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USDA/APHIS RIN: 0579-AD06 Publication ID: Fall 2017 
Title: Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product 
Abstract:

This rulemaking will amend the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. It will also require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specify a single standard for determining the expiration date for veterinary biologics

 
Agency: Department of Agriculture(USDA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 9 CFR 101    9 CFR 114   
Legal Authority: 21 U.S.C. 151 to 159   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/17/2010  75 FR 56916   
NPRM Comment Period End  11/16/2010    
Final Rule  11/00/2017 
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