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 2014_register executive 2014-10-07 article Rules and Regulations D09002ee1c7f89b4b D09002ee1c7f89c20 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 veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results. 79 FR 55968 https://www.govinfo.gov/app/details/FR-2014-09-18/2014-22294 2014-22294 fr18se14-3 RIN 0579-AD86 3410-34-P Docket No. APHIS-2013-0034 https://www.govinfo.gov/app/details/FR-2014-09-18/2014-22294 https://www.govinfo.gov/content/pkg/FR-2014-09-18/html/2014-22294.htm https://www.govinfo.gov/content/pkg/FR-2014-09-18/pdf/2014-22294.pdf Animal Biologics Exports Imports Reporting and Recordkeeping Requirements 2 p. 55968 55969 79 FR 55968 Title 9 Part 101 9 CFR Part 101 Title 9 Part 113 9 CFR Part 113 RIN 0579-AD86 Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results; Federal Register Vol. 79, Issue RULE 2014-22294 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 2014-10-20 Docket No. APHIS-2013-0034 3410-34-P 2014-22294 Final rule.

We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.

Effective Date: October 20, 2014. Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737- 1231; (301) 851-3426. Animal Biologics Exports Imports Reporting and Recordkeeping Requirements Viruses, Serums, Toxins, and Analogous Products; Standard Requirements: Addition of Terminology to Define Veterinary Biologics Test Results , http://www.regulations.gov/#!docketDetail Regulations.gov Vol. 79, no. 181 Office of the Federal Register, National Archives and Records Administration 2014-09-18 continuing daily deposited born digital 263 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-09-18 P0b002ee189db06b6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18se14 https://www.govinfo.gov/app/details/FR-2014-09-18 https://www.govinfo.gov/content/pkg/FR-2014-09-18/pdf/FR-2014-09-18.pdf https://www.govinfo.gov/content/pkg/FR-2014-09-18/xml/FR-2014-09-18.xml fdlp 55963 56215 DGPO 2014-10-07 2024-06-02 FR-2014-09-18 machine generated eng FR FR-2014-09-18 79 181