42 CFR 493.649
§ 493.649 Additional fees applicable to approved State laboratory programs.
United States · 42 CFR — Public Health · Status: effective
Cite this
- Citation
- 42 CFR 493.649, § 493.649 Additional fees applicable to approved State laboratory programs, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/207755
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Full text
(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]
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.