Current through October 31, 2024
Section 493.649 - Additional fees applicable to approved State laboratory programs(a)Approved State laboratory programs. State laboratory programs approved by HHS are assessed a fee for the following:(1) Costs of Federal inspections of laboratories in that State (that is, CLIA-exempt laboratories) to verify that standards are being enforced in an appropriate manner.(2) Costs incurred for investigations of complaints against the State's CLIA-exempt laboratories if the complaint is substantiated.(3) The State's pro rata share of general overhead to administer the laboratory certification program under section 353 of the PHS Act. 88 FR 90037 , Dec. 28, 2023