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 2016_register executive 2018-02-09 article Rules and Regulations D09002ee1c7f44929 D09002ee1c7f44a4c 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 regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product. 81 FR 59427 https://www.govinfo.gov/app/details/FR-2016-08-30/2016-20749 2016-20749 fr30au16-2 RIN 0579-AD19 3410-34-P Docket No. APHIS-2008-0008 https://www.govinfo.gov/app/details/FR-2016-08-30/2016-20749 https://www.govinfo.gov/content/pkg/FR-2016-08-30/html/2016-20749.htm https://www.govinfo.gov/content/pkg/FR-2016-08-30/pdf/2016-20749.pdf Animal Biologics Reporting and Recordkeeping Requirements Exports Imports Labeling Packaging and Containers 10 p. 59427 59436 81 FR 59427 Title 9 Part 101 9 CFR Part 101 Title 9 Part 103 9 CFR Part 103 Title 9 Part 112 9 CFR Part 112 Title 9 Part 113 9 CFR Part 113 Title 9 Part 114 9 CFR Part 114 RIN 0579-AD19 Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling; Federal Register Vol. 81, Issue RULE 2016-20749 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 2016-10-31 Docket No. APHIS-2008-0008 3410-34-P 2016-20749 Final rule.

We are amending the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product.

Effective October 31, 2016. Dr. Donna L. Malloy, Section Leader, Operational Support, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851-3426. Animal Biologics Reporting and Recordkeeping Requirements Exports Imports Labeling Packaging and Containers Viruses, Serums, Toxins, and Analogous Products: Packaging and Labeling , http://www.aphis.usda.gov/animalhealth/cvb/forms http://www.regulations.gov/#!docketDetail https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologics-regulations-and-guidance/ct_vb_vs_memos Regulations.gov Vol. 81, no. 168 Office of the Federal Register, National Archives and Records Administration 2016-08-30 continuing daily deposited born digital 418 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-08-30 P0b002ee1985ec3a1 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30au16 https://www.govinfo.gov/app/details/FR-2016-08-30 https://www.govinfo.gov/content/pkg/FR-2016-08-30/pdf/FR-2016-08-30.pdf https://www.govinfo.gov/content/pkg/FR-2016-08-30/xml/FR-2016-08-30.xml fdlp 59421 59826 DGPO 2018-02-09 2024-06-01 FR-2016-08-30 machine generated eng FR FR-2016-08-30 81 168