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

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

Therefore, FDA certifies that it:

1. has the authority to protect from public disclosure such non-public information provided to FDA in confidence by PHAC;
    
2.  will not publicly disclose such PHAC-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 PHAC that the information no longer has non-public status;
    
3. will inform PHAC promptly of any effort made by judicial or legislative mandate to obtain PHAC provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of PHAC provided non-public information, FDA 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 PHAC of any changes to the United States of America’s laws, or to any relevant policies or procedures that would affect FDA’s ability to honor the commitments in this document.

Signed of behalf of FDA

_____________/s/_____________

August 30, 2011
Date

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs

Address: Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
UNITED STATES OF AMERICA

 

Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937