Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Extension of Effective Date; Reopening of Administrative Record

The Food and Drug Administration (FDA) is extending to December 31, 2002, the effective date for the final monograph for over- the-counter (OTC) sunscreen drug products that published in the Federal Register of May 21, 1999 (64 FR 27666). The final monograph established conditions under which OTC sunscreen drug products are generally recognized as safe and effective and not misbranded. The extension of the effective date applies to all OTC sunscreen drug products that would be regulated under parts 310, 352, and 700 (21 CFR parts 310, 352, and 700). In addition, FDA is reopening the administrative record for the rulemaking for OTC sunscreen drug products to allow for comment specifically on the information requested in this document. FDA is taking this action in response to a citizen petition requesting that the agency, among other things, initiate an administrative process to publish a "comprehensive" sunscreen final monograph that addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection.