21 CFR § 58.10 - Applicability to studies performed under grants and contracts.

---
identifier: "/us/cfr/t21/s58.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 58.10 - Applicability to studies performed under grants and contracts."
title_number: 21
title_name: "Food and Drugs"
section_number: "58.10"
section_name: "Applicability to studies performed under grants and contracts."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "58"
part_name: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n."
regulatory_source: "43 FR 60013, Dec. 22, 1978, unless otherwise noted."
cfr_part: "58"
---


# 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.