Changes to an Approved Application

The Food and Drug Administration (FDA) is amending the biologics regulations for reporting changes to an approved application in order to reduce unnecessary reporting burdens on applicants holding licenses approved by the Center for Biologics Evaluation and Research (CBER) under the Public Health Service Act (the PHS Act) to manufacture biological products. In addition, FDA is amending the corresponding drug regulations for submitting supplements and reporting changes to an application approved under the Federal Food, Drug, and Cosmetic Act (the act) for specified biotechnology products reviewed in the Center for Drug Evaluation and Research (CDER) to harmonize the drugs and biologics regulations. This final rule is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives.