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PHS HIRING FREEZE THREATENS DEVICE USER FEE NEGOTIATIONS

This article was originally published in The Gray Sheet

Executive Summary

PHS HIRING FREEZE THREATENS DEVICE USER FEE NEGOTIATIONS between industry and FDA, the Health Industry Manufacturers Association says in a Dec. 22 letter to HHS Assistant Secretary for Health Philip Lee. The Public Health Service hiring freeze, which went into effect Dec. 8 ("The Gray Sheet" Dec. 20, I&W-1), "jeopardizes current negotiations between industry and the agency with respect to user fees designed to enhance the performance of the Center for Devices and Radiological Health," HIMA asserts. The association appears to be concerned that the freeze could hamper FDA's, ability to meet performance goals that will likely be part of device user fee legislation.

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