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USDA/APHIS

RIN: 0579-AE11

Publication ID: Spring 2018

Title: VSTA Records and Reports Specific to International Standards for Pharmacovigilance
Abstract: 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.
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: Not subject to, not significant
CFR Citation: 9 CFR 101 9 CFR 116
Legal Authority: 21 U.S.C. 151 to 159

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	09/04/2015	80 FR 53475
NPRM Comment Period End	11/03/2015
Final Rule	06/00/2018

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: Federal
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
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