Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability, 7450 [E9-3170]
Download as PDF
<![CDATA[
7450
Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen 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 document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–3166 Filed 2–13–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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:
pocasourcecoderequest@fda.hhs.gov.
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.
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Nov<24>2008
19:45 Feb 13, 2009
Jkt 217001
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.
Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–3170 Filed 2–13–09; 8:45 am]
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 orthographically1
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
https://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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
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
https://www.merriam-webster.com/dictionary.htm.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
BILLING CODE 4160–01–S
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, March
11, 2009, 8 a.m. to March 12, 2009, 6
p.m., National Cancer Institute/NIH,
6116 Executive Blvd., Room 8053,
Rockville, MD 20852 which was
published in the Federal Register on
January 29, 2009, 74FR5170.
The meeting notice is changed to
reflect the date change from March 11–
12, 2009 to March 18–19, 2009. The
meeting is closed to the public.
Dated: February 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–3309 Filed 2–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Limited
Competition for Data Sharing for
Demographic Research Infrastructure.
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Page 7450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3170]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
pocasourcecoderequest@fda.hhs.gov. 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.
---------------------------------------------------------------------------
\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 https://
www.merriam-webster.com/dictionary.htm.
---------------------------------------------------------------------------
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 https://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
