[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