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USDA/APHIS RIN: 0579-AD64 Publication ID: Fall 2015 
Title: Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products 
Abstract:

This rulemaking amends the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which reflected any of four different levels of effectiveness, is replaced with a single, uniform label format. We are also requiring biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to their customers.

 

 
Agency: Department of Agriculture(USDA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 112   
Legal Authority: 21 U.S.C. 151 to 159   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Notice  05/24/2011  76 FR 30093   
Comment Period End  07/25/2011 
NPRM  04/21/2014  79 FR 22048   
NPRM Comment Period End  06/20/2014 
Final Rule  07/10/2015  80 FR 39669   
Final Rule Effective  09/08/2015 
Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
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