View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AH64 Publication ID: Spring 2018 
Title: New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator 

The FDA is amending its 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 FDA Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator will be ineligible to conduct both clinical and nonclinical studies 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 16.1(b)(2)    21 CFR 511.1(c)   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 351 to 353    21 U.S.C. 355(i)    21 U.S.C. 360b    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
Final Action  12/28/2017  82 FR 61443   
Final Action Effective  01/29/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Vernon Toelle
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
7519 Standish Place, Room 142,
Rockville, MD 20855
Phone:240 402-5637