AGENCY CITATION TITLE EXCERPT FDA 69 Fed. Reg. 55,164 (Sep. 13, 2004) International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled "S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization and includes information concerning nonclinical assays and an integrated risk assessment. The draft guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk. The draft guidance provides guidance on nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk. The draft guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization and includes information concerning nonclinical assays and an integrated risk assessment. This draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. FDA 69 Fed. Reg. 55,163 (Sep. 13, 2004) International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. The draft guidance is intended to encourage the assessment of drug effects on the QT/QTc interval as a standard part of drug development and to encourage the early discussion of this assessment with FDA. NHTSA 69 Fed. Reg. 55,550 (Sep. 15, 2004) Anthropomorphic Test Devices; ES-2re Side Impact Crash Test Dummy (ES-2 With Rib Extensions); 50th Percentile Adult Male Today's NPRM proposes specifications and qualification requirements for the new mid-size adult male crash test dummy. The new 50th percentile adult male side impact test dummy has enhanced injury assessment capabilities compared to devices existing today, which allows for a fuller assessment of the types and magnitudes of the injuries occurring in side impacts and of the efficacy of countermeasures in improving occupant protection. Further, incorporation of the ES-2re test dummy into 49 CFR Part 572 would be a step toward harmonizing our regulations with non-U.S. regulations. The ES-2 dummy has not yet supplanted the EuroSID-1 dummy in Europe or elsewhere for use in regulations as of this time. However, based on a proposal from the Netherlands, the UN/ECE's Working Party on Passive Safety (GRSP) has recommended to the WP.29 that ECE Regulation No. 95 be amended to use the ES-2 dummy in place of the EuroSID-1. The GRSP's proposal takes into account the modifications that NHTSA has done to ES-2 to fix the back plate problem, as well as other minor outstanding technical problems raised by other participants. If this is adopted, the European Union is expected to also amend its Directive 96/27/EC to use the ES-2 dummy. Adopting the ES-2re into part 572 would also accord with the practices of the European New Car Assessment Program (EuroNCAP) on side impact. EuroNCAP began using the ES-2 dummy with the injury criteria specified in EU 96/27/EC in February 2003.