Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products
other · US Department of Health and Human Services · Rule · Published 1996-05-14 · Effective 1996-05-24 · 61 FR 24226
Document
Document number
96-12144
Federal Register citation
61 FR 24226
CFR reference
21 CFR 600
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-05-14
Effective date
1996-05-24
HHS docket
Docket No. 95N-0411
Abstract
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.