This rule expands the scope in part 511 of disqualification of a clinical investigator to include ineligibility to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. A final rule published on April 30, 2012 (77 FR 25353), prevents a disqualified investigator from conducting any clinical investigation, and therefore applies explicitly to clinical investigations. However, that rule was silent on nonclinical laboratory studies. Thus, before this final rule, a disqualified investigator could conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. Because the reason for disqualification in part 511 is typically the repeated or deliberate submission of false information to us or to sponsors in a required report, preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is essential to adequate protection of animal research subjects and data integrity.

We will not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator because we already post the names of any disqualified investigator on FDA’s Internet site at Clinical Investigators - Disqualification Proceedings. Similarly, industry will not incur additional costs because the rule does not require applicants to perform additional tasks. For instance, upon disqualification, we post the respective investigator's name on FDA's Internet site, which helps mitigate the employment of a disqualified investigator for clinical investigations or nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. The benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations will be enhanced protection of animal research subjects and data integrity.

Federal Register: 82 FR 61443, December 28, 2017

Docket: FDA–2011–N–0079