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USDA/APHIS

RIN: 0579-AD19

Publication ID: Spring 2016

Title: Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling
Abstract: This rulemaking would amend the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside-face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labeling for autogenous biologics to specify the microorganism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, it would amend the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These proposed amendments are necessary in order to update and clarify labeling requirements and ensure that information provided in labeling is accurate with regard to the expected performance of the product.
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 103 9 CFR 112 9 CFR 114
Legal Authority: 21 U.S.C. 151 to 159

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	01/13/2011	76 FR 2268
NPRM Comment Period End	03/14/2011
Final Action	06/00/2016

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
Small Entities Affected: Businesses	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