21 CFR 58.10
§ 58.10 Applicability to studies performed under grants and contracts.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 58.10, § 58.10 Applicability to studies performed under grants and contracts, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83501
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Full text
When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.