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

This rulemaking will amend the Virus-Serum-Toxin Act regulations to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. It also will require 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 single 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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
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  05/00/2015 
Final Rule Effective  07/00/2015 
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: Yes 
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