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U.S. Department of Health and Human Services

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FDA - NZFSA

CONFIDENTIALITY COMMITMENT
STATEMENT OF LEGAL AUTHORITY
AND COMMITMENT
FROM
THE U. S. FOOD AND DRUG ADMINISTRATION (USFDA),
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE NEW ZEALAND FOOD SAFETY AUTHORITY (NZFSA)

The New Zealand Food Safety Authority (NZFSA) is authorized to disclose non-public information to the U.S. Food and Drug Administration (USFDA) regarding NZFSA regulated products as part of cooperative law enforcement or cooperative regulatory activities.

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

Therefore, USFDA certifies that it:

  1. has the authority to protect from public disclosure the non-public information provided to USFDA in confidence by NZFSA; 
  2. will not publicly disclose the NZFSA-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 NZFSA that the information no longer has non-public status; 
  3. will inform NZFSA within two working days of any effort made to obtain NZFSA- provided non-public information from USFDA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of NZFSA-provided non-public information, USFDA will take all 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 NZFSA of any changes to United States laws, USFDA policies, or USFDA procedures that would affect USFDA’s ability to honor the commitments in this document.

 

____________/s/____________                         Date: Oct 28 2004
Lester M. Crawford, D.V.M., Ph.D

Lester M. Crawford
___________________________________
(Print name)

Acting Commissioner of Food and Drugs
United States Food and Drug Administration
United States Department of Health and Human Services

HF-1
5600 Fishers Lane
Rockville , Maryland
USA-20857

Telephone: +1 301 827 2410
Facsimile: +1 301 827 3100