[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Proposed Rules]
[Pages 67770-67771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, and 358

[Docket No. 96N-0420]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period on specific data.

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SUMMARY: 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.

DATES: Submit written comments on Study B by February 13, 1998.

ADDRESSES: Submit written comments on the information collected in 
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.

FOR FURTHER INFORMATION CONTACT: Kathryn J. Aikin, Food and Drug 
Administration, Division of Drug Marketing, Advertising, and 
Communications (HFD-40), 5600 Fishers Lane, Rockville, MD, 20857, 301-
827-2828, A[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of February 27, 1997 
(62 FR 9024), FDA published a proposed rule intended to enable 
consumers to read and understand OTC drug product labeling and to more 
effectively apply the information in the labeling to the safe and 
effective use of such products. An important element of FDA's proposed 
rule is a standardized labeling format for OTC drug products.
    After issuing the proposed rule, FDA published in the Federal 
Register a notice under the Paperwork Reduction Act of 1995 announcing 
the agency's intention to conduct four studies relating to OTC drug 
products (62 FR 28482, May 23, 1997). The agency intends at this time 
to use two of the studies (``Evaluation of Proposed Over-the-Counter 
(OTC) Label Formats, Study A,'' and ``Over-the-Counter (OTC) Label 
Format Preference, Study B'' ) in deliberations on developing a 
standardized, easy to read and easy to understand, labeling format for 
OTC drug products (see 62 FR 9024). The data and frequency tabulations 
for one of these studies, Study B, are now available.
    In Study B, consumers were invited to view examples and variations 
of current OTC label designs. Respondents were asked to indicate their 
preference for various designs and to evaluate labeling terminology and 
graphics to help the agency understand how consumers interpret various 
ways of communicating drug safety and drug effectiveness information. 
The agency is now seeking comments on the data developed under Study B, 
including the opinions of the respondents on the various labeling 
format elements used in the Study. The comments on Study B will be 
included in the agency's deliberations on developing a final, 
standardized OTC labeling format regulation.
    After the results for Study A are tabulated, the agency will 
publish a notice in the Federal Register announcing when the data and 
tabulations are available for viewing.

[[Page 67771]]

    Interested persons may, on or before February 13, 1998, submit 
written comments on the data developed under Study B to the Dockets 
Management Branch (address above). Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document and labeled ``ATTN: Study B, OTC Drug Labeling Data 
Collection.'' The data, frequency tabulations, and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday. An electronic format of the data are available on the 
internet at: www.fda.gov/CDER/ or can be obtained in electronic form 
from the Dockets Management Branch at the address listed above.

    Dated: December 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33803 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F