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  1. Confidentiality Commitments

FDA - NICNAS Australia, 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 AUSTRALIAN GOVERNMENT NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

Subject to any relevant law or policy binding on it, the Australian Government National Industrial Chemicals Notification and Assessment Scheme (NICNAS), is authorized to disclose non-public information to United States Food and Drug Administration (FDA) regarding NICNAS regulated products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from NICNAS may include non-public information exempt from public disclosure under the laws and regulations of Australia, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that NICNAS 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 NICNAS and FDA. NICNAS 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 NICNAS;
     
  2. will not publicly disclose such NICNAS 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 NICNAS that the information no longer has non-public status;
     
  3. will inform NICNAS promptly of any effort made by judicial or legislative mandate to obtain NICNAS provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of NICNAS provided non-public information, 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 NICNAS of any changes to U.S. laws, or to any relevant policies or procedures, that would affect FDA’s ability to honor the commitments in this document.

For FDA:

 

__________/s/______________

March 8, 2011
Date

Murray M. Lumpkin, M.D., M.Sc
Deputy Commissioner
International Programs

Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
UNITED STATES OF AMERICA

Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937

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