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U.S. Department of Health and Human Services

International Programs

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FDA-The Ministry

CONFIDENTIALITY ARRANGEMENT
FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
TO
THE NEW ZEALAND MINISTRY OF HEALTH
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED

The New Zealand Ministry of Health (the Ministry) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding the Ministry-regulated Tobacco products as part of cooperative law enforcement or cooperative regulatory activities.

FDA understands that some of the information it receives from the Ministry may include non-public information exempt from public disclosure under the laws and regulations of New Zealand, 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 the Ministry 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 FDA and the Ministry. The Ministry will advise FDA of the non-public status of the information at the time that the information is shared.

Therefore, FDA confirms that it:

  1. has the authority to protect from public disclosure such non-public information provided to FDA in confidence by the Ministry;
  2. will not publicly disclose such the Ministry-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 the Ministry that the information no longer has non-public status;
  3. will inform the Ministry promptly of any effort made by judicial or legislative mandate to obtain the Ministry-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of the Ministry-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 the Ministry 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.

This Arrangement will take effect when signed by the last Participant. It will continue to be in effect until terminated by FDA on 30 days written notice to the Ministry except that all non-public information received by FDA from the Ministry will continue to be covered by this Arrangement.

 

Signed of behalf of FDA

 

_____________/s/_____________                                                 September 20, 2011
Murray M. Lumpkin, M.D., M.Sc.                                                         Date
Deputy Commissioner
International Programs

 

Address: 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