[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Notices]
[Pages 2054-2057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-252]



[[Page 2054]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-05-8008]


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.

    Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S


[[Page 2055]]

[GRAPHIC] [TIFF OMITTED] TN12JA06.005


[[Page 2056]]


[GRAPHIC] [TIFF OMITTED] TN12JA06.006


[[Page 2057]]


[GRAPHIC] [TIFF OMITTED] TN12JA06.007

[FR Doc. 06-252 Filed 1-11-06; 8:45 am]
BILLING CODE 4160-01-C