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FDA – Australian Government Department of Agriculture, Water and the Environment Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF AGRICULTURE, WATER AND THE ENVIRONMENT

The Australian Government Department of Agriculture, Water and the Environment (DAWE), is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding DAWE-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA acknowledges that:

  1. this Statement of Authority and Confidentiality Commitment replaces and continues the protections of information previously shared under the 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, signed by the FDA on March 17, 2009 (“2009 Statement of Authority and Confidentiality Commitment”);
  2. as a result of machinery of government changes implemented under Australian Law, DAWE has assumed the responsibilities of the Department of State of which Australian Quarantine and Inspection Service (AQIS) was a division. Further changes may occur in the future which may result in other Australian Government Departments or agencies becoming responsible for this Statement of Authority and Confidentiality Commitment; and
     
  3. FDA will continue to provide the same protections for any non-public information provided by the FDA under the 2009 Statement of Authority and Confidentiality Commitment.
     

FDA understands that some of the information it receives from DAWE may include non-public information exempt from public disclosure under the laws and regulations of Australia, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that DAWE 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 DAWE and FDA. DAWE will advise FDA of the non-public 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 DAWE;
     
  2. will not publicly disclose such non-public information provided by DAWE 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 DAWE that the information no longer has non-public status;
     
  3.  
  4. will inform DAWE promptly of any effort made by judicial or legislative mandate to obtain non-public information provided by DAWE from FDA. If such judicial or legislative mandate orders disclosure of non-public information provided by DAWE, 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
     
  5. will promptly inform DAWE 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 on behalf of FDA:

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_____________________________

Mark Abdoo                                                                Date:   December 10, 2020
Associate Commissioner
Office of Global Policy and Strategy

The United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States of America

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