FTA, FMCSA and USCG testing. I have read comments in support of this proposal. I found them to be very logically, technically and scientifically sound. Some urge the FDA to act more broadly than proposed in this Notice. I wish to formally add my support to their statements, specifically those submitted by the National Drug and Alcohol Screening Association (NDASA), Substance Abuse Program Administrators Association (SAPAA), and Patrice Kelly Consulting, LLC. Additionally, I would like to add some personal perspective. I provide employee and supervisor education regarding these programs for my employer. On a regular basis, someone will ask, “I thought we were going to be able to do saliva testing. What ever happened with that?” When I start in to the explanation with, “multiple federal agencies and subagencies each have a piece of the process . . . “ their eyes glaze over. Some share unique and colorful language regarding bureaucratic tangle. I find their frustration completely understandable. We are a taxpayer-funded organization facing horrific budgetary shortfalls and very difficult decisions in the next biennium and beyond. Yet our safety-sensitive employees have been advised by coworkers and the internet that they essentially have a paid three-hour break if they want it. Taxpayers are paying their wages while they surf social media, play games and watch movies on their phones as they sip water to provide a sufficient urine sample. The fact that the Shy Bladder procedure is still our only tool in this situation, more than three years after oral fluid was approved by DOT, is just not OK. It’s costing employers, in many cases taxpayers, and by extension all Americans, a fortune for no good return on their investment. The FDA has essential work to do that only you can do. This is not that. You have a sister agency in SAMHSA with a NLCP that is entirely capable of making these determinations. Also, the current administration tasked federal agencies with eliminating burdensome, duplicative regulations. This is an easy win! I urge you to let workplace testing programs advance to meet current needs, take the credit for simplifying this process, and turn your focus to the vital work only FDA can do. Thank you for your time and consideration.

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