[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46646-46647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0201]


Minimizing Medication Errors--Methods for Evaluating Proprietary 
Names for Their Confusion Potential; Public Meeting; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) held a public meeting 
on June 26, 2003, to discuss current methods and approaches used to 
evaluate proprietary drug names for similarities. In the document that 
published in the Federal Register of May 30, 2003 (68 FR 32529), 
announcing the June 26, 2003, meeting, the agency requested comments by 
July 15, 2003, on questions relating to the issues discussed at the 
meeting. FDA is reopening the comment period until September 5, 2003, 
on issues discussed at that meeting in response to a request that the 
agency allow interested parties additional time to review and to submit 
comments on this issue.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic questions to http://www.fda.gov/ohrms/dockets.

DATES: Submit written or electronic comments by September 5, 2003.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug 
Evaluation and Research (HFD-400), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7849, FAX: 301-443-9664.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 30, 2003, FDA published a document 
announcing a public meeting, which was to be held on June 26, 2003, in 
cooperation with the Institute for Safe Medication Practices and the 
Pharmaceutical Research and Manufacturers of America. The purpose of 
the meeting was to encourage discussion among representatives from 
industry, the health care professions, consumer groups, academia, and 
others on how best to minimize the potential for medication errors due 
to similarities in drug names, including a discussion of current 
methods and approaches. The Department of Health and Human Services 
(DHHS), Office of the Secretary published a recommendation (from the 
November 21, 2002, report from the DHHS Advisory Committee on 
Regulatory Reform) that called for FDA to shift, in most cases, from 
performing drug name safety testing to reviewing data submitted by 
sponsors. At the June 26, 2003, meeting, several tools with the 
potential to minimize naming errors resulting from look alike and sound 
alike drug names were considered. Potential tools included sampling, 
questionnaire construction, handwriting and voice recognition models, 
expert committees, computer assisted decision analysis, failure modes 
and effects analysis and premarketing risk management programs. In the 
document announcing that meeting, the agency requested information in 
response to FDA questions that had been posted at

[[Page 46647]]

http://www.fda.gov/cder/workshop.htm (choose Minimizing Medication 
Errors--Evaluating the Drug Naming Process; Public Meeting). Comments 
were to be received by July 15, 2003. However, in response to a request 
that the agency allow interested parties additional time to review and 
to submit comments on this issue, FDA is reopening the comment period 
on issues discussed at that meeting until September 5, 2003.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. A copy of the document and received comments 
are available for public examination in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the issues on which 
comments are requested at http://www.fda.gov/cder/workshop.htm. Paper 
copies of the questions may be obtained by contacting Mary Gross (see 
FOR FURTHER INFORMATION CONTACT).

    Dated: July 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20063 Filed 8-5-03; 8:45 am]
BILLING CODE 4160-01-S