Drugs

Label Format Preference (Study B)

SUMMARY: On February 27, 1997, the Food and Drug Administration (FDA) issued a proposed rule to establish a standardized, easy to read format for the labeling of over-the-counter (OTC) drug products (62 FR 9024). As part of that rulemaking proceeding, the agency has collected data under a study entitled "Over-the-Counter (OTC) Label Format Preference," also known as "Study B". In Study B (OTC Label Format Preference), consumers were invited to view examples and variations of current OTC label designs. Respondents were asked to indicate their preference for various designs. Also, consumers were asked to evaluate labeling terminology and graphics to investigate how they interpret various ways of communicating drug safety and effectiveness. This document announces the availability of the frequency tabulations that summarize the Study B data, and reopens the comment period for the OTC rulemaking proceeding for 45 days to allow an opportunity to comment on these materials.

REQUEST FOR COMMENTS: Interested persons may, on or before (insert date 45 days after date of publication in the FEDERAL REGISTER) submit written comments on STUDY B to the Dockets Management Branch (HFA-305), ATTN: STUDY B: OTC Drug Labeling Data Collection, Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with docket number (insert from FR notice) and labeled "ATTN: STUDY B: OTC Drug Labeling Data Collection."

TABLE OF CONTENTS

Variable Frequencies