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U.S. Department of Health and Human Services

International Programs

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FDA - TGA

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 THERAPEUTIC GOODS ADMINISTRATION

The Australian Therapeutic Goods Administration, a division of the Department of Health and Ageing, (TGA) is authorized to disclose non-public information to the United States Food and Drug Administration of the Department of Health and Human Services (HHS/FDA) regarding TGA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

HHS/FDA understands that some of the information it receives from TGA may include sensitive non-public information, 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 TGA 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 TGA and HHS/FDA. TGA 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 TGA; 
  2. will not publicly disclose such TGA-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 TGA that the information no longer has non-public status; 
  3. will inform TGA promptly of any effort made by judicial or legislative mandate to obtain TGA-provided non-public information from HHS/FDA. If such judicial or legislative mandate orders disclosure of TGA-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 TGA of any changes to relevant laws, regulations, policies, or procedures that would affect HHS/FDA’s ability to honor the commitments in this document.

 

___________/s/____________                                                March 5, 2008
Murray M. Lumpkin, M.D.                                                        Date

Deputy Commissioner
International and Special Programs
Food and Drug Administration
Department of Health and Human Services
UNITED STATES OF AMERICA

 

5600 Fishers Lane
Rockville, MD 20857

301-827-5709 (ph)
301-827- 3100 (fax)