STATEMENT OF LEGAL AUTHORITY
AND COMMITMENT FROM
BELGIUM'S SCIENTIFIC INSTITUTE OF PUBLIC HEALTH
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION
BY THE U. S. FOOD AND DRUG ADMINISTRATION (USFDA),
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
The United States Food and Drug Administration (USFDA), a part of the United States Department of Health and Human Services, is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to the Scientific Institute of Public Health regarding USFDA regulated products as part of cooperative law enforcement or cooperative regulatory activities. This sharing is in the interest of public health, as it relates to the monitoring of nonclinical laboratories and nonclinical laboratory studies, by reason of the Scientific Institute of Public Health possessing information concerning the safety, efficacy, or quality of a product or information concerning an investigation.
The Scientific Institute of Public Health understands that some of the information it receives from USFDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. The Scientific Institute of Public Health understands that this non-public information is shared in confidence, and that USFDA considers it critical that the Scientific Institute of Public Health - Louis Pasteur maintain the confidentiality of the information. Public disclosure of this information by the Scientific Institute of Public Health could seriously jeopardize any further scientific and regulatory interactions between USFDA and the Scientific Institute of Public Health. US FDA will advise the Scientific Institute of Public Health of the non-public status of the information at the time that the information is shared.
Therefore, the Scientific Institute of Public Health certifies that it:
- has the authority to protect the non-public information provided to the Scientific Institute of Public Health in confidence by the USFDA from public disclosure;
- will not publicly disclose the USFDA-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 USFDA that the information no longer has non-public status;
- will inform USFDA within two working days of any effort made to obtain USFDA- provided non-public information from the Scientific Institute of Public Health by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, the Scientific Institute of Public Health 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
- will promptly inform USFDA of any changes to Belgian laws or the Scientific institute of Public Health's policies or procedures that would affect the Scientific Institute of Public Health's ability to honor the agreements in this document.
___________________/s/_______________________ Date: 15/12/2004
Signature of Scientific Institute of Public Health official
Dr. GODFRIED THIERS
Printed name of Scientific Institute of Public Health official
Title of foreign government agency official
Scientific Institute of Public Health
Juliette Wystman Street, 14
1050 Brussels, Belgium
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