Revision of the Requirements for a Responsible Head for Biological Establishments

The Food and Drug Administration (FDA) is amending the biologics regulations by deleting the requirements for a biologics establishment to name a ``responsible head'' or ``designated qualified person'' to exercise control of the establishment in all matters relating to compliance with regulatory requirements and to represent the establishment in its dealings with FDA. Because many manufacturers of biological products are firms that have more than one manufacturing location and complex corporate structures, it may no longer be practical for one individual to represent a manufacturer or possess expertise in all matters. This change will provide manufacturers with more flexibility in assigning control and oversight responsibility within a company. This final rule is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiative, and it is intended to reduce the burden of unnecessary regulations on industry without diminishing public health protection.