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Rolnictwo i żywność · 18/07/1995

Viruses, Serums, Toxins, and Analogous Products; In Vitro Potency Testing for Serial Release

We are extending by 30 days the comment period for our proposed rule that would amend the regulations regarding the use of in vitro potency testing for serial release. The regulations pertaining to in vitro testing for serial release would require that such immunoassays be parallel line assays based upon unexpired reference preparations and would specify procedures and requirements for qualifying reference preparations for inactivated products. This extension will provide interested persons with additional time to prepare comments on the proposed rule. We are also advising the producers of veterinary biologics and other interested persons that the Animal and Plant Health Inspection Service will be holding a public hearing in Ames, IA, at our Veterinary Biologics Public Meeting to discuss issues related to in vitro potency testing.

Source: Federal Register — Agriculture DepartmentOpen original release →