# New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
> **Food and Drug Administration** · Final rule. · Published 2017-12-28 · Effective 2018-01-29 · 82 FR 61443
## Document
- **Document number:** 2017-27973
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 61443
- **CFR reference:** 21 CFR 16
- **Publication date:** 2017-12-28
- **Effective date:** 2018-01-29
- **HHS docket:** Docket No. FDA-2011-N-0079
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/12/28/2017-27973/new-animal-drugs-for-investigational-use-disqualification-of-a-clinical-investigator)
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