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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. |
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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 |
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Timetable:
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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 |