Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines

Document ID: APHIS-2006-0079-0001
Document Type: Proposed Rule
Agency: Animal And Plant Health Inspection Service
Topics: Animal Biologics, Exports, Imports, Reporting and Recordkeeping Requirements
Federal Register Number: E7-01531
CFR Citation: 9 CFR 113
View Document:

Details Information

Abstract:	We are proposing to amend the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are proposing to amend the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These proposed changes would update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.
Document Subtype:	Proposed rule
Received Date:	January 31 2007, at 07:07 AM Eastern Standard Time
Start-End Page:	4470 - 4472
Comment Start Date:	January 31 2007, at 12:00 AM Eastern Standard Time
Comment Due Date:	April 2 2007, at 11:59 PM Eastern Standard Time

Total: 2

Comment from Lee Jan, DVM, Texas Animal Health Commission
Submitter: Jan, DVM, Lee Posted: 03/09/2007 ID: APHIS-2006-0079-0002

Comment Period Closed
Apr 02,2007 11:59 PM ET

Comment from Kent D McClure, Animal Health Institute
Submitter: McClure, Kent Posted: 04/03/2007 ID: APHIS-2006-0079-0003

Comment Period Closed
Apr 02,2007 11:59 PM ET