federal_register: 96-12144

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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
96-12144 Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products Rule The Food and Drug Administration (FDA) is amending 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). This final rule also exempts these biotechnology and synthetic biological products from certain biologics regulations and harmonizes 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). This final rule is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives, and it is intended to reduce unnecessary burdens for industry without diminishing public health protection. 1996-05-14 1996 5 https://www.federalregister.gov/documents/1996/05/14/96-12144/elimination-of-establishment-license-application-for-specified-biotechnology-and-specified-synthetic https://www.govinfo.gov/content/pkg/FR-1996-05-14/pdf/96-12144.pdf Health and Human Services Department 221 The Food and Drug Administration (FDA) is amending 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... 0910-AA71

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