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HHS/FDA RIN: 0910-AH64 Publication ID: Fall 2017 
Title: ●New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator 
Abstract:

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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
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    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 352    21 U.S.C. 355    21 U.S.C. 360(b)    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Action  04/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
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
Email: vernon.toelle@fda.hhs.gov