[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Page 7450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-S-0002]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: 
[email protected]. 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.
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    \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.
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    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.
[FR Doc. E9-3170 Filed 2-13-09; 8:45 am]
BILLING CODE 4160-01-S