Over-the-Counter Human Drugs; Proposed Labeling Requirements; Notice of Availability of Study Data and Reopening of Comment Period

Resumo

The Food and Drug Administration (FDA) is reopening to March 30, 1998 the comment period on specific data related to the February 27, 1997, proposed rule to establish a standardized format for the labeling of over-the-counter (OTC) drug products (62 FR 9024). As part of that rulemaking proceeding, the agency collected data under a study entitled ``Evaluation of Proposed Over-the-Counter (OTC) Label Format Comprehension,'' (Study A). This document announces the availability of the data and frequency tabulations that summarize the Study A data and reopens the comment period for the OTC rulemaking proceeding to allow an opportunity for comment on Study A.