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This updated burden estimate is a decrease of 960 hours [(3,200 HOPDs 0.167 hours 2 quarters)(3,200 HOPDs 20 percent 0.167 hours 1 quarter)] at a savings of $52,858 (960 hours $55.06) for the CY 2027 reporting period, and a decrease of 2,027 hours [(3,200 HOPDs 20 percent 0.167 hours 3 quarters) + (3,200 HOPDs 80 percent 0.167 hours 4 quarters)] at a savings of $111,607 (2,027 hours $55.06/hour) annually beginning with the CY 2028 reporting period

"Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) to ensure complete and accurate records," the agency added

According to the applicant, Chew et al

General protocols used in regenerative medicine practice

Some diabetics also suffer from nerve damage due to enzyme build-up

Use for this purpose should be considered investigational and discussed thoroughly with a qualified healthcare provider