[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Proposed Rules]
[Page 7331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3625]
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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 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.
DATES: Submit written comments on Study A by March 30, 1998.
ADDRESSES: Submit written comments on the information collected in
Study A to the Dockets Management Branch (HFA-305), ATTN: Study A, 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 better 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 Format Comprehension, 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). In the Federal
Register of December 30, 1997 (62 FR 67770), the agency requested
comments specifically related to Study B. The data and frequency
tabulations for Study A are now available.
In Study A, consumers were invited to view examples of OTC label
designs. Respondents were asked questions designed to measure knowledge
and attitudes about OTC drug products, as well as decisions about
proper use of the products. The agency is now seeking comments on the
data developed under Study A, including the participants' responses on
the comprehension elements measured for the specific label designs
viewed. The comments on Study A will be included in the agency's
deliberations on developing a final, standardized OTC labeling format
regulation.
Interested persons may, on or before March 30, 1998, submit written
comments on the data developed under Study A 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 A, 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 previously.
Dated: February 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3625 Filed 2-12-98; 8:45 am]
BILLING CODE 4160-01-F