federal_register: 2014-08995
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-08995 | Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products | Proposed Rule | We are proposing to amend 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. We intend to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. We are also proposing to require 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. | 2014-04-21 | 2014 | 4 | https://www.federalregister.gov/documents/2014/04/21/2014-08995/viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-products | https://www.govinfo.gov/content/pkg/FR-2014-04-21/pdf/2014-08995.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | We are proposing to amend 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. We intend to replace the current label format, which reflects any of four... |