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  1. Confidentiality Commitments

FDA - AQIS Australia, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE AUSTRALIAN QUARANTINE AND INSPECTION SERVICE

The Australian Quarantine and Inspection Service (AQIS) is authorized to disclose non-public information to United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHS/FDA) regarding AQIS-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, HHS/FDA certifies that it:

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

__________/s/____________ 

17 March 2009
Date

Murray M. Lumpkin, M.D.
Deputy Commissioner for International Programs
United States Food and Drug Administration
5600 Fishers Lane (HF-3)
Rockville, MD 20857

Telephone: 301-827-5709
Facsimile: 301-443-3100

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