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

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The Food and Drug Administration (FDA) is reopening to February 13, 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 ``Over-the-Counter (OTC) Label Format Preference, Study B.'' (Study B). This document announces the availability of the data and frequency tabulations that summarize the Study B data and reopens the comment period for the OTC rulemaking proceeding to allow an opportunity for comment on Study B.