E9-3170. Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another. POCA is one analytic tool that FDA uses to review proposed proprietary drug and biologic names.

ADDRESSES:

Requests for single copies of the POCA software should be submitted to the following e-mail address: [e-mail]. Communications other than requests for POCA software should be directed to the Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research, 10903 New Hampshire Ave. Bldg. 22, Mail Stop 4447, Silver Spring, MD 20993-0002, 301-796-2360.

FOR FURTHER INFORMATION CONTACT:

Carol Holquist, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4416, Silver Spring, MD 20993-0002, 301-796-2360.

SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of the source code and supporting technical documentation for the POCA software program, an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically^[1] similar to one another. POCA is one analytic tool that FDA uses in its review of proposed proprietary drug and biologic names to help FDA identify proprietary names that look alike or sound alike. FDA is not providing technical support for the software program.

In title I of the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85), Congress reauthorized and expanded the Prescription Drug User Fee Act (PDUFA IV). As part of the PDUFA IV performance goals, FDA agreed to provide the full source code and supporting technical documentation for the POCA tool and make it available on disk for use by industry and others from the general public (see section IX.C.2. at http://www.fda.gov/​oc/​pdufa4/​pdufa4goals.html).

The POCA software was produced under a U.S. Government contract, and the United States has unlimited rights in the software. The United States has determined that it is in its best interest to provide it royalty-free to the public to use or modify the software for any purpose. Thus, the software is hereby provided free of any restriction on use or distribution. The software is furthermore provided “as is” without warranty of any kind or any guarantee that the software will work for any purpose. Project Performance Corp. developed the software under a U.S. Government contract.

Single copies of the POCA software are available from FDA upon request (see ADDRESSES).

Dated: February 6, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

Footnotes

1. Merriam-Webster Online defines the term “orthography” in part as: (1) The representation of the sounds of a language by written or printed symbols or (2) a part of language study that deals with letters and spelling. Complete definitions of “orthography” and “orthographic” are available at http://www.merriam-webster.com/​dictionary.htm.