5062 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / 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300-mg tablets were not withdrawn 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were withdrawn from sale as a result of 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were withdrawn from sale.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withdrawn from sale for reasons of 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 

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were not withdrawn from sale for 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, 

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. 

BILLING CODE 4160–01–S 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 5063 


sroberts on PROD1PC70 with NOTICESEN02FE07.004</GPH>
5064 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 


sroberts on PROD1PC70 with NOTICESEN02FE07.005</GPH>
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 5065 


sroberts on PROD1PC70 with NOTICESEN02FE07.006</GPH>
5066 Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 


sroberts on PROD1PC70 with NOTICESEN02FE07.007</GPH>
Federal Register / Vol. 72, No. 22 / Friday, February 2, 2007 / Notices 5067 


sroberts on PROD1PC70 with NOTICESEN02FE07.008</GPH>
5068 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 


sroberts on PROD1PC70 with NOTICESEN02FE07.009</GPH>