Memorandum of Understanding Between the Food and Drug Administration, Duke University and Duke University Health System, Inc., 5062-5068 [07-454]

Download as PDF 5062 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices sroberts on PROD1PC70 with NOTICES 300-mg tablets were not withdrawn from sale for reasons of safety or effectiveness. To date, BMS has never marketed SUSTIVA (efavirenz) 300-mg tablets. In previous instances (see, e.g., 67 FR 79640, December 30, 2002 (addressing a relisting request for Diazepam Autoinjector)), the agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. The petitioner identified no data or other information suggesting that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale as a result of safety or effectiveness concerns. FDA has reviewed its files for records concerning the withdrawal of SUSTIVA (efavirenz) 300-mg tablets. There is no indication that the decision not to market SUSTIVA (efavirenz) 300-mg tablets commercially is a function of safety or effectiveness concerns, and no information has been submitted to the docket concerning the reasons for which SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale. FDA’s independent evaluation of relevant information has uncovered nothing that would indicate that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons of safety or effectiveness. For the reasons outlined in this document, FDA has determined that VerDate Aug<31>2005 16:13 Feb 01, 2007 Jkt 211001 SUSTIVA (efavirenz) 300-mg tablets were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list SUSTIVA (efavirenz) 300-mg tablets in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety and effectiveness. ANDAs that refer to SUSTIVA (efavirenz) 300-mg tablets may be approved by the agency, as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. Dated: January 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–1748 Filed 2–1–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FDA 225–05–6001 Memorandum of Understanding Between the Food and Drug Administration, Duke University and Duke University Health System, Inc. AGENCY: Food and Drug Administration, Frm 00065 Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA, Duke University (DU) and Duke University Health System, Inc. (DUHS). The purpose of the MOU is to establish the terms of collaboration between FDA, DU and DUHS to support shared interests and will begin with an initiative entitled: The FDA, DU and DUMC Elective Program. The agreement became effective September 18, 2006. DATES: FOR FURTHER INFORMATION CONTACT: Nancy L. Pluhowski, Center for Devices and Radiological Health (HFZ–1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–827–2890. In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. SUPPLEMENTARY INFORMATION: Dated: January 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S HHS. PO 00000 ACTION: Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 VerDate Aug<31>2005 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\02FEN1.SGM 02FEN1 5063 EN02FE07.004</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices VerDate Aug<31>2005 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\02FEN1.SGM 02FEN1 EN02FE07.005</GPH> sroberts on PROD1PC70 with NOTICES 5064 VerDate Aug<31>2005 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\02FEN1.SGM 02FEN1 5065 EN02FE07.006</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices VerDate Aug<31>2005 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\02FEN1.SGM 02FEN1 EN02FE07.007</GPH> sroberts on PROD1PC70 with NOTICES 5066 VerDate Aug<31>2005 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\02FEN1.SGM 02FEN1 5067 EN02FE07.008</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices [FR Doc. 07–454 Filed 2–1–07; 8:45 am] BILLING CODE 4160–01–C VerDate Aug<31>2005 16:13 Feb 01, 2007 Jkt 211001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 EN02FE07.009</GPH> sroberts on PROD1PC70 with NOTICES 5068

Agencies

[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5062-5068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FDA 225-05-6001


Memorandum of Understanding Between the Food and Drug 
Administration, Duke University and Duke University Health System, Inc.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA, Duke University (DU) 
and Duke University Health System, Inc. (DUHS). The purpose of the MOU 
is to establish the terms of collaboration between FDA, DU and DUHS to 
support shared interests and will begin with an initiative entitled: 
The FDA, DU and DUMC Elective Program.

DATES: The agreement became effective September 18, 2006.

FOR FURTHER INFORMATION CONTACT: Nancy L. Pluhowski, Center for Devices 
and Radiological Health (HFZ-1), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-2890.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 07-454 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-C?>

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