[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
