STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE PUBLIC HEALTH AGENCY OF CANADA NOT TO PUBLICLY DISCLOSE NON-PUBLlC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION

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

Therefore, PHAC certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to PHAC in confidence by FDA;
    
2. will not publicly disclose such FDA-provided non-public information without the written authorization of the owner or the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA that the information no longer has non-public status;
    
3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from PHAC. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, PHAC will take all appropriate legal 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 FDA of any changes to Canada's laws, or to any relevant policies or procedures that would affect PHAC's ability to honor the commitments in this document.

Signed on behalf of the PHAC

_____________/s/_____________

September 28, 2011
Date

David Butler Jones
Chief Public Health Officer

Public Health Agency of Canada
130 Colonnade Rd. Ottawa, ON, KIA OK9
Thorndon
Wellington 6011
Canada

Telephone: 613-954-8524 Facsimile: 613-954-8529