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, 2054-2057 [06-252]

Download as PDF 2054 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices 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: erjones on PROD1PC68 with NOTICES Notice. VerDate Aug<31>2005 15:02 Jan 11, 2006 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 worksharing agreements, the agency is publishing notice of this Protocol. DATES: The Protocol became effective December 1, 2005. Dated: January 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. ACTION: 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). BILLING CODE 4160–01–S Matthew E. Eckel, Office of Jkt 208001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1 VerDate Aug<31>2005 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 2055 EN12JA06.005</GPH> erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 EN12JA06.006</GPH> erjones on PROD1PC68 with NOTICES 2056 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices BILLING CODE 4160–01–C Food and Drug Administration [Docket No. 2003D–0386 (formerly Docket No. 03D–0386)] Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Availability AGENCY: Food and Drug Administration, HHS. erjones on PROD1PC68 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.’’ The guidance describes a formal, two-tiered dispute resolution process intended to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP) that arise during FDA inspections of pharmaceutical manufacturers. VerDate Aug<31>2005 15:02 Jan 11, 2006 Jkt 208001 Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852–1448; or Communications Staff (HFV–12), Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855. The guidance may also be obtained by mail by calling the Center for Biologics Evaluation and Research at 1–800–835– 4709 or 301–827–1800. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 28052. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Edward M. Sherwood, Center for Drug Evaluation and Research (HFD–3), Food and Drug Administration, White Oak 21, rm. 3528, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796– 1605. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.’’ The guidance was developed as part of the FDA initiative ‘‘Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach,’’ which was announced in August 2002. The initiative focuses on FDA’s current CGMP program and covers the manufacture of veterinary and human drugs, including human biological drug products. The agency formed the Dispute Resolution Working Group comprising representatives from the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM). The working group met weekly on issues related to the dispute resolution process E:\FR\FM\12JAN1.SGM 12JAN1 EN12JA06.007</GPH> Submit written or electronic comments on agency guidances at any time. DATES: [FR Doc. 06–252 Filed 1–11–06; 8:45 am] 2057

Agencies

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



[[Page 2054]]

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