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USDA/APHIS RIN: 0579-AD06 Publication ID: Fall 2010 
Title: ●Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product 
Abstract: This action would amend the Virus-Serum-Toxin Act regulations concerning expiration dating 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 would 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; require stability monitoring of products after licensing; and specify a single standard for determining the expiration date for veterinary biologics in place of the current standard that specifies different procedures for products contingent upon whether they consist of viable or nonviable organisms. These amendments would update and clarify the regulations concerning expiration dating and establish a single uniform standard for determining the stability of veterinary biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. 
Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 101; 9 CFR 114 
Legal Authority: 21 USC 151 to 159 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2010   
NPRM Comment Period End  02/00/2011   
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:
Albert P. Morgan
Chief of Operational Support, CVB, Licensing and Policy Development, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 148, 4700 River Road, Unit 148,
Riverdale, MD 20737-1231
Phone:301 734-8245

 
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