0579-AE11 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0579 Animal and Plant Health Inspection Service APHIS 0500 Department of Agriculture USDA VSTA Records and Reports Specific to International Standards for Pharmacovigilance

This rulemaking will amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change requires veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service will be provided in separate guidance documents. These records and reports will help ensure that APHIS can provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Not subject to, not significant 9 CFR 101 9 CFR 116 21 U.S.C. 151 to 159 No NPRM 09/04/2015 80 FR 53475 NPRM Comment Period End 11/03/2015 Final Rule 06/00/2018 Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Yes Businesses Federal No Yes No Donna Malloy L. Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS 0579 Animal and Plant Health Inspection Service APHIS 301 851-3426 Unit 38, 4700 River Road, Unit 148, Riverdale MD 20737-1231