Protocol Regarding the Sharing of the Phonetic and Orthographic Computer Analysis Tool to Support Review and Evaluate Proprietary Names of Therapeutic Products Between the Food and Drug Administration Department of Health and Human Services of the United States of America and Health Products and Food Branch, Health Canada of Canada

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of a protocol regarding the sharing of the Phonetic and Orthographic Computer Analysis Tool to support review and evaluate proprietary names of therapeutic products between FDA and the Health Products and Food Branch, Health Canada of Canada (the Protocol). This Protocol is intended to enable, enhance, and strengthen the exchange of information about computerized software programs developed by FDA to minimize medication errors due to similar proprietary names of therapeutic products (Phonetic and Orthographic Computer Analysis).

DATES:

The Protocol became effective December 1, 2005.

FOR FURTHER INFORMATION CONTACT:

Matthew E. Eckel, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480, FAX: 301-480-0716.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 20.108(a) and (c), which states that all written agreements and understandings signed by FDA and other departments, agencies, and organizations shall be published in the Federal Register, except those agreements and memoranda of understanding between FDA and State or local government agencies that are cooperative work-sharing agreements, the agency is publishing notice of this Protocol.

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