# Administrative Actions for Noncompliance; Lesser Administrative Actions
> **Food and Drug Administration** · Direct final rule. · Published 2016-04-04 · Effective 2016-08-17 · 81 FR 19033
## Document
- **Document number:** 2016-07523
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 19033
- **CFR reference:** 21 CFR 56
- **Publication date:** 2016-04-04
- **Effective date:** 2016-08-17
- **HHS docket:** Docket No. FDA-2015-N-5052
## Abstract

The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/04/04/2016-07523/administrative-actions-for-noncompliance-lesser-administrative-actions)
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