Executive Summary

Roughly 500 nonprescription drugs introduced annually through new drug applications or abbreviated NDAs must comply with FDA's standardized format and content requirements for labeling marketed OTC drug products. In a June 3 Federal Register notice seeking comments on a proposed collection of information on industry's burden for compliance with the 1999 OTC labeling final rule, FDA says the Consumer Healthcare Products Association provided data for the estimate. The notice also says some 4,750 OTC sunscreen stock-keeping units have not complied with the labeling rule, but need to by a date the agency will set when it publishes a final rule for the OTC sunscreen monograph. FDA estimates firms need five hours to prepare labeling for OTC NDAs and ANDAs and two hours for sunscreen labeling prior to submitting the information to the agency. Monograph OTC drugs already must comply with the labeling rule. The deadline for comments is Aug. 3