FDA - FSANZ Australia, Confidentiality Commitment
STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE FOOD STANDARDS AUSTRALIA NEW ZEALAND
The Food Standards Australia New Zealand (FSANZ) is authorized to disclose non-public information to United States Food and Drug Administration (USFDA), a part of the United States Department of Health and Human Services, regarding FSANZ-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
USFDA acknowledges that some of the information it receives from FSANZ may include non-public information exempt from public disclosure under the laws and regulations of Australia and New Zealand, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information.
USFDA acknowledges that this non-public information is shared in confidence, and that FSANZ considers it critical that USFDA maintain the confidentiality of the information. Public disclosure of this information by USFDA could seriously jeopardize any further scientific and regulatory interactions between FSANZ and USFDA.
FSANZ will advise USFDA of the status of the non-public information at the time that the information is shared.
USFDA has the authority to protect such non-public information provided to it in confidence by FSANZ from public disclosure.
USFDA will not publicly disclose such FSANZ-provided non-public information without:
(a) the written authorization of the owner of the information;
(b) the written authorization from the individual who is the subject of the personal privacy information; or
(c) a written statement from FSANZ that the information no longer has non-public status.
USFDA will inform FSANZ promptly of any effort made to obtain FSANZ-provided non-public information from USFDA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of FSANZ-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.
USFDA will promptly inform FSANZ of any changes to its legislation, regulations, policies or procedures that would affect USFDA’s ability to honor the commitments in this document.
The officer responsible for day-to-day operations under this confidentiality commitment is Russell Campbell Jr., Associate Director for Asia and the Pacific.
Date: April 15, 08
Murray M. Lumpkin, M.D.
International and Special Programs
Office of the Commissioner
Food and Drug Administration
Department of Health and Human Services
United States of America
5600 Fishers Lane
Rockville, Maryland 20857