Title 21

SECTION 58.10

58.10 Applicability to studies performed under grants and contracts.

§ 58.10 Applicability to studies performed under grants and contracts.

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.

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