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USDA/APHIS

RIN: 0579-AB90

Publication ID: Fall 2008

Title: Viruses, Serums, Toxins, and Analogous Products; Records and Reports
Abstract: This rulemaking will amend the Virus-Serum-Toxin Act regulations concerning records and reports to require veterinary biologics licensees and permittees to record and submit reports to the Animal and Plant Health Inspection Service (APHIS) concerning adverse events associated with the use of biological products that they produce or distribute. We will specify the information that must be included in the adverse event report and will require veterinary biologics manufacturers to report to APHIS the number of doses of each licensed product that they distribute. These actions will assist APHIS in providing 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: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
CFR Citation: 9 CFR 101    9 CFR 116
Legal Authority: 21 USC 151 to 159

Legal Deadline:  None

Timetable: Action Date FR Cite NPRM  08/17/2005  70 FR 48325    NPRM Comment Period End  10/17/2005     Final Rule  To Be Determined

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
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