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U.S. Department of Health and Human Services

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BFUNR - FDA

CONFIDENTIALITY COMMITMENT
STATEMENT OF LEGAL AUTHORITY
AND COMMITMENT FROM BUNDESMINISTERIUM FÜR UMWELT, NATURSCHUTZ UND REAKTORSICHERHEIT
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION
SHARED
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 Germany´s Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit 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 Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit possessing information concerning the safety, efficacy, or quality of a product or information concerning an investigation.

The Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit 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 Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit understands that this non-public information is shared in confidence, and that USFDA considers it critical that the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit maintain the confidentiality of the information. Public disclosure of this information by the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit could seriously jeopardize any fürther scientific and regulatory interactions between USFDA and the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit. US FDA will advise the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit of the non-public status of the information at the time that the information is shared.

Therefore the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit certifies that if:

  1. has the authority to protect the non-public information provided to the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit in confidence by the USFDA from public disclosure; 
  2. 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; 
  3. will inform USFDA within two working days of any effort made to obtain USFDA- provided non-public information from the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit 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 USFDA of any changes to German laws or the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit policies or procedures that would affect the Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit ´s ability to honor the agreements in this document.

 

______________/s/_____________                    Bonn, 4 February 2005
Signature Bundesministerium fur Umwelt, Naturschutz
und Reaktorsicherheit official

Prof Dr. Schlolttmann
_____________________________________
Printed name of Bundesministerium fur Umwelt, Naturschutz und Reaktorsicherheit official

Head of Division International Chemical Safety
_________________________________________________________________________
Title of Bundesministerium fur Umwelt, Naturschutz und Reaktorsicherheit official

Bundesministerium fur Umwelt, Naturschutz und Reaktorsicherheit
Postfach 12 06 29
5300 Bonn I
Germany

Telephone and facsimile: +49-228-305-2740 / Fax: -305 -3524