[Federal Register Volume 60, Number 178 (Thursday, September 14, 1995)]
[Notices]
[Page 47752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22788]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0259]


Over-the-Counter Drug Labeling; Public Meeting; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of August 16, 1995 (60 FR 42578). 
The document announced a public hearing to discuss over-the-counter 
(OTC) drug labeling issues. The document also solicited comments from 
interested persons on various aspects of OTC drug labeling that would 
improve the communication of information to consumers and solicited 
specific comments and/or data on the costs and benefits of an improved 
labeling format. The document was published with some errors. The date 
in which comments are due to the agency, and the date that notices of 
participation are due to the agency were erroneous. This document 
corrects those errors and adds a question for public comment which was 
inadvertently omitted.

FOR FURTHER INFORMATION CONTACT: Ilisa B. G. Bernstein, Office of the 
Commissioner, Office of Policy (HF-23), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), ATTN: OTC Drug Labeling Hearing, Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or 
FAX 301-594-3215.

    In FR Doc. 95-20245, appearing on page 42578 in the Federal 
Register of August 16, 1995, the following corrections are made:
    1. On page 42578, in the first column, under the DATES caption, in 
the last sentence ``December 29, 1995'' is corrected to read ``October 
30, 1995.''
    2. On page 42580, in the third column, in the first full paragraph, 
in line 6, the date ``September 11, 1995'' is corrected to read 
``September 15, 1995''. Additionally, on the same page, in the second 
column, after the fifth paragraph, new section ``F.'' is added to read 
as follows:
F. Process Issue
     As part of FDA's ongoing effort to improve OTC labeling, the 
agency believes that it may have to revise many of the OTC monographs 
to improve and simplify communication of the information. Because 
revising the labeling portion of the monographs would be a major 
undertaking, the agency seeks public comment on the process that should 
be followed by FDA to ensure that the revisions are completed in an 
efficient and expedient manner. The agency intends on using its own 
experts to develop revised language that would be published in a notice 
of proposed rulemaking (NPRM). The agency also intends to allow a 
longer than usual comment period of 120, 150, or 180 days, to allow for 
consumer testing of the proposed language by FDA and other interested 
parties. Based on the results of the testing and comments received, the 
agency would then develop a final rule for the monograph(s). The agency 
would group monographs together, so as to develop a small number of 
NPRM's for this effort. Please comment on whether this process is 
appropriate, or if other steps should be taken for monograph revisions.

    Dated: September 7, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-22788 Filed 9-13-95; 8:45 am]
BILLING CODE 4160-01-F