[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, Aikink@cder.fda.gov.
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
