Department of Health and Human Services April 4, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).

At the request of the U.S. Environmental Protection Agency (EPA), the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is planning to assess the validation status of a proposed non-animal approach for evaluating the eye irritation potential of AMCPs that meets hazard classification and labeling requirements. On behalf of ICCVAM, NICEATM requests: 1. Nominations of expert scientists to serve as members of an independent peer review panel. 2. Submission of relevant data and information on AMCPs or related substances obtained from (1) human testing or experience including reports from accidental exposures, (2) rabbits using the standard eye test or the low volume eye test (LVET), and (3) in vitro test methods for assessing ocular irritation, such as the Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test, and the EpiOcular test, and data supporting the accuracy and reproducibility of these methods.