CONFIDENTIALITY COMMITMENT STATEMENT OF LEGAL AUTHORITY AND COMMITMENT FROM THE PHARMACEUTICAL AND FOOD SAFETY BUREAU, MINISTRY OF HEALTH, LABOUR AND WELFARE, GOVERNMENT OF JAPAN (PFSB), NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, GOVERNMENT OF THE UNITED STATES OF AMERICA (USFDA)

The Food and Drug Administration, Department of Health and Human Services, Government of the United States of America (USFDA) is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Government of Japan (PFSB) regarding USFDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

The PFSB understands that some of the information it receives from the USFDA may include non-public information exempt from public disclosure under the laws and regulations of the Government of the United States of America, such as confidential commercial information; trade secret information;' personal privacy information; law enforcement information; or internal, pre-decisional information. The PFSB understands that this non-public information is shared in confidence, and that the USFDA considers it critical that the PFSB maintain the confidentiality of the information. Public disclosure of this information by the PFSB could seriously jeopardize any further scientific and regulatory interactions between the USFDA and PFSB. The US FDA will advise the PFSB of the non-public status of the information at the time that the information is shared.

Therefore, the PFSB certifies that it:

1. has the authority to protect the non-public information provided to the PFSB in confidence by the US FDA from public disclosure; 
    
2. will not publicly disclose the US FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from the USFDA that the information no longer has non-public status;
    
3. will inform the US FDA within two working days of any effort made to obtain the US FDA-provided non-public information from the PFSB by judicial or, legislative mandate. If such judicial or legislative mandate orders disclosure of the USFDA- provided non-public information, the PFSB will take all measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and 
    
4. will promptly inform the US FDA of any changes to laws, policies or procedures that would affect the PFSB’s ability to honor the agreements in this document.

______________/s/_______________
Signature of foreign government official

Mr. Shinji Asonuma
________________________________
Print or Type foreign government official

Director General of Pharmaceutical and Food Safety Bureau
___________________________________
Title of foreign government agency official

Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
______________________________
Name of foreign government agency
Address: 2-2. Kasumigaseki l-chome. Chiyoda-ku. Tokyo 100-8916

Contact point:
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau
Telephone: +81-3-3595-2431 ,
Facsimile: +81-3-3597-9535

Date: July 23, 2004