United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Rules and Regulations D09002ee1c809902d D09002ee1c8099127 United States Department of Agriculture originator org United States Government Agency or Subagency United States Animal and Plant Health Inspection Service originator org United States Government Agency or Subagency We are amending 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 amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product. 72 FR 72563 https://www.govinfo.gov/app/details/FR-2007-12-21/E7-24649 E7-24649 fr21de07-1 RIN 0579-AC30 3410-34-P Docket No. APHIS-2006-0079 https://www.govinfo.gov/app/details/FR-2007-12-21/E7-24649 https://www.govinfo.gov/content/pkg/FR-2007-12-21/html/E7-24649.htm https://www.govinfo.gov/content/pkg/FR-2007-12-21/pdf/E7-24649.pdf Animal Biologics Exports Imports Reporting and Recordkeeping Requirements 2 p. 72563 72564 72 FR 72563 Title 9 Part 113 9 CFR Part 113 RIN 0579-AC30 Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines; Federal Register Vol. 72, Issue RULE E7-24649 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 2008-01-22 Docket No. APHIS-2006-0079 3410-34-P E7-24649 Final rule.

We are amending 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 amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.

Effective Date: January 22, 2008. Dr. Albert P. Morgan, Chief Staff Officer, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, APHIS, USDA, 4700 River Road, Unit 148, Riverdale, MD 20737-1228; (301) 734-8245. Animal Biologics Exports Imports Reporting and Recordkeeping Requirements Viruses, serums, toxins, and analogous products: Live vaccines; standard requirements, http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0079 Vol. 72, no. 245 Office of the Federal Register, National Archives and Records Administration 2007-12-21 continuing daily deposited born digital 344 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-12-21 P0b002ee18095964b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21de07 https://www.govinfo.gov/app/details/FR-2007-12-21 https://www.govinfo.gov/content/pkg/FR-2007-12-21/pdf/FR-2007-12-21.pdf https://www.govinfo.gov/content/pkg/FR-2007-12-21/xml/FR-2007-12-21.xml fdlp 72563 72896 DGPO 2010-09-22 2024-06-05 FR-2007-12-21 machine generated eng FR FR-2007-12-21 72 245