View Rule

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

USDA/APHIS RIN: 0579-AD66 Publication ID: Fall 2015 
Title: ●Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License 
Abstract:

This rulemaking amends the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship. This rule is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act and to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.

 
Agency: Department of Agriculture(USDA)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 107   
Legal Authority: 21 U.S.C. 151 to 159   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/18/2012  77 FR 42195   
NPRM Comment Period End  09/17/2012 
NPRM Comment Period Reopened  09/20/2012  77 FR 58323   
NPRM Comment Period Reopened End  11/16/2012  77 FR 58323   
Final Rule  05/11/2015  80 FR 26819   
Final Rule Effective  07/10/2015 
Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.
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:
Donna L. Malloy
Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 38, 4700 River Road, Unit 148,
Riverdale, MD 20737-1231
Phone:301 851-3426