Sunscreen Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Reopening of Comment Period

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The Food and Drug Administration (FDA) is reopening to March 21, 1994, the comment period on the notice of proposed rulemaking that would establish conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded (May 12, 1993, 58 FR 28194). FDA is taking this action in response to a request to extend the comment period for an additional 40 days to allow more time to comment on this proposal. This reopening of the comment period does not apply to comments on ultraviolet A (UVA) testing, protection, ingredients, and labeling. The comment period for these issues closed on November 8, 1993. Subsequently, the agency extended the comment period until February 7, 1994, in order to have a workshop on these subjects in the spring of 1994. A notice concerning this workshop will appear in a future issue of the Federal Register. This proposal is part of the ongoing review of OTC drug products conducted by the FDA.