Department of Health and Human Services June 20, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in existing FDA regulations governing State enforcement notifications.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' The guidance was originally published in November 1996. However, because of potentially significant adverse effects seen in healthy subjects who had not previously used clozapine, FDA proposed a revision to the guidance in a draft published in December 2003. FDA did not receive comments on the draft guidance during the comment period. This final version of the 2003 draft guidance includes a change in the recommended patient population as well as other minor changes that are based on current information available to FDA.