Department of Health and Human Services August 27, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on August 13, 2007 (72 FR 45250). The document announced a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, October 27 through November 1, 2007, at which discussion of the topics underway and the future of ICH will continue.

The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule.