FDA to DHA

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

The United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Australian Government Department of Health and Ageing (DHA) regarding FDA-regulated Tobacco products as part of cooperative law enforcement or cooperative regulatory activities.

DHA understands that some of the information it receives from FDA 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. DHA understands that this non-public information is shared in confidence and that FDA considers it critical that DHA maintain the confidentiality of the information. Public disclosure of this information by DHA could seriously jeopardize any further scientific and regulatory interactions between FDA and DHA. FDA will advise DHA of the non-public status of the information at the time that the information is shared.

Therefore, DHA certifies that it:

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

Signed on behalf of DHA:

______---/s/---_________ 

Date: 8/8/2012

Sarah Jane Halton
Secretary
Department of Health and Ageing
Australia

Level 14, Scarborough House
Atlantic Street, Phillip ACT 2606, Australia

Telephone: 02 6289 8401
Facsimile: 02 6285 1994