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. (b) [Reserved] [88 FR 90037, Dec. 28, 2023]