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USDA/APHIS | RIN: 0579-AE11 | Publication ID: Fall 2017 |
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. |
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Agency: Department of Agriculture(USDA) | Priority: Substantive, Nonsignificant |
RIN Status: First time 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 |
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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: 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 |