federal_register: 2015-16898

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-16898 Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products Rule We are amending the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which reflected any of four different levels of effectiveness, is replaced with a single, uniform label format. We are also requiring biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to their customers. 2015-07-10 2015 7 https://www.federalregister.gov/documents/2015/07/10/2015-16898/viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-products https://www.govinfo.gov/content/pkg/FR-2015-07-10/pdf/2015-16898.pdf Agriculture Department; Animal and Plant Health Inspection Service 12,22 We are amending the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which reflected any of four...  

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