Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products; Correction

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 14, 1996 (61 FR 24227). The document amended the biologics regulations to eliminate the establishment license application (ELA) requirement for certain biotechnology and synthetic biological products subject to licensing under the Public Health Service Act (PHS Act); exempted these biotechnology and synthetic biological products from certain biologics regulations; and harmonized the requirements applicable to these products with those applicable to similar drug products which are approved under the Federal Food, Drug, and Cosmetic Act (the act). The document referenced certain regulations that were later removed from Title 21 of the Code of Federal Regulations (CFR). This document removes those references to ensure the consistency and accuracy of the CFR.