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I/V Use Only

Users frequently describe reduced discomfort after administration

The merging step resulted in ~25 M merged reads per sample

others feel the effects build gradually over a day or two

Several commenters requested that CMS not finalize these proposals due to resource constraints, particularly for small and rural hospitals, and a few commenters indicated the proposed effective date of January 1, 2026, would make complying with the requirements, if finalized as proposed, especially challenging

Refrigerated storage below 4C (39F) is generally appropriate for short-term preservation when the material will be utilized within weeks or months of receipt