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However, given that the cost of cell or tissue procurement is typically a very small fraction of the overall cost of the product and that some manufacturer-paid amounts may be excluded from ASP under this policy, we anticipate that any financial impact will not be substantial

Response: We appreciate the commenters for their recommendation for further clarification regarding ASM quality measure reporting

[340] While we acknowledge that cellular-enabled scales may facilitate weight tracking, the regulation already permits the provision of technology that advances the clinical goal of weight loss as a BEI

the exact window depends on the product and diluent

Not for human or animal consumption.