§493.649. Additional fees applicable to approved State laboratory programs.
42 C.F.R. § 493.649
Approved State laboratory programs. State laboratory programs approved by HHS are assessed a fee for the following:
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.
Costs incurred for investigations of complaints against the State's CLIA-exempt laboratories if the complaint is substantiated.
The State's pro rata share of general overhead to administer the laboratory certification program under section 353 of the PHS Act.
[Reserved]
Notes, amendments, and revision history
Amendments
[88 FR 90037, Dec. 28, 2023]
Source
Source: 57 FR 7138, 7213, Feb. 28, 1992, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).
Source
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Amendments
[88 FR 90037, Dec. 28, 2023]