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AQIS - FDA

Australian Government
_____________________________________
Australian Quarantine and Inspection Service

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

The US Food and Drug Administration of the Department of Health and Human Services (USFDA) is authorised to disclose non-public information to the Australian Quarantine and Inspection Service (AQIS) regarding USFDA-regulated products as . part of cooperative law enforcement or cooperative regulatory activities.

AQIS understands that some of the information it receives from USFDA 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; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. AQIS understands that this non-public information is shared in confidence and that USFDA considers it critical that AQIS maintains the confidentiality of the information. Public disclosure of this information by AQIS could seriously jeopardise any further scientific and regulatory interactions between USFDA and AQIS. USFDA will advise AQIS of the non-public status of the information at the time that the information is shared.

Therefore, AQIS certifies that it:

  1. has the authority to protect from public disclosure the non-public information provided to AQIS in confidence by USFDA; 
  2. unless, despite the measures taken by AQIS under clause 3 below, AQIS is required by force of law, judicial process or Parliamentary process to disclose the non-public information, AQIS will not publicly disclose the USFDA provided non-public information without the written authorisation of the owner of the information, the written authorisation from the individual who is the subject of the personal privacy information, or a written statement from USFDA that the information no longer has non-public status; 
  3. will inform USFDA within two working days of any effort made by judicial or legislative mandate to obtain USFDA provided non-public information from AQIS. If such judicial or legislative mandate orders disclosure of US FDA provided non-public information, AQIS 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, as promptly as possible, inform USFDA of any changes to AQIS laws, and any relevant policies or procedures, that would affect AQIS's ability to honour the agreements in this document.

_____/s/______                                 17 March 2009
Greg Read                                         Date
Executive Manager
Australian Quarantine and Inspection Service

PO Box 858
CANBERRA ACT 2601

Telephone: + 61 262723594
Facsimile: + 61 262724389