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HHS/FDA | RIN: 0910-AH64 | Publication ID: Spring 2018 |
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. |
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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 |
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Timetable:
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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 Email: vernon.toelle@fda.hhs.gov |