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  1. Confidentiality Commitments

The New Zealand Ministry of Health-FDA

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

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

The Ministry 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 Sates of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information.

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

Therefore, the Ministry confirms that it:

  1. has the authority to protect from public disclosure such non-public information provided to the Ministry in confidence by FDA;
  2. 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 ofthe 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 the Ministry. If suchjudicial or legislative mandate orders disclosure of FDA-provided non-public information, the Ministry will take all appropriate legal measures 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 New Zealand's laws, or to any relevant policies or procedures, that would affect the Ministry'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 the Ministry on 30 days written notice to FDA except that all non-public information received by the Ministry from FDA will continue to be covered by this Arrangement

Signed on behalf of the Ministry

 

_____________/s/_____________                 September 30, 2011
Kevin Woods                                                                    Date
Director-General

 

The New Zealand Ministry of Health
No 1-3 The Terrace
Thorndon
Wellington 6011
NEW ZEALAND

 

Telephone: 0064 4 816 2550
Facsimile: 0064 4 496 2340

 
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